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Sample records for oral contraceptive tablets

  1. [Oral contraception].

    PubMed

    Guillat, J C

    1980-04-20

    OC (oral contraception) includes the combined and sequential methods, postcoital and progestin only contraception, mini pills, and macro pills. The mechanism of action of OC modifies the hypothalamo-hypophysary secretion, the uterine mucosa, and the cervical mucus. Effectiveness of OC is nearly 100%; prescription of OC requires a complete clinical and biological evaluation of the patient. Contraindications to OC are any form of cancer, hypertension, vascular or thrombotic antecedents, obesity, tabagism, diabetes. OC users must be checked at least every 6 months, and treatment can last, if there are no evident signs of side effects, until about age 40. The most commonly known side effects of OC are menstruation disorders, cardio- and cerebrovascular effects, hepatic and metabolic effects; there is no evidence that OC can cause carcinogenic effects, but it can increase teratogenic risk. The association of OC with such drugs as Rifampicine, anticonvulsants and/or tranquillizers, can nullify contraceptive effectiveness. PMID:6900393

  2. Oral Contraceptives and Cancer Risk

    MedlinePlus

    ... oral contraceptives are available in the United States today? How could oral contraceptives influence cancer risk? How ... oral contraceptives are available in the United States today? Two types of oral contraceptives (birth control pills) ...

  3. Oral Contraceptive Pill and PCOS

    MedlinePlus

    ... Health Gynecology Medical Conditions Nutrition & Fitness Emotional Health PCOS: The Oral Contraceptive Pill Posted under Health Guides . ... of oral contraceptive pills for young women with PCOS? Regular and Lighter Periods: Oral contraceptive pills can ...

  4. History of oral contraception.

    PubMed

    Dhont, Marc

    2010-12-01

    On the 50th birthday of the pill, it is appropriate to recall the milestones which have led to its development and evolution during the last five decades. The main contraceptive effect of the pill being inhibition of ovulation, it may be called a small miracle that this drug was developed long before the complex regulation of ovulation and the menstrual cycle was elucidated. Another stumbling block on its way was the hostile climate with regard to contraception that prevailed at the time. Animal experiments on the effect of sex steroids on ovulation, and the synthesis of sex steroids and orally active analogues were the necessary preliminaries. We owe the development of oral contraceptives to a handful of persons: two determined feminists, Margaret Sanger and Katherine McCormick; a biologist, Gregory Pincus; and a gynaecologist, John Rock. Soon after the introduction of the first pills, some nasty and life-threatening side effects emerged, which were due to the high doses of sex steroids. This led to the development of new preparations with reduced oestrogen content, progestins with more specific action, and alternative administration routes. Almost every decade we have witnessed a breakthrough in oral contraception. Social and moral objections to birth control have gradually disappeared and, notwithstanding some pill scares, oral contraceptives are now one of the most used methods of contraception. Finally, all's well that ends well: recent reports have substantiated the multiple noncontraceptive health benefits paving the way for a bright future for this 50-year-old product. PMID:21091163

  5. History of oral contraception.

    PubMed

    Dhont, Marc

    2010-12-01

    On the 50th birthday of the pill, it is appropriate to recall the milestones which have led to its development and evolution during the last five decades. The main contraceptive effect of the pill being inhibition of ovulation, it may be called a small miracle that this drug was developed long before the complex regulation of ovulation and the menstrual cycle was elucidated. Another stumbling block on its way was the hostile climate with regard to contraception that prevailed at the time. Animal experiments on the effect of sex steroids on ovulation, and the synthesis of sex steroids and orally active analogues were the necessary preliminaries. We owe the development of oral contraceptives to a handful of persons: two determined feminists, Margaret Sanger and Katherine McCormick; a biologist, Gregory Pincus; and a gynaecologist, John Rock. Soon after the introduction of the first pills, some nasty and life-threatening side effects emerged, which were due to the high doses of sex steroids. This led to the development of new preparations with reduced oestrogen content, progestins with more specific action, and alternative administration routes. Almost every decade we have witnessed a breakthrough in oral contraception. Social and moral objections to birth control have gradually disappeared and, notwithstanding some pill scares, oral contraceptives are now one of the most used methods of contraception. Finally, all's well that ends well: recent reports have substantiated the multiple noncontraceptive health benefits paving the way for a bright future for this 50-year-old product.

  6. Oral contraceptives and dysmenorrhea.

    PubMed

    Cholst, I N; Carlon, A T

    1987-01-01

    This artical examines the risks and benefits associated with use of the oral contraceptive pill (OCP) by adolescents and the various alternatives and methods of prescribing OCPs. Any adolescent who is either sexually active or contemplating sexual activity should be offered a contraceptive method that is appropriate to her individual needs. The contraceptive needs to be highly effective, safe and within the means and desires of the adolescent. For the majority of teenagers, the contraceptive of choice will be the OCP. The IUD should almost never be prescribed to the adolescent. Most OCPs marketed today are combination pills containing both an estrogen and a progestin in each pill. A variety of contraceptive actions combines to create a contraceptive method that is 99.3-99.9% effective. OCPs provide some protection against the development of pelvic inflammatory disease (PID). Oral contraceptives also decrease the incidence of anemia by decreasing the amount and duration of menstrual flow. Ovarian cysts do not form in the ovaries of the OCP user. On the other hand, a serious risk of the use of OCPs is the increased danger of thromboembolic events including deep venous thrombosis, pulmonary embolus, and myocardial infarction. The increased risk of myocardial infarction in OCP users is additive with other risk factors including hypertension, hypercholesterolemia, cigarette smoking, obesity, diabetes mellitus, and age. OCP use seems to provide some protection against development of endometrial or ovarian cancer. Oral contraceptives are associated with the development of benign hepatocellular adenomas. A variety of metabolic and hormonal alterations also occur in pill users. Most appropriate for the adolescent is a formulation containing a low dose of estrogen because of the decreased risk of thromboembolic complications. Dysmenorrhea effects more than 1/2 of female adolescents, and can best be treated with ibuprofen.

  7. Estrogen and Progestin (Oral Contraceptives)

    MedlinePlus

    ... of serious side effects from oral contraceptives, including heart attacks, blood clots, and strokes. This risk is higher for women over 35 years of age and heavy smokers (15 or more cigarettes per day). If you take oral contraceptives, you should not smoke.

  8. The future of oral contraceptives: research priorities.

    PubMed

    Spitzer, W O

    1996-04-01

    The author believes that currently-marketed oral contraceptives are among the most safe and effective methods of fertility control. The data on oral contraceptives and myocardial infarction are consistent with a protective, death-sparing role for third-generation oral contraceptives. Moreover, the benefit-risk profile of second-generation pills is evaluated and approved by national and international regulatory bodies. Researchers, however, should still keep working to try to provide women with the best possible contraceptive methods. Specifically, the search for safer oral contraceptives should continue, clinical research should address unanswered questions about better oral contraceptive fits for women with distinctive clinical requirements, more research is needed into the benefits of oral contraceptive use, epidemiologists and biostatisticians must develop and improve methods which permit disentangling the effect from bias in observational research, and World Health Organization and Transnational European Project data on oral contraceptives and myocardial infarction need to be meta-analyzed.

  9. Progestin-Only Oral Contraceptives

    MedlinePlus

    ... on another day, use a backup method of birth control (such as a condom and/or a spermicide) for the next 48 hours. If you have had a miscarriage or an abortion, you can start taking progestin-only oral contraceptives ...

  10. Alternatives to oral regimens of contraception.

    PubMed

    Simon, M; Shulman, L P

    2007-06-01

    Alternatives to oral contraceptives are an integral part of contraception used worldwide. In order to empower women to correctly use contraception for as long as they choose not to become pregnant, healthcare practitioners and their patients must be educated about these methods as well as the full spectrum of available birth control options. Effective counseling is a key factor in helping a woman effectively chose a method that is appropriate for her. In order for contraceptive counseling to be effective, information should be accurate and provided in an unbiased manner. This review will help provide healthcare practitioners with current information regarding the use of nonoral contraceptives so as to facilitate the counseling of women and allow them to make informed and appropriate contraceptive decisions.

  11. [Selected aspects of oral contraception side effects].

    PubMed

    Wolski, Hubert

    2014-12-01

    The first hormonal pill was approved in the 60s of the twentieth century Since that time, oral contraception has been used worldwide by dozens of women due to its high availability as well as relative ease and safety of taking. The main side effects of oral contraception include elevated risk for venous thromboembolism (VTE). Estrogens increase the probability of VTE development, depending on the dose in medication, and third-generation progestins increase the risk of VTE development more than older-generation progestins. Also, the coexistence of hereditary thrombophilia increases the risk of VTE development in women using oral contraceptives. Other side effects include changes in the carbohydrate and lipid economy Progestins in oral contraceptives decrease HDL cholesterol levels but increase LDL cholesterol and total cholesterol levels. Additionally estrogens are a recognized mitogenic factor for the epithelium of the mammary gland, acting proliferative on the glandular tissue and in the same way influence on the increased risk of breast cancer development. Patients sometimes complain about some subjective side symptoms such as headache, mood changes, nausea, back pain, breast pain and swelling, as well as decreased libido. Some patients discontinue oral contraception due to fear of side effects or temporary ailments before con- sulting their doctor what may result in unintended pregnancy The aim of the following paper was to present most frequent side effects of oral contraception, ways of their moni- toring and diagnosis. PMID:25669065

  12. Oral contraceptives and birth defects.

    PubMed

    Smithells, R W

    1981-06-01

    Although OCs (oral contraceptives) are not designed to be taken during pregnancy, in Europe and the U.S. they are taken by 2-5% of women in early pregnancy and by 1/4-1/3 of women 3-4 months prior to conception. The effects of OCs on folic acid and other vitamin metabolism are well known and provide a theoretical basis for possible teratogenicity, even when stopped prior to conception. Both hormone support therapy for threatened abortions and hormonal pregnancy tests have been abandoned in recent years, the first because it proved inefficacious, the second because there are better alternatives available. In neither of these cases were sex hormones shown to be teratogenic. Most cohort (prospective) and many case-control (retrospective) studies have shown no association between OC use and birth defects. Case-control methodology can be criticized because of recall bias and because of the difficulty of choosing entirely matched controls. Several studies have shown OC users to have characteristics slightly different from the general population, e.g., they are younger, more often unmarried, and are more likely to smoke during pregnancy. Any of these characteristics might influence the occurrence of teratogenicity. It is impossible to prove that OCs constitute a low-level teratogen. The author considers them nonteratogenic.

  13. Oral contraceptives in polycystic ovary syndrome.

    PubMed

    Helvaci, N; Yildiz, B O

    2014-09-01

    Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of women of reproductive age and combined oral contraceptives (OCs) are often the first-line treatment of the syndrome by improving hyperandrogenism and regulating menstrual cycles. Oral contraceptives have some cardiovascular and metabolic effects that varies among different formulations depending upon the dose and type of the both estrogen and progestin components. These cardiometabolic effects of OCs raise some concerns about their long-term use in PCOS, but available data suggest that the benefits outweigh the risks. More studies are needed to clarify the safety of long-term use of OCs in PCOS.

  14. The metabolic impact of oral contraceptives.

    PubMed

    Krauss, R M; Burkman, R T

    1992-10-01

    The hormonal components of oral contraceptives exert major effects on plasma lipoprotein metabolism. Estrogens may increase production of plasma triglycerides, leading to increased levels of very low-density lipoproteins, but they may also reduce levels of cholesterol-enriched and potentially atherogenic intermediate- and low-density lipoproteins. Furthermore, estrogens increase levels of high-density lipoproteins (HDLs), particularly the HDL2 subspecies, an effect linked to reduced mortality rates from cardiovascular disease in postmenopausal women receiving hormone replacement therapy. All combination oral contraceptives in use in the United States tend to raise levels of plasma triglycerides, low-density lipoprotein, and HDL3 to varying degrees. In contrast, changes in HDL and HDL2 reflect the combined effects of estrogen dose and relative androgenicity of the progestin component. Although in general, the lipoprotein changes are greater in magnitude with higher dose oral contraceptive preparations, they can be significant in lower dose preparations as well. Oral contraceptives also affect carbohydrate metabolism, primarily through the activity of progestin. Studies have demonstrated insulin resistance, rises in plasma insulin, and relative glucose intolerance by means of curve analysis of glucose tolerance tests. These effects are far less pronounced with lower dose preparations and with formulations using the newer progestins.

  15. An Oral Contraceptive Drug Interaction Study

    ERIC Educational Resources Information Center

    Bradstreet, Thomas E.; Panebianco, Deborah L.

    2004-01-01

    This article focuses on a two treatment, two period, two treatment sequence crossover drug interaction study of a new drug and a standard oral contraceptive therapy. Both normal theory and distribution-free statistical analyses are provided along with a notable amount of graphical insight into the dataset. For one of the variables, the decision on…

  16. Oral contraceptives in the etiology of isolated hypospadias.

    PubMed

    Källén, B; Mastroiacovo, P; Lancaster, P A; Mutchinick, O; Kringelbach, M; Martínez-Frías, M L; Robert, E; Castilla, E E

    1991-08-01

    With the objective of identifying whether hypospadias in infants is associated with maternal use of oral contraceptives before pregnancy or in early pregnancy, 846 case-control pairs were collected from eight different malformation monitoring programs around the world and mothers were interviewed using structured questionnaires administered after the birth of the infants. There was no difference in the preconceptional use of oral contraceptives between cases and controls, neither with respect to the number of years of oral contraceptive usage nor the time between stopping oral contraceptives and the present pregnancy. To this material was added data on oral contraceptive usage in early pregnancy from two other sources: an ongoing case-control study in Spain (725 infants with hypospadias) and a population-based study in Sweden (631 infants with hypospadias). There was no statistically significant difference in oral contraceptive exposure in early pregnancy between cases and controls. There is no demonstrable association between oral contraceptive use and infant hypospadias.

  17. [Emergency oral contraception policy: the Peruvian experience].

    PubMed

    Pretell-Zárate, Eduardo A

    2013-07-01

    Emergency oral contraception is part of the sexual and reproductive rights of women. In 2001, this health policy was incorporated into the Rules of the National Family Planning Program of the Ministry of Health, primarily to prevent unwanted pregnancy and its serious consequences, induced abortion and the high associated maternal mortality rate, which are major public health problems. Scientific research has confirmed that the main mechanism of action of levonorgestrel, component of emergency oral contraception (EOC) is to inhibit or delay ovulation, preventing fertilization of the egg; additionally, it increases the thickening of the cervical mucus, making the sperm migration more difficult. No study has found endometrial abnormalities that may interfere with the implantation of the fertilized egg or embryo development of an implanted egg. However, despite the support of medical science and legal backing, the EOC is available only to users with economic resources, but its use has not been fully implemented in public sector services, due to obstacles created by groups opposed to contraception under claim of an alleged abortive effect that has already been ruled out scientifically. This article describes the administrative experience and legal confrontations between groups of power that prevent the proper implementation of an emergency contraception policy in Peru.

  18. Combined oral contraceptives: acceptability and effective use.

    PubMed

    Kubba, A; Guillebaud, J

    1993-01-01

    With over 60 million users of 'the pill' worldwide, safety and efficacy remain the two most relevant issues to both the consumer and the research scientist. Safety of combined oral contraception (COC) has advanced appreciably. Lessons learned from cohort and case-control studies have been applied to the practical management of oral contraception use, based on screening, selection and regular monitoring of users. Most health risks of COCs appear to be dependent on the dose and potency (or biological impact) of the constituent steroids. While many of the non-contraceptive benefits of COCs are maintained when modern low dose preparations are used, most, if not all, of the adverse effects have been reduced progressively. Moreover the range of modern hormonal contraceptives has widened with the introduction of a new generation of 'selective' progestogens (Desogestrel, Norgestimate and Gestodene), which have minimal androgenicity. User failure of COCs is still high in many countries. The cause is a combination of poor compliance and anxiety about perceived adverse effects. Compliance can be enhanced by improving the quality of instruction in pill use. Fears of adverse effects of COCs may be allayed through education of users and providers, and sympathetic management of side effects.

  19. [Contraceptives].

    PubMed

    Jimenez Vargas, J

    1974-01-01

    Contraceptives are defined as any means of avoiding pregnancy and not as therapy. Importance is generally placed on the mechanism of action and efficiency when selection is made. Anovulatory and postcoital contraceptives (morning-after pill) are said to be linked with abortion, as are all contraceptives since a transition from using contraceptives to having abortions has often been noted in countries allowing the latter. The author in fact ascribes a general depreciation for human life to increased use of contraceptives. Detailed explanations of the female reproductive cycle and the effects of oral contraceptives on it and on the woman in general are included. Fetal development is also traced.

  20. Communication about Contraception and Knowledge of Oral Contraceptives amongst Norwegian High School Students.

    ERIC Educational Resources Information Center

    Hansen, Thomas; Skjeldestad, Finn Egil

    2003-01-01

    Examines communication about contraception and specific knowledge of oral contraceptives (OCs) in a sample of Norwegian high school students. More females than males discussed contraception at least monthly. Discussions were predominantly held with peers and not adults. Females were far more knowledgeable about OCs than males. The most significant…

  1. The Current Status of Oral Contraceptives: Progress and Recent Innovations.

    PubMed

    Golobof, Alexandra; Kiley, Jessica

    2016-05-01

    Millions of women in the United States and abroad use oral contraceptive pills. These popular contraceptives are the most common reversible birth control method in the United States, and a wide variety of pills are available for prescription. Oral contraceptives provide safe and effective protection against pregnancy and offer several noncontraceptive benefits. Over the years, advances in the laboratory and knowledge gained through epidemiologic data promoted the development of new contraceptive preparations. Generations of oral contraceptives emerged over time, containing lower doses of estrogens and new and novel progestins. The current review discusses the clinical characteristics of oral contraceptives, with emphasis on basic pharmacology and the evolution of various contraceptive formulations and regimens. PMID:26960906

  2. Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects

    ClinicalTrials.gov

    2012-02-17

    Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction; Laymen Terminology Level of Oral Contraceptive in Blood, Oral Contraceptive, Rheumatoid Arthritis, Drug -Drug Interaction

  3. [Inefficacy of oral contraception during use of minocycline].

    PubMed

    de Groot, A C; Eshuis, H; Stricker, B H

    1990-06-23

    A healthy woman aged 21 years who used the oral contraceptive Trigynon became pregnant while being treated with Minocin (minocycline; 100 mg per day) for acne conglobata. While the risk of use of antibiotics such as this one reducing the efficacy of oral contraceptives is small, patients should nevertheless be informed that the risk exists.

  4. Affective and Physical Changes Associated with Oral Contraceptive Use.

    ERIC Educational Resources Information Center

    Wiener, Alane L.; And Others

    Although investigations of the physiological effects of oral contraceptives suggest that affective changes may accompany their use, empirical documentation of these effects has not been consistent. This study examined physiological and affective changes accompanying use of a low-dosage oral contraceptive while controlling for possible expectancy…

  5. Human cervical mucus. V. Oral contraceptives and mucus rheologic properties.

    PubMed

    Wolf, D P; Blasco, L; Khan, M A; Litt, M

    1979-08-01

    Mucus viscoelasticity on individual samples obtained from patients using combination oral contraceptives was quantitated by microrheometry. These results, in conjunction with mucus chemical characterization, indicate that combination oral contraceptive use eliminates the cyclic variations in mucus chemical, physicochemical, and rheologic properties associated with the ovulatory menstrual cycle. A correlation was demonstrated between the mucus elastic modulus and mucus nondialyzable dry weight, and the mucins produced during oral contraceptive therapy were shown to be similar to those recovered from ovulatory donors. Differences in mucus properties were noted when donors using estrogenic contraceptives were contrasted with those using androgenic contraceptives. On the basis of established relationships between sperm penetrability and mucus solids content, it was concluded that the use of contraceptives, as examined in this study, provided a secondary degree of fertility control at the cervical level.

  6. Relative risks of oral contraceptive usage.

    PubMed

    Kirkham, C; Reid, R L

    1987-04-01

    Women seeking safe, reliable contraception must weigh the risks associated with such methods with their benefits. To make this assessment process more meaningful, the authors have prepared a chart that sets forth the risks of oral contraceptive (OC) use by different user factors (e.g., age, cigarette smoking) in proportion to the risks inherent in a variety of sporting activities and types of accidents. Mortality rates reported for OC use include those due to the method and those due to pregnancies resulting from method failure. Scrutiny of this chart reveals that the risk of death associated with swimming, boating, and automobile use exceeds the risk of death for nonsmokers who use OCs up to 34 years of age (1.6 deaths/100,000 population). OC use by women 15-24 years of age who smoke carries a lower mortality risk (3.0/1000) than scuba diving or falling, while OC users 25-34 years old who smoke are more likely to die as a result of homicide, suicide, or automobile accidents than they are as a result of their use of OCs (mortality rate, 10.2/1000). On the other hand, OC use by smokers 35-44 years of age is associated with a mortality rate of 84.5/1000, which is a higher risk than that associated with the sport of hang-gliding.

  7. Oral contraceptives, human papillomavirus and cervical cancer.

    PubMed

    La Vecchia, Carlo; Boccia, Stefania

    2014-03-01

    Oncogenic human papillomavirus is the key determinant of cervical cancer, but other risk factors interact with it to define individual risk. Among these, there is oral contraceptive (OC) use. A quantitative review of the link between OCs and cervical cancer was performed. Long-term (>5 year) current or recent OC use has been related to an about two-fold excess risk of cervical cancer. Such an excess risk, however, levels off after stopping use, and approaches unity 10 or more years after stopping. The public health implications of OC use for cervical cancer are limited. In any case, such implications are greater in middle-income and low-income countries, as well as in central and eastern Europe and Latin America, where cervical cancer screening and control remain inadequate.

  8. Pharmacological profile of estrogens in oral contraception.

    PubMed

    Bitzer, J

    2011-06-01

    The synthetic estrogen ethinylestradiol (EE)given by mouth is stable and yields satisfactory results in terms of ovulation inhibition and effects on the endometrium. It increases however the risk especially for venous thrombotic events and to a lesser degree also arterial thrombosis. Therefore research focused on diminuition of the EE dosage and the development of a different estrogen component in oral contraceptives, specifically an estrogen occurring during physiological processes in the female body. Two estrogens emerge: 17ß Estradiol is the most potent natural estrogen and it is the major estrogen secreted by the ovaries. Estetrol is a human sex steroid (15 alpha hydroxyestriol) which is only produced during pregnancy by the fetal liver. The pharmacolokinetic and pharmacodynamic properties of these estrogens are compared to those of EE (absorption, metabolization, bioavailability etc.) and the clinical profile is described as far it is known from a limited number of studies. PMID:21654614

  9. Oral contraceptives and the prothrombin time.

    PubMed

    Pangrazzi, J; Roncaglioni, M C; Donati, M B

    1980-02-01

    Dr. De Teresa and others reported that mean prothrombin time ratio of 12 patients on long-term anticoagulation with warfarin was significantly higher when they were also taking oral contraceptives (OCs). A study of prothrombin complex activity was recently conducted in female rats treated with an estrogen-progestogen combination (lynestrenol 5 mg; mestranol 0.3 mg/kg body weight) which resulted in a 100% infertility in this species. After 1 treatment for only 1 estral cycle, OC-treated rats had a significantly longer Normotest clotting time (37.7+ or-0.5 sec) than control rats (31.0+or-0.4); the difference was even more notable after 10 cycles. Although this finding has not been reported in women on OCs, it may be that the estrogen-induced "lability" of the prothrombin complex occurs in humans only in special conditions, such as anticoagulation. Alternatively, liver dysfunction occurring among women on OCs may be responsible for reduced metabolism of warfarin, contributing to the effectiveness of the anticoagulation. Further pharmacology studies should be done to clarify the interaction between OCs and oral anticoagulants.

  10. [Social psychological and sexological aspects of oral contraception (author's transl)].

    PubMed

    Van Keep, P A

    1976-01-01

    An inventory is made on the hindrances to the acceptance of contraception in general and oral contraception in particular. They are grouped as hindrances related to the social and psychological significance of "making children", hindrances related to the social and psychological significance of "having children" hindrances, related to the method of oral contraception itself, to be divided in social hindrances, psychological hindrances and medical hindrances and finally hindrances related to the provision of the pill to the individual user. Each of these is amply discussed, the author expresses the hope that by identification of these hindrances, lessons may be learned for the future, when other methods of contreception become available.

  11. [Oral contraception and induced depressive states].

    PubMed

    Richou, H; Hug, R

    1974-06-01

    Cultural, psychological, and biochemical explanations for depression in users of oral contraceptives are discussed. The suppression of taboos against sexuality cannot be expected to bring about instant psychological adjustment, as shown by the large numbers of women who are afraid to take the pill or who develop psychosomatic disorders and depression. Incidence of depression as reported in the literature ranges from 5% to 45%. Some authors attribute psychogenic causes for depression associated with the pill, such as temporary castration, instant sexual liberation, or womens' undeniable maternal instinct. Others present evidence for biochemical causes of depression. General explanations for pill-related depression include imbalance of hypothalamic amines and consequently of releasing factor, prolactin-inhibiting factor, decreased brain serotonin due to inhibition of tryptophan hydroxylase by progestagens, or diminished brain biogenic amines because of lowered pyridoxal levels. From clinical work with neuroleptic drugs it is known that drugs, stress, or anxiety can disturb the biochemical balance and result in amenorrhea. High progestin levels may be responsible for premenstrual anxiety and headaches.

  12. [Individualization of low-dose oral contraceptives. Pharmacological principles and practical indications for oral contraceptives].

    PubMed

    Cianci, A; De Leo, V

    2007-08-01

    The contraceptive pill has been a revolution of the last 40 years. In Italy, however, it is much less widely used than in other countries. Explanations for this phenomenon range from religious implications and customs to misinformation and word-of-mouth communication of negative experiences. The oral contraceptive pill is often used to correct menstrual disorders, leading to poor results and side-effects. Recent advances in oral contraception have led to a substantial reduction in doses and side-effects. Low-dose pills contain minimal doses of progesterones and estrogens and ensure good control of the menstrual cycle. Although reduction of ethinyl estradiol (EE) concentrations has reduced the incidence of negative systemic side effects such as water retention, edema and swollen breasts, the low estrogen dose may be associated with spotting and hypomenorrhea or amenorrhea in the long term, as well as dyspareunia due to reduced vaginal trophism, which may induce women to suspend use of the drug. It is also true that only one type of estrogen is used in the pill, albeit at different doses, whereas the progesterone may differ and in many cases is the cause of common side-effects. The choice of progesterone therefore involves not only its effect on the endometrium in synergy with estrogen, but also possible residual androgenic activity which may have negative metabolic repercussions. Indeed, addition of a progesterone, especially androgen-derived, attenuates the positive metabolic effects of estrogen. Two new monophasic oral contraceptives were recently released. They contain 30 microg (Yasmin) or 20 muicrog (Yasminelle) EE and a new progesterone, drospirenone, derived from spirolactone, which has antiandrogenic and antimineralcorticoid activity similar to endogenous progesterone. Like progesterone, the drospirenone molecule is an aldosterone antagonist and has a natriuretic effect that opposes the sodium retention effect of EE. It may, therefore, help to prevent the

  13. Pharmacokinetic and pharmacodynamic drug interactions between antiretrovirals and oral contraceptives.

    PubMed

    Tittle, Victoria; Bull, Lauren; Boffito, Marta; Nwokolo, Nneka

    2015-01-01

    More than 50 % of women living with HIV in low- and middle-income countries are of reproductive age, but there are limitations to the administration of oral contraception for HIV-infected women receiving antiretroviral therapy due to drug-drug interactions caused by metabolism via the cytochrome P450 isoenzymes and glucuronidation. However, with the development of newer antiretrovirals that use alternative metabolic pathways, options for contraception in HIV-positive women are increasing. This paper aims to review the literature on the pharmacokinetics and pharmacodynamics of oral hormonal contraceptives when given with antiretroviral agents, including those currently used in developed countries, older ones that might still be used in salvage regimens, or those used in resource-limited settings, as well as newer drugs. Nucleos(t)ide reverse transcriptase inhibitors (NRTIs), the usual backbone to most combined antiretroviral treatments (cARTs) are characterised by a low potential for drug-drug interactions with oral contraceptives. On the other hand non-NRTIs (NNRTIs) and protease inhibitors (PIs) may interact with oral contraceptives. Of the NNRTIs, efavirenz and nevirapine have been demonstrated to cause drug-drug interactions; however, etravirine and rilpivirine appear safe to use without dose adjustment. PIs boosted with ritonavir are not recommended to be used with oral contraceptives, with the exception of boosted atazanavir which should be used with doses of at least 35 µg of estrogen. Maraviroc, an entry inhibitor, is safe for co-administration with oral contraceptives, as are the integrase inhibitors (INIs) raltegravir and dolutegravir. However, the INI elvitegravir, which is given in combination with cobicistat, requires a dose of estrogen of at least 30 µg. Despite the growing evidence in this field, data are still lacking in terms of large cohort studies, randomised trials and correlations to real clinical outcomes, such as pregnancy rates, in women

  14. Contraception.

    PubMed

    Lane, C; Barnes, A B

    1981-03-01

    The number of women using contraception is increasing. There are today several methods of contraception available. Behavioral methods of contraception include coitus interruptus, not ideal for psychological reasons, the rhythm method, and the cervical mucus method; they all involve periodic sexual abstinence and need extended patient education. Barrier methods include the condom, the vaginal diaphragm, the cervical cap, and all types of spermicidal agents used locally; barrier contraception can be 97% effective when properly used. Effectiveness of the IUD is 90-99%; many women experience excessive bleeding and/or expulsion of the device. IUDs are not indicated for women with vaginal infections and must be removed if pregnancy occurrs. IUDs are indicated in multiparous, healthy women. Oral contraception is the most effective way to control fertility despite the well documented side effects. Contraceptive pills contain different doses of estrogen and progesterone, and must be prescribed only after careful medical examination. Postcoital contraception can be obtained either with ethinyl estradiol and norgestrel or with diethylstilbestrol; side effects are numerous. In 1976, sexual sterilization was the 3rd most frequent surgical procedure in the U.S. The procedure must be considered a permanent one despite the increasing number of reversal successes; psychological side effects are possible but rare. Induced abortion is used as contraception and is safest when performed during the earlier stages of pregnancy. Risk of maternal death is about the same as for delivery, or 12/100,100. Methods of abortion vary according to the length of gestation. It has been suggested that barrier methods of birth control and using abortion for failures is currently the safest approach to contraception. The choice of the best contraceptive method must be made by a doctor in accordance with the clinical history and the life style of the patient, and especially taking into consideration age

  15. Combined oral contraceptives: do we know all of their effects?

    PubMed

    Hannaford, P C

    1995-06-01

    Combined oral contraceptives are undoubtedly popular. By the end of the 1980's, an estimated 63 million married women around the world were using this method of contraception. In Britain, perhaps 95% of all sexually active women have used the pill at some time before their 30th birthday. Commensurate with such widespread usage, huge amounts of money have been spent during the past 35 years investigating the health effects of this method of contraception. Since it appears that all of the potential risks and benefits have now been identified, can we divert resources from pill-related research into new areas of activity. While this proposition may be attractive to funding bodies, and other researchers competing for increasingly scarce resources, it ignores the fact that several major uncertainties remain concerning the safety of combined oral contraceptives. PMID:7554970

  16. Influence of combined oral contraceptives on the periodontal condition

    PubMed Central

    DOMINGUES, Roberta Santos; FERRAZ, Bruna Fidêncio Rahal; GREGHI, Sebastião Luiz Aguiar; de REZENDE, Maria Lúcia Rubo; PASSANEZI, Euloir; SANT'ANA, Adriana Campos Passanezi

    2012-01-01

    Most studies investigating the impact of oral contraceptives have been performed some years ago, when the level of sexual hormones was greater than the actual formulations. Objective The aim of this study was to evaluate the effects of current combined oral contraceptives (COC) on periodontal tissues, correlating the clinical parameters examined with the total duration of continuous oral contraceptive intake. Material and methods Twenty-five women (19-35 years old) taking combined oral contraceptives for at least 1 year were included in the test group. The control group was composed by 25 patients at the same age range reporting no use of hormone-based contraceptive methods. Clinical parameters investigated included pocket probing depth (PD), clinical attachment level (CAL), sulcular bleeding index (SBI) and plaque index (Pl.I). Data were statistically evaluated by unpaired t test, Pearson's correlation test and Spearman's correlation test. Results The test group showed increased PD (2.228±0.011 x 2.154±0.012; p<0.0001) and SBI (0.229±0.006 x 0.148±0.005, p<0.0001) than controls. No significant differences between groups were found in CAL (0.435±0.01 x 0.412±0.01; p=0.11). The control group showed greater Pl.I than the test group (0.206±0.007 x 0.303±0.008; p<0.0001). No correlation between the duration of oral contraceptive intake, age and periodontal parameters was observed. Conclusions These findings suggest that the use of currently available combined oral contraceptives can influence the periodontal conditions of the patients, independently of the level of plaque accumulation or total duration of medication intake, resulting in increased gingival inflammation. PMID:22666846

  17. Interactions between oral contraceptives and malaria infections in rhesus monkeys*

    PubMed Central

    Dutta, G. P.; Puri, S. K.; Kamboj, K. K.; Srivastava, S. K.; Kamboj, V. P.

    1984-01-01

    The interaction of oral contraceptives with malaria infection (Plasmodium cynomolgi B and P. coatneyi) in adult female rhesus monkeys (Macaca mulatta) was studied. The oral contraceptives (Norinyl and Ovral-28) were administered for 12 consecutive menstrual cycles, from day 5 to 25 of each cycle, at either ⅓ of the human dose of Norinyl (norethisterone 0.33 mg + ethinylestradiol 0.012 mg) or ⅙ of the human dose of Ovral-28 (norgestrel 0.083 mg + ethinylestradiol 0.008 mg). The animals were divided into three groups for each infection (control, Norinyl and Ovral-28 treated) with 10 monkeys in each group for P. cynomolgi B infection and 12 in each group for P. coatneyi infection. The animals were infected after 6 cycles of oral contraceptive administration, and the course of infection was studied during the 7th and 8th cycles. This was followed by radical cure during the 9th and 10th cycles and rechallenge in the 11th and 12th cycles. The present study showed that (1) the contraceptive-treated animals maintained a slightly increased cumulative parasite load; (2) the contraceptives did not interfere with the radical curative action of chloroquine; (3) the contraceptive-treated animals showed no significant change in the course of parasitaemia on rechallenge or in the malaria indirect fluorescent antibody levels; (4) the liver function tests were not altered significantly by the administration of contraceptives and subsequent infection; and (5) the haematological changes observed in the contraceptive-treated animals were similar to those observed in the control group. PMID:6335851

  18. Maternal folate deficiency and pregnancy wastage. IV. Effects of folic acid supplements, anticonvulsants, and oral contraceptives.

    PubMed

    Pritchard, J A; Scott, D E; Whalley, P J

    1971-02-01

    A group of studies on indigent hospital patients were conducted on the role of folate supplements, pregnancy and oral contraceptives in megaloblastic anemia. First 25 pregnant women, given 500 mg iron dextran and 30 mg folic acid for 2-3 months, had 12.4% hemoglogin at delivery, compared with 49 women given only iron who had 12.5% hemoglobin, and 49 untreated women who had 11.3% hemoglobin. Second, plasma folate levels in groups of pregnant women were compared: mean folate was 4.7 ng/ml in 82 normal women, 3.1 in 21 treated epileptics, and about 1.2 in 31 women with megaloblastic anemia. In 77 pregnancies in 43 epileptic women there were no reasons to blame low folate levels for pregnancy wastage since no abruptio placentae or bleeding occurred; and incidence of low birth weight, perinatal death, and prematurity was lower than in the general population. Third, the effect of oral contraceptives on folate levels was observed. Mean plasma folate levels were 8.1 ng/ml in 55 control women, 8.0 in 57 women using the pill, 4.7 in normal women in late pregnancy, and about 1.1 in pregnant women with megaloblastic anemia. Fourth, mean hemoglobin levels rose from 7.6 to 13.4 9m/100 ml within a few weeks in 5 women with gestational megaloblastic anemia after treatment with normal diet, without supplement, and oral contraceptives. One woman with puerperal megaloblastic anemia failed to respond to a regular diet while taking Ovulen, 6 tablets daily. The results suggest that plasma folate levels were neither lower in oral contracepting women nor did the pill prevent the increase in folate in megaloblastic anemia patients treated with diet. Thus the authors concluded that folate supplement is not needed for pill users. PMID:5549181

  19. Laryngeal Aerodynamics Associated with Oral Contraceptive Use: Preliminary Findings

    ERIC Educational Resources Information Center

    Gorham-Rowan, Mary; Fowler, Linda

    2009-01-01

    The purpose of this study was to examine possible differences in laryngeal aerodynamic measures during connected speech associated with oral contraceptive (OC) use. Eight women taking an OC, and eight others not taking an OC, participated in the study. Three trials of syllable /p[subscript alpha] /repetitions were obtained using a…

  20. Oral contraceptives and breast cancer: a national study.

    PubMed Central

    Paul, C; Skegg, D C; Spears, G F; Kaldor, J M

    1986-01-01

    In a population based case-control study 433 New Zealand women aged 25-54 with newly diagnosed breast cancer were compared with 897 women selected at random from the electoral rolls. The relative risk of breast cancer in women who had ever used oral contraceptives was 0.94 (95% confidence interval 0.70 to 1.25). The relative risk in women aged 25-34 at diagnosis was estimated to be 2.2 (95% confidence interval 0.47 to 9.9) and in older women less than 1. Analyses of risk by duration of use of oral contraceptives, age at first use, and time since first use showed no adverse effect of the pill. In particular, there was no increased risk in women who had used oral contraceptives before the age of 25 or before their first pregnancy, even for prolonged periods. Given the high prevalence of use in New Zealand, this study provides strong evidence against the hypothesis that use of oral contraceptives at young ages increases the risk of breast cancer. PMID:3094626

  1. [Current trends in the development of oral contraception].

    PubMed

    Korkhov, V V

    1985-01-01

    After a brief review of worldwide trends in the development and application of oral contraceptives (OCs), some of the results obtained in the laboratory of the Institute of Obstetrics and Gynecology in Leningrad, USSR, are presented. Experimental and clinical studies of modified synthetic steroids resulted in the development of Mezigepron, an original preparation that combines a strong contraceptive effect with a therapeutic action on certain gynecological disorders. Analysis of gestagenic and contraceptive properties of new progesterone derivatives revealed some highly active gestagenic agents, e.g., mepregenol diacetate. The Laboratory is studying the biological activity of 8-isoestradiol and other modified analogs of steroidal estrogens. These synthetic estrogens show a strong contraceptive effect with no significant uterotropic action. Such properties are important to the development of OCs which are free of any side effects. A new research program is studying the pharmacological properties of some synthetic analogs of luliberin. It is shown that short amino acid sequences produce a paradoxical antifertile effect which can be used for the development of new contraceptives. The biological activity of approximately 20 plant preparations was also studied. The greatest contraceptive activity was found in a combination of triterpenic glycosides.

  2. Adherence to a flexible extended regimen for oral hormonal contraception provided in blister packaging compared with an adherence-supporting digital tablet dispenser: historical comparison of data from two clinical studies

    PubMed Central

    Elliesen, Jörg; Trummer, Dietmar

    2016-01-01

    Background The Clyk™ digital pill dispenser helps ensure correct and consistent administration of a flexible extended regimen of the combined oral contraceptive, ethinylestradiol (EE) 20 μg/drospirenone 3 mg (EE/drospirenone ; YAZ® Flex Flex), guiding users through the intake cycle and 4-day pill break and providing visible and acoustic daily reminders when pill intake is due. A study showed that the audible alarm function of the dispenser could help reduce the number of missed pills, but it lacked an appropriate “non-dispenser” group for a meaningful assessment of the impact of the dispenser on adherence. This study indirectly assessed the overall effect of the digital dispenser on adherence by comparing data from a treatment with standard blister packaging. Materials and methods One-year adherence data were compared from two similarly designed, Phase III, open-label, randomized trials of EE/drospirenoneFlex. In study 1, women used diary cards to record adherence with EE/drospirenoneFlex dispensed in blister packs (n=640), and in study 2 the dispenser was used with the alarm activated (n=250) or deactivated (n=248) in addition to using diary cards. Results A mean (±SD) of 4.3 (±4.24) missed pills over 1 year were recorded in diary cards among women who dispensed their pills from the blister packages (study 1) compared with 1.0 (±2.4) recorded by the alarm-activated dispenser (study 2). In study 2, a mean of 1.9 (±4.2) missed pills were reported in the diaries over 1 year compared with 4.4 (±9.1) from automatic recording by the dispenser (both arms of study 2), indicating underreporting of missed pills in diary cards vs the digital dispenser. Adjusting for this rate of underreporting, an estimated mean of ten pills were missed over 1 year by women using EE/drospirenoneFlex in blister packs, or ten times more than with the digital dispenser with activated acoustic alarm. Conclusion The digital dispenser helps reduce the number of missed pills and

  3. Conscience clauses and oral contraceptives: conscientious objection or calculated obstruction?

    PubMed

    Collins, Mary K

    2006-01-01

    This article examines the ethical and legal implications of conscience clauses, which allow pharmacists to refuse to fill prescriptions for oral contraceptives due to their belief that they may constitute abortifacients. The author provides an informative background on contraception and the history of how abortion has been viewed in this country, then takes a critical look at some of the conscience laws already in existence, using a bioethical framework to examine them. She concludes by providing suggestions to reduce the negative ethical implications resulting from the enactment of conscience clauses.

  4. Pulmonary embolus, oral contraceptives, and a clinical search.

    PubMed

    Maharry, J M

    1970-01-01

    At the Presbyterian Intercommunity Hospital, Whittier, California, 120 cases of pulmonary emboli occurred from 1959 through 1968. During this time there were 124,000 admissions and more than 20,000 live births. 51 of the pulmonary embolic cases were female; 25 were of childbearing age. 10 of these showed relationship to the use of oral contraceptives. 6 of them received oral contraceptives after pulmonary embolism without apparent aggravation or recurrence of thromboembolic disease. 2 of the 10 were taking birth control pills at the time they underwent hysterectomy. A pulmonary embolus followed each operation. 2 more were taking the pills and experienced pulmonary embolism without evidence of any predisposing cause. Short case summaries of the 10 are given, all of whom are living and well. Improvement of diagnosis by lung scanning shows that pulmonary embolism is more prevalent and less serious than previously believed. As thrombotic disease is considered a recurring disorder, its relationship to steroid contraceptives has not been totally substantiated. It is concluded that a history of such disease does not necessarily contraindicate the use of oral contraceptives. Following discussion, the author quotes an FDA claim that women who take birth control pills develop thrombo-phlebitis 3 times as frequently as women who do not. He notes that, even according to these Food and Drug Administration statistics, a woman could take the pills for 30 years without as much danger from thrombo-phlebitis as from a single pregnancy.

  5. Pharmacokinetic interaction study between riociguat and the combined oral contraceptives levonorgestrel and ethinylestradiol in healthy postmenopausal women

    PubMed Central

    Unger, Sigrun; van der Mey, Dorina; Becker, Corina; Saleh, Soundos; Wensing, Georg; Mück, Wolfgang

    2016-01-01

    Abstract Female patients requiring treatment for pulmonary arterial hypertension (PAH) are advised to avoid pregnancy because of the high associated mortality rate. Oral contraception is one of the main methods of preventing pregnancy in this context, mandating pharmacokinetic and safety studies for new agents in this setting. Riociguat is a soluble guanylate cyclase stimulator approved for treatment of PAH and inoperable and persistent or recurrent chronic thromboembolic pulmonary hypertension. This single-center, randomized, nonblinded study involving healthy postmenopausal women investigated the effect of riociguat on plasma concentrations of levonorgestrel (0.15 mg) and ethinylestradiol (0.03 mg) in a combined oral contraceptive. Treatment A was a single oral tablet of levonorgestrel-ethinylestradiol. In treatment B, subjects received 2.5 mg riociguat 3 times daily for 12 days. On the eighth day, they also received a single oral tablet of levonorgestrel-ethinylestradiol. Subjects received both regimens in a crossover design. There was no change in area under the plasma concentration–time curves of levonorgestrel or ethinylestradiol or maximum concentration in plasma (Cmax) of levonorgestrel during combined administration versus levonorgestrel-ethinylestradiol alone. A 20% increase in the Cmax of ethinylestradiol was noted during coadministration; this is not anticipated to adversely impact the contraceptive efficacy or to require any dose adjustment for ethinylestradiol. Plasma concentrations and exposures of riociguat were within the expected range and were not influenced by coadministration with levonorgestrel-ethinylestradiol. Combined treatment was safe and well tolerated. In conclusion, riociguat did not change the exposure to levonorgestrel or ethinylestradiol relative to oral contraceptive administered alone. PMID:27162633

  6. Pharmacokinetic interaction study between riociguat and the combined oral contraceptives levonorgestrel and ethinylestradiol in healthy postmenopausal women.

    PubMed

    Frey, Reiner; Unger, Sigrun; van der Mey, Dorina; Becker, Corina; Saleh, Soundos; Wensing, Georg; Mück, Wolfgang

    2016-03-01

    Female patients requiring treatment for pulmonary arterial hypertension (PAH) are advised to avoid pregnancy because of the high associated mortality rate. Oral contraception is one of the main methods of preventing pregnancy in this context, mandating pharmacokinetic and safety studies for new agents in this setting. Riociguat is a soluble guanylate cyclase stimulator approved for treatment of PAH and inoperable and persistent or recurrent chronic thromboembolic pulmonary hypertension. This single-center, randomized, nonblinded study involving healthy postmenopausal women investigated the effect of riociguat on plasma concentrations of levonorgestrel (0.15 mg) and ethinylestradiol (0.03 mg) in a combined oral contraceptive. Treatment A was a single oral tablet of levonorgestrel-ethinylestradiol. In treatment B, subjects received 2.5 mg riociguat 3 times daily for 12 days. On the eighth day, they also received a single oral tablet of levonorgestrel-ethinylestradiol. Subjects received both regimens in a crossover design. There was no change in area under the plasma concentration-time curves of levonorgestrel or ethinylestradiol or maximum concentration in plasma (C max) of levonorgestrel during combined administration versus levonorgestrel-ethinylestradiol alone. A 20% increase in the C max of ethinylestradiol was noted during coadministration; this is not anticipated to adversely impact the contraceptive efficacy or to require any dose adjustment for ethinylestradiol. Plasma concentrations and exposures of riociguat were within the expected range and were not influenced by coadministration with levonorgestrel-ethinylestradiol. Combined treatment was safe and well tolerated. In conclusion, riociguat did not change the exposure to levonorgestrel or ethinylestradiol relative to oral contraceptive administered alone.

  7. Congenital limb reduction deformities and use of oral contraceptives.

    PubMed

    Kricker, A; Elliott, J W; Forrest, J M; McCredie, J

    1986-11-01

    A study of congenital limb deficiencies in two Australian states indicated that use of an oral contraceptive during pregnancy by the mother was associated with an increased risk of limb defect in the child. The study included mothers of 155 children born with absence or reduction of the major long bones during a 12-year period from 1970 onward; 274 mothers with births of normal infants, matched for date of birth and area of residence, made up the control group. Compared with control infants, the case infants were more likely to have been conceived while the mother was using an oral contraceptive, especially when the deformity was a transverse or amputation type. It is too early in our state of knowledge of teratogenic mechanisms to exclude the possible existence of a biologic mechanism that would explain this statistical association.

  8. Oral contraceptives: effect of folate and vitamin B12 metabolism.

    PubMed Central

    Shojania, A. M.

    1982-01-01

    Women who use oral contraceptives have impaired folate metabolism as shown by slightly but significantly lower levels of folate in the serum and the erythrocytes and an increased urinary excretion of formiminoglutamic acid. The vitamin B12 level in their serum is also significantly lower than that of control groups. However, there is no evidence of tissue depletion of vitamin B12 associated with the use of oral contraceptives. The causes and clinical significance of the impairment of folate and vitamin B12 metabolism in these women is discussed in this review of the literature. Clinicians are advised to ensure that women who shop taking "the pill" because they wish to conceive have adequate folate stores before becoming pregnant. PMID:7037144

  9. A current appraisal of side effects of oral contraceptives.

    PubMed

    Evans, J H

    1976-05-01

    Oral contraception, although offering almost 100 per cent protection against pregnancy, is associated with many side effects which have resulted in much unnecessary adverse publicity. Such side effects, the majority of which are of annoying nature only, are due to the synthetic hormones used, and have resulted in many changes in formulation and in the withdrawal of several preparations. The types of preparations available are discussed and the side effects appraised from both the patient's and the physician's viewpoint.

  10. Increased capillary permeability for plasma proteins in oral contraceptive users.

    PubMed

    Tollan, A; Kvenild, K; Strand, H; Oian, P; Maltau, J M

    1992-05-01

    The transcapillary fluid balance was examined in eleven women before administration of a monophasic oral contraceptive (desogestrel 0.15 mg, ethinylestradiol 0.03 mg), and after three and six months of use. The interstitial colloid osmotic pressure was measured by the "wick" method, and the interstitial hydrostatic pressure by the "wick-in-needle" method in subcutaneous tissue on thorax and leg. During the six-month observation period, the following changes were observed: Plasma colloid osmotic pressure decreased (mean 1.8 mmHg, p = 0.047), as well as serum albumin (mean 5.1 g/l, p = 0.0006), total protein concentration (mean 2.8 g/l, p = 0.0006), hemoglobin (mean 0.5 g/dl, p = 0.014) and hematocrit (mean 1.8%, p = 0.047). Blood pressure and body weight remained unchanged, but foot volume showed a significant increase. The colloid osmotic pressure gradient (plasma-interstitium) was significantly reduced. The results indicate an increase in plasma volume in addition to an increased capillary permeability to plasma proteins during oral contraceptive use. We suggest that the observed changes in transcapillary fluid balance is caused by the estrogen component of the oral contraceptive pill.

  11. Relative bioavailability of different oral sustained release oxprenolol tablets.

    PubMed

    Leucuta, S E; Follidis, M; Capalneanu, R; Mocan, A

    1998-01-01

    The bioequivalence of oral dosage forms of oxprenolol was assessed in a triple crossover study on two groups of 12 volunteers each. Single 160 mg doses of oxprenolol hydrochloride were given after an overnight fast of either oxprenolol sustained-release tablets in a megaloporous system, a hydrophil matrix and Slow-Trasicor (Ciba-Geigy) in the first group, or floating slow-release tablets administered with food or in absence of food, and rapid release Oxprenolol (Terapia, Cluj-Napoca) tablets, in the second group. Serum oxprenolol concentrations were measured by a gas chromatographic method. Pharmacokinetic parameters which describe bioavailability and general kinetic behavior of the drug were calculated from individual serum profiles. They were subjected to statistical analysis (paired Student's t test, p < 0.05). The customary bioequivalence criterion was used: 0.8 < parameter ratio(tested/standard) < 1.2. Megaloporous tablets showed bioequivalence with the reference sustained release product Slow-Trasicor. Hydrophil tablets showed moderate sustained-release characteristics. Floating tablets showed significantly greater oxprenolol absorption when taken with food and were non-bioequivalent with floating tablets without food, as well as with the reference rapid release tablets, of oxprenolol. However, fasting tablets were bioequivalent to the Slow-Trasicor product, when taken with food. PMID:9725478

  12. The risks of oral contraceptives and estrogen replacement therapy.

    PubMed

    Coe, F L; Parks, J H

    1989-01-01

    The benefits and risks of both oral contraceptives and estrogen replacement therapy (ERT) are evaluated by summarizing briefly the results of the most evidential studies on breast, ovarian, endometrial, and hepatobiliary cancer, heart attack, stroke and venous thromboembolism. The methods used to estimate risk ratios, prospective random-allocation, double-blind trials, and retrospective case- controlled studies, are explained briefly. The ERT used today resemble sequential oral contraceptives, except that only 10-20 mcg ethinyl estradiol is taken for 25 days, and progestins are used on the last 10 days. Breast cancer risk is not different in pill users from nonusers, based on the U.K. General PRactitioner, Oxford Family Planning, Harvard nurses or U.S. SEER National Cancer Institute studies. Studies on ERT and breast cancer are mixed, but only injected estrogens raised the risks. Ovarian cancer is prevented by pill use in proportion to length of use. No studies were reported for ERT. The risk of hepatic cancer is 3.8 to 7.8 higher in pill users, but the number of cases is so rare that this should not affect prescriptions. Neither pill nor ERT raise the risk of myocardial infarction, and after premature surgical menopause, ERT lowers the risk. Based on studies done in the 1970s, oral contraceptives raise the risk of thrombotic stroke while women are taking them, from 10-13/100,000 to 41/100,000. ERT has no clear association with stroke. Similarly, orals increase the risk of venous thromboembolism, 8-fold in the Oxford Family Planning study published in 1986, although the absolute numbers are very small. ERT had no effects no risk of thromboembolism according to the lipid Research, Framingham and Nachtigall studies.

  13. The influence of oral contraceptives on the metabolism of methaqualone in man.

    PubMed

    Oram, M; Wilson, K; Burnett, D

    1982-09-01

    1 Oral contraceptives were shown to suppress the mid-cycle increase in methaqualone metabolism observed in premenopausal women not receiving oral contraceptive therapy. No women were identified in whom this suppression was not observed. 2 Combined oestrogen-progestogen contraceptives produced the effect in all nine women studied. The effect was also observed in one woman who was receiving progestogen-only contraceptives. 3 The effect of the combined contraceptives was observed within one month of the commencement of the contraceptive therapy. 4 The results emphasise the need to monitor the effect of the menstrual cycle in women not receiving oral contraceptive therapy when the effects of such therapy is studied. 5 These effects are more likely to be the consequence of an inhibition of hormonal control of hepatic metabolic activity by the synthetic steroids than they are to simple inhibition of hepatic metabolism.

  14. [Specificities of the epileptic women (oral contraceptives, pregnancy)].

    PubMed

    Dupont, Sophie

    2011-03-01

    The enzyme-inducing antiepileptic drugs such as carbamazepine, phenytoin, barbiturates, oxcarbazepine do not allow oral contraceptives. The pregnancy must be planned. Every patient in childbearing age should be informed by her practitioner. The rule is to optimize the antiepileptic treatment before the pregnancy: less drugs, less dosages. This optimization will depend on the epileptic syndrome and the nature of the treatment. Valproate of sodium should be avoided, if possible, during pregnancy. Preconceptional supplementation by folic acid should be considered. Antiepileptic drugs monitoring is required during pregnancy. Natural delivery with peridural anaesthesiology is mandatory. The breast feeding must be considered individually. PMID:21216127

  15. A case of panic disorder induced by oral contraceptive.

    PubMed

    Ushiroyama, T; Okamoto, Y; Toyoda, K; Sugimoto, O

    1992-01-01

    A 27-year-old woman experienced feelings of unreality and fear after taking an oral contraceptive in the form of birth control pills. She subsequently experienced a panic attack just after she had stopped taking the pills. This was characterized by palpitation, general fatigue, trembling of the whole body, and dyspnea. The panic disorder experienced by the patient could have been due to the drug's potentiating of the sympathoadrenal response to simple physiological stimuli, or possibly to a disorder in psychological functioning caused by an anxiotropic effect of rapid endocrinological change. PMID:1315108

  16. Mesenteric venous thrombosis associated with oral contraceptives: a case report.

    PubMed

    Milne, P Y; Thomas, R J

    1976-05-01

    Small-bowel infarction resulting from mesenteric venous thrombosis is a rare but life-threatening complication to which young women taking oral contraceptives are liable. The patient characteristically presents with an "acute abdomen" after a variable prodromal period of vague abdominal pain. The correct diagnosis can be made from the macroscopic appearance at laparotomy, provided the surgeon is alert to the condition. An accurate diagnosis is important, as anticoagulation measures must be instituted early to counter the commonly associated thromboembolic phenomena. PMID:1067070

  17. Cardiovascular disease and use of oral contraceptives. WHO Collaborative Study.

    PubMed Central

    1989-01-01

    Considerable evidence from the United Kingdom and North America has shown that oral contraceptive use is associated with an increased risk of cardiovascular disease. However, since little is known about the link between the two in other parts of the world, WHO initiated a hospital-based case-control study in three centres in Mexico, Hong Kong, and the German Democratic Republic. Both cases and controls were asked about their past and current use of contraception as well as details on a number of potential confounding factors. Three main diagnostic categories were studied: venous thromboembolism (VTE) and pulmonary embolism (PE), ischaemic heart disease (IHD), and stroke. An overall relative risk of 2.9 (95% confidence limits, 1.4-6.1) for VTE/PE was found among recent or current users of oral contraceptives. Although this elevated risk is consistent with the results of other studies, the possibility of detection bias cannot be ruled out. The small number of cases (8) of IHD identified in the course of this study greatly limited the conclusions that could be drawn for this disease. Similarly with stroke, the small number of cases limited the conclusions that could be drawn, particularly since it was not possible to distinguish between thrombotic and haemorrhagic stroke. In addition to suggesting an increased risk of VTE/PE, the study pointed out the importance of ensuring an adequate sample size based on newly-diagnosed cases, the need for a coordinating centre to monitor the study closely in each centre and to provide a central review of each case, and the necessity of more specific diagnoses for meaningful interpretation of the data. PMID:2805219

  18. [ORAL CONTRACEPTIVES AND MOOD/SEXUAL DISORDERS IN WOMEN].

    PubMed

    Sirakov, M; Tomova, E

    2015-01-01

    Oral contraceptives are used since more than 50 years and are very popular due to offering more than 99% confidence in preventing pregnancy. Over 100 million women worldwide use oral contraceptives. In the UK 27% of women between 16 and 49 y. use pills. In the United States they are about 30%, in Germany - 40%, and in The Netherlands - 60%. According to a study by B. Pehlivanov, 2008, in Bulgaria only 4% of women use OC. (1) Despite the convenience and security, in the U.S.A. 29% of women taking OC interrupt prematurely their use (2), while the percentage of adolescents appears to be higher (3) Earlier studies of the reasons for refusal of OC focus on their influence on the menstrual cycle, as well as on some physical side effects such as the appearance of hair growth, weight gain, bloating etc. They paid very little attention to their impact on mood and sexual behavior of women (4). Newer studies suggest that the side effects associated with mood and sexual behavior proved more powerful factor leading to early termination of the use of OC (5). This paper is a review of the literature and evaluation of the facts presented in studies from different countries. They found a high incidence of symptoms such as anxiety, susceptibility to stress, mood changes, incl. depression, anxiety, increased irritability and affection of sexual desire of women. (6) There are many indications that OC-users are at increased risk of suicide and mental illnesses. (9). PMID:26411194

  19. Effect of Oral and Vaginal Hormonal Contraceptives on Inflammatory Blood Biomarkers

    PubMed Central

    Divani, Afshin A.; Luo, Xianghua; Datta, Yvonne H.; Flaherty, James D.; Panoskaltsis-Mortari, Angela

    2015-01-01

    The use of combined hormonal contraceptives has been reported to increase the level of C-reactive protein (CRP). We assessed the effect of hormonal contraceptive use on inflammatory cytokines including CRP, monocyte chemotactic protein-1, soluble tumor necrosis factor (sTNF), interleukin-6 (IL-6), and soluble CD40 ligand. We used 79 female subjects (19 to 30 years old) who were combined oral contraceptives users (n = 29), combined vaginal contraceptive users (n = 20), and nonusers (n = 30) with CRP values of ≤1 (n = 46) or ≥3 (n = 33). Information on medical history, physical activities, and dietary and sleeping habits were collected. Both oral and vaginal contraceptive users had higher levels of CRP (P < 0.0001), compared to nonusers. Only oral contraceptive users exhibited elevated sCD40L (P < 0.01). When comparing the groups with CRP ≤ 1 and CRP ≥ 3, levels of IL-6 and sTNF-RI were positively correlated with CRP among oral contraceptive users. We did not observe the same elevation for other inflammatory biomarkers for the CRP ≥ 3 group among vaginal contraceptive users. The clear cause of elevation in CRP level due to the use of different hormonal contraceptive formulations and methods is not well understood. Longitudinal studies with larger sample size are required to better assess the true cause of CRP elevation among hormonal contraceptive users. PMID:25861161

  20. Ginger Orally Disintegrating Tablets to Improve Swallowing in Older People.

    PubMed

    Hirata, Ayumu; Funato, Hiroki; Nakai, Megumi; Iizuka, Michiro; Abe, Noriaki; Yagi, Yusuke; Shiraishi, Hisashi; Jobu, Kohei; Yokota, Junko; Hirose, Kahori; Hyodo, Masamitsu; Miyamura, Mitsuhiko

    2016-01-01

    We previously prepared and pharmaceutically evaluated ginger orally disintegrating (OD) tablets, optimized the base formulation, and carried out a clinical trial in healthy adults in their 20 s and 50s to measure their effect on salivary substance P (SP) level and improved swallowing function. In this study, we conducted clinical trials using the ginger OD tablets in older people to clinically evaluate the improvements in swallowing function resulting from the functional components of the tablet. The ginger OD tablets were prepared by mixing the excipients with the same amount of mannitol and sucrose to a concentration of 1% ginger. Eighteen healthy older adult volunteers aged 63 to 90 were included in the swallowing function test. Saliva was collected before and 15 min after administration of the placebo and ginger OD tablets. Swallowing endoscopy was performed by an otolaryngologist before administration and 15 min after administration of the ginger OD tablets. A scoring method was used to evaluate the endoscopic swallowing. Fifteen minutes after taking the ginger OD tablets, the salivary SP amount was significantly higher than prior to ingestion or after taking the placebo (p<0.05). Among 10 subjects, one scored 1-3 using the four evaluation criteria. Overall, no aspiration occurred and a significant improvement in the swallowing function score was observed (p<0.05) after taking the ginger OD tablets. Our findings showed that the ginger OD tablets increased the salivary SP amount and improved swallowing function in older people with appreciably reduced swallowing function. PMID:27374286

  1. Efficacy and safety of metformin or oral contraceptives, or both in polycystic ovary syndrome

    PubMed Central

    Yang, Young-Mo; Choi, Eun Joo

    2015-01-01

    Background Polycystic ovary syndrome (PCOS) is an endocrinopathy that affects approximately 10% of reproductive-aged women throughout their lives. Women with PCOS present with heterogeneous symptoms including ovulatory dysfunction, hyperandrogenism, and polycystic ovaries. Therefore, lifelong individualized management should be considered. Pharmacological agents commonly used to manage the symptoms are metformin and oral contraceptive pills. Although these medications have been beneficial in treating PCOS symptoms, their efficacy and safety are still not entirely elucidated. This study aimed to report the efficacy and safety of metformin, oral contraceptives, or their combination in the treatment of PCOS and to define their specific individual roles. Methods A literature search of original studies published in PubMed and Scopus was conducted to identify studies comparing metformin with oral contraceptives or evaluating the combination of both in PCOS. Results Eight clinical trials involving 313 patients were examined in the review. The intervention dosage of metformin ranged from 1,000 to 2,000 mg/d and that of oral contraceptives was ethinylestradiol 35 µg and cyproterone acetate 2 mg. Lower body mass index was observed with regimens including metformin, but increased body mass index was observed in monotherapy with oral contraceptives. Administration of metformin or oral contraceptives, especially as monotherapy, had a negative effect on lipid profiles. In addition, there are still uncertainties surrounding the effects of metformin or oral contraceptives in the management of insulin level, although they improved total testosterone and sex hormone-binding globulin levels. In the included studies, significant side effects due to metformin or oral contraceptives were not reported. Conclusion The clinical trials suggest that metformin or oral contraceptives are at least patient convenient, efficacious, and safe for the treatment of PCOS. However, well

  2. Inherited thrombophilia and stratification of ischaemic stroke risk among users of oral contraceptives

    PubMed Central

    Pezzini, A; Grassi, M; Iacoviello, L; Del Zotto, E; Archetti, S; Giossi, A; Padovani, A

    2007-01-01

    Background Whether use of oral contraceptives is a risk factor for arterial ischaemic stroke is controversial. In particular, few data are available on what criteria should be adopted to establish an individual profile of risk before the start of oral contraceptives. Patients and methods The effects of oral contraceptives and their interaction with the G1691A polymorphisms of the factor V gene, the G20210A polymorphisms of the prothrombin gene and the C677T polymorphisms of the MTHFR gene on the risk of cerebral ischaemia were determined in a series of 108 consecutive women aged <45 years with ischaemic stroke and 216 controls, in a hospital‐based case–control study design. Results Use of oral contraceptives was associated with an increased risk of cerebral ischaemia (odds ratio (OR) 3.95; 95% confidence interval (CI) 2.29 to 6.78). ORs for stroke were 2.25 (95% CI 1.15 to 4.40), 3.94 (95% CI 2.28 to 6.81) and 8.87 (95% CI 3.72 to 21.1) for non‐oral contraceptive users with the TT MTHFR genotype, oral contraceptive users without the TT MTHFR genotype and oral contraceptive users with the TT MTHFR genotype, respectively, when compared with non‐oral contraceptive users without the TT MTHFR genotype, with a multiplicative independent effect. Compared with non‐oral contraceptive users, ORs for stroke were 2.65 (95% CI 1.46 to 4.81) for oral contraceptive users with none of the studied polymorphisms and 22.8 (95% CI 4.46 to 116.00) for oral contraceptive users with at least one of the studied polymorphisms, with a synergistic effect. Conclusions Exposure to the effects of oral contraceptives may increase the risk of ischaemic stroke in women with an inherited prothrombotic background. Testing for these genetic variants may allow more accurate stratification of the population at risk before long‐term use of oral contraceptives is prescribed. PMID:17098841

  3. Vitamin nutritional status of women using oral contraceptive pills.

    PubMed

    Murthy, N K; Vijaya, S

    1980-03-01

    A comparative study was conducted to assess the biochemical effects of a low-estrogen combined OC (oral contraceptive). The focus of the study was on possible biochemical effects indicative of altered nutritional status. Both low and high income women on pills were compared with others not on pills. The groups were further divided according to the duration of OC usage. Blood hemoglobin, serum Vitamin A, plasma ascorbic acid, folic acid, riboflavin, and aspartate transaminase levels were measured. Higher income women had better measures on all the indices than the low income women, indicating a better initial nutritional status. Deficiencies increased with duration of use. Results of the study show that OCs reduce the vitamin nutritional level in women. For poor women on OCs, special nutrition intervention programs should be instituted.

  4. Treating acne with oral contraceptives: use of lower doses.

    PubMed

    Huber, Johannes; Walch, Katharina

    2006-01-01

    Oral contraceptives (OCs) have been shown to effectively treat acne. Clinical trials of various doses of ethinyl estradiol (EE) combined with progestins such as levonorgestrel, desogestrel, norgestimate, gestodene, cyproterone acetate and drospirenone in monophasic, triphasic and combiphasic formulations used to treat acne in women are reviewed here. Open-label and comparative studies beginning in the 1980s were the first to demonstrate objective and subjective reductions in the incidence of acne, severity of existing acne and seborrhea. Placebo-controlled trials have corroborated these findings with a trend toward effective acne treatment with declining doses of EE. Significant reductions in total, inflammatory and noninflammatory lesions compared with placebo have been demonstrated with an OC containing the low dose of 20 microg of EE. Collectively, these findings support the use of low-dose OCs for the treatment of acne. PMID:16371290

  5. [Pharmacological aspects of oral contraceptives: part 2 (author's transl)].

    PubMed

    Weil-levy, C; Soubrie, C; Simon, P

    1980-05-01

    This article is a long list of the known side effects of OC (oral contraception). Less serious side effects include skin alterations, genito-urinary infections, anemia, headaches, psychological problems of various kinds, cholestasis and/or jaundice, menstruation disorders, and metabolic perturbations. Very serious side effects include all cardiovascular, cerebrovascular and blood coagulation problems; carcinogenic effects are to be included among serious ones, even if not totally proven. Factors increasing the risk of severe disorders are tabagism, obesity, age, hypertension, and family antecedents of thrombotic accidents. Sex hormones are suspected to induce malformation in the fetus. OC must be carefully chosen according to the clinical and biological characteristics of the users; the lowest dosage is always recommended when effectiveness is equal. PMID:12261834

  6. A randomized double blind study of two oral contraceptives.

    PubMed

    Sanhueza, H; Sivin, I; Kumar, S; Kessler, M; Carrasco, A; Yee, J

    1979-07-01

    To study the question of whether one brand of oral contraceptives may be as acceptable as another for use of publicly-assisted family planning programs, a double blind study of two well-known brands, Ovral and Norinyl, was undertaken in Costa Rica and Trinidad. The pills were randomly assigned to 1,200 women. Common side effects - nausea, dizziness, vomiting, headaches - were associated with both Norinyl and Ovral. Differences in event rates for these conditions were much more marked by country than by the pill used. Ovral was associated with increases in skin problems, notably chloasma, in Cost Rica. A higher percentage of women using Norinyl reported intermenstrual bleeding and spotting in both countries. In Costa Rica continuation rates for Norinyl were adversely affected by this. With these exceptions there appear to be no important differences between the brands that would affect their use in family planning programs. PMID:477315

  7. Oral contraceptive use and female genital arousal: methodological considerations.

    PubMed

    Seal, Brooke N; Brotto, Lori A; Gorzalka, Boris B

    2005-08-01

    This study explored effects of oral contraceptive pill (OCP) use on physiological sexual arousal as measured by a vaginal photoplethysmograph. Sixteen women aged 18-29 viewed audiovisual neutral and erotic stimuli before and an average of 6 weeks following the onset of OCP use. Although subjective measures of sexual arousal, including perceptions of genital arousal, significantly increased in response to erotic stimuli both before and after OCP onset, physiological sexual arousal only increased before OCP use. A comparison of individual responses before and after OCP onset reveals a much higher degree of intrasubject variability after OCP onset. We discuss these findings as they relate to OCP use as a confounding methodological variable to consider in future investigations employing vaginal photoplethysmography. PMID:19817038

  8. Pharmacist conscience clauses and access to oral contraceptives.

    PubMed

    Flynn, D P

    2008-07-01

    The introduction of conscience clauses after the 1973 US Supreme Court decision in Roe v. Wade allowed physicians and nurses to opt out of medical procedures, particularly abortions, to which they were morally opposed. In recent years pharmacists have requested the same consideration with regard to dispensing some medicines. This paper examines the pharmacists' role and their professional and moral obligations to patients in the light of recent refusals by pharmacists to dispense oral contraceptives. A review of John Rawls's concepts of the "original position" and the "veil of ignorance", along with consideration of the concept of compartmentalisation, are used to assess pharmacists' requests and the moral and legal rights of patients to have their prescriptive needs met.

  9. Oral Contraceptives and Multiple Sclerosis/Clinically Isolated Syndrome Susceptibility

    PubMed Central

    Hellwig, Kerstin; Chen, Lie H.; Stancyzk, Frank Z.; Langer-Gould, Annette M.

    2016-01-01

    Background The incidence of multiple sclerosis (MS) is rising in women. Objective To determine whether the use of combined oral contraceptives (COCs) are associated with MS risk and whether this varies by progestin content. Methods We conducted a nested case-control study of females ages 14–48 years with incident MS or clinically isolated syndrome (CIS) 2008–2011 from the membership of Kaiser Permanente Southern California. Controls were matched on age, race/ethnicity and membership characteristics. COC use up to ten years prior to symptom onset was obtained from the complete electronic health record. Results We identified 400 women with incident MS/CIS and 3904 matched controls. Forty- percent of cases and 32% of controls had used COCs prior to symptom onset. The use of COCs was associated with a slightly increased risk of MS/CIS (adjusted OR = 1.52, 95%CI = 1.21–1.91; p<0.001). This risk did not vary by duration of COC use. The association varied by progestin content being more pronounced for levenorgestrol (adjusted OR = 1.75, 95%CI = 1.29–2.37; p<0.001) than norethindrone (adjusted OR = 1.57, 95%CI = 1.16–2.12; p = 0.003) and absent for the newest progestin, drospirenone (p = 0.95). Conclusions Our findings should be interpreted cautiously. While the use of some combination oral contraceptives may contribute to the rising incidence of MS in women, an unmeasured confounder associated with the modern woman’s lifestyle is a more likely explanation for this weak association. PMID:26950301

  10. Oral contraceptives as anti-androgenic treatment of acne.

    PubMed

    Lemay, André; Poulin, Yves

    2002-07-01

    Although acne is seldom associated with high serum levels of androgens, it has been shown that female acne patients have definite increases in ovarian and adrenal androgen levels when compared to appropriate controls. As shown in several pilot and in multiple open and comparative studies, oral contraceptives (OCs) are effective in causing a significant regression of mild to moderate acne. These results have been confirmed by multicentre randomized trials where low-dose OCs did not cause side effects different from those of the placebo-controlled group. The beneficial effect of OCs is related to a decrease in ovarian and adrenal androgen precursors; to an increase in sex hormone-binding globulin (SHBG), which limits free testosterone; and to a decrease in 3a-androstenediol glucuronide conjugate, the catabolite of dihydrotestosterone (DHT) formed in peripheral tissues. The estrogen-progestin combination containing cyproterone acetate (CPA) is particularly effective in treating acne, since this progestin also has a direct peripheral anti-androgenic action in blocking the androgen receptor. Only two open studies and one randomized study on small numbers of patients have reported some efficacy of spironolactone used alone or in combination with an OC in the treatment of acne. The new non-steroidal anti-androgens flutamide and finasteride are being evaluated for the treatment of hirsutism. Oral antibiotics are prescribed to patients with inflammatory lesions, where they are effective in decreasing the activity of microbes, the activity of microbial enzymes, and leukocyte chemotaxis. Concomitant intake of an OC and an antibiotic usually prescribed for acne does not impair the contraceptive efficacy of the OC. A second effective contraceptive method should be used whenever there would be decreased absorption or efficacy of the OC (digestive problems, breakthrough bleeding), lack of compliance and use of a type or dose of antibiotic different from that usually prescribed

  11. New contraceptive eligibility checklists for provision of combined oral contraceptives and depot-medroxyprogesterone acetate in community-based programmes.

    PubMed Central

    Stang, A.; Schwingl, P.; Rivera, R.

    2000-01-01

    Community-based services (CBS) have long used checklists to determine eligibility for contraceptive method use, in particular for combined oral contraceptives (COCs) and the 3-month injectable contraceptive depot-medroxyprogesterone acetate (DMPA). As safety information changes, however, checklists can quickly become outdated. Inconsistent checklists and eligibility criteria often cause uneven access to contraceptives. In 1996, WHO produced updated eligibility criteria for the use of all contraceptive methods. Based on these criteria, new checklists for COCs and DMPA were developed. This article describes the new checklists and their development. Several rounds of expert review produced checklists that were correct, comprehensible and consistent with the eligibility requirements. Nevertheless, field-testing of the checklists revealed that approximately half (48%) of the respondents felt that one or more questions still needed greater comprehensibility. These findings indicated the need for a checklist guide. In March 2000, WHO convened a meeting of experts to review the medical eligibility criteria for contraceptive use. The article reflects also the resulting updated checklist. PMID:10994285

  12. Oral contraceptives after myomectomy: a short term trial.

    PubMed

    Luisi, Stefano; Ciani, Valentina; Gabbanini, Massimo; Sollazzi, Sofia; Torricelli, Michela; Calonaci, Francesco; Petraglia, Felice

    2009-01-01

    Following myomectomy the rate of fertility is restored and pregnancy may be attempted with a good outcome. In the present study a 3 month treatment with OCs in a group of women after a myomectomy was evaluated. The drug compliance and side effects, the benefits of OC in order to reduce symptoms, to increase post-surgical hemoglobin levels and to avoid an early pregnancy after myomectomy were analyzed. A group of women (n = 55) each with myoma >/=5 cm was recruited: they presented menorrhagia, pelvic pain, dyspareunia and dysmenorrhae. After laparotomic myomectomy the women were divided into 3 groups. Group 1: women (n = 16) treated with pill A (15 mcg of ethynilestradiol + 60 mcg of gestodene); group 2: women (n = 23) treated with pill B (20 mcg of ethynilestradiol + 100 mcg of levonorgestrel); group 3: women (n = 16) treated with a placebo (oral calcium). After three months from myomectomy and treatment patients in each group reported a reduced menorrhagia, dismenorrhea and pelvic pain. Serum haemoglobin levels increased in all women (P < .05). No pregnancy occurred in any group and the compliance was good. A post surgery treatment by using oral contraceptives guarentees pregnancy prevention, associated with reduction of pain, and improvement of haematologic conditions.

  13. Oral Contraceptives after Myomectomy: A Short Term Trial

    PubMed Central

    Luisi, Stefano; Ciani, Valentina; Gabbanini, Massimo; Sollazzi, Sofia; Torricelli, Michela; Calonaci, Francesco; Petraglia, Felice

    2009-01-01

    Following myomectomy the rate of fertility is restored and pregnancy may be attempted with a good outcome. In the present study a 3 month treatment with OCs in a group of women after a myomectomy was evaluated. The drug compliance and side effects, the benefits of OC in order to reduce symptoms, to increase post-surgical hemoglobin levels and to avoid an early pregnancy after myomectomy were analyzed. A group of women (n = 55) each with myoma ≥5 cm was recruited: they presented menorrhagia, pelvic pain, dyspareunia and dysmenorrhae. After laparotomic myomectomy the women were divided into 3 groups. Group 1: women (n = 16) treated with pill A (15 mcg of ethynilestradiol + 60 mcg of gestodene); group 2: women (n = 23) treated with pill B (20 mcg of ethynilestradiol + 100 mcg of levonorgestrel); group 3: women (n = 16) treated with a placebo (oral calcium). After three months from myomectomy and treatment patients in each group reported a reduced menorrhagia, dismenorrhea and pelvic pain. Serum haemoglobin levels increased in all women (P < .05). No pregnancy occurred in any group and the compliance was good. A post surgery treatment by using oral contraceptives guarentees pregnancy prevention, associated with reduction of pain, and improvement of haematologic conditions. PMID:19946429

  14. The relationship of self-concept and autonomy to oral contraceptive compliance among adolescent females.

    PubMed

    Neel, E U; Jay, S; Litt, I F

    1985-11-01

    Self-concept and autonomy are typically negotiated during adolescence, a time when many females also become sexually active. Nonuse and discontinuation of contraceptives by teenagers place them at high risk for pregnancy. The present study explores the relationship between these psychological factors and contraceptive noncompliance during adolescence. Fifty-five adolescent females beginning a contraceptive regimen were entered into the study. Compliance at four months after the initiation of an oral contraceptive was associated with scoring high on the Behavior Subscale of the Piers-Harris Self-Concept Scale and the Autonomy Scale modified from Eysenk.

  15. The relationship of self-concept and autonomy to oral contraceptive compliance among adolescent females.

    PubMed

    Neel, E U; Jay, S; Litt, I F

    1985-11-01

    Self-concept and autonomy are typically negotiated during adolescence, a time when many females also become sexually active. Nonuse and discontinuation of contraceptives by teenagers place them at high risk for pregnancy. The present study explores the relationship between these psychological factors and contraceptive noncompliance during adolescence. Fifty-five adolescent females beginning a contraceptive regimen were entered into the study. Compliance at four months after the initiation of an oral contraceptive was associated with scoring high on the Behavior Subscale of the Piers-Harris Self-Concept Scale and the Autonomy Scale modified from Eysenk. PMID:4055464

  16. [Treatment of diminished sexual response associated with the use of oral contraceptives (author's transl)].

    PubMed

    Fucs, G B; Coutinho, E M

    1975-01-01

    Loss of libido associated with the use of oral contraceptives has been studied in 113 women of reproductive age who had taken a combined pill for periods ranging from 1 to 3 years. The patients were divided in four groups. In the first group (I) of 24 women oral contraceptive treatment was discontinued and all women received in intra-uterine contraceptive device (IUCD). The second group (II) of 36 patients, the brand of oral contraceptive was changed. Women in group (III) had their oral contraceptive maintained receiving in addition a mixture of an androgen and an estrogen (methyltestosterone 4 mg and ethynilestradiol 0.002 mg) daily. To women of group (IV) the oral contraceptive was discontinued but the androgen-estrogen mixture was given. All women in this group received an IUCD. Evaluation of the psyco-sexual parameters included changes in libido, time to reach an orgasm, duration and intensity or orgasms. Frequency of intercourse and response to autostimulation was also investigated. Libido was restored in 94.2% of patients in group II, in 97.3% of group III and in 92.8% of group IV. In group I only 55.6% of patients had libido fully restored. In view of the prompt restoration of libido in all groups except in patients discontinuing oral contraceptive therapy, it is suggested that loss of libido in oral contraceptive users has an important physological component which can be overcome probably by psychotherapy. Short term treatment with a mixture of methyltestosterone and ethynilestradiol seems to be highly effective in restoring libido in all patients.

  17. The effects of oral contraceptives on plasma lipids and lipoproteins.

    PubMed

    Krauss, R M

    1988-01-01

    It has been well documented that low-density lipoproteins and intermediate-density lipoproteins play a role in the development of atherosclerosis. Data also indicate that high-density lipoproteins (HDLs), have potentially antiatherogenic effects. The individual estrogen and progestogen components of oral contraceptives (OCs) have been shown to affect plasma lipoproteins in both cross-sectional and longitudinal studies. This effect depends on both the type of steroid used and the dose of each of the OC components. Estrogen and progestogen have opposing effects on lipoprotein physiology. Estrogens raise the level of HDL cholesterol, while progestogens tend to lower HDL levels. Thus, in OC formulations, as the ratio of estrogen to progestogen increases in favor of estrogen, there is a greater increase in HDL cholesterol--a potentially beneficial effect. Although there is no direct evidence that favorable lipoprotein changes produced by OCs are cardioprotective, the physician prescribing an OC should minimize adverse lipoprotein effects by prescribing a balanced low-dose, low-impact formulation.

  18. Chlamydial salpingitis in female guinea pigs receiving oral contraceptives.

    PubMed

    Barron, A L; Pasley, J N; Rank, R G; White, H J; Mrak, R E

    1988-01-01

    Female guinea pigs were given daily doses of a combination of oral contraceptive (OC) agents, consisting of mestranol and norethynodrel suspended in sesame oil or distilled H2O, and were infected in the genital tract with the chlamydial agent of guinea pig inclusion conjunctivitis (GPIC). Counts of chlamydial inclusions in cells of vaginal smears collected during infection, showed prolongation and enhancement of infection in OC-treated animals as compared with controls. Appearance of IgG and IgA antibodies to GPIC in genital secretions, as determined by enzyme-linked immunosorbent assay (ELISA), was also delayed in OC-treated animals as compared with controls. OC-treated infected animals were killed on days 15 and 43, and gross pathological evidence for ascending infection culminating in salpingitis was found in all of five and four of five animals, respectively. On the other hand, among untreated infected controls on each sacrifice day, only one of five animals had any evidence for ascending infection. Chlamydiae were detected by light and electron microscopy in fallopian tube tissue collected on day 15 following OC-treatment but not in tissue from control animals.

  19. Clinical utility of folate-containing oral contraceptives

    PubMed Central

    Lassi, Zohra S; Bhutta, Zulfiqar A

    2012-01-01

    Folate is a generic term for a water-soluble B-complex vitamin which plays an important role in protein synthesis and metabolism and other processes related to cell multiplication and tissue growth. Pregnant and lactating women are at increased risk of folic acid deficiency because generally their dietary folate is insufficient to meet their physiological requirements and the metabolic demands of the growing fetus. The evidence pertaining to the reduction of the risk of neural tube defects (NTDs) due to folate is so compelling that supplementation with 400 μg of folic acid to all women trying to conceive until 12 weeks of pregnancy has been recommended by every relevant authority. A recent Cochrane review has also found protective effects of folate supplementation in occurrence and reoccurrence of NTDs. Despite food fortification and targeted public health campaigns promoting folic acid supplementation, 4,300,000 new cases occur each year worldwide resulting in an estimated 41,000 deaths and 2.3 million disability-adjusted life years (DALYS). This article will review the burden and risk factors of NTDS, and the role of folate in preventing NTDs. It will also describe different modes of supplementing folate and the newer evidence of the effectiveness of adding folate in oral contraceptives for raising serum and red blood cell folate levels. PMID:22570577

  20. Inconsistent use of oral contraceptives in rural Bangladesh.

    PubMed

    Khan, M Asaduzzaman; Trottier, Dorace A; Islam, M Ataharul

    2002-06-01

    The purpose of this study is to explore predictors of inconsistent use of oral contraceptives (OCs) in rural Bangladesh. A total of 801 rural OC users were included in the study, about half of them (49%) missed one or more active pill(s) during the 6 months before the survey.Multivariate analysis revealed that Muslim women were 60% more likely to be inconsistent OC users compared to their non-Muslim counterparts. Women who lacked knowledge about contraindications were 60% more likely to take the pill inconsistently than were women who had the knowledge. Women who were not visited by family planning workers or did not have access to mass media were 40% more likely to be inconsistent OC users.OC users need increased information about correct OC use, which could be provided via improved access to mass media with specific messages on how to use OCs properly. Better access to the community clinics could improve the pill-taking behaviors of rural Bangladeshi women.

  1. Headache induced by the use of combined oral contraceptives.

    PubMed

    Allais, Gianni; Gabellari, Ilaria Castagnoli; Airola, Gisella; Borgogno, Paola; Schiapparelli, Paola; Benedetto, Chiara

    2009-05-01

    Although combined oral contraceptives (COCs) are a safe and highly effective method of birth control, they may also give rise to problems of clinical tolerability in migraine patients. Indeed, headache is among the most common side effects reported with the use of COCs, frequently leading to their being discontinued. The latest International Classification of Headache Disorders identified at least two entities evidently related to the use of COCs, i.e., exogenous hormone-induced headache and estrogen-withdrawal headache. As to the former, the newest formulations of COCs are generally well tolerated by migraine without aura patients, but can worsen headache in migraine with aura patients. Headache associated with COCs, generally, tends to improve as their use continues. However, although it is not yet clear if there is an association between headache and the composition of COCs (both in the type and amount of hormones), it has been observed that the incidence of headache during COC use seems greater if migraine is associated with menstrual trigger. The estrogen-withdrawal headache is a headache that generally appears within the first 5 days after cessation of estrogen use and resolves within 3 days, even if in some cases it may appear on the sixth or seventh day after pill suspension and lasts more than 3 days.

  2. Follow-up of adolescent oral contraceptive users.

    PubMed

    Delmore, T; Kalagian, W F; Loewen, I R

    1991-01-01

    Clients in birth control centers (St. Catharines, Niagara Falls, and Welland) in Ontario, Canada were profiled in 1989; factors affecting compliance with the use of oral contraceptives (OCs) were investigated. Compliance was assessed for those 16 years and after 3 months of OC use. A control group and 2 study groups were randomly formed. 1 group was told about a follow up telephone call if the 3-month checkup appointment was not kept and the other not told. Compliance was determined by keeping the follow-up appointment and taking the pill as directed. Self-administered questionnaires were obtained at the 1st appointment and the 2nd study group was interviewed at the 3-month appointment time. Of the 334 intake interviews, 28.4% were adolescents 16 years old. Information on birth control came most frequently from friends (78.7%; then high school classmates, 61.4% grade school classmates, 61.4%; and family, 38.0%). 94.3% had a boyfriend, primarily a steady one. 82.4% were sexually active before the Center visit. 21.3% had had sex when 15 years old. 9.2% of those sexually active had never used birth control. 85.2% of those using contraception had used a condom at least once, and 33.9% used withdrawal. In the preceding month, birth control was used 60% of the time. 46% of mothers and 25% of fathers were considered supportive of birth control. 228 16 years participated in the compliance study. The 2 study groups and the control group were not significantly different in their compliance. The only statistically significant predictor of compliance (from the intake interview) was the previous use of the condom. Those more likely to be compliant were the 10.9% sexually active who had never used a condom. Continuing with the family doctor, not sexually active, advice to stop, side effects concerns, and remembering to take the pill were the most common reasons for noncompliance. The implication for health and sex education is that emphasis needs to the placed on the risks taken

  3. Reproductive Health Outcomes of Insured Women Who Access Oral Levonorgestrel Emergency Contraception

    PubMed Central

    Raine-Bennett, Tina; Merchant, Maqdooda; Sinclair, Fiona; Lee, Justine W.; Goler, Nancy

    2015-01-01

    Objectives To assess the level of risk for women who seek emergency contraception through various clinical routes and the opportunities for improved care provision. Methods This study looked at a retrospective cohort to assess contraception and other reproductive health outcomes among women aged 15-44 who accessed oral levonorgestrel emergency contraception through an office visit or the call center at Kaiser Permanente Northern California from 2010 to 2011. Results Of 21,421 prescriptions, 14,531(67.8%) were accessed through the call center. In the subsequent 12 months, 12,127(56.6%) women had short-acting contraception (pills, patches, rings, depot medroxyprogesterone) dispensed and 2,264(10.6%) initiated very effective contraception (intrauterine contraception, implants, sterilization). Initiation of very effective contraception was similar for women who accessed it through the call center -1,569(10.8%) and office visits – 695(10.1%) (adjusted OR 1.02 95% confidence interval (CI) 0.93-1.13). In the subsequent 6 months, 2,056(9.6%) women became pregnant. Women who accessed emergency contraception through the call center were less likely to become pregnant within 3 months of accessing emergency contraception than woman who accessed it through office visits (adjusted OR 0.82 95% CI 0.72-0.94); however they were more likely to become pregnant within 4-6 months (adjusted OR 1.37 95%CI 1.16-1.60). Among women who were tested for chlamydia and gonorrhea, 689(7.8%) and 928(7.9%) were positive in the 12 months before and after accessing emergency contraception, respectively. Conclusions Protocols to routinely address unmet need for contraception at every call for emergency contraception and all office visits including visits with primary care providers should be investigated. PMID:25751211

  4. Greater Beta-Adrenergic Receptor Mediated Vasodilation in Women Using Oral Contraceptives

    PubMed Central

    Limberg, Jacqueline K.; Peltonen, Garrett L.; Johansson, Rebecca E.; Harrell, John W.; Kellawan, Jeremy M.; Eldridge, Marlowe W.; Sebranek, Joshua J.; Walker, Benjamin J.; Schrage, William G.

    2016-01-01

    Background: β-adrenergic receptors play an important role in mitigating the pressor effects of sympathetic nervous system activity in young women. Based on recent data showing oral contraceptive use in women abolishes the relationship between muscle sympathetic nervous system activity and blood pressure, we hypothesized forearm blood flow responses to a β-adrenergic receptor agonist would be greater in young women currently using oral contraceptives (OC+, n = 13) when compared to those not using oral contraceptives (OC–, n = 10). Methods: Women (18–35 years) were studied during the early follicular phase of the menstrual cycle (days 1–5) or placebo phase of oral contraceptive use. Forearm blood flow (FBF, Doppler ultrasound) and mean arterial blood pressure (MAP, brachial arterial catheter) were measured at baseline and during graded brachial artery infusion of the β-adrenergic receptor agonist, Isoproterenol (ISO), as well as Acetylcholine (ACH, endothelium-dependent vasodilation) and Nitroprusside (NTP, endothelium-independent vasodilation). Forearm vascular conductance was calculated (FVC = FBF/MAP, ml/min/100 mmHg) and the rise in FVC from baseline during infusion quantified vasodilation (ΔFVC = FVCinfusion − FVCbaseline). Results: ISO increased FVC in both groups (p < 0.01) and ISO-mediated ΔFVC was greater in OC+ compared to OC– (Main effect of group, p = 0.02). Expressing data as FVC and FBF resulted in similar conclusions. FVC responses to both ACH and NTP were also greater in OC+ compared to OC–. Conclusions: These data are the first to demonstrate greater β-adrenergic receptor-mediated vasodilation in the forearm of women currently using oral contraceptives (placebo phase) when compared to those not using oral contraceptives (early follicular phase), and suggest oral contraceptive use influences neurovascular control. PMID:27375493

  5. Effect of injectable and oral contraceptives on serum lipids

    PubMed Central

    Berenson, Abbey B.; Rahman, Mahbubur; Wilkinson, Gregg

    2010-01-01

    Objective To estimate the effects of using depot medroxyprogesterone acetate (DMPA) or oral contraceptives (OC) containing 20 micrograms ethinyl estradiol and 0.15 mg desogestrel on serum lipid levels. Methods Serum lipids were measured at baseline and every 6 months thereafter for 3 years on 703 white, black, and Hispanic women using DMPA, OC, or nonhormonal (NH) birth control. DMPA discontinuers were followed for up to 2 additional years. Participants completed questionnaires containing demographic and behavioral measures every 6 months and underwent 24 hour dietary recalls annually. Mixed model regression analyses and general estimating equations procedures were used to estimate changes over time in lipids by method, along with their predictors. Results OC users experienced significantly greater increases in levels of triglycerides (TG), total cholesterol (TC), very low density lipoprotein cholesterol (VLDL-C), and high density lipoprotein cholesterol (HDL-C) than NH users (P<.001). However, no difference was noted in the LDL-C to HDL-C ratio between OC and NH users. Among DMPA users, HDL-C levels initially decreased for 6 months, but then returned to baseline. The LDL-C to HDL-C ratio rose during the first 6 months of DMPA use, but then dropped back to baseline over the next 24 months. After DMPA was discontinued, women who used OC increased their TG, TC, VLDL-C, and HDL-C levels significantly more than those who chose NH (P< .05). Conclusion Use of very low dose OC containing desogestrel can elevate lipid levels. DMPA users were at increased risk of developing an abnormally low HDL-C level as well as an abnormally high LDL level and an increase in the LDL to HDL cholesterol ratio, although these effects appeared to be temporary. PMID:19888036

  6. Estrogen-free oral hormonal contraception: benefits of the progestin-only pill.

    PubMed

    de Melo, Nilson Roberto

    2010-09-01

    Although combined oral contraceptives (COCs) are commonly used and highly effective in preventing pregnancy, they may not be suitable for some women. COC use is associated with increased rates of cardiovascular events and is not recommended in nonbreastfeeding women in the immediate postpartum period or in breastfeeding women during the initial 6 months of breastfeeding. Moreover, estrogen-related adverse effects, such as headache, are common. Estrogen-free progestin-only pills (POPs) are a valuable option in women who prefer to take an oral hormonal contraceptive, but are ineligible for, or choose not to use, COCs. Although some POPs have been associated with lower contraceptive effectiveness than COCs, the POP containing desogestrel has shown similar contraceptive effectiveness to COCs. The most commonly reported complaints in women using all POPs are bleeding problems. Counseling women interested in using POPs about the variable bleeding patterns associated with this method may improve compliance and acceptance. PMID:21080791

  7. Novel oral contraceptive for heavy menstrual bleeding: estradiol valerate and dienogest

    PubMed Central

    Rafie, Sally; Borgelt, Laura; Koepf, Erin R; Temple-Cooper, Mary E; Lehman, K Joy

    2013-01-01

    Abnormal uterine bleeding (AUB) is associated with significant direct medical costs and impacts both society and the quality of life for individual women. Heavy menstrual bleeding, a subset of AUB, also referred to as menorrhagia, is defined as menstrual blood loss greater than 80 mL or the patient’s perception of excessive blood loss. The newest treatment option available is a novel combination oral contraceptive product containing estradiol valerate (E2V) and dienogest (DNG). As with other combination oral contraceptives, E2V/DNG works primarily by preventing ovulation. However, in contrast with other combination oral contraceptives, it is the progestin component of E2V/DNG that is responsible for endometrial stabilization. Use of E2V/DNG for six months has led to significant reductions in heavy menstrual bleeding with an average 65% reduction in mean blood loss. Approximately half of the women with heavy menstrual bleeding who received E2V/DNG for six months demonstrated an 80% reduction in mean blood loss. Additionally, significant improvements in hematologic indicators (ie, ferritin, hemoglobin, and hematocrit) have been shown. Based on its chemical properties, E2V/DNG may have fewer adverse effects on lipid and glucose metabolism and reduced risk of thromboembolic complications compared with other combination oral contraceptives. This has not yet been shown in clinical trials and until then it should be assumed that E2V/DNG has a safety profile similar to other combination oral contraceptives containing 35 μg or less of ethinyl estradiol. E2V/DNG has been compared with another combination oral contraceptive in healthy women without heavy menstrual bleeding and demonstrated improved bleeding patterns. E2V/DNG has not been compared with the levonorgestrel intrauterine device or other treatments for heavy menstrual bleeding. When compared with some other treatment options for AUB, E2V/DNG provides the added advantage of effective contraception. PMID:23788843

  8. [Choosing contraception].

    PubMed

    Gonzalez Velez, A C

    1998-06-01

    The development of contraception has allowed women to think about and experience motherhood not as their destiny but as an option. Humans have always been interested in controlling their fertility. Writings unearthed in the 18th century demonstrated the interest of the ancient Egyptians and Greeks in fertility control. The oral contraceptive (OC) pill, developed in the 1950s by Pincus and Rock, has allowed millions of women to avoid unwanted pregnancy. Since 1960, when the oral contraceptive Enovid was first marketed in the US, over 200 million women throughout the world have used OCs. Modern formulations have low hormone doses, which has minimized side effects. OCs now have an effectiveness of 98%. The method is controlled by the woman, permitting autonomous decisions about pregnancy. Currently, in Colombia, 12.9% of women in union use OCs, 25.7% are sterilized, 11.1% each use IUDs and traditional methods, 4.3% use condoms, 2.5% use injectables, 1.4% use vaginal tablets, 0.7% each use Norplant and vasectomy, and 1.8% use other methods. 27.8% use no method. OCs can be used as an emergency method in case of rape, an unexpected sexual encounter, or failure of another method. When used as a postcoital method, OCs must be taken within 72 hours of unprotected sexual intercourse.

  9. Use of Oral Contraceptives for Management of Acne Vulgaris: Practical Considerations in Real World Practice.

    PubMed

    Harper, Julie C

    2016-04-01

    Acne vulgaris may be effectively treated with combination oral contraceptive pills (COCs) in women. COCs may be useful in any woman with acne in the absence of known contraindications. When prescribing a COC to a woman who also desires contraception, the risks of the COC are compared with the risks associated with pregnancy. When prescribing a COC to a woman who does not desire contraception, the risks of the COC must be weighed against the risks associated with acne. COCs may take 3 cycles of use to show an effect in acne lesion count reductions.

  10. The in vitro effect of aspirin on increased whole blood platelet aggregation in oral contraceptive users.

    PubMed

    Norris, L A; Bonnar, J

    1994-05-01

    The effects of triphasic oral contraceptives on whole blood platelet aggregation in 36 Italian women are reported here. Aspirin's effects on platelet aggregation were also studied. 18 women took a triphasic oral contraceptive; 10 women took Trinordiol, while 8 took Trinovum for at least 90 days. The remaining 18 women took nothing and served as controls. The study was aligned with each woman's birth control pill cycle. Blood was taken daily on days 15-21 of their cycle. Either saline solution or acetylsalicylic acid was added to the blood samples and compared. All data was statistically analyzed using unpaired student's t-test. Effects of 3 aggregating agents, ADP, PAF, and EDTA, on platelet aggregation were studied. Arachidonic acid and adrenalin bitartrate were also studied in this manner. An increase in platelet aggregation was observed in women taking oral contraceptives. No difference was found between patients taking Trinordiol and those taking Trinovum. The results of this study indicate an increase in whole blood platelet sensitivity to collagen, adrenalin, and arachidonic acid when using oral contraceptives. Aspirin, at low doses, may have a role in preventing early thrombus formation in women taking oral contraceptives. PMID:8042198

  11. Comparing the effects of the second-and third-generation oral contraceptives on sexual functioning

    PubMed Central

    Shahnazi, Mahnaz; Bayatipayan, Somaye; Khalili, Azizeh Farshbaf; Kochaksaraei, Fatemeh Ranjbar; Jafarabadi, Mohammad Asghari; Banoi, Kamala Gaza; Nahaee, Jila

    2015-01-01

    Background: The aim of this study was to compare the effects of the second- and third-generation oral contraceptives on women's reproductive sexual function. Materials and Methods: This randomized, double-blind, placebo-controlled clinical trial was conducted on 82 married women of reproductive age in Tehran. Samples were randomized into the groups receiving second- and third-generation oral contraceptive pills. Female Sexual Function Index (FSFI) tool was used before the intervention and 2 and 4 months after the intervention. Data analysis was carried out using analysis of variance (ANOVA) within repeated measures and P < 0.05 were considered significant. Results: There was a statistically significant difference in the positive and negative moods between the experimental and control groups before the intervention in the second and fourth months. The second-generation pills caused a decrease in sexual function in the second month and an increase in sexual function in the fourth month, but the third-generation pills led to an increase in sexual function in the second and fourth months. The increase in sexual function that resulted from using the third-generation pills was significantly higher than that resulted on using the second-generation pills. Conclusions: According to the results of this study, sexual functioning decreased in the second month of using the second-generation pills and sexual performance was significantly more on using the third-generation pills compared to second-generation pills. The most common type of oral contraceptive used in Iran is the second-generation oral contraceptive LD™ (low-dose estrogen), which is freely distributed in health centers. Therefore, it is necessary for women who wish to use these contraceptive methods to be educated and consulted before they start using them. The third-generation contraceptive pills can be recommended to women who wish to use oral contraceptives. PMID:25709690

  12. Early Impact Of The Affordable Care Act On Oral Contraceptive Cost Sharing, Discontinuation, And Nonadherence.

    PubMed

    Pace, Lydia E; Dusetzina, Stacie B; Keating, Nancy L

    2016-09-01

    The oral contraceptive pill is the contraceptive method most commonly used by US women, but inconsistent use of the pill is a contributor to high rates of unintended pregnancy. The relationship between consumer cost sharing and consistent use of the pill is not well understood, and the impact of the elimination of cost sharing for oral contraceptive pills in a mandate in the Affordable Care Act (ACA) is not yet known. We analyzed insurance claims for 635,075 women with employer-sponsored insurance who were initiating use of the pill, to examine rates of discontinuation and nonadherence, their relationship with cost sharing, and trends before and during the first year after implementation of the ACA mandate. We found that cost sharing for oral contraceptives decreased markedly following implementation, more significantly for generic than for brand-name versions. Higher copays were associated with greater discontinuation of and nonadherence to generic pills than was the case with zero copayments. Discontinuation of the use of generic or brand-name pills decreased slightly but significantly following ACA implementation, as did nonadherence to brand-name pills. Our findings suggest a modest early impact of the ACA on improving consistent use of oral contraceptives among women initiating their use.

  13. Early Impact Of The Affordable Care Act On Oral Contraceptive Cost Sharing, Discontinuation, And Nonadherence.

    PubMed

    Pace, Lydia E; Dusetzina, Stacie B; Keating, Nancy L

    2016-09-01

    The oral contraceptive pill is the contraceptive method most commonly used by US women, but inconsistent use of the pill is a contributor to high rates of unintended pregnancy. The relationship between consumer cost sharing and consistent use of the pill is not well understood, and the impact of the elimination of cost sharing for oral contraceptive pills in a mandate in the Affordable Care Act (ACA) is not yet known. We analyzed insurance claims for 635,075 women with employer-sponsored insurance who were initiating use of the pill, to examine rates of discontinuation and nonadherence, their relationship with cost sharing, and trends before and during the first year after implementation of the ACA mandate. We found that cost sharing for oral contraceptives decreased markedly following implementation, more significantly for generic than for brand-name versions. Higher copays were associated with greater discontinuation of and nonadherence to generic pills than was the case with zero copayments. Discontinuation of the use of generic or brand-name pills decreased slightly but significantly following ACA implementation, as did nonadherence to brand-name pills. Our findings suggest a modest early impact of the ACA on improving consistent use of oral contraceptives among women initiating their use. PMID:27605641

  14. Partner choice, relationship satisfaction, and oral contraception: the congruency hypothesis.

    PubMed

    Roberts, S Craig; Little, Anthony C; Burriss, Robert P; Cobey, Kelly D; Klapilová, Kateřina; Havlíček, Jan; Jones, Benedict C; DeBruine, Lisa; Petrie, Marion

    2014-07-01

    Hormonal fluctuation across the menstrual cycle explains temporal variation in women's judgment of the attractiveness of members of the opposite sex. Use of hormonal contraceptives could therefore influence both initial partner choice and, if contraceptive use subsequently changes, intrapair dynamics. Associations between hormonal contraceptive use and relationship satisfaction may thus be best understood by considering whether current use is congruent with use when relationships formed, rather than by considering current use alone. In the study reported here, we tested this congruency hypothesis in a survey of 365 couples. Controlling for potential confounds (including relationship duration, age, parenthood, and income), we found that congruency in current and previous hormonal contraceptive use, but not current use alone, predicted women's sexual satisfaction with their partners. Congruency was not associated with women's nonsexual satisfaction or with the satisfaction of their male partners. Our results provide empirical support for the congruency hypothesis and suggest that women's sexual satisfaction is influenced by changes in partner preference associated with change in hormonal contraceptive use.

  15. Lack of effect of oral contraceptive use on the pharmacokinetics of quinine.

    PubMed Central

    Wanwimolruk, S; Kaewvichit, S; Tanthayaphinant, O; Suwannarach, C; Oranratnachai, A

    1991-01-01

    The pharmacokinetics of quinine after a single 600 mg oral dose of quinine sulphate were studied in seven female subjects who used oral contraceptives and in seven age-matched female controls who did not. There were no significant differences (P greater than 0.05) in the maximum plasma concentration (Cmax) and the time of peak concentration (tmax) between the subjects who used oral contraceptives (Cmax = 5.3 +/- 1.0 (s.d.) mg l-1; tmax = 1.4 +/- 0.7 h) and the control subjects (Cmax = 5.6 +/- 0.9 mg l-1; tmax = 2.1 +/- 0.9 h). The mean elimination half-life of quinine in the oral contraceptives user group (12.5 +/- 1.9 h) was similar (P greater than 0.05) to that in the control group (11.8 +/- 2.7 h). The oral clearance of quinine in the oral contraceptive user group was 0.133 +/- 0.055 l h-1 kg-1 (range 0.073-0.233) and was not significantly different (P greater than 0.05) from that observed in the control group (0.125 +/- 0.025 l h-1 kg-1, range 0.075-0.148). PMID:2049234

  16. A refractory fixed drug reaction to a dye used in an oral contraceptive.

    PubMed

    Ritter, Steven E; Meffert, Jeffrey

    2004-10-01

    A young woman presented with a classic fixed drug eruption (FDE) after taking the inactive green pills of her oral contraceptives (OCs). The patient's history was unique in that the FDE did not occur every time she took the inactive pills but was refractory, occurring every third month within hours after she took the green pills. After discontinuing the green pills but continuing the active oral contraceptive pills, the patient has not experienced a recurrence of the rash in more than 2 years. This case report reviews the unusual phenomenon of refractory periods in FDEs and highlights the importance of understanding this phenomenon in the diagnosis of drug eruptions. PMID:15551717

  17. Gonadotropin and estradiol secretion during the week of placebo therapy in oral contraceptive pill users.

    PubMed

    van der Spuy, Z M; Sohnius, U; Pienaar, C A; Schall, R

    1990-12-01

    The changes in the hypothalamic-pituitary-ovarian axis during the placebo week in oral contraceptive pill users were assessed. Fifteen women using the combined oral contraceptive pill were studied for eight hours at the start and at the end of the placebo week and gonadotropin secretion and estradiol concentrations were compared with those in control women in the follicular phase of an unmedicated menstrual cycle. Both gonadotropin and estradiol concentrations were suppressed at the start of the placebo week. By day 7 of placebo, gonadotropin concentrations and pulse patterns were indistinguishable from those of the control subjects although estradiol concentrations were still significantly lower.

  18. A randomized double-blind trial of two low dose combined oral contraceptives.

    PubMed

    Bounds, W; Vessey, M; Wiggins, P

    1979-04-01

    Fifty-five women using Loestrin-20 (20 microgram ethinyl oestradiol and 1 mg norethisterone acetate) as an oral contraceptive have been compared with a like number using Microgynon-30 (30 microgram ethinyl oestradiol and 150 microgram levonorgestrel) in a randomized, double-blind trial. Despite the small sample size, the main finding in the trial is clear-cut; Loestrin-20 provides poor cycle control and is thus less acceptable as an oral contraceptive than Microgynon-30. Although there is also a suggestion that Loestrin-20 may be less effective than Microgynon-30, the difference in the accidental pregnancy rates is not statistically significant.

  19. [Vascular risk of oral contraceptive agents: realities and mechanisms. I. Risk evaluation].

    PubMed

    Beaumont, V; Beaumont, J L

    1989-06-17

    The suspected risk of oral contraception was confirmed when large scale epidemiological studies became available. The present work recalls the methodology of a good evaluation, the pros and cons of retrospective and prospective studies, the different appreciations provided by measuring "relative risk" or "attributable risk". In terms of public health, the data obtained supported the necessity to include mortality related to oral contraception in an evaluation of reproductive mortality. This work compares the incidence of vascular complications evaluated through different studies, according to the criteria selected and the type of vascular disease. The advantage of lowering estrogen content is considered. PMID:2525761

  20. Orally disintegrating mini-tablets (ODMTs)--a novel solid oral dosage form for paediatric use.

    PubMed

    Stoltenberg, I; Breitkreutz, J

    2011-08-01

    The new European regulations on paediatric medicines and recent WHO recommendations have induced an increased need for research into novel child-appropriate dosage forms. The aim of this study was the development of orally disintegrating mini-tablets (ODMTs) as a suitable dosage form for paediatric patients. The suitability of five commercially available ready-to-use tableting excipients, Ludiflash, Parteck ODT, Pearlitol Flash, Pharmaburst 500 and Prosolv ODT, to be directly compressed into mini-tablets, with 2 mm in diameter, was examined. All of the excipients are based on co-processed mannitol. Drug-free ODMTs and ODMTs with a child-appropriate dose of hydrochlorothiazide were investigated. ODMTs could be produced with all investigated excipients. ODMTs with a sufficient crushing strength >7 N and a low friability <1% could be obtained, as well as ODMTs with a short simulated wetting test-time <5 s. ODMTs made of Ludiflash showed the best results with crushing strengths from 7.8 N up to 11.8 N and excellent simulated wetting test-times from 3.1 s to 5.0 s. For each excipient, ODMTs with accordance to the pharmacopoeial specification content uniformity could be obtained. The promising results indicate that orally disintegrating mini-tablets may serve as a novel platform technology for paediatrics in future. PMID:21324357

  1. Forgettable contraception.

    PubMed

    Grimes, David A

    2009-12-01

    The term "forgettable contraception" has received less attention in family planning than has "long-acting reversible contraception." Defined here as a method requiring attention no more often than every 3 years, forgettable contraception includes sterilization (female or male), intrauterine devices, and implants. Five principal factors determine contraceptive effectiveness: efficacy, compliance, continuation, fecundity, and the timing of coitus. Of these, compliance and continuation dominate; the key determinants of contraceptive effectiveness are human, not pharmacological. Human nature undermines methods with high theoretical efficacy, such as oral contraceptives and injectable contraceptives. By obviating the need to think about contraception for long intervals, forgettable contraception can help overcome our human fallibility. As a result, all forgettable contraception methods provide first-tier effectiveness (contraceptives today with exclusively first-tier effectiveness is the one that can be started -- and then forgotten for years.

  2. Decreased maximal aerobic capacity with use of a triphasic oral contraceptive in highly active women: a randomised controlled trial

    PubMed Central

    Lebrun, C; Petit, M; McKenzie, D; Taunton, J; Prior, J

    2003-01-01

    Background: Oral contraceptives are commonly used by women athletes. However, their effect on athletic performance is unclear. Objectives: To examine the effects of a moderate dose, triphasic oral contraceptive on measures of athletic performance in highly trained women athletes. Methods: This is a double blind, placebo controlled trial in 14 women with ovulatory menstrual cycles and maximal aerobic capacity (VO2MAX) ≥50 ml/kg/min. Four measures of athletic performance were tested: VO2MAX, anaerobic capacity (anaerobic speed test), aerobic endurance (time to fatigue at 90% of VO2MAX), and isokinetic strength (Cybex II dynamometer). Height, weight, and six skinfold measurements were also recorded. All these observational tests were completed during both the follicular and mid-luteal phases of an ovulatory menstrual cycle. Cycle phases were confirmed by assaying plasma oestradiol and progesterone. Participants were subsequently randomly assigned to either a tricyclic oral contraceptive or placebo and retested in identical fashion (oral contraceptive phase). Results: Absolute and relative changes in VO2MAX from follicular to oral contraceptive phase decreased in the oral contraceptive group by 4.7%, whereas the placebo group showed a slight increase (+1.5%) over the same time period. Two of the women taking oral contraceptive had decreases of 4 and 9 ml/kg/min. In contrast, most women in the placebo group improved or maintained VO2MAX. There was also a significant increase in the sum of skinfolds in women taking oral contraceptive compared with those taking placebo (p<0.01). There were no significant changes in other physiological variables (maximum ventilation, heart rate, respiratory exchange ratio, packed cell volume) or measures of performance (anaerobic speed test, aerobic endurance, isokinetic strength) as a function of oral contraceptive treatment. Conclusions: The decrease in VO2MAX that occurs when oral contraceptive is taken may influence elite sporting

  3. Effects of the Menstrual Cycle and Oral Contraception on Singers' Pitch Control

    ERIC Educational Resources Information Center

    La, Filipa M. B.; Sundberg, Johan; Howard, David M.; Sa-Couto, Pedro; Freitas, Adelaide

    2012-01-01

    Purpose: Difficulties with intonation and vibrato control during the menstrual cycle have been reported by singers; however, this phenomenon has not yet been systematically investigated. Method: A double-blind randomized placebo-controlled trial assessing effects of the menstrual cycle and use of a combined oral contraceptive pill (OCP) on pitch…

  4. Factor V Leiden: should we screen oral contraceptive users and pregnant women?

    PubMed Central

    Vandenbroucke, J. P.; van der Meer, F. J.; Helmerhorst, F. M.; Rosendaal, F. R.

    1996-01-01

    The factor V Leiden mutation is the most common genetic risk factor for deep vein thrombosis: it is present in about 5% of the white population. The risk of deep vein thrombosis among women who use oral contraceptives is greatly increased by the presence of the mutation. The same seems to be true of the risk of postpartum thrombosis. Several authors have called for all women to be screened before prescription of oral contraceptives and during pregnancy. Such a policy might deny effective contraception to a substantial number of women while preventing only a small number of deaths due to pulmonary emboli. Moreover, in pregnancy the ensuing use of oral anticoagulation prophylaxis might carry a penalty of fatal bleeding that is equal to or exceeds the risk of death due to postpartum thrombosis. It might pay, however, to take a personal and family history of deep vein thrombosis when prescribing oral contraceptives or at a first antenatal visit to detect women from families with a tendency to multiple thrombosis. Images p1129-a PMID:8916702

  5. Meta-analysis of the role of oral contraceptive agents in inflammatory bowel disease.

    PubMed

    Godet, P G; May, G R; Sutherland, L R

    1995-11-01

    Numerous epidemiological studies have been performed to determine factors that might contribute to the development of inflammatory bowel disease. Although the role of oral contraceptive agents in Crohn's disease (CD) and ulcerative colitis (UC) have been assessed, most studies were of small sample size and characterised by low statistical precision. A meta-analysis was performed to increase the statistical power and to investigate the association between the use of oral contraceptives and the development of CD and UC. The study was based on a search of a Medline database from 1975 to October 1993 and a review of reference lists from published articles, reviews, symposia proceedings, and abstracts from major gastrointestinal meetings. All studies specifically designed to evaluate this association were selected. The combined results of nine studies--two cohort studies (30,379 unexposed and 30,673 exposed patients) and seven case-control studies (482 CD, 237 UC, and 3198 controls)--which satisfied our selection criteria were evaluated. The pooled relative risk (adjusted for smoking) associated with oral contraceptive use was 1.44 (1.12, 1.86) for CD and 1.29 (0.94, 1.77) for UC. These results suggest modest associations between the use of oral contraceptives and the development of CD and UC. As these associations are weak, non-causal explanations for the findings cannot be eliminated.

  6. [DVT and combined oral contraceptives: update of the pluridisciplinary CNGOF-FNCGM-GEHT-SFMV group].

    PubMed

    Chabbert-Buffet, N; Guigues, B; Trillot, N; Biron, C; Morange, P; Pernod, G; Scheffler, M; Brugere, S; Hedon, B

    2013-06-01

    Thrombotic risk among combined oral contraceptives (COC) users has recently been debated following a court action initiated by a patient. Recent epidemiological data, as well as accumulating biological data underlying these data, have led French Health authorities to modify COC prescription and reimbursement modalities. A short synthesis is proposed by a multidisciplinary group of experts from four French societies (CGOF, FNCGM, GHT, and SFMV).

  7. 21 CFR 310.501 - Patient package inserts for oral contraceptives.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    .... 310.501 Section 310.501 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... concerning the increased risks associated with cigarette smoking and oral contraceptive use. (5) A discussion..., Division of Reproductive and Urologic Products, Food and Drug Administration, 10903 New Hampshire...

  8. 21 CFR 310.501 - Patient package inserts for oral contraceptives.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    .... 310.501 Section 310.501 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... concerning the increased risks associated with cigarette smoking and oral contraceptive use. (5) A discussion..., Division of Reproductive and Urologic Products, Food and Drug Administration, 10903 New Hampshire...

  9. 21 CFR 310.501 - Patient package inserts for oral contraceptives.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    .... 310.501 Section 310.501 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... concerning the increased risks associated with cigarette smoking and oral contraceptive use. (5) A discussion..., Division of Reproductive and Urologic Products, Food and Drug Administration, 10903 New Hampshire...

  10. 21 CFR 310.501 - Patient package inserts for oral contraceptives.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    .... 310.501 Section 310.501 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... concerning the increased risks associated with cigarette smoking and oral contraceptive use. (5) A discussion..., Division of Reproductive and Urologic Products, Food and Drug Administration, 10903 New Hampshire...

  11. Factor V Leiden: should we screen oral contraceptive users and pregnant women?

    PubMed

    Vandenbroucke, J P; van der Meer, F J; Helmerhorst, F M; Rosendaal, F R

    1996-11-01

    The factor V Leiden mutation is the most common genetic risk factor for deep vein thrombosis: it is present in about 5% of the white population. The risk of deep vein thrombosis among women who use oral contraceptives is greatly increased by the presence of the mutation. The same seems to be true of the risk of postpartum thrombosis. Several authors have called for all women to be screened before prescription of oral contraceptives and during pregnancy. Such a policy might deny effective contraception to a substantial number of women while preventing only a small number of deaths due to pulmonary emboli. Moreover, in pregnancy the ensuing use of oral anticoagulation prophylaxis might carry a penalty of fatal bleeding that is equal to or exceeds the risk of death due to postpartum thrombosis. It might pay, however, to take a personal and family history of deep vein thrombosis when prescribing oral contraceptives or at a first antenatal visit to detect women from families with a tendency to multiple thrombosis.

  12. A double-blind, placebo-controlled evaluation of the effect of oral doses of rizatriptan 10 mg on oral contraceptive pharmacokinetics in healthy female volunteers.

    PubMed

    Shadle, C R; Liu, G; Goldberg, M R

    2000-03-01

    Rizatriptan (MAXALT), a potent, oral 5-HT1B/1D agonist with a rapid onset of action, is available now for the acute treatment of migraine. This study examined the pharmacokinetic and clinical interaction between rizatriptan 10 mg and the components (ethinyl estradiol [EE] 35 micrograms and norethindrone [NET] 1.0 mg) of a well-established oral contraceptive combination product, ORTHO-NOVUM 1/35. Levels of sex hormone binding globulin (SHBG), a protein increased by EE to which NET binds, were also examined. In this two-period crossover study, 20 healthy young female subjects received a coadministration of 8 days of rizatriptan treatment (6 days of single-dose 10 mg rizatriptan and 2 days of multiple-dose rizatriptan, 10 mg q 4 hours for three doses, giving a total daily dose of 30 mg on Days 7 and 8) or matching placebo along with their daily dose (one tablet) of ORTHO-NOVUM 1/35 within their oral contraceptive cycle. Plasma was sampled for EE, NET, and SHBG concentrations. Safety evaluations included routine laboratory safety studies, physical examinations, and monitoring for ECG, vital signs, and adverse events. There were no statistically significant differences in any of the pharmacokinetic parameters of EE or NET between the rizatriptan and placebo treatment periods, thus indicating that rizatriptan had no meaningful effect on the disposition of either the EE or the NET component of ORTHO-NOVUM 1/35. The SHBG concentration did not change throughout the entire study. Clinically, coadministration of rizatriptan with ORTHO-NOVUM 1/35 was well tolerated. Blood pressure, heart rate, and temperature showed no consistent trend or clinically important changes. Adverse events following coadministration of rizatriptan with ORTHO-NOVUM 1/35 were similar to those reported when placebo was given with ORTHO-NOVUM 1/35. The findings of this study indicate that there is little potential for dosages as high as 30 mg/day, the maximum recommended dosing schedule, of rizatriptan

  13. Enhanced oral bioavailability of felodipine by novel solid self-microemulsifying tablets.

    PubMed

    Jing, Boyu; Wang, Zhiyuan; Yang, Rui; Zheng, Xia; Zhao, Jia; Tang, Si; He, Zhonggui

    2016-01-01

    The novel self-microemulsifying (SME) tablets were developed to enhance the oral bioavailability of a poor water-soluble drug felodipine (FDP). Firstly, FDP was dissolved in the optimized liquid self-microemusifying drug delivery systems (SMEDDS) containing Miglyol® 812, Cremophor® RH 40, Tween 80 and Transcutol® P, and the mixture was solidified with porous silicon dioxide and crospovidone as adsorbents. Then after combining the solidified powders with other excipients, the solid SME tablets were prepared by wet granulation-compression method. The prepared tablets possessed satisfactory characterization; the droplet size of the SME tablets following self-emulsification in water was nearly equivalent to the liquid SMEDDS (68.4 ± 14.0 and 64.4 ± 12.0 nm); differential scanning calorimetry (DSC) and powder X-ray diffractometry (PXRD) analysis demonstrated that FDP in SME tablets had undergone a polymorphism transition from a crystal form to an amorphous state, which was further confirmed by transmission electron microscopy (TEM). A similar dissolution performance of SME tablets and liquid SMEDDS was also obtained under the sink condition (85% within 10 min), both significantly higher than commercial tablets. The oral bioavailability was evaluated for the SME tablets, liquid SMEDDS and commercial conventional tablets in the fasted beagle dogs. The AUC of FDP from the SME tablets was about 2-fold greater than that of conventional tablets, but no significant difference was found when compared with the liquid SMEDDS. Accordingly, these preliminary results suggest that this formulation approach offers a useful large-scale producing method to prepare the solid SME tablets from the liquid SMEDDS for oral bioavailability equivalent enhancement of poorly soluble FDP. PMID:26177197

  14. The link between oral contraceptive use and prevalence in autism spectrum disorder.

    PubMed

    Strifert, Kim

    2014-12-01

    Autism spectrum disorder (ASD) is a group of developmental disabilities that include full syndrome autism, Asperger's syndrome, and other pervasive developmental disorders. The identified prevalence of ASD has increased in a short time period across multiple studies causing some to conclude that it has reached epidemic proportions in the U.S. Many possible explanations for the rise in numbers of individuals diagnosed with ASD have been offered and yet, causes and contributing factors for ASD are inadequately understood. Current evidence suggests that both genetics and environment play a part in causing ASD. One possible risk factor for the increase in prevalence has been profoundly overlooked in the existing biomedical and epidemiologic literature. As the prevalence of ASD has risen in the last sixty years, so has the prevalence of the usage of the oral contraceptives and other modern hormonal delivery methods. In 1960 about one million American women were using oral contraceptives, today close to 11 million women in the U.S. use oral contraceptives. Eighty-two percent of sexually active women in the U.S. have used oral contraceptives at some point during their reproductive years. Thus, the growth in use of progesterone/estrogen-based contraceptives in the United State has reached near-ubiquitous levels among women in the child-bearing age range. The suppression of ovulation produced by estrogen-progesterone is an indisputable abnormality. It is logical to consider the outcome of the ovum that would have been normally released from the ovary during ovulation. To date there is no comprehensive research into the potential neurodevelopmental effects of oral contraceptive use on progeny. The issue has been only sparsely considered in the biomedical literature. This article hypothesizes that the compounds, estrogen and progesterone, used in oral contraceptives modify the condition of the oocyte and give rise to a potent risk factor that helps explain the recent increase

  15. Contraceptive Development.

    ERIC Educational Resources Information Center

    Troen, Philip; And Others

    This report provides an overview of research activities and needs in the area of contraceptive development. In a review of the present state, discussions are offered on the effectiveness and drawbacks of oral contraceptives, intrauterine devices, barrier methods, natural family planning, and sterilization. Methods of contraception that are in the…

  16. Contraceptive knowledge and attitudes of Austrian adolescents after mass media reports linking third-generation oral contraceptives with an increased risk of venous thromboembolism.

    PubMed

    Egarter, C; Strohmer, H; Lehner, R; Földy, M; Leitich, H; Berghammer, P

    1997-09-01

    We performed a representative survey to determine the level of knowledge of 1,010 Austrian adolescents aged 14 to 24 years about selected facts relating to the recent massive news coverage of the increase in the risk of venous thromboembolism in users of third-generation oral contraceptives and to assess the contraceptive behavior of this population. The overall use rate of oral contraceptives and condoms had increased significantly between 1991 and 1996. Sixty-six percent of the adolescents surveyed stated not having heard or read any media reports on oral contraceptives. Only 8% of those who had knew that most reports focused on the pill as a possible cause of venous thromboembolism, whereas the majority of respondents indicated that the media conveyed doubts regarding the health safety of oral contraceptives in general. Nearly half of adolescents were unable to define what a thrombosis was. Thus, although the mass media play an important role in transmitting medical information, the dissemination of practical, accurate advice on the risks of a drug and competent patient counseling is reserved for the health care professionals. PMID:9347204

  17. Part III: the convenience of, and patient preference for, zolmitriptan orally disintegrating tablet.

    PubMed

    Dowson, Andrew J; Almqvist, Per

    2005-01-01

    As part of an optimal strategy for the management of migraine, the individual needs and preferences of patients need to be considered when of patients need to be considered when prescribing treatments. Zolmitriptan has been available as a conventional oral tablet for more than seven years, and is established as a highly effective, well-tolerated compound for the acute treatment of migraine. A bioequivalent, orally disintegrating tablet (ODT) of zolmitriptan, which dissolves on the tongue without the need for additional fluid intake, has been developed. In a study designed to compare patient preference for zolmitriptan ODT and conventional oral sumatriptan tablets, > 60% of the 186 patients questioned had an overall preference for zolmitriptan ODT, with > 80% of patients reporting that this was the more convenient and less disruptive therapy to take. Approximately 90% of patients agreed that, unlike a conventional tablet, zolmitriptan ODT can be taken wherever and whenever a migraine occurs. When patient preference for zolmitriptan ODT and the ODT formulation of rizatriptan was compared in 171 migraineurs, 70% had an overall preference for zolmitriptan ODT to be superior to rizatriptan ODT with respect to taste and aftertaste, as well as packaging. In summary, not only is zolmitriptan ODT a convenient tablets, such as the sumatriptan oral tablet, but patients generally consider it to be a more attractive option for the acute treatment of migraine than the orally disintegrating version of rizatriptan.

  18. MHC-correlated odour preferences in humans and the use of oral contraceptives

    PubMed Central

    Roberts, S. Craig; Gosling, L. Morris; Carter, Vaughan; Petrie, Marion

    2008-01-01

    Previous studies in animals and humans show that genes in the major histocompatibility complex (MHC) influence individual odours and that females often prefer odour of MHC-dissimilar males, perhaps to increase offspring heterozygosity or reduce inbreeding. Women using oral hormonal contraceptives have been reported to have the opposite preference, raising the possibility that oral contraceptives alter female preference towards MHC similarity, with possible fertility costs. Here we test directly whether contraceptive pill use alters odour preferences using a longitudinal design in which women were tested before and after initiating pill use; a control group of non-users were tested with a comparable interval between test sessions. In contrast to some previous studies, there was no significant difference in ratings between odours of MHC-dissimilar and MHC-similar men among women during the follicular cycle phase. However, single women preferred odours of MHC-similar men, while women in relationships preferred odours of MHC-dissimilar men, a result consistent with studies in other species, suggesting that paired females may seek to improve offspring quality through extra-pair partnerships. Across tests, we found a significant preference shift towards MHC similarity associated with pill use, which was not evident in the control group. If odour plays a role in human mate choice, our results suggest that contraceptive pill use could disrupt disassortative mate preferences. PMID:18700206

  19. Emergency contraception.

    PubMed

    2012-12-01

    Despite significant declines over the past 2 decades, the United States continues to have teen birth rates that are significantly higher than other industrialized nations. Use of emergency contraception can reduce the risk of pregnancy if used up to 120 hours after unprotected intercourse or contraceptive failure and is most effective if used in the first 24 hours. Indications for the use of emergency contraception include sexual assault, unprotected intercourse, condom breakage or slippage, and missed or late doses of hormonal contraceptives, including the oral contraceptive pill, contraceptive patch, contraceptive ring (ie, improper placement or loss/expulsion), and injectable contraception. Adolescents younger than 17 years must obtain a prescription from a physician to access emergency contraception in most states. In all states, both males and females 17 years or older can obtain emergency contraception without a prescription. Adolescents are more likely to use emergency contraception if it has been prescribed in advance of need. The aim of this updated policy statement is to (1) educate pediatricians and other physicians on available emergency contraceptive methods; (2) provide current data on safety, efficacy, and use of emergency contraception in teenagers; and (3) encourage routine counseling and advance emergency-contraception prescription as 1 part of a public health strategy to reduce teen pregnancy. This policy focuses on pharmacologic methods of emergency contraception used within 120 hours of unprotected or underprotected coitus for the prevention of unintended pregnancy. Emergency contraceptive medications include products labeled and dedicated for use as emergency contraception by the US Food and Drug Administration (levonorgestrel and ulipristal) and the "off-label" use of combination oral contraceptives.

  20. Safety, efficacy and patient satisfaction with continuous daily administration of levonorgestrel/ethinylestradiol oral contraceptives.

    PubMed

    Benagiano, Giuseppe; Carrara, Sabina; Filippi, Valentina

    2009-01-01

    The progestational steroid norgestrel was synthesized and tested between 1960 and 1965 through an international cooperation between Wyeth, USA and Schering, Berlin. It is a mixture of two "enantiomers," with only one form (designated as levonorgestrel) biologically active. When taken orally, it is rapidly absorbed, not subjected to a "first-pass" effect and is approximately 90% bioavailable, with a circulating half-life around 15 hours. Its contraceptive action is exerted at the central (hypothalamic) and peripheral (cervical mucus and endometrium) levels. Levonorgestrel (LNG), alone or in combination with ethinyl estradiol (EE), is the most widely employed contraceptive progestin: it is used in combined oral contraceptives, progestogen-only pills, long-acting contraceptive implants, intrauterine contraceptive systems and in emergency contraception. It is also the steroid of choice for new oral contraceptive regimens aimed at reducing the frequency of bleeding episodes. This novel approach, already tried more than 30 years ago, gained interest around the year 2000 when surveys of women's attitudes toward monthly menstrual bleeding started to show a major change: more and more women declared that they would welcome a hormonal contraceptive method that reduced bleeding episodes to 4, 2 or even 1 per year. At this point, while the debate on the significance and "usefulness" of menstruation went on, attention focused on new regimens. The first new modality consisted of changing the 7-day medication-free interval, either shortening it to fewer than 7 days, or by the administration of low-dose estrogens during the interval between packages. Then, continuous administration regimens started to be investigated. This, however, did not happen suddenly, since, in specific situations, doctors had for years empirically utilized various continuous administration regimens. The first extended-cycle oral contraceptive regimen introduced in clinical practice is an 84-day regimen that

  1. Acetaminophen-containing chewable tablets with suppressed bitterness and improved oral feeling.

    PubMed

    Suzuki, Hiroyuki; Onishi, Hiraku; Hisamatsu, Seiji; Masuda, Kosuke; Takahashi, Yuri; Iwata, Masanori; Machida, Yoshiharu

    2004-06-18

    The aim of this study was to develop acetaminophen chewable tablets with suppressed bitterness and improved oral feeling by examination of hard fats as the matrix base and of sweetening agents as corrigents. Witepsol H-15, W-35, S-55, E-75 and E-85, and Witocan H and 42/44 were used as hard fats. Witocan H and 42/44 were selected in view of improved oral feeling. Witocan H/Witocan 42/44 mixture tablets showed different melting characteristics and drug release rates dependent on their ratios, and those with the Witocan H/Witocan 42/44 ratio of 92.5% (w/w) and more showed good drug release. Sucrose, xylitol, saccharin, saccharin sodium, aspartame and sucralose were used as sweetening agents, and applied alone or with Benecoat BMI-40 or cocoa powder. The Witocan H tablet with 1% (w/w) saccharin plus 5% (w/w) Benecoat BMI-40 (Sc1-B5), and the Witocan H/Witocan 42/44 (92.5:7.5, w/w) mixture tablet with 1% (w/w) aspartame plus 5% (w/w) Benecoat BMI-40 suppressed bitterness and sweetness excellently, but the former tablet showed better drug release. Thus, the Witocan H tablet with Sc1-B5 is suggested as the best acetaminophen chewable tablet, exhibiting suppressed bitterness, low sweetness, improved oral feeling and good drug release.

  2. Massive postoperative pulmonary embolism in a young woman using oral contraceptives: the value of a preoperative anesthetic consult.

    PubMed

    Amar, S; Van Boven, M; Rooijakkers, H; Momeni, M

    2014-01-01

    We describe the case of a woman with a history of active tabagism and on the oral contraceptive Yasmin, presenting in the Post-Anesthesia Care Unit (PACU) with a cardiac arrest due to massive pulmonary embolism following transforaminal lumbar interbody fusion surgery. The patient had preoperatively several risk factors for deep venous thrombosis. This case-report emphasizes the value of a preoperative anesthetic visit and eventual temporary cessation of certain oral contraceptives in specific cases. PMID:25223166

  3. Homozygous patients with APC resistance may remain paucisymptomatic or asymptomatic during oral contraception.

    PubMed

    Girolami, A; Simioni, P; Girolami, B; Radossi, P

    1996-09-01

    The effect of oral contraceptive therapy was studied in five patients with homozygous activated protein C resistance. Patients with this congenital abnormality, in contrast to those with antithrombin, protein C or protein S deficiencies, showed only a mild thrombotic tendency. In fact, only two of six observations (one patient took the pill on two separate occasions many years apart) showed deep vein thrombosis. No patient had pulmonary embolism. Two additional patients had a superficial vein thrombosis of the legs. In two instances, a superficial vein thrombosis and a deep vein thrombosis, concomitant risk factors were present (immobilization and surgery for an ovarian cyst, respectively). However, compared with heterozygous for the same abnormality, the symptomatic homozygous patients with APC resistance appeared to develop thrombosis after a shorter period of oral contraception.

  4. Encephalopathy in renovascular hypertension associated with the use of oral contraceptives.

    PubMed Central

    Bradley, J. R.; Reynolds, J.; Williams, P. F.; Appleton, D. S.

    1986-01-01

    Two female patients aged 19 years and 27 years presented with hypertensive encephalopathy and were subsequently found to have renal artery stenosis due to fibromuscular dysplasia. Both patients had had normal blood pressures recorded within the previous 6 months whilst taking the oral contraceptive pill. Their neurological state returned to normal with hypertensive control and in one case the hypertension was cured by dilatation of the renal artery stenosis by balloon angioplasty. Images Figure 1 Figure 2 PMID:3114727

  5. Plasma fibrinogen in women: relationships with oral contraception, the menopause and hormone replacement therapy.

    PubMed

    Lee, A J; Lowe, G D; Smith, W C; Tunstall-Pedoe, H

    1993-04-01

    Plasma fibrinogen was measured in 4837 women aged 25-64 years as part of the Scottish Heart Health Study and Scottish MONICA population surveys. The relationships of oral contraceptive use, the menopause and hormone replacement therapy were examined. Univariate analyses found that women with a history of oral contraceptive use, premenopausal women and those on hormone replacement therapy all had significantly lower fibrinogen levels than women who had never used oral contraceptives, postmenopausal women and non-hormone replacement users respectively. These differences persisted after age standardization. On multivariate analysis, menopausal status and hormone replacement therapy had independent effects on fibrinogen levels. Together with the common risk factors, 9.9% of the total variation in plasma fibrinogen levels was explained. However, less than 1% of this was from the combined menopausal and hormonal factors. These results confirm a postmenopausal rise in fibrinogen level which may be relevant to an increased risk of coronary heart disease. In addition, a protective effect with hormone replacement therapy is noted, although this was probably due to selection bias.

  6. Resting state alpha frequency is associated with menstrual cycle phase, estradiol and use of oral contraceptives

    PubMed Central

    Brötzner, Christina P.; Klimesch, Wolfgang; Doppelmayr, Michael; Zauner, Andrea; Kerschbaum, Hubert H.

    2014-01-01

    Ongoing intrinsic brain activity in resting, but awake humans is dominated by alpha oscillations. In human, individual alpha frequency (IAF) is associated with cognitive performance. Noticeable, performance in cognitive and emotional tasks in women is associated with menstrual cycle phase and sex hormone levels, respectively. In the present study, we correlated frequency of alpha oscillation in resting women with menstrual cycle phase, sex hormone level, or use of oral contraceptives. Electroencephalogram (EEG) was recorded from 57 women (aged 24.07±3.67 years) having a natural menstrual cycle as well as from 57 women (aged 22.37±2.20 years) using oral contraceptives while they sat in an armchair with eyes closed. Alpha frequency was related to the menstrual cycle phase. Luteal women showed highest and late follicular women showed lowest IAF or center frequency. Furthermore, IAF as well as center frequency correlated negatively with endogenous estradiol level, but did not reveal an association with endogenous progesterone. Women using oral contraceptives showed an alpha frequency similar to women in the early follicular phase. We suggest that endogenous estradiol modulate resting alpha frequency. PMID:25010817

  7. Development and evaluation of cetirizine HCl taste-masked oral disintegrating tablets.

    PubMed

    Douroumis, Dionysios Dennis; Gryczke, Andreas; Schminke, Silke

    2011-03-01

    The purpose of the current study was to mask the taste of cetirizine HCl and to incorporate the granules produced in oral disintegrating tablets (ODT). The bitter, active substance was coated by fluidized bed coating using Eudragit® RL30-D at levels between 15% and 40% w/w. The ODTs were developed by varying the ratio of superdisintegrants such as sodium croscarmellose, crospovidone grades and low substituted hydroxypropyl cellulose (L-HPC). A direct compression process was used to compress the ODTs under various compaction forces to optimize tablet robustness. The properties of the compressed tablets including porosity, hardness, friability and dissolution profiles were further investigated. The in vitro and in vivo evaluation of the tablet disintegration times showed almost identical rapid disintegration below 10 s at the optimal levels of each superdisintegrant. Finally, the taste and sensory evaluation in human volunteers demonstrated excellence in masking the bitter active and tablet palatability.

  8. Development and evaluation of orally disintegrating tablets (ODTs) containing Ibuprofen granules prepared by hot melt extrusion.

    PubMed

    Gryczke, Andreas; Schminke, Silke; Maniruzzaman, Mohammed; Beck, Julien; Douroumis, Dennis

    2011-09-01

    In the current study Ibuprofen was embedded in a methacrylate copolymer (Eudragit® EPO) matrix to produce solid dispersions by hot-melt extrusion (HME) processing. The obtained granules were incorporated in orally disintegrating tablets (ODTs). The tablets were developed by varying the ratio of superdisintegrants such as sodium croscarmellose and crosslinked polyvinylpyrrolidone grades while a direct compression process was used to compress the ODTs under various compaction forces to optimize tablet robustness. The properties of the compressed tablets which included porosity, hardness, friability and dissolution profiles were further evaluated and compared with Nurofen® Meltlet ODTs. The taste and sensory evaluation in human volunteers demonstrated excellence in masking the bitter active and improved tablet palatability.

  9. Chitosan-based mucoadhesive tablets for oral delivery of ibuprofen.

    PubMed

    Sogias, Ioannis A; Williams, Adrian C; Khutoryanskiy, Vitaliy V

    2012-10-15

    Chitosan and its half-acetylated derivative have been compared as excipients in mucoadhesive tablets containing ibuprofen. Initially the powder formulations containing the polymers and the drug were prepared by either co-spray drying or physical co-grinding. Polymer-drug interactions and the degree of drug crystallinity in these formulations were assessed by infrared spectroscopy and differential scanning calorimetry. Tablets were prepared and their swelling and dissolution properties were studied in media of various pHs. Mucoadhesive properties of ibuprofen-loaded and drug-free tablets were evaluated by analysing their detachment from pig gastric mucosa over a range of pHs. Greater polymer-drug interactions were seen for spray-dried particles compared to co-ground samples and drug loading into chitosan-based microparticles (41%) was greater than the corresponding half-acetylated samples (32%). Swelling and drug release was greater with the half-acetylated chitosan tablets than tablets containing the parent polymer and both tablets were mucoadhesive, the extent of which was dependent on substrate pH. The results illustrate the potential sustained drug delivery benefits of both chitosan and its half-acetylated derivative as mucoadhesive tablet excipients. PMID:22842627

  10. Why Iranian married women use withdrawal instead of oral contraceptives? A qualitative study from Iran

    PubMed Central

    2010-01-01

    Background Withdrawal as a method of birth control is still used in Iran. The aim of this study was to explore married women's perspectives and attitudes on withdrawal use instead of oral contraceptive (OC) in Tehran, Iran. Methods This was a qualitative study. Participants were 50 married women, not currently pregnant, not desiring pregnancy and who had been using withdrawal for contraception. Face-to face interviews were conducted to collect data. Content analysis was performed to analyze the data. Results Four major themes were extracted from the interviews: advantages, disadvantages, barriers for OC use, and husband-related factors. Advantages of withdrawal use were identified as: easy to use, convenient, ease of access, natural. Even those participants who had experienced unwanted pregnancy while using withdrawal, relied on withdrawal as their contraceptive method. Disadvantages of OC included concerns about side effects. Barriers related to use of OC included the need for medical advice, vaginal examination and daily use. Husband-related factors included: the husband wanted to be the primary decision maker on the number of children and that he preferred withdrawal. Conclusion Health providers should address misunderstandings that exist about OC and highlight the non-contraceptive health benefits of OC to balance the information provided for women. We suggest that not only women but also their spouses be advised in family planning programs. PMID:20509885

  11. Development of oral dispersible tablets containing prednisolone nanoparticles for the management of pediatric asthma.

    PubMed

    Chen, Yi-Dan; Liang, Zhong-Yuan; Cen, Yan-Yan; Zhang, He; Han, Mei-Gui; Tian, Yun-Qiao; Zhang, Jie; Li, Shu-Jun; Yang, Da-Sheng

    2015-01-01

    The purpose of the present study was to develop oral dispersible tablets containing prednisolone (PDS)-loaded chitosan nanoparticles using microcrystalline cellulose (MCC 101), lactose, and croscarmellose sodium (CCS). The PDS-loaded chitosan nanoparticles were formulated by ionotropic external gelation technique in order to enhance the solubility of PDS in salivary pH. Prepared nanoparticles were used for the development of oral fast disintegrating tablets by direct compression method. The prepared tablets were evaluated for disintegration time (DT), in vitro drug release (DR), thickness, weight variation, drug content uniformity, friability, and hardness. The effect of concentrations of the dependent variables (MCC, lactose, CCS) on DT and in vitro DR was studied. Fast disintegrating tablets of PDS can be prepared by using MCC, CCS, and lactose with enhanced solubility of PDS. The minimum DT was found to be 15 seconds, and the maximum DR within 30 minutes was 98.50%. All independent variables selected for the study were statistically significant. Oral fast disintegrating tablets containing PDS nanoparticles could be the better choice for the pediatric patients that would result in better patient compliance. From this study, it can be concluded that fast disintegrating tablets could be a potential drug delivery technology for the management of asthma in pediatrics.

  12. Development of oral dispersible tablets containing prednisolone nanoparticles for the management of pediatric asthma.

    PubMed

    Chen, Yi-Dan; Liang, Zhong-Yuan; Cen, Yan-Yan; Zhang, He; Han, Mei-Gui; Tian, Yun-Qiao; Zhang, Jie; Li, Shu-Jun; Yang, Da-Sheng

    2015-01-01

    The purpose of the present study was to develop oral dispersible tablets containing prednisolone (PDS)-loaded chitosan nanoparticles using microcrystalline cellulose (MCC 101), lactose, and croscarmellose sodium (CCS). The PDS-loaded chitosan nanoparticles were formulated by ionotropic external gelation technique in order to enhance the solubility of PDS in salivary pH. Prepared nanoparticles were used for the development of oral fast disintegrating tablets by direct compression method. The prepared tablets were evaluated for disintegration time (DT), in vitro drug release (DR), thickness, weight variation, drug content uniformity, friability, and hardness. The effect of concentrations of the dependent variables (MCC, lactose, CCS) on DT and in vitro DR was studied. Fast disintegrating tablets of PDS can be prepared by using MCC, CCS, and lactose with enhanced solubility of PDS. The minimum DT was found to be 15 seconds, and the maximum DR within 30 minutes was 98.50%. All independent variables selected for the study were statistically significant. Oral fast disintegrating tablets containing PDS nanoparticles could be the better choice for the pediatric patients that would result in better patient compliance. From this study, it can be concluded that fast disintegrating tablets could be a potential drug delivery technology for the management of asthma in pediatrics. PMID:26640367

  13. Bioavailability, pharmacokinetics, and safety of riociguat given as an oral suspension or crushed tablet with and without food

    PubMed Central

    Frey, Reiner; Becker, Corina; Unger, Sigrun; Wensing, Georg; Mück, Wolfgang

    2016-01-01

    Abstract Riociguat is approved for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Some patients have difficulty swallowing tablets; therefore, 2 randomized, nonblinded, crossover studies compared the relative bioavailability of riociguat oral suspensions and immediate-release (IR) tablet and of crushed-tablet preparations versus whole IR tablet. In study 1, 30 healthy subjects received 5 single riociguat doses: 0.3 and 2.4 mg (0.15 mg/mL suspensions), 0.15 mg (0.03 mg/mL), and 1.0 mg (whole IR tablet) under fasted conditions and 2.4 mg (0.15 mg/mL) after a high-fat, high-calorie American-style breakfast. In study 2, 25 healthy men received 4 single 2.5-mg doses: whole IR tablet and crushed IR tablet suspended in applesauce and water, respectively, under fasted conditions, and whole IR tablet after a continental breakfast. In study 1, dose-normalized pharmacokinetics of riociguat oral suspensions and 1.0-mg whole IR tablet were similar in fasted conditions; 90% confidence intervals for riociguat area under the curve (AUC) to dose and mean maximum concentration (Cmax) to dose were within bioequivalence criteria. After food, dose-normalized AUC and Cmax decreased by 15% and 38%, respectively. In study 2, riociguat exposure was similar for all preparations; AUC ratios for crushed-IR-tablet preparations to whole IR tablet were within bioequivalence criteria. The Cmax increased by 17% for crushed IR tablet in water versus whole IR tablet. Food intake decreased Cmax of the whole tablet by 16%, with unaltered AUC versus fasted conditions. Riociguat bioavailability was similar between the oral suspensions and the whole IR tablet; exposure was similar between whole IR tablet and crushed-IR-tablet preparations. Minor food effects were observed. Results suggest that riociguat formulations are interchangeable. PMID:27162630

  14. Formulation and in vivo evaluation of ondansetron orally disintegrating tablets using different superdisintegrants.

    PubMed

    Sheshala, Ravi; Khan, Nurzalina; Chitneni, Mallikarjun; Darwis, Yusrida

    2011-11-01

    The aim of this study was to formulate cost effective taste-masked orally disintegrating tablets of ondansetron, a bitter drug using different superdisintegrants by a wet granulation technique. Microcrystalline cellulose (Avicel) as a diluent and disintegrant in addition to aspartame as a sweetener were used in all formulations. The prepared tablets were evaluated for weight variation, thickness, hardness, friability, drug content, water content, in vitro disintegration time and in vitro drug release. The tablets' hardness was maintained in the range of 2-3 kg and friability was <1% for all batches. All tablet formulations disintegrated rapidly in vitro within 5.83 to 33.0 sec. The optimized formulation containing 15% Polyplasdone XL-10 released more than 90% of drug within 5 min and the release was comparable to that of a commercial product. In human volunteers, optimized formulation was found to have a pleasant taste and mouth feel and they disintegrated in the oral cavity within 12 sec. The stability results were also satisfactory. A pharmacokinetic study with the optimized formulation was performed in comparison with a reference (Zofer MD 8®) and they were found to be bioequivalent. In conclusion, a cost effective ondansetron orally disintegrating tablet was successfully prepared with acceptable hardness, desirable taste and rapid disintegration in the oral cavity.

  15. Effect of Oral Contraceptive Pills on the Blood Serum Enzymes and DNA Damage in Lymphocytes Among Users.

    PubMed

    Naz, Falaq; Jyoti, Smita; Rahul; Akhtar, Nishat; Siddique, Yasir Hasan

    2016-07-01

    The continuous use of synthetic hormones as contraceptive pill or hormonal replacement therapy among women is increasing day by day. The widespread use of different formulations as oral contraceptives by women throughout their reproductive cycle has given rise to a serious concern for studying the effects of oral contraceptives on enzymatic profile and DNA damage in peripheral blood lymphocytes among users. The present study was carried out on women taking oral contraceptives. The study was based on the questionnaire having the information of reproductive history, fasting, age, health, nature of menstrual cycle, bleeding and other disease. The profile of the blood serum enzymes i.e. alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), lactate dehydrogenase (LDH), aminotransferases (SGOT and SGPT), serum proteins (albumin and globulin) and DNA damage in lymphocytes was studied among users and non-users. The results of the present study suggest that OCs not only effects enzymatic activity but also results in DNA damage that may vary with the duration of using oral contraceptives. A significant increase in LDH, GGT, SGPT, SGOT, globulin and decrease in ALP as well as albumin was found among users as compared to non-users. The observed DNA damage was more in users as compared to non-users. Hormonal contraceptives seem to exert DNA damage and also have significant effects on blood serum enzymes. PMID:27382200

  16. Extended regimen combined oral contraception: A review of evolving concepts and acceptance by women and clinicians

    PubMed Central

    Nappi, Rossella E.; Kaunitz, Andrew M.; Bitzer, Johannes

    2016-01-01

    ABSTRACT Objectives: The clinical utility of extended regimen combined oral contraceptives (COCs) is increasingly being recognised. Our objective was to understand the attitudes of women and clinicians about the use of these regimens. We present the rationale for extended regimen COCs from a historical perspective, and trace their evolution and growing popularity in light of their clinical benefits. We conclude by offering potential strategies for counselling women about extended regimen COC options. Methods: We conducted a MEDLINE search to identify and summarise studies of extended regimen COCs, focusing on attitudes of women and clinicians regarding efficacy, safety/tolerability and fewer scheduled bleeding episodes and other potential benefits. Results: The body of contemporary literature on extended regimen COCs suggests that their contraceptive efficacy is comparable to that of conventional 28-day (i.e., 21/7) regimens. For women seeking contraception that allows infrequent scheduled bleeding episodes, particularly those who suffer from hormone withdrawal symptoms and cyclical symptoms (e.g., headache, mood changes, dysmenorrhoea, heavy menstrual bleeding), extended regimen COCs are an effective and safe option. Although satisfaction with extended regimen COCs in clinical trials is high, misperceptions about continuous hormone use may still limit the widespread acceptance of this approach. Conclusions: Despite the widespread acceptance among clinicians of extended regimen COCs as an effective and safe contraceptive option, these regimens are underused, likely due to a lack of awareness about their availability and utility among women. Improved patient education and counselling regarding the safety and benefits of extended regimen COCs may help women make more informed contraceptive choices. PMID:26572318

  17. Clinical Trial of a Combination of Lynestrenol and Mestranol (Lyndiol) as an Oral Contraceptive Agent

    PubMed Central

    Rice-Wray, Edris; Becerra, Carmen; Esquivel, Julio; Maqueo, Manuel

    1966-01-01

    Contraception with lynestrenol-mestranol (Lyndiol) was studied in 332 Mexican women during a period of two and one-half years. Side effects were minimal or transient. No pregnancies occurred in those who took the medication according to instructions. The women were followed with yearly pelvic examinations and Papanicolaou smears, serial endometrial biopsies and extensive studies of blood, liver and glandular function. Complete ophthalmological studies were done on 30 patients. No clinical or laboratory evidence of harmful effects could be demonstrated. Return to ovulation (using pregnanediol excretion and endometrial biopsies as parameters) occurred in all of 22 women studied in the first three post-treatment cycles. Eight posttreatment pregnancies and the resulting offspring were normal. The first post-treatment cycle, as with other oral contraceptives, was unpredictable and tended to be prolonged. It varied in length from 22 to 60 days. ImagesFig. 3Fig. 4 PMID:5332557

  18. Formulation and Characterization of Oral Mucoadhesive Chlorhexidine Tablets Using Cordia myxa Mucilage

    PubMed Central

    Moghimipour, Eskandar; Aghel, Nasrin; Adelpour, Akram

    2012-01-01

    Background The dilution and rapid elimination of topically applied drugs due to the flushing action of saliva is a major difficulty in the effort to eradicate infections of oral cavity. Utilization a proper delivery system for incorporation of drugs has a major impact on drug delivery and such a system should be formulated for prolonged drug retention in oral cavity. Objectives The aim of the present study was the use of mucilage of Cordia myxa as a mucoadhesive material in production of chlorhexidine buccal tablets and its substitution for synthetic polymers such as HPMC. Materials and Methods The influence of mucilage concentration on the physicochemical responses (hardness, friability, disintegration time, dissolution, swelling, and muco-adhesiveness strength) was studied and swelling of mucilage and HPMC were compared. The evaluated responses included pharmacopoeial characteristics of tablets, the force needed to separate tablets from mucosa, and the amount of water absorbed by tablets. Results In comparison to HPMC, the rise of mucilage concentration in the formulations increased disintegration time, drug dissolution rate, and reduced MDT. Also, compared to 30% HPMC, muco-adhesiveness strength of buccal tablets containing 20% mucilage was significantly higher. Conclusions It can be concluded that the presence of Cordia myxa powdered mucilage may significantly affect the tablet characteristics, and increasing in muco-adhesiveness may be achieved by using 20% w/w mucilage. PMID:24624170

  19. Spray dried excipient base: a novel technique for the formulation of orally disintegrating tablets.

    PubMed

    Mishra, Dina Nath; Bindal, Madhu; Singh, Shailendra Kumar; Vijaya Kumar, Sengodan Gurusamy

    2006-01-01

    Orally disintegrating tablets (ODT) are gaining popularity over conventional tablets due to their convenience in administration and suitability for patients having dysphagia. Moreover no water is required for swallowing the tablets and hence suitable for geriatric, pediatric and traveling patients. The purpose of this study is to assess the suitability of spray dried excipient base in the formulation of ODTs of Valdecoxib (low aqueous solubility) and Metoclopramide (high aqueous solubility). Spray dried excipient base was prepared using Scientech spray drier. Super disintegrants (such as Ac-Di-Sol, Kollidon CL, sodium starch glycolate), diluent (mannitol) alongwith sweetening agent (aspartame) were used in the formulation of tablets. The tablets were evaluated for hardness, friability, water absorption ratio, disintegration time (DT) and in vitro drug release. Using the same excipients, the tablets were prepared by direct compression and were evaluated in the similar way. Maximum drug release and minimum DT were observed with Kollidon CL excipient base as compared to tablets prepared by direct compression, showing the superiority of the spray dried excipient base technique over direct compression technique.

  20. [The role of age, smoking habits, and oral contraceptives in the frequency of myocardial infarction in young women (author's transl)].

    PubMed

    Goldzieher, J W

    1980-01-01

    Owing to the discussion aroused by different papers which have appeared in the last few years on the possible side-effects of oral contraceptives, an examination is made in this paper of the methods used in some of these studies, trying to elucidate to what extent we can trust the conclusions obtained, in order to decide whether oral contraceptives, by themselves, are a real and considerable risk to women's health, and analysing the role of oral contraceptives associated with other risk factors which can influence the frequency of myocardial infarction in young women. It is concluded that the use of oral contraceptives does not represent a statistically significant risk and, therefore, a causal inference cannot be attributed to them; but there exist other risk factors which prove to be of statistically demonstrable danger for myocardial infarction, such as smoking and obesity. Also, it seems evident that the combined effect of smoking and oral contraceptive use is synergistic. However, even though these two factors associated can increase the risk of myocardial infarction, we must not dismiss the possibility of this increment being influenced by other, equally logical circumstances.

  1. Effects of menstrual cycle phase and oral contraceptives on alertness, cognitive performance, and circadian rhythms during sleep deprivation

    NASA Technical Reports Server (NTRS)

    Wright, K. P. Jr; Badia, P.; Czeisler, C. A. (Principal Investigator)

    1999-01-01

    The influence of menstrual cycle phase and oral contraceptive use on neurobehavioral function and circadian rhythms were studied in healthy young women (n = 25) using a modified constant routine procedure during 24 h of sleep deprivation. Alertness and performance worsened across sleep deprivation and also varied with circadian phase. Entrained circadian rhythms of melatonin and body temperature were evident in women regardless of menstrual phase or oral contraceptive use. No significant difference in melatonin levels, duration, or phase was observed between women in the luteal and follicular phases, whereas oral contraceptives appeared to increase melatonin levels. Temperature levels were higher in the luteal phase and in oral contraceptive users compared to women in the follicular phase. Alertness on the maintenance of wakefulness test and some tests of cognitive performance were poorest for women in the follicular phase especially near the circadian trough of body temperature. These observations suggest that hormonal changes associated with the menstrual cycle and the use of oral contraceptives contribute to changes in nighttime waking neurobehavioral function and temperature level whereas these factors do not appear to affect circadian phase.

  2. How does Intimate Partner Violence Affect Condom and Oral Contraceptive Use in the United States? A Systematic Review of the Literature

    PubMed Central

    Bergmann, Julie N.; Stockman, Jamila K.

    2015-01-01

    INTRODUCTION Intimate partner violence (IPV) is estimated to affect 25% of adult women in the US alone. IPV directly impacts women’s ability to use contraception, resulting in many of unintended pregnancies and STIs. This review examines the relationship between IPV and condom and oral contraceptive use within the United States at two levels: the female victim’s perspective on barriers to condom and oral contraceptive use, in conjunction with experiencing IPV (Aim 1) and the male perpetrator’s perspective regarding condom and oral contraceptive use (Aim 2). STUDY DESIGN We systematically reviewed and synthesized all publications meeting the study criteria published since 1997. We aimed to categorize the results by emerging themes related to each study aim. RESULTS We identified 42 studies that met our inclusion criteria. We found 37 studies that addressed Aim 1. Within this we identified three themes: violence resulting in reduced condom or oral contraceptive use (n=15); condom or oral contraceptive use negotiation (n=15); which we further categorized as IPV due to condom or oral contraceptive request, perceived violence (or fear) of IPV resulting in decreased condom or oral contraceptive use, and sexual relationship power imbalances decreasing the ability to use condoms or oral contraceptives; and reproductive coercion (n=7). We found 5 studies that addressed Aim 2. Most studies were cross-sectional, limiting the ability to determine causality between IPV and condom or oral contraceptive use; however, most studies did find a positive relationship between IPV and decreased condom or oral contraceptive use. CONCLUSIONS Quantitative, qualitative, and mixed methods research has demonstrated the linkages between female IPV victimization/male IPV perpetration and condom or oral contraceptive use. However, additional qualitative and longitudinal research is needed to improve the understanding of dynamics in relationships with IPV and determine causality between IPV

  3. Endometrial Hyperplasia Risk in Relation to Recent Use of Oral Contraceptives and Hormone Therapy

    PubMed Central

    Epplein, Meira; Reed, Susan D.; Voigt, Lynda F.; Newton, Katherine M.; Holt, Victoria L.; Weiss, Noel S.

    2008-01-01

    Purpose Examine the relationship between recent use of oral contraceptives and hormone therapy and endometrial hyperplasia (EH) risk. Methods Cases comprised women diagnosed with complex EH (n=289) or atypical EH (n=173) between 1985-2003. One age-matched control was selected for each case; excluded were women with a prior hysterectomy or diagnosis of EH or endometrial cancer. Hormone use in the six months prior to the date of the case’s first symptoms was ascertained using a pharmacy database and medical records. Odds ratios (OR) and 95% confidence intervals (CI) were calculated. Results Three (1.1%) cases had used oral contraceptives, compared to sixteen (6.0%) controls (OR = 0.2, 95% CI: 0.0–0.6). Fifty-one (16.8%) cases had taken estrogen-only hormone therapy, in contrast to two (0.7%) controls (OR = 37.6, 95% CI: 8.8–160.0). The risk of EH among estrogen plus progestin hormone users did not differ from that of non-users (OR = 0.7, 95% CI: 0.4–1.1). Conclusions This study suggests that previous findings of the association of estrogen-only hormone therapy with increased risk of EH and the lack of an association between estrogen plus progestin hormone therapy and EH risk are likely to apply to both complex EH and atypical EH. Further examination of the association between oral contraceptives and EH, with greater numbers of OC users, is warranted. PMID:19064186

  4. Use of a monophasic, low-dose oral contraceptive in relation to mental functioning.

    PubMed

    Deijen, J B; Duyn, K J; Jansen, W A; Klitsie, J W

    1992-10-01

    The objective of the study was to evaluate the effect of Minulet, a new low-dose oral contraceptive on mood in two groups and to compare the effect with a control group of women not taking oral contraceptives (OC). The women participating were between 16 and 45 years of age. They completed the Amsterdam Mood Questionnaire (AMQ) and the Sickness Impact Profile (SIP) three times. They were filled in before treatment started, after taking Minulet for one month and then again after three months. The questionnaires were filled in by a group of 200 women who had not taken OC before (starters), and by a second group of 370 women who were already taking OC (switchers). A group of 140 women who did not use any OC during the study served as a control group. These women also filled in the same questionnaires, both at the start, and after one and three months. As far as the AMQ was concerned, the switchers appeared in the initial measurement to have significantly higher scores (that is to say, a worse mood) for "tiredness", "depression", "moodiness", "anxiety" and "anger", than those of the starters and the control group. Moreover, the switchers had reduced scores (that is to say, an improved mood) on the AMQ-scales during their use of Minulet compared to their initial use of oral contraceptives. The scores of the starters and the control group on the AMQ-scales remained unchanged on all three measurements. It can be concluded from this that these groups felt as well as they did before.(ABSTRACT TRUNCATED AT 250 WORDS)

  5. The effect of oral contraceptives in malaria infections in rhesus monkeys*

    PubMed Central

    Collins, William E.; Campbell, Carlos C.; Barber, Ann; Skinner, Jimmie C.; Huong, Alan Y.

    1984-01-01

    Rhesus monkeys, Macaca mulatta, were treated with the oral contraceptives Brevicon (norethisterone with ethinylestradiol) and Ovral (norgestrel with ethinylestradiol), and subsequently inoculated with the simian malaria parasites Plasmodium cynomologi bastianellii or P. coatneyi. Parasitological, serological, and serum biochemical studies indicated that although there were some significant differences, in general the patterns of response to infection in both treated and control animals were similar. During the primary infection, however, Brevicon resulted in increased levels of parasitaemia, whereas Ovral resulted in decreased parasitaemias, as compared with the untreated control animals. There were no differences in the responses following secondary parasite infection. PMID:6333297

  6. Cardiovascular risk and combined oral contraceptives: clinical decisions in settings of uncertainty.

    PubMed

    Beller, Jennifer P; McCartney, Christopher R

    2013-01-01

    Although generally safe, combined oral contraceptives (COCs) are associated with risks, including an estimated 2-fold increased relative risk of cardiovascular events. For most women taking COCs for contraception, absolute cardiovascular risks are very low, and the overall risks of COCs are outweighed by the risks of unwanted pregnancy. Nonetheless, risks of COCs may be excessive in some women, and both the American College of Obstetricians (ACOG) and the World Health Organization (WHO) have offered contraindications for COC use. Complicating this issue, COCs are commonly used for reasons other than contraception (eg, polycystic ovary syndrome, which is associated with subfertility and cardiovascular risk factors). Thus, in some clinical scenarios, ACOG and WHO guidelines may offer incomplete guidance regarding whether COC use would be associated with an unacceptable risk-benefit ratio. We propose that cardiovascular risk calculators may be helpful in some patients, as an adjunct to ACOG and WHO guidelines, by allowing physicians to estimate the attributable risk of COC-related cardiovascular events.

  7. Relationship satisfaction and outcome in women who meet their partner while using oral contraception.

    PubMed

    Roberts, S Craig; Klapilová, Katerina; Little, Anthony C; Burriss, Robert P; Jones, Benedict C; DeBruine, Lisa M; Petrie, Marion; Havlícek, Jan

    2012-04-01

    Hormonal variation over the menstrual cycle alters women's preferences for phenotypic indicators of men's genetic or parental quality. Hormonal contraceptives suppress these shifts, inducing different mate preference patterns among users and non-users. This raises the possibility that women using oral contraception (OC) choose different partners than they would do otherwise but, to date, we know neither whether these laboratory-measured effects are sufficient to exert real-world consequences, nor what these consequences would be. Here, we test for differences in relationship quality and survival between women who were using or not using OC when they chose the partner who fathered their first child. Women who used OC scored lower on measures of sexual satisfaction and partner attraction, experienced increasing sexual dissatisfaction during the relationship, and were more likely to be the one to initiate an eventual separation if it occurred. However, the same women were more satisfied with their partner's paternal provision, and thus had longer relationships and were less likely to separate. These effects are congruent with evolutionary predictions based on cyclical preference shifts. Our results demonstrate that widespread use of hormonal contraception may contribute to relationship outcome, with implications for human reproductive behaviour, family cohesion and quality of life.

  8. Relationship satisfaction and outcome in women who meet their partner while using oral contraception

    PubMed Central

    Roberts, S. Craig; Klapilová, Kateřina; Little, Anthony C.; Burriss, Robert P.; Jones, Benedict C.; DeBruine, Lisa M.; Petrie, Marion; Havlíček, Jan

    2012-01-01

    Hormonal variation over the menstrual cycle alters women's preferences for phenotypic indicators of men's genetic or parental quality. Hormonal contraceptives suppress these shifts, inducing different mate preference patterns among users and non-users. This raises the possibility that women using oral contraception (OC) choose different partners than they would do otherwise but, to date, we know neither whether these laboratory-measured effects are sufficient to exert real-world consequences, nor what these consequences would be. Here, we test for differences in relationship quality and survival between women who were using or not using OC when they chose the partner who fathered their first child. Women who used OC scored lower on measures of sexual satisfaction and partner attraction, experienced increasing sexual dissatisfaction during the relationship, and were more likely to be the one to initiate an eventual separation if it occurred. However, the same women were more satisfied with their partner's paternal provision, and thus had longer relationships and were less likely to separate. These effects are congruent with evolutionary predictions based on cyclical preference shifts. Our results demonstrate that widespread use of hormonal contraception may contribute to relationship outcome, with implications for human reproductive behaviour, family cohesion and quality of life. PMID:21993500

  9. [Angiodysplasia of moya-moya type disclosed by choreic unvoluntary abnormal movements during oral contraception. Apropos of 2 cases].

    PubMed

    Pelletier, J; Cabanot, C; Lévrier, O; Thuillier, J N; Chérif, A A

    1997-07-01

    Two seventeen year-old women, developed acute onset left choreic movements following two months and two weeks use of oral contraceptives. Left hemiparesia appeared a few days later, while involuntary movements discontinued. Cranial CT scan and MRI showed bilateral ischemic lesion in the frontal region for the first case and isolated lesion in the right centrum ovale for the second. Angiography showed nearly complete obstruction of the terminal portion of the internal carotid artery with an outline Moya-Moya network. After discontinuing oral contraceptives, there has been no relapse of neurologic dysfunction for more than three years for the first case and twelve months for the second one. The role of perfusion insufficiency in limb-shaking carotid transient ischemic attack is discussed and the possible relations between oral contraceptives, chorea and angiographic features resembling Moya-Moya disease are evaluated. PMID:9684005

  10. Knowledge and attitudes of Latin American gynecologists regarding unplanned pregnancy and use of combined oral contraceptives

    PubMed Central

    Bahamondes, Luis; Lira-Plascencia, Josefina; Martin, Ricardo; Marin, Victor; Makuch, Maria Y

    2015-01-01

    Background Unintended pregnancy is a public health problem and unmet medical need worldwide. It is estimated that in the year 2012, almost 213 million pregnancies occurred, and the global pregnancy rate decreased only slightly from 2008 to 2012. It was also estimated that 85 million pregnancies (40% of all pregnancies) were unintended and that 38% ended in an unintended birth. Objectives To assess knowledge and attitudes of Latin American (LA) obstetricians and gynecologists (OBGYNs) regarding unintended pregnancies and aspects of combined oral contraceptive (COC) use. Methods A survey was conducted during a scientific meeting about contraception in 2014, in which OBGYNs from 12 LA countries who provide attention in contraception were invited to respond to a multiple-choice questionnaire to assess their knowledge and attitudes regarding unplanned pregnancy and some aspects regarding COC use. Results A total of 210 OBGYNs participated in the study. Their knowledge regarding COC failure was low. The participants reported they believed that their patients habitually forgot to take a pill and that their patients did not know what to do in these situations. They were aware of the benefits of COC use; however, they were less prone to prescribe COCs for the purpose of protecting against ovarian and endometrial cancer, and one-quarter of them had doubts about the association between COC use and cancer risk. Conclusion The interviewed LA OBGYNs showed some flaws in terms of knowledge of COC failure rates and the non-contraceptive benefits and risks of COCs. To adequately counsel their patients regarding COC intake, OBGYNs must be updated regarding all aspects of COC use. PMID:25999766

  11. The underrated benefits of oral contraception: consequences of pregnancy and induced abortion in teenagers.

    PubMed

    Dreyfus, R

    1992-01-01

    If complications occur within a pregnancy planned and brought to term, they often can be dealt with and accepted. They are even more traumatic when they occur in an unwanted pregnancy that could have been prevented through contraception. Teenagers, because of their physical and psychological immaturity and also because of their social environment, seem to suffer with undue frequency from the complications of induced abortion. Its result, for the teenager, is a handicapped future in comparison to other women. Hence, access to contraception is important for all women, and especially for teenagers, in order to avoid such prejudicial situations. It is important, then, to prescribe oral contraception for its efficacy and its short- and long-term innocuousness. Because of her immaturity, the pregnant teenager is at risk: of spontaneous abortion, pre-eclampsia, anemia, hemorrhage, and prematurity. She is also at risk because of the social difficulties she will be facing. This is particularly true in families from developing countries. From birth, the child is also at risk: of low birth weight for the term, mortality in the first year of life, and all risks linked to abandonment, or education by a third party. In a proportion of 13 to 30% in western countries and in a proportion of 3% in East Asia or in Northwest Africa (Maghreb), induced abortions are a reflection of the following: early sexual activity without contraception even if fertility is still low in very young teenagers, absence of social protection or social independence, refusal of forced marriage, and presence or absence of liberal legislation.(ABSTRACT TRUNCATED AT 250 WORDS)

  12. Comparison of Glucosamine Absorption After Administration of Oral Liquid, Chewable, and Tablet Formulations to Dogs.

    PubMed

    Maxwell, Lara K; Regier, Penny; Achanta, Satyanarayana

    2016-01-01

    Glucosamine (GS) is commonly administered as a nutritional supplement to support joint function. Although many supplements are available, the effect of formulation on oral absorption in dogs is unknown. The purpose of this study was to determine the relative bioavailability of GS for liquid, chewable, and tablet formulations containing GS sulfate or hydrochloride and chondroitin sulfate. In a randomized cross-over design, supplements were administered daily for 8 days with a 1 wk washout period between treatments. Liquid or Tablet A was administered to four dogs, whereas Liquid or Tablet B was administered to four additional dogs. When nutraceutical exposure was normalized to the administered dose of GS free base, similar relative bioavailabilities were determined for all three formulations. However, the dose-normalized maximum plasma GS concentration was higher for the liquid supplement (5.5 ± 0.5 μg/mL) than for the two tablets (3.1 ± 0.6 and 2.1 ± 0.6 μg/mL, P < 0.001). Similarly, the time at which maximal plasma GS concentrations occurred was shorter for the liquid formulation (0.7 ± 0.5 hr) than for the two tablets (4.2 ± 0.6 and 5.0 ± 0.6 hr, P < 0.001). These data show that the formulation of joint supplements affects the oral absorption of GS in dogs.

  13. The effects of short-term jump training on bone metabolism in females using oral contraceptives.

    PubMed

    Reiger, Jamie; Yingling, Vanessa R

    2016-01-01

    The purpose of this study was to determine the effect of oral contraceptive use on bone serum markers following a 3-week jumping protocol. Twenty-three females (18-25 years) were grouped as oral contraceptive users (OC+) or non-users (OC-). Following a 3-week observation period, participants completed a 3-week (15-day) jump protocol. Jump sessions consisting of ten 42 cm drop jumps with a 30 s rest interval between jumps were completed each day, 5 days per week. Peak vertical ground reaction force and loading rate were measured and the osteogenic index was calculated. Serum markers for bone formation, bone alkaline phosphatase (BAP) and bone resorption, C-terminal telopeptides of type I collagen (CTX) were measured at three time points (pre-, mid-, post-jump). BAP and CTX increased significantly (P = 0.0017, 0.0488) in both groups post-jump; however, bone metabolic markers were not different between the OC+ and OC- groups. Osteogenic index, ground reaction force and vertical jump height were similar between groups. Correlations between markers of bone metabolism and participants' age at menarche, weight, loading rate and years on OC were not significant. A 3-week jumping protocol was found to be effective in stimulating bone metabolism in both OC+ and OC- groups. PMID:26008875

  14. [Effect of levonorgestrel in the ovulation, endometrium, and spermatozoa for emergency oral contraception].

    PubMed

    Suárez, Víctor J; Zavala, Renzo; Ureta, Juan Manuel; Hijar, Gisely; Lucero, Jorge; Pachas, Paul

    2010-06-01

    There is wide controversy about the mechanism of action of the levonorgestrel used for emergency oral contraception, and many organizations, both scientific as well as from the civil society, show their discrepancy with its use, due to its possible action as an abortion- inducer. In order to evaluate the scientific evidence available on the mechanisms of action of the levonorgestrel used for emergency oral contraception (EOC), a systematic revision was performed in the Medline and Cochrane library databases. We found 444 articles. After reviewing the abstracts, we selected 22 articles, whose complete texts were evaluated. We found that the main mechanism of action of the levonorgestrel, given at the doses recommended for EOC, is the inhibition or retardation of the ovulation, it doesn't affect the spermatozoa in their migration or egg-penetration capacities. No morphological or molecular alterations in the endometrium that could interfere with the implantation of the fertilized egg have been demonstrated. There is no actual scientific evidence available supporting that the use of levonorgestrel for EOC is abortive.

  15. Exogenous Hormone Use: Oral Contraceptives, Postmenopausal Hormone Therapy, and Health Outcomes in the Nurses’ Health Study

    PubMed Central

    Grodstein, Francine; Stampfer, Meir J.; Willett, Walter C.; Hu, Frank B.; Manson, JoAnn E.

    2016-01-01

    Objectives. To review the contribution of the Nurses’ Health Study (NHS) to our understanding of the complex relationship between exogenous hormones and health outcomes in women. Methods. We performed a narrative review of the publications of the NHS and NHS II from 1976 to 2016. Results. Oral contraceptive and postmenopausal hormone use were studied in relation to major health outcomes, including cardiovascular disease and cancer. Current or recent oral contraceptive use is associated with a higher risk of cardiovascular disease (mainly among smokers), melanoma, and breast cancer, and a lower risk of colorectal and ovarian cancer. Although hormone therapy is not indicated primarily for chronic disease prevention, findings from the NHS and a recent analysis of the Women’s Health Initiative indicate that younger women who are closer to menopause onset have a more favorable risk–benefit profile than do older women from use of hormone therapy for relief of vasomotor symptoms. Conclusions. With updated information on hormone use, lifestyle factors, and other variables, the NHS and NHS II continue to contribute to our understanding of the complex relationship between exogenous hormones and health outcomes in women. PMID:27459451

  16. Adiponectin and bone metabolism markers in female rowers: eumenorrheic and oral contraceptive users.

    PubMed

    Jürimäe, J; Vaiksaar, S; Mäestu, J; Purge, P; Jürimäe, T

    2011-12-01

    This study investigated whether adiponectin, bone formation (osteocalcin) and bone resorption [type I carboxyterminal telopeptide (ICTP)] values are influenced by menstrual cycle phase and oral contraceptive use in female rowers. Twenty-four rowers divided into normally cycling athletes (NOC; no.=15) and athletes taking oral contraceptive pills (OC; no.=9) participated in this study. Fasting blood samples, body composition and aerobic capacity measurements were taken during the follicular (FP) and the luteal (LP) phases of the menstrual cycle. Adiponectin, insulin, glucose, insulin resistance, body composition and aerobic capacity did not fluctuate significantly during menstrual cycle in both groups. Osteocalcin and ICTP were lower (p<0.05) in OC compared with NOC, but did not change significantly across menstrual cycle phases in both groups. Estradiol and progesterone were not related to adiponectin, osteocalcin or ICTP (r<0.147; p>0.05). Adiponectin was correlated (p<0.05) with osteocalcin (r=0.452) and fat free mass (r=0.428), and osteocalcin was related (p<0.05) to insulin (r=-0.413), glucose (r=-0.486) and insulin resistance (r=-0.528). In conclusion, adiponectin was not affected by menstrual cycle phase and OC use in female rowers, while bone metabolism markers were lower in OC compared to NOC groups. Adiponectin and osteocalcin were interrelated and may characterise energy homeostasis in female athletes. PMID:21169728

  17. Effects of the oral contraceptive pill cycle on physiological responses to hypoxic exercise

    NASA Technical Reports Server (NTRS)

    Sandoval, Darleen A.; Matt, Kathleen S.

    2003-01-01

    To test whether the oral contraceptive pill cycle affects endocrine and metabolic responses to hypoxic (fraction of inspired oxygen = 13%, P(IO2): 95 mmHg; H) versus normoxic (P(IO2):153 mmHg; N) exercise, we examined eight women (28 +/- 1.2 yr) during the third (PILL) and placebo (PLA) weeks of their monthly oral contraceptive pill cycle. Cardiopulmonary, metabolic, and neuroendocrine measurements were taken before, during, and after three 5-min consecutive workloads at 30%, 45%, and 60% of normoxic V(O2peak) in H and N trials. Heart rate response to exercise was greater in H versus N, but was not different between PILL and PLA. Lactate levels were significantly greater during exercise, and both lactate and glucose levels were significantly greater for 30 min after exercise in H versus N (p < 0.0001). When expressed relative to baseline, lactate levels were lower in PILL versus PLA, but glucose was greater in PILL versus PLA (p < 0.001). Cortisol levels were also significantly greater in PILL versus PLA (p < 0.001). Norepinephrine levels were significantly increased during exercise (p < 0.0001) and in H versus N (p < 0.0001). However, epinephrine levels were not different over time or with trial. Thus, the presence of circulating estradiol and progesterone during the PILL phase reduces glucose and lactate responses to hypoxic exercise.

  18. Oral contraceptive use among female elite athletes and age-matched controls and its relation to low back pain.

    PubMed

    Brynhildsen, J; Lennartsson, H; Klemetz, M; Dahlquist, P; Hedin, B; Hammar, M

    1997-10-01

    Exogenous and endogenous female sex steroids may influence the risk of low back pain. The fact that back pain is a very common symptom during pregnancy supports this theory. Back pain is also more common among female than male athletes. Oral contraceptives have been suggested to increase the risk of low back pain. The aim of this study was to evaluate whether the prevalence of low back pain is higher among oral contraceptive users than non-users and if it differs between women taking part in different sports. A questionnaire was sent to female elite athletes in volleyball (n = 205), basketball (n = 150), and soccer (n = 361) as well as to age-matched controls (n = 113). The questionnaire comprised questions about age, constitution, occupation, parity, and use of contraceptive method as well as previous and current back pain and possible consequences of the back problems. The response rate was 85%. Between 42% and 52% of the women in the different groups used oral contraceptives. The groups were similar in most background variables, except that the volleyball and basketball players were taller. The prevalence of current low back pain was between 21% and 34% in the different athlete groups, with an average of 30%, whereas only 18% of the controls suffered from low back pain (p 0.01). The prevalence of low back pain within each group--athletes as well as controls--was similar in women who used and did not use oral contraceptives. This study does not support the theory that low back pain is affected by the use of oral contraceptives. Instead, constitutional factors and mechanical stress during intense physical activity are probably more important.

  19. The role of oral controlled release matrix tablets in drug delivery systems.

    PubMed

    Nokhodchi, Ali; Raja, Shaista; Patel, Pryia; Asare-Addo, Kofi

    2012-01-01

    Formulations that are able to control the release of drug have become an integral part of the pharmaceutical industry. In particular oral drug delivery has been the focus of pharmaceutical research for many years. This type of drug delivery has been at the centre of research due to its many benefits over conventional dosage. The focus of this review is on matrix tablets due to their widely use and simplicity of the formulation. This includes the discussion of various types of matrix tablets and factors affecting the drug release from these formulations. The mechanism of drug release from HPMC matrices is also discussed. PMID:23678458

  20. Formulation of cyclodextrin inclusion complex-based orally disintegrating tablet of eslicarbazepine acetate for improved oral bioavailability.

    PubMed

    Desai, Samixa; Poddar, Aditi; Sawant, Krutika

    2016-01-01

    The present investigation was aimed towards developing a beta-cyclodextrin (β-CD) solid dispersion (SD) based orally disintegrating tablet (ODT) of eslicarbazepine acetate (ESL), for improving the dissolution and providing fast onset of anti-epileptic action. Optimum ratio of ESL and β-CD was determined by Job's plot. Thereafter, solid dispersions were prepared by solvent evaporation method and evaluated for yield, assay, Differential scanning calorimetry (DSC), Fourier transform infra red spectroscopy (FTIR), X-ray diffraction (XRD), and in vitro dissolution. Optimized SD was compressed into ODT by direct compression using super disintegrants and evaluated for wetting time, drug content, in vitro drug release and in vivo studies. The results of DSC, FTIR and XRD analysis supported the formation of inclusion complex. An improved dissolution with 99.95 ± 2.80% drug release in 60 min was observed in comparison to 24.85 ± 2.96% release from a plain drug suspension. Tablets with crosspovidone as a super disintegrant showed the least disintegration time of 24.66 ± 1.52 s and higher in vitro drug release against marketed tablets. In vivo studies indicated that the formulated tablets had 2 times higher bioavailability than marketed tablets. Thus, the developed β-CD-ESL SD-ODT could provide faster onset of action and higher bioavailability, which would be beneficial in case of epileptic seizures. PMID:26478377

  1. PREPARATION AND CHARACTERIZATION OF ORALLY DISINTEGRATING LORATADINE TABLETS MANUFACTURED WITH CO-PROCESSED MIXTURES.

    PubMed

    Amelian, Aleksandra; Szekalska, Marta; Wilczewska, Agnieszka Zofia; Basa, Anna; Winnicka, Katarzyna

    2016-01-01

    The aim of this study was to develop orally disintegrated tablets (ODT) with loratadine using Parteck ODT and Ludiflash--new commercially available tableting excipients based on co-processed mannitol. ODT containing loratadine were prepared with 3% addition of various superdisintegrants (AcDiSol, Kollidon CL-F and Kollidon CL-SF) by direct compression method. Obtained tablets were characterized for friability, pore structure, and wetting and disintegration time measured by four independents methods. In order to identify possible interactions between loratadine and the excipients, differential scanning calorimetry was used. The results showed that all formulated ODT were characterized by appropriate mechanical properties (friability < 1%), the uniform content of the drug substance and pleasant mouth feeling. Disintegration time below 30 s was observed in formulations with crospovidones as disintegrant. PMID:27180438

  2. Localization of fluconazole in oral cavity by preferential coating of buccoadhesive tablet for treatment of oral thrush

    PubMed Central

    Pathak, Kamla; Sharma, Vijay; Akhtar, Nida; Rastogi, Pragya

    2016-01-01

    Background: The present research work was aimed at localization of fluconazole in the oral cavity by preferential coating of buccoadhesive tablet for the treatment of oral thrush. Materials and Methods: In order to achieve the aim, buccoadhesive tablets were optimized using 32 full factorial design to study the influence of varying content of chitosan and carbopol 934P (input variables) on the responses. Results: Perturbation plots revealed high sensitivity of the input variables to ex vivo mucoadhesion force and percent cumulative drug release (CDR) whereas the ex vivo mucoadhesion time was less sensitive to the input variables. Based on the highest desirability factor of 0.693 the formulation F9 was identified as the optimized formulation and was preferentially coated with ethyl cellulose (3% w/v) on one tablet face to get F9C. In reference to F9, F9C showed superior mucoadhesive features (P < 0.05) but the % CDR was comparable (f2 = 50.80). The preferential coating (F9C, Jss = 0.812 μg/cm2/h) limited the permeation of fluconazole across goat buccal mucosa by almost half the value of F9 (Jss = 1.34 μg/cm2/h) that could serve as an advantage in establishing high local concentration of drug in the oral cavity, thereby facilitating faster attainment of minimum inhibitory concentration. Scanning electron microscopy and histological analysis established nonirritant potential. The developed formulation was stable and demonstrated antifungal activity against Candida albicans. Conclusion: Thus it can be concluded that preferentially coated buccoadhesive tablets of fluconazole might be considered as a precise approach to localize the drug delivery in oral cavity. PMID:27051630

  3. Cancers in Australia in 2010 attributable to and prevented by the use of combined oral contraceptives

    PubMed Central

    Jordan, Susan J; Wilson, Louise F; Nagle, Christina M; Green, Adele C; Olsen, Catherine M; Bain, Christopher J; Pandeya, Nirmala; Whiteman, David C; Webb, Penelope M

    2015-01-01

    Objectives To estimate the proportion and number of cancers occurring in Australia in 2010 attributable to combined oral contraceptive pill (OCP) use. Methods We estimated the population attributable fraction (PAF) for cancers causally associated with combined OCP use (breast, cervix), and the proportion of endometrial and ovarian cancers prevented (prevented fraction [PF]). We used standard formulae incorporating prevalence of combined OCP use in the Australian population, relative risks of cancer associated with this exposure and cancer incidence. Results An estimated 105 breast and 52 cervical cancers (0.7% and 6.4% of each cancer, respectively) in Australia in 2010 were attributable to current use of combined OCP. Past combined OCP use was estimated to have prevented 1,032 endometrial and 308 ovarian cancers in 2010, reducing the number of cancers that would otherwise have occurred by 31% and 19%, respectively. Conclusions A small proportion of breast and cervical cancers is attributable to combined OCP use; OCP use is likely to have prevented larger numbers of endometrial and ovarian cancers. Implications Women seeking contraceptive advice should be told of potential adverse effects, but should also be told that – along with reproductive health benefits – combined OCP use can reduce long-term risks of ovarian and endometrial cancers. PMID:26437729

  4. Bone Mineral Density in Adolescent Females Using Injectable or Oral Contraceptives: A 24 Month Prospective Study

    PubMed Central

    Cromer, Barbara A.; Bonny, Andrea E.; Stager, Margaret; Lazebnik, Rina; Rome, Ellen; Ziegler, Julie; Camlin-Shingler, Kelly; Secic, Michelle

    2008-01-01

    Study Objective To determine whether bone mineral density (BMD) is lower in hormonal contraceptive users than that in an untreated, comparison group. Design Observational, prospective cohort; duration: 24 months. Setting Adolescent clinics in a midwestern, metropolitan setting. Patients 433 postmenarcheal girls, aged 12–18 years, on depot medroxyprogesterone acetate (DMPA) [n=58], oral contraceptives (OC) [n=187], or untreated (n=188). Intervention DMPA and OC containing 100 mcg levonorgestrel and 20 mcg ethinyl estradiol. Main Outcome Measure BMD measurements at spine and femoral neck were obtained with dual x-ray absorptiometry (DXA) at baseline and 6-month intervals. Results Over 24 months, mean percent change in spine BMD was: DMPA −1.5%, OC +4.2%, and untreated +6.3%. Mean percent change in femoral neck BMD was: DMPA −5.2%, OC +3.0%, untreated +3.8%. Statistical significance was found between the DMPA group and other two groups (p<.001). In the DMPA group, mean percent change in spine BMD over the first 12 months was −1.4%; the rate of change slowed to −0.1% over the second 12 months. No bone density loss reached the level of osteopenia. Conclusions Adolescent girls receiving DMPA had significant loss in BMD compared with bone gain in the OC and untreated group. However, its clinical significance is mitigated by slowed loss after the first year of DMPA use and general maintenance of bone density values within the normal range. PMID:18222431

  5. A combined oral contraceptive affects mucosal SHIV susceptibility factors in a pigtail macaque model

    PubMed Central

    Ostergaard, Sharon Dietz; Butler, Katherine; Ritter, Jana M.; Johnson, Ryan; Sanders, Jeanine; Powell, Nathaniel; Lathrop, George; Zaki, Sherif R.; McNicholl, Janet M.; Kersh, Ellen N.

    2015-01-01

    Background Injectable hormonal contraception may increase women’s risk of HIV acquisition, and can affect biological risk factors in animal models of HIV. We established, for the first time, a model to investigate whether combined oral contraceptives (COC) alter SHIV susceptibility in macaques. Methods Seven pigtail macaques were administered a monophasic levonorgestrel (LNG)/ethinyl estradiol (EE) COC at 33% or 66% of the human dose for 60 days. Menstrual cycling, vaginal epithelial thickness and other SHIV susceptibility factors were monitored for a mean of 18 weeks. Results Mean vaginal epithelial thicknesses was 290.8 μm at baseline and 186.2 μm during COC (p=0.0141, Mann Whitney test). Vaginal pH decreased from 8.5 during to 6.5 post- treatment (0.0176 two-tailed t-test). Measured microflora was unchanged. Conclusions COC caused thinning of the vaginal epithelium and vaginal pH changes, which may increase SHIV susceptibility. 0.033 mg LNG + 0.0066 mg EE appeared effective in suppressing ovulation. PMID:25536296

  6. [Gynecological use of a phlebokinetic drug with special reference to its combination with oral contraceptives].

    PubMed

    Cazzola, D

    1975-09-30

    Controlled experiments confirmed the therapeutic usefulness in gynecology of a phlebokinetic drug, in which EPL (polyunsaturated phosphatidylcholine) was combined with escine and rutine. The drug is particularly recommended for the prophylaxis and treatment of vein disorders caused by oral contraceptives. A total of 75 patients were treated with the drug (Essaven), in addition to the usual treatment (such as anticoagulants), while 75 controls received the usual treatment only. Results were excellent in cases of varicose veins, where the symptoms were eliminated in almost all cases. In cases of phlebitis and thrombophlebitis, the response was less univocal, but a definite improvement was evident in a good number of cases treated with Essaven; the drug also favored the return to normal conditions after thrombophlebitis attacks, reducing the duration of their painful aftereffects. The drug can be used daily for very long periods without side effects. It can also be used safely during pregnancy, without adverse effects on the fetus and on delivery. It is regarded as ideal to avoid the side effects of contraceptives on the venous system.

  7. A case-control study of the possible association between oral contraceptives and malignant melanoma.

    PubMed Central

    Adam, S. A.; Sheaves, J. K.; Wright, N. H.; Mosser, G.; Harris, R. W.; Vessey, M. P.

    1981-01-01

    In a case-control study, we investigated 169 women aged 15-49 years with malignant melanoma notified to the Oxford and South Western cancer registries during the years 1971-1976, together with 507 matched controls. Data about medical, reproductive, drug and smoking histories were obtained both by reviewing general practitioner (GP) records and from the women themselves by postal questionnaires. There was no significant evidence of any overall increase in the risk of melanoma in oral contraceptive (OC) users (data from GP records-ever use vs never use, relative risk (RR) 1.34, 95% confidence limits 0.92-1.96; corresponding data from postal questionnaires-RR 1.13, limits 0.73-1.75). However, although not significant, the risk estimated from data in the postal questionnaires was higher in women who had used OCs for 5 years or more (use greater than or equal to 5 years vs never use, RR 1.57, limits 0.83-3.03). Previously demonstrated risk factors for melanoma, such as fair skin, blond or red hair and Celtic origin were found to be commoner in the cases than in the controls. Data from the Oxford/Family Planning Association contraceptive study were also examined. Unexpectedly there was a strong suggestion of a negative association between OC use and melanoma risk, but the analysis was based on only 12 women with the disease. PMID:7259960

  8. Evaluation of body composition during low-dose estrogen oral contraceptives treatment.

    PubMed

    Franchini, M; Caruso, C; Nigrelli, S; Poggiali, C

    1995-01-01

    The effect of two low-dose oral contraceptives (OCs) on weight and body composition was evaluated in 80 family planning clinic outpatients 18-43 years of age. These women were randomly assigned to receive OCs containing either 20 mcg ethinyl estradiol and 150 mcg desogestrel or 30 mcg ethinyl estradiol and 75 mcg gestodene. 20 IUD users served as controls. Anthropometric measurements and body composition (estimated by Bioelectrical Impedance Analysis) were assessed at baseline and after 6 and 12 months of OC use. In all three groups, body weight, body mass index, total body water, and body cellular mass remained unchanged during the 12-month study period. These findings confirm that the new low-dose OCs have no significant effects on body weight or composition.

  9. Programmed oocyte retrieval: clinical and biological effects of oral contraceptives administered before in vitro fertilization.

    PubMed

    Mashiach, S; Dor, J; Goldenberg, M; Shalev, J; Levran, D; Rudak, E; Nebel, L; Goldman, B; Blankstein, J; Ben-Rafael, Z

    1989-06-01

    We have prospectively compared two regimens of suppression of the hypothalamic-pituitary-ovarian axis by oral contraceptives (OCs) for 15 or 30 days and two ovarian stimulation protocols. The latent phase, which represents a period of ovarian insensitivity, was prolonged and directly correlated to the duration of suppression. Thirty days' suppression, compared with 15 days', resulted in the cancellation of more cycles and a lower fertilization and pregnancy percentage. No significant increase in either serum progesterone or luteinizing hormone was noted in suppressed cycles. It is concluded that if programming is desired, OCs should be used for the shortest period possible. The variation in the length of the follicular phase indicates that there is a different 'fixed' day for retrieval for each suppression-stimulation protocol and this day should be established prospectively.

  10. The Combined Influence of Oral Contraceptives and Human Papillomavirus Virus on Cutaneous Squamous Cell Carcinoma

    PubMed Central

    Efird, Jimmy T.; Toland, Amanda E.; Lea, C. Suzanne; Phillips, Christopher J.

    2011-01-01

    The vast majority of cutaneous squamous cell carcinoma (CSCC) will occur in those with fair complexion, tendency to burn, and high ultraviolet radiation (UVR) exposure. Organ transplant recipients also are an important population at great risk for CSCC. An association has been reported between oral contraceptive (OC) use, human papillomavirus virus (HPV) and cervical cancer, and there could be a similar association for CSCC. The cutaneous HPV β-E6 protein, a close cousin of the transformative E6 protein underlying anogenital cancers, has been shown to inhibit apoptosis in response to UVR damage and stimulate morphologic transformation in rodent fibroblast cell lines. Furthermore, OC use has been shown to enhance HPV transcription and may contribute to CSCC risk through this pathway. PMID:21499554

  11. Influence of menstrual cycle, parity and oral contraceptive use on steroid hormone receptors in normal breast.

    PubMed Central

    Battersby, S.; Robertson, B. J.; Anderson, T. J.; King, R. J.; McPherson, K.

    1992-01-01

    Steroid receptor was assessed immunohistochemically in 158 samples of normal breast for variation through the menstrual cycle. Patterns and intensity of reaction were used in a semi-quantitative scoring system to examine the influence of cycle phase, cycle type, parity and age. The changes in oestrogen receptor for natural cycle and oral contraceptive (OC) cycles indicated down-regulation by progestins. Progesterone receptor did not vary significantly in natural cycles, but increased steadily through OC cycles. This study provides strong evidence that both oestrogen and progesterone influence breast epithelium, but dissimilarities from the endometrium are apparent. The interval since pregnancy had a significant negative effect on frequency and score of oestrogen receptor and score of progesterone receptor. Multivariate analysis established the phase of cycle and OC use as independent significant influences on oestrogen receptor. The interval since pregnancy was an independent significant factor for both oestrogen and progesterone receptor presence. Images Figure 1 Figure 2 PMID:1562470

  12. Are oral contraceptives a significant contributor to the estrogenicity of drinking water?

    PubMed

    Wise, Amber; O'Brien, Kacie; Woodruff, Tracey

    2011-01-01

    Recent observed feminization of aquatic animals has raised concerns about estrogenic compounds in water supplies and the potential for these chemicals to reach drinking water. Public perception frequently attributes this feminization to oral contraceptives (OCs) in wastewater and raises concerns that exposure to OCs in drinking water may contribute to the recent rise in human reproductive problems. This paper reviews the literature regarding various sources of estrogens, in surface, source and drinking water, with an emphasis on the active molecule that comes from OCs. It includes discussion of the various agricultural, industrial, and municipal sources and outlines the contributions of estrogenic chemicals to the estrogenicity of waterways and estimates that the risk of exposure to synthetic estrogens in drinking water on human health is negligible. This paper also provides recommendations for strategies to better understand all the potential sources of estrogenic compounds in the environment and possibilities to reduce the levels of estrogenic chemicals in the water supply.

  13. Dolutegravir Has No Effect on the Pharmacokinetics of Oral Contraceptives With Norgestimate and Ethinyl Estradiol

    PubMed Central

    Borland, Julie; Chen, Shuguang; Wajima, Toshihiro; Peppercorn, Amanda F.; Piscitelli, Stephen C.

    2015-01-01

    Background: Dolutegravir (DTG; Tivicay; ViiV Healthcare, Research Triangle Park, NC) is an HIV-1-unboosted integrase inhibitor with no cytochrome P450 or uridine 5′diphosphate-glucuronosyltransferase inhibition or induction. As DTG is administered to HIV-1–infected women receiving oral contraceptives, assessing the potential for drug interactions was warranted. Objective: To determine the impact of DTG on the pharmacokinetics (PK) and pharmacodynamics (PD) of a common oral contraceptive, norgestimate/ethinyl estradiol (NGM/EE; Ortho-Cyclen; Ortho-McNeil-Janssen Pharmaceuticals, Inc, Raritan, NJ). Methods: This randomized, 2-period, double-blind, placebo-controlled study was conducted within 1 menstrual cycle at 1 clinical center in the United States; 16 women were enrolled. Participants received NGM 0.25 mg/EE 0.035 mg throughout the study. During days 1 to 10, they were randomized to receive twice-daily DTG 50 mg or matching placebo with food and switched to the other treatment during days 12 to 21. Results: Ratios of area under the concentration-time curve from time 0 until end of the dosage interval (AUC0-τ), maximum plasma concentration, and concentration at the end of the dosage interval of norelgestromin with DTG treatment to the same PK parameters with placebo treatment were 0.975, 0.890, and 0.932, respectively; for EE, ratios were 1.03, 0.99, and 1.02, respectively. No significant differences in luteinizing hormone, follicle-stimulating hormone, and progesterone were detected on days 1, 10, 11, 21, and 22. DTG steady-state AUC0-τ was similar to historical data. No severe or grade 3/4 adverse events occurred. Conclusions: DTG had no effect on NGM/EE PK or PD. NGM/EE can be administered with DTG without dose adjustment. PMID:25862012

  14. Auxiliary midwife prescription of oral contraceptives. An experimental project in Thailand.

    PubMed

    Rosenfield, A G; Limcharoen, C

    1972-12-01

    In 1969, the Thai Ministry of Public Health initiated a study in which auxiliary midwives in 4 rural provinces were allowed to prescribe oral contraceptives without a physician examination. In rural areas in Thailand there is approximately 1 physician per 110,000 people. However, there is a relative abundance of auxiliary midwives. These women have 10 years basic education and receive an 18 month midwife and public health course. There is 1 such auxiliary midwife per 8000 rural inhabitants. In prescribing oral contraceptives, the auxiliary midwives used a simple checklist to rule out contraindications, and no pelvic examinations were performed. In addition to the 4 rural provinces studied, 13 control provinces were observed;y There was a 4 fold increase in the number of pill acceptors in the 4 study provinces in the 6 months following the initiation of the study in 1969 compared to the 6 months before. There was no increase noted in the incidence of side effects or complications. There was a larger number of pill acceptors and a higher percentage of the eligible female population who accepted the pill in the 4 study provinces than in the 13 control provinces. The continuation rates were higher for pills prescribed by midwives than for those prescribed by physicians. At the end of 1 year of study, the Minstry of Public Health ruled that the more than 3000 auxiliary midwives throughout the country who had received basic family planning training could prescribe the pill, with a resultant 3-fold increase in the number of pill acceptors nationwide, from approximately 8800 in April 1970 to almost 31,000 in December 1971. It is emphasized that the increased utilization of nursing and paramedical personnel is an absolute necessity in many parts of the world.

  15. Hypertensive Crisis and Left Ventricular Thrombi after an Upper Respiratory Infection during the Long-term Use of Oral Contraceptives.

    PubMed

    Suzuki, Natsuko; Suzuki, Keisuke; Mizuno, Tomofumi; Kato, Yukari; Suga, Norihiro; Yoshino, Masabumi; Miura, Naoto; Banno, Shogo; Imai, Hirokazu

    2016-01-01

    A 34-year-old woman who had been using oral contraceptives for 10 years developed hypertensive crisis with papilloedema after an upper respiratory infection. Laboratory data showed hyperreninemic hyperaldosteronism and elevated levels of fibrinogen, fibrin, and fibrinogen degradation products. Echocardiography demonstrated two masses (18 mm) in the left ventricle. On the fourth hospital day, cerebral infarction, renal infarction, and upper mesenteric artery occlusion suddenly occurred despite the blood pressure being well-controlled using anti-hypertensive drugs. Echocardiography revealed the disappearance of the left ventricular masses, which suggested left ventricular thrombi. Cessation of the contraceptives and administration of heparin, warfarin, and anti-platelets drugs improved her general condition.

  16. The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis.

    PubMed

    Zhou, Xiaofang; Li, Ting; Fan, Shangrong; Zhu, Yuxia; Liu, Xiaoping; Guo, Xuedong; Liang, Yiheng

    2016-07-01

    To compare the efficacy and safety of two doses of clotrimazole vaginal tablet 500 mg with two doses of oral fluconazole 150 mg in treating severe vulvovaginal candidiasis (SVVC), 240 consecutive patients with SVVC were studied at the Department of Obstetrics and Gynaecology of Peking University Shenzhen Hospital between June 2014, and September 2015. Patients were randomly assigned in a 1 : 1 ratio to receive treatment with either two doses of clotrimazole vaginal tablet or two doses of oral fluconazole. The clinical cure rates in the clotrimazole group and the fluconazole group at days 7-14 follow-up were 88.7% (102/115) and 89.1% (98/110) respectively; the clinical cure rates at days 30-35 in the two groups were 71.9% (82/114) and 78.0% (85/109) respectively. The mycological cure rates at days 7-14 follow-up in the two groups were 78.3% (90/115) and 73.6% (81/110) respectively. The mycological cure rates of the patients at days 30-35 in the two groups were 54.4% (62/114) and 56.0% (61/109) respectively (P > 0.05). The adverse events of clotrimazole were mainly local. This study demonstrated that two doses of clotrimazole vaginal tablet 500 mg were as effective as two doses of oral fluconazole 150 mg in the treatment of patients with SVVC and could be an appropriate treatment for this disorder.

  17. Iron supplement tablet embedded in the oral cavity mimicking neoplasm: a case report

    PubMed Central

    2016-01-01

    The detection of foreign bodies in the upper-aerodigestive tract is a fairly frequent event and can occur in various areas and for various reasons. In rare cases, foreign bodies can simulate a neoplasia. We evaluated similar cases during emergency regimen with an oral cavity mucosal lesion, causing lockjaw, sore throat, dysphagia, and swelling of the submandibular and laterocervical region. Physical examination revealed an extensive mucosal ulceration in the floor of the mouth and the lateral surface of the tongue, comparable to oral cancer. During a second, more accurate assessment, a partially deteriorated iron supplement tablet was found embedded in a mucosal pocket. After removing the tablet, gradual normalization of the tissue was observed without any sequelae. This is one of the many reasons why it is advisable and useful in cases of oral lesions to collect a detailed medical history and to perform an accurate clinical evaluation, including inspection and palpation of the lesion, before proceeding to further diagnostic assessments, especially in elderly patients taking many medications. However unlikely, it is possible that difficulty in swallowing pills or tablets could generate tumorlike lesions. PMID:27162752

  18. Cycle-Related Changes in Mood, Sexual Desire, and Sexual Activity in Oral Contraception-Using and Nonhormonal-Contraception-Using Couples.

    PubMed

    Elaut, Els; Buysse, Ann; De Sutter, Petra; Gerris, Jan; De Cuypere, Griet; T'Sjoen, Guy

    2016-01-01

    Findings on women's sexuality across the menstrual cycle are inconsistent. One relatively consistent finding is a midcycle and premenstrual peak in sexual desire in freely cycling women. Results on the cycle-related effects on sexual behavior are less clear. Large proportions of reproductive-aged women use combined oral contraception (COC), but studies on potential cycle-related shifts in sexual desire and behavior are sparse. A prospective diary study assessed sexual desire, sexual behavior, and mood in 89 heterosexual couples. Women were using one of four contraceptive methods: (1) nonhormonal contraception, (2) low-dose COC containing 20 mcg ethinylestradiol and 75 mcg gestoden or desogestrel, (3) COC containing 35 mcg ethinylestradiol and 2 mg cyproteronacetate, and (4) COC containing 30 mcg ethinylestradiol and 3 mg drospirenone. No cycle effects of sexual desire were established in the COC group, but frequency of sexual intercourse declined in the last days of active pill taking. These results were similar in both female and male partners. Negative affect did not covary with sexual desire.

  19. A Novel Multilayered Multidisk Oral Tablet for Chronotherapeutic Drug Delivery

    PubMed Central

    Khan, Zaheeda; Choonara, Yahya E.; du Toit, Lisa C.; Ndesendo, Valence M. K.; Pillay, Viness

    2013-01-01

    A Multilayered Multidisk Tablet (MLMDT) comprising two drug-loaded disks enveloped by three drug-free barrier layers was developed for use in chronotherapeutic disorders, employing two model drugs, theophylline and diltiazem HCl. The MLMDT was designed to achieve two pulses of drug release separated by a lag phase. The polymer disk comprised hydroxyethylcellulose (HEC) and ethylcellulose (EC) granulated using an aqueous dispersion of EC. The polymeric barrier layers constituted a combination of pectin/Avicel (PBL) (1st barrier layer) and hydroxypropylmethylcellulose (HPMC) (HBL1 and HBL2) as the 2nd and 3rd barrier layers, respectively. Sodium bicarbonate was incorporated into the diltiazem-containing formulation for delayed drug release. Erosion and swelling studies confirmed the manner in which the drug was released with theophylline formulations exhibiting a maximum swelling of 97% and diltiazem containing formulations with a maximum swelling of 119%. FTIR spectra displayed no interactions between drugs and polymers. Molecular mechanics simulations were undertaken to predict the possible orientation of the polymer morphologies most likely affecting the MLMDT performance. The MLMDT provided two pulses of drug release, separated by a lag phase, and additionally it displayed desirable friability, hardness, and uniformity of mass indicating a stable formulation that may be a desirable candidate for chronotherapeutic drug delivery. PMID:24024200

  20. Relative bioavailability of diclofenac potassium from softgel capsule versus powder for oral solution and immediate-release tablet formulation.

    PubMed

    Bende, Girish; Biswal, Shibadas; Bhad, Prafulla; Chen, Yuming; Salunke, Atish; Winter, Serge; Wagner, Robert; Sunkara, Gangadhar

    2016-01-01

    The oral bioavailability of diclofenac potassium 50 mg administered as a soft gelatin capsule (softgel capsule), powder for oral solution (oral solution), and tablet was evaluated in a randomized, open-label, 3-period, 6-sequence crossover study in healthy adults. Plasma diclofenac concentrations were measured using a validated liquid chromatography-mass spectrometry/mass spectrometry method, and pharmacokinetic analysis was performed by noncompartmental methods. The median time to achieve peak plasma concentrations of diclofenac was 0.5, 0.25, and 0.75 hours with the softgel capsule, oral solution, and tablet formulations, respectively. The geometric mean ratio and associated 90%CI for AUCinf, and Cmax of the softgel capsule formulation relative to the oral solution formulation were 0.97 (0.95-1.00) and 0.85 (0.76-0.95), respectively. The geometric mean ratio and associated 90%CI for AUCinf and Cmax of the softgel capsule formulation relative to the tablet formulation were 1.04 (1.00-1.08) and 1.67 (1.43-1.96), respectively. In conclusion, the exposure (AUC) of diclofenac with the new diclofenac potassium softgel capsule formulation was comparable to that of the existing oral solution and tablet formulations. The peak plasma concentration of diclofenac from the new softgel capsule was 67% higher than the existing tablet formulation, whereas it was 15% lower in comparison with the oral solution formulation. PMID:27119581

  1. Evaluation of the coagulation profile among oral and vaginal combined hormonal contraceptive users using sonoclot coagulation analyzer.

    PubMed

    Brandy, Kyle R; Meyer, Rachel M; Luo, Xianghua; Rao, Gundu H; Datta, Yvonne H; Divani, Afshin A

    2012-11-01

    Combined hormonal contraceptives possess an inherent risk of thrombus-related events. The purpose of this study is to elucidate alterations in the coagulation profile among young women using combined oral contraceptive (COC) or combined vaginal contraceptive (CVC) compared to a normal, healthy, female control group using the Sonoclot coagulation analyzer. We enrolled 159 participants (64 control individuals, 51 COC users, and 44 CVC users). Each participant completed a survey of medical history, family medical history, and lifestyle choices. Citrated venous whole blood was collected and analyzed using the Sonoclot coagulation analyzer. After adjusting for age, race, alcohol consumption, sleeping habits, and family history of cardiovascular disease, and stroke, we observed COC and CVC users had mostly similar coagulation profiles except when compared to the control, and COC and CVC users had an elevated glass bead peak signal while COC users had a shorter peak time.

  2. Determination of the in vitro disintegration profile of rapidly disintegrating tablets and correlation with oral disintegration.

    PubMed

    Abdelbary, G; Eouani, C; Prinderre, P; Joachim, J; Reynier, Jp; Piccerelle, Ph

    2005-03-23

    The assessment of the in vitro disintegration profile of rapidly disintegrating tablets (RDT) is very important in the evaluation and the development of new formulations of this type. So far neither the US Pharmacopoeia nor the European Pharmacopoeia has defined a specific disintegration test for RDT; currently, it is only possible to refer to the tests on dispersible or effervescent tablets for the evaluation of RDT's disintegration capacity. In the present study, we have evaluated the disintegration profile of RDT manufactured by main commercialised technologies, using the texture analyser (TA). In order to simulate as much as possible the oral disintegration of these dosage forms, a new operating structure was developed. This structure mimics the situation in the patient's mouth and provides a gradual elimination of the detached particles during the disintegration process. The obtained time-distance profiles or disintegration profiles enabled the calculation of certain quantitative values as the disintegration onset (t1) and the total disintegration time (t2). These values were used in the characterisation of the effect of test variables as the disintegration medium and temperature on the disintegration time of RDT. Moreover, the oral disintegration time of the same products was evaluated by 14 healthy volunteers. Results obtained when artificial saliva at 37 degrees C was employed as disintegration medium were used to correlate the in vitro (t2) and oral disintegration times. Excellent correlation was found and in addition, we were able to achieve a qualitative measure of the mouthfeel by comparing the thickness of the tablets and the penetration distance obtained from the disintegration profile. This method also permitted the discrimination between different RDT, where differences in the disintegration mechanism were reflected on the disintegration profile achieved for each tablet. PMID:15725551

  3. Impact of active ingredients on the swelling properties of orally disintegrating tablets prepared by microwave treatment.

    PubMed

    Sano, Syusuke; Iwao, Yasunori; Kimura, Susumu; Noguchi, Shuji; Itai, Shigeru

    2014-07-01

    The impact of different active pharmaceutical ingredients (APIs) loading on the properties of orally disintegrating tablets (ODTs) prepared according to our previously reported microwave (MW) treatment process was evaluated using famotidine (FAM), acetaminophen (AAP), and ibuprofen (IBU). None of the APIs interrupted the tablet swelling during the MW treatment and the tablet hardness were improved by more than 20 N. MW treatment, however, led to a significant increase in the disintegration time of the ODTs containing IBU, but it had no impact on that of the ODTs containing FAM or AAP. This increased disintegration time of the ODTs containing IBU was attributed to the relatively low melting point of IBU (Tm=76 °C), with the IBU particles melting during the MW treatment to form agglomerates, which interrupted the penetration of water into the tablets and delayed their disintegration. The effects of the MW treatment on the chemical stability and dissolution properties of ODTs were also evaluated. The results revealed that MW treatment did not promote the degradations of FAM and AAP or delay their release from the ODTs, while dissolution of the ODTs containing IBU delayed by MW treatment. Based on these results, the MW method would be applicable to the preparation of ODTs containing APIs with melting points higher than 110 °C.

  4. Formulation and evaluation of taste-masked levocetirizine dihydrochloride orally disintegrating tablets.

    PubMed

    Devireddy, Srinivas Reddy; Gonugunta, Chandra Sekhara Rao; Veerareddy, Prabhakar Reddy

    2009-01-01

    Orally disintegrating tablets of levocetirizine dihydrochloride were formulated with different superdisintegrants (sodium starch glycollate, croscarmellose sodium, and crospovidone) using mannitol as a diluent. Tulsion-335, Indion-204, and poly kyron T-134 cation exchange resins were used as taste-masking agents. The drug and resin complex was prepared by the kneading method. Ten formulations were prepared with varying combinations of superdisintegrants and ion-exchange resins by the wet granulation technique, using polyvinylpyrrolidone K-30 as the binder. The prepared tablets were evaluated for degree of taste masking, weight variation, hardness, friability, in vitro and in vivo disintegration time, content uniformity, and water absorption ratio. Dissolution studies were performed in two dissolution media: 0.1N HCl and distilled water. The corresponding dissolution rates were compared with the marketed formulation. Differential scanning calorimetry studies were carried out on the drug-resin complexes. Prepared tablets were good in appearance and showed acceptable results for hardness and friability. In vitro and in vivo disintegration times for the optimum formulation (F-1) were found to be 22 and 55 s, respectively. Relatively acceptable taste was achieved with both Indion-204 and Tulsion-335. Rapid disintegration time was achieved in tablets containing crosspovidone as the superdisintegrant. Dissolution studies indicated the formation of the complex of drug and resin. Differential scanning calorimetry studies indicated the formation of drug-resin complex.

  5. Lack of Pharmacokinetic Interactions Between Macitentan and a Combined Oral Contraceptive in Healthy Female Subjects.

    PubMed

    Hurst, Noémie; Pellek, Matthias; Dingemanse, Jasper; Sidharta, Patricia N

    2016-06-01

    Macitentan, a dual endothelin receptor antagonist used in pulmonary arterial hypertension, induces cytochrome P450 (CYP) 3A at supratherapeutic concentrations in vitro. Most combined oral hormonal contraceptives (OCs) are CYP3A substrates and their efficacy can be affected by CYP3A inducers. This randomized crossover study assessed possible pharmacokinetic (PK) interactions between macitentan and an OC containing ethinyl estradiol and norethindrone (or norethisterone). Twenty-six healthy women received a single oral dose of OC alone (reference) and concomitantly with 10 mg macitentan at steady state (test). No PK interaction was concluded if the 90% confidence intervals (CIs) of geometric mean ratios (GMRs; test/reference) of the peak plasma concentration (Cmax ) and the exposure from 0 to infinity (AUC0 - ∞ ) to the OC components were within the equivalence limits of 0.8 to 1.25. Cmax and AUC0-∞ of the OC were within the equivalence limits. For ethinyl estradiol, GMRs (90%CIs) of Cmax and AUC0-∞ were 0.92 (0.85-0.99) and 0.95 (0.90-0.99). For norethindrone, these values were 1.02 (0.95-1.09) and 1.04 (0.98-1.09), respectively. Overall, study treatments were well tolerated. No major changes from baseline in safety parameters were reported in either treatment. Macitentan does not affect the PK of OCs.

  6. Refractory thrombotic thrombocytopenic purpura associated with oral contraceptives and factor V Leiden: a case report

    PubMed Central

    Tsirakis, George; Mantadakis, Elpis; Xylouri, Irini; Foudoulakis, Andreas; Vardaki, Eleftheria; Katsipi, Irene; Daphnis, Eugene; Samonis, George

    2009-01-01

    Introduction Thrombotic microangiopathies constitute a heterogeneous group of diseases characterised by microangiopathic haemolytic anaemia and thrombocytopaenia associated with platelet aggregation in the microcirculation responsible for ischaemic manifestations. Classically, thrombotic microangiopathies are described as encompassing two main syndromes: thrombotic thrombocytopaenic purpura and the haemolytic-uraemic syndrome Many cases of idiopathic thrombotic thrombocytopaenic purpura have, to date, been associated with severe ADAMTS13 metalloprotease deficiency while haemolytic uraemic syndrome usually occurs in the context of normal protease activity. Oestrogens and factor V Leiden have rarely been implicated in the pathogenesis of thrombotic microangiopathy. Case presentation We describe the case of a 17-year-old female with refractory thrombotic thrombocytopaenic purpura. The patient was receiving a new generation of oral contraceptives for dysmenorrhoea and had factor V Leiden. After undergoing prolonged and intense plasma exchange therapy for 40 days and high dose oral corticosteroids therapy for 90 days, our patient recovered fully. Conclusion Patients with refractory thrombotic thrombocytopaenic purpura should likely be evaluated for congenital thrombophilic disorders and for ingestion of drugs that have been associated with this rare form of thrombotic microangiopathy. Identification of these and as yet other unknown genetic and/or acquired risk factors may lead to more judicious treatment approaches. PMID:19829833

  7. Emergency contraception.

    PubMed

    Grimes, David A; Raymond, Elizabeth G

    2002-08-01

    Emergency contraception is used to prevent pregnancy after a coital act not adequately protected by a regular method of contraception. In contrast to early medical abortion, emergency contraception prevents a pregnancy from starting and does not disrupt an established pregnancy. The most commonly used approaches consist of two oral doses of contraceptive steroids. The levonorgestrel-only regimen (levonorgestrel, 0.75 mg, repeated in 12 hours) appears to be more effective and better tolerated than the Yuzpe regimen (ethinyl estradiol, 100 microg, and levonorgestrel, 0.5 mg, repeated in 12 hours). In the largest randomized, controlled trial to date, levonorgestrel prevented about 85% of pregnancies that would have occurred without its use. Hormonal emergency contraception has no known medical contraindications, although it is not indicated for suspected or confirmed pregnancy. However, if hormonal emergency contraception is inadvertently taken in early pregnancy, neither the woman nor the fetus will be harmed. Nausea and vomiting associated with the Yuzpe regimen can be reduced by prophylactic use of meclizine. A strong medical and legal case exists for making hormonal emergency contraception available over the counter, as has happened in countries other than the United States. Easier access to and wider use of emergency contraception could dramatically lower the high rates of unintended pregnancy and induced abortion in the United States. PMID:12160366

  8. Oral contraceptive use, muscle sympathetic nerve activity, and systemic hemodynamics in young women

    PubMed Central

    Harvey, Ronee E.; Hart, Emma C.; Charkoudian, Nisha; Curry, Timothy B.; Carter, Jason R.; Fu, Qi; Minson, Christopher T.; Joyner, Michael J.; Barnes, Jill N.

    2015-01-01

    Endogenous female sex hormones influence muscle sympathetic nerve activity (MSNA), a regulator of arterial blood pressure and important factor in hypertension development. While nearly 80% of American women report using hormonal contraceptives sometime during their life, the influence of combined oral contraceptives (OCs) on MSNA and systemic hemodynamics remains equivocal. The goal of this study was to determine if women taking OCs have altered MSNA and hemodynamics (cardiac output and total peripheral resistance) at rest during the placebo phase of OC use compared to women with natural menstrual cycles during the early follicular phase. We retrospectively analyzed data from studies in which healthy, premenopausal women (ages 18–35 years old) participated. We collected MSNA values at rest and hemodynamic measurements in women taking OCs (n=53, 25±4 yr) and women with natural menstrual cycles (n=74, 25±4 yr). Blood pressure was higher in women taking OCs versus those with natural menstrual cycles (mean arterial pressure: 89±1 vs. 85±1 mmHg, respectively; p=0.01), although MSNA was similar in both groups (MSNA burst incidence: 16±1 vs. 18±1 bursts/100 heartbeats, respectively, p=0.19). In a subset of women in which detailed hemodynamic data were available, those taking OCs (n=33) had similar cardiac output (4.9±0.2 vs. 4.7±0.2 L/min, respectively; p=0.47) and total peripheral resistance (19.2±0.8 vs. 20.0±0.9 units, respectively; p=0.51) as women with natural menstrual cycles (n=22). In conclusion, women taking OCs have higher resting blood pressure and similar MSNA and hemodynamics during the placebo phase of OC use compared to naturally menstruating women in the early follicular phase. PMID:26101348

  9. Pre-gravid oral contraceptive use in relation to birth weight: a prospective cohort study.

    PubMed

    Hatch, Elizabeth E; Hahn, Kristen A; Mikkelsen, Ellen M; Riis, Anders H; Sorensen, Henrik Toft; Rothman, Kenneth J; Wise, Lauren A

    2015-11-01

    Few studies have evaluated the association between pregravid oral contraceptive (OC) use and birth weight, and findings have been conflicting. We conducted a prospective cohort study of 5921 pregnancy planners in Denmark to evaluate recency, duration, and type of OC used before conception in relation to infant birth weight. Participants completed online questionnaires and reported detailed information on contraceptive history and covariates at baseline. Participants completed bimonthly follow-up questionnaires to update their pregnancy status for up to 12 months or until conception occurred. Birth weight data were ascertained from the Danish Medical Birth Registry for 4046 live births delivered by study participants between 2008 and 2010. We used multivariable linear and log-binomial regression analyses to control for confounding. Mean birth weight was higher among women who had used OCs within 0-1 months (mean difference = 97 g, CI 26, 168) or 2-6 months (mean difference = 40 g, CI -5, 85) before conception, compared with more than 12 months before conception. Mean birth weight was lower among women who had used OCs for long durations (mean difference comparing ≥12 with <4 years of OC use = -85 g, CI -158, -11). Our findings indicate that pregravid OC use within 6 months of conception may be associated with a small increase in birth weight, but that long duration of use may have the opposite effect. Results were stronger among male infants, among 2nd and 4th generation OC users, and among users of OCs with a higher estrogen dose.

  10. Oral Contraceptive Use, Muscle Sympathetic Nerve Activity, and Systemic Hemodynamics in Young Women.

    PubMed

    Harvey, Ronee E; Hart, Emma C; Charkoudian, Nisha; Curry, Timothy B; Carter, Jason R; Fu, Qi; Minson, Christopher T; Joyner, Michael J; Barnes, Jill N

    2015-09-01

    Endogenous female sex hormones influence muscle sympathetic nerve activity (MSNA), a regulator of arterial blood pressure and important factor in hypertension development. Although ≈80% of American women report using hormonal contraceptives sometime during their life, the influence of combined oral contraceptives (OCs) on MSNA and systemic hemodynamics remains equivocal. The goal of this study was to determine whether women taking OCs have altered MSNA and hemodynamics (cardiac output and total peripheral resistance) at rest during the placebo phase of OC use compared with women with natural menstrual cycles during the early follicular phase. We retrospectively analyzed data from studies in which healthy, premenopausal women (aged 18-35 years) participated. We collected MSNA values at rest and hemodynamic measurements in women taking OCs (n=53; 25±4 years) and women with natural menstrual cycles (n=74; 25±4 years). Blood pressure was higher in women taking OCs versus those with natural menstrual cycles (mean arterial pressure, 89±1 versus 85±1 mm Hg, respectively; P=0.01), although MSNA was similar in both groups (MSNA burst incidence, 16±1 versus 18±1 bursts/100 heartbeats, respectively; P=0.19). In a subset of women in which detailed hemodynamic data were available, those taking OCs (n=33) had similar cardiac output (4.9±0.2 versus 4.7±0.2 L/min, respectively; P=0.47) and total peripheral resistance (19.2±0.8 versus 20.0±0.9 U, respectively; P=0.51) as women with natural menstrual cycles (n=22). In conclusion, women taking OCs have higher resting blood pressure and similar MSNA and hemodynamics during the placebo phase of OC use when compared with naturally menstruating women in the early follicular phase. PMID:26101348

  11. Effects of oral contraceptives, or lanosterol, on ADP-induced aggregation and binding of /sup 125/I-fibrinogen to rat platelets

    SciTech Connect

    McGregor, L.; Toor, B.; McGregor, J.L.; Renaud, S.; Clemetson, K.J.

    1984-03-01

    The aggregation to ADP and the binding of /sup 125/I-fibrinogen to platelets from rats treated with oral contraceptives or normal platelets treated in vitro with lanosterol were compared to their respective controls. Both types of platelets showed a significant increase in ADP-induced aggregation and in binding of fibrinogen, indicating that the effect of oral contraceptives could be partly due to increased levels of lanosterol in platelet membrane.

  12. Oral contraceptives did not affect biochemical folate indexes and homocysteine concentrations in adolescent females.

    PubMed

    Green, T J; Houghton, L A; Donovan, U; Gibson, R S; O'Connor, D L

    1998-01-01

    The impact of oral contraceptive (OC) use, smoking, and alcohol drinking on biochemical indexes of folate and vitamin B-12 was investigated in 229 adolescents 14-20 years old recruited from advertisements in Ontario, Canada. Subjects completed a life-style questionnaire and a 3-day, weighed food record, followed by overnight fasting and the collection of blood samples. Of the 48 participants (21%) who were OC users, 30 had used the pill for more than 12 months. Only 37 adolescents (16%) smoked, but 94 (60%) had consumed alcohol in the month preceding the study. Median daily intake of folate and vitamin B-12 (including intake from supplements) was 215 mcg and 1.9 mcg, respectively. OC use, smoking, and alcohol consumption were not significantly associated with lower serum or red blood cell folate levels, after controlling for folate intake. Serum homocysteine levels were not correlated with smoking or OC use, but were 13% higher among alcohol drinkers than nondrinkers. Finally, although smoking and alcohol use were not associated with serum B-12 levels, OC use was linked with an estimated 33% lower serum B-12 level than was nonuse. These findings fail to validate concerns that OC use has a negative impact on the folate status of adolescent females, but suggest a need to improve the dietary folate intake of young women who smoke.

  13. Efficacy and safety of combined ethinyl estradiol/drospirenone oral contraceptives in the treatment of acne

    PubMed Central

    Tan, Jerry KL; Ediriweera, Chemanthi

    2010-01-01

    Acne is a common disorder affecting the majority of adolescents and often extends into adulthood. The central pathophysiological feature of acne is increased androgenic stimulation and/or end-organ sensitivity of pilosebaceous units leading to sebum hypersecretion and infundibular hyperkeratinization. These events lead to Propionibacterium acnes proliferation and subsequent inflammation. Hormonal therapy, including combined oral contraceptives (OCs), can attenuate the proximate androgenic trigger of this sequence. For many women, hormonal therapy is a rational option for acne treatment as it may be useful across the spectrum of severity. Drospirenone (DRSP) is a unique progestin structurally related to spironolactone with progestogenic, antimineralocorticoid, and antiandrogenic properties. It is available in 2 combined OC preparations (30 μg EE/3 mg DRSP; Yasmin® in a 21/7 regimen; and 20 μg EE/3 mg DRSP; Yaz® in a 24/4 regimen). These preparations are bereft of the fluid retentional side effects typical of other progestins and their safety has been demonstrated in large epidemiological studies in which no increased risk of vascular thromboembolic disease or arrhythmias was observed. In acne, the efficacy of DRSP-containing OCs has been shown in placebo-controlled superiority trials and in active-comparator non-inferiority trials. PMID:21072290

  14. Sex steroids, sexual behavior, and selection attention for erotic stimuli in women using oral contraceptives.

    PubMed

    Alexander, G M; Sherwin, B B

    1993-01-01

    The relationship between sex steroids and sexual behavior was examined in 19 oral contraceptive users. Retrospective assessment of sexual attitudes were obtained and women completed daily ratings of sexual behavior and well-being for 28 days. Plasma levels of free testosterone (T), estradiol, and progesterone were measured at weekly intervals. In addition, women performed a novel selective attention task designed to measure the strength of the tendency to be distracted by sexual stimuli. Multiple regression analyses using average sexual behavior variables as dependent variables, and hormone levels sexual attitudes and well-being as predictor variables, showed that free T was strongly and positively associated with sexual desire, sexual thoughts, and anticipation of sexual activity. A role for T in attention to sexual stimuli was also supported by the positive correlation between free T and the bias for sexual stimuli in a subgroup of women. These results are consistent with the hypothesis that T may enhance cognitive aspects of women's sexual behavior. PMID:8493300

  15. A prospective treatment study of premenstrual symptoms using a triphasic oral contraceptive.

    PubMed

    Graham, C A; Sherwin, B B

    1992-04-01

    Eighty-two women with complaints of moderate to severe premenstrual symptoms were recruited for a double-blind, controlled trial of a triphasic oral contraceptive (o.c.). Subjects made daily ratings of symptoms for at least one baseline cycle and were then randomly assigned to receive either placebo or o.c. for three months. Twenty-three women dropped out of the study (18 o.c., 5 placebo), 13 failed to show prospective confirmation of moderate to severe premenstrual symptoms, and one placebo subject had an anovulatory cycle. Forty-five women with prospectively-confirmed premenstrual changes (20 o.c., 25 placebo) completed the study. Premenstrual breast pain and bloating were significantly reduced with active treatment compared to placebo (p less than 0.03) but there were no beneficial effects of the o.c. over placebo for any of the mood symptoms. Women who received o.c.s reported decreased sexual interest after starting treatment and this effect was independent of any adverse influence on mood. PMID:1564678

  16. The combined oral contraceptive pill and the assumed 28-day cycle.

    PubMed

    Dowse, M St Leger; Gunby, A; Moncad, R; Fife, C; Smerdon, G; Bryson, P

    2007-07-01

    Some studies involving women taking the combined oral contraceptive pill (COCP) have on occasion assumed the COCP group to have a rigid 28-day pharmaceutically driven cycle. Anecdotal evidence suggests otherwise, with many women adjusting their COCP usage to alter the time between break-through bleeds for sporting and social reasons. A prospective field study involving 533 scuba diving females allowed all menstrual cycle lengths (COCP and non-COCP) to be observed for up to three consecutive years (St Leger Dowse et al. 2006). A total of 29% of women were COCP users who reported 3,241 cycles. Of these cycles, only 42% had a rigid 28-day cycle, with the remainder varying in length from 21 to 60 days. When performing studies involving the menstrual cycle, it should not be assumed that COCP users have a rigid confirmed 28-day cycle and careful consideration should be given to data collection and analysis. The effects of differing data interpretations are shown.

  17. Relative impact of smoking and oral contraceptive use on women in the US

    SciTech Connect

    Goldbaum, G.M.; Kendrick, J.S.; Hogelin, G.C.; Gentry, E.M.

    1987-09-11

    Women who smoke and use oral contraceptives (OCs) are at increased risk for cardiovascular and cerebrovascular disease. To study the prevalence of smoking and OC use and of other behaviors affecting health, 28 states and the District of Columbia conducted telephone surveys during 1981 through 1983. More than 22,000 US adults were interviewed, of whom 5779 women aged 18 to 44 years were studied. Data were weighted to represent the US population. Overall, 7.4% of US women aged 18 to 44 years reported smoking and using OCs' 1.1% reported smoking 25 or more cigarettes per day while using OCs. Although women aged 18 to 24 years were most likely to smoke and use OCs, combined smoking and OC use contributed substantially to the number of excess cases of myocardial infarctions occurring among US women aged 35 to 44 years. However, regardless of OC use, smoking accounted for most of the excess cases. Therefore, health care providers need to intensity their efforts to reduce smoking among their patients.

  18. Toward a new concept of "natural balance" in oral estroprogestin contraception.

    PubMed

    Chabbert-Buffet, Nathalie; Gerris, Jan; Jamin, Christian; Lello, Stefano; Lete, Inaki; Lobo, Paloma; Nappi, Rossella E; Pintiaux, Axelle

    2013-10-01

    The Pill has undergone many changes since its first appearance some 50 years ago. Key developments included the reduction of ethinylestradiol doses and the synthesis of new progestins in order to increase safety, compliance and efficiency. Low-dose combined oral contraceptives (COCs) are currently the preferred option for millions of women. Due to this widespread use, it has been argued that the safety of COCs should be even better, raising the threshold for excellence. Yet in spite of major improvements, there is still an associated risk of venous thromboembolism (VTE). The next step in COCs' evolution should take total estrogenicity and hepatic estro-androgenic balance into account. The focus on the estrogen component--which has not changed in 50 years--has yielded a new class of natural estrogen pills. Following the introduction of a first quadriphasic pill, a monophasic estradiol pill based on the concept of "natural balance" was subsequently made available. These recent achievements could represent a step forward in the evolution of COCs and pave the way for better safety.

  19. Effects of combination oral contraceptives on strength development in women athletes.

    PubMed

    Nichols, Andrew W; Hetzler, Ronald K; Villanueva, Richard J; Stickley, Christopher D; Kimura, Iris F

    2008-09-01

    This study was designed to investigate the effects of combination oral contraceptive agents (OCAs) on strength and torque production in collegiate women softball and water polo athletes who participated in a 12-week strength development program. A double-blind research design was used to mask subjects to the main outcome of interest. Thirty-one women collegiate softball and water polo players were divided into experimental (OCA users, n = 13), and control (non-OCA users, n = 18) groups. All subjects participated in the same supervised 12-week preseason strength development program. One-repetition maximum bench press (1RMBP), 10-repetition maximum leg extension (10RMLE), isokinetic peak torque bench press (IKBP), and isokinetic peak torque leg extension (IKLE) data were collected at weeks 0 (pre-test), 4, 8, and 12 (post-test). Significant increases in strength and torque production over time were identified regardless of group for 1RMBP, 10RMLE, and IKLE. No significant differences in IKBP torque production occurred during the 12-week strength training program. No significant differences in 1RMBP, 10RMLE, IKBP, or IKLE occurred between the OCA users and the non-OCA users groups. It was concluded that, within the limitations of the study, the use of combination OCAs did not provide sufficient androgenic effect to increase strength gains beyond the stimulus of the training protocol.

  20. Diminished nap effects on memory consolidation are seen under oral contraceptive use.

    PubMed

    Genzel, Lisa; Bäurle, Anna; Potyka, Alina; Wehrle, Renate; Adamczyk, Marek; Friess, Elisabeth; Steiger, Axel; Dresler, Martin

    2014-01-01

    Many young females take exogenous hormones as oral contraceptive (OC), a condition rarely controlled for in studies on sleep and memory consolidation even though sex hormones influence consolidation. This study investigated the effects of OCs on sleep-related consolidation of a motor and declarative task, utilizing a daytime nap protocol. Fifteen healthy, young females taking OCs came to the sleep lab for three different conditions: nap with previous learning, wake with previous learning and nap without learning. They underwent each condition twice, once during the "pill-active" weeks and once during the "pill-free" week, resulting in 6 visits. In all conditions, participants showed a significant off-line consolidation effect, independent of pill week or nap/wake condition. There were no significant differences in sleep stage duration, spindle activity or spectral EEG frequency bands between naps with or without the learning condition. The present data showed a significant off-line enhancement in memory irrespective of potential beneficial effects of a nap. In comparison to previous studies, this may suggest that the use of OCs may enhance off-line memory consolidation in motor and verbal tasks per se. These results stress the importance to control for the use of OCs in studies focusing on memory performance. PMID:25720656

  1. Design Features of Drug-Drug Interaction Trials Between Antivirals and Oral Contraceptives.

    PubMed

    Ayala, Ruben C; Arya, Vikram; Younis, Islam R

    2016-05-01

    The aim of this work was to explore the major design features of drug-drug interaction trials between antiviral medications (AVs) and oral contraceptives (OCs). Information on these trials (n = 27) was collected from approved drug labels and clinical pharmacology reviews conducted by the U.S. Food and Drug Administration. The primary objective of all trials was to evaluate changes in OC exposure following the coadministration of AVs. In addition, an evaluation of potential pharmacodynamic interaction was performed in 10 of these trials. Twenty-two trials were open label with a fixed-sequence design, and 5 trials used a double-blind crossover design. The trials were conducted using one, two, or three 28-day ovulatory cycles in 10, 8, and 9 trials, respectively. Only 1 trial enrolled HIV-infected women. The median number of women in a trial was 20 (range, 12 to 52). Norethindrone/ethinyl estradiol (EE) combination was the most commonly used OC (n = 16, 59%) followed by norgestimate/EE (n = 9, 33%). Labeling recommendations were based on exposure changes in 25 cases and on safety observations in the trial in 2 cases. In conclusion, a wide variety of trial designs was used, and there is no preferred design. The answer to the exposure question can be achieved using multiple designs.

  2. Oral Contraceptive Use and the ECG: Evidence of an Adverse QT Effect on Corrected QT Interval

    PubMed Central

    Sedlak, Tara; Shufelt, Chrisandra; Iribarren, Carlos; Lyon, Liisa L; Merz, C. Noel Bairey

    2013-01-01

    Background A prolonged corrected QT (QTc) interval is a marker for an increased risk of sudden cardiac death. We evaluated the relationship between oral contraceptive (OC) use, type of OC, and QTc interval. Methods We identified 410,782 ECGs performed at Northern California Kaiser Permanente on female patients between 15–53 years from January, 1995 to June, 2008. QT was corrected for heart rate using log-linear regression. OC generation (first, second and third) was classified by increasing progestin androgenic potency, while the fourth generation was classified as anti-androgenic. Results Among 410,782 women, 8.4% were on OC. In multivariate analysis after correction for comorbidities, there was an independent shortening effect of OCs overall (slope = −0.5ms; SE = 0.12, p<0.0002). Users of first and second generation progestins had a significantly shorter QTc than non-users (p<0.0001), while users of fourth generation had a significantly longer QTc than non-users (slope = 3.6ms, SE = 0.35, p<0.0001). Conclusion Overall, OC use has a shortening effect on the QTc. Shorter QTc is seen with first and second generation OC while fourth generation OC use has a lengthening effect on the QTc. Careful examination of adverse event rates in fourth generation OC users is needed. PMID:23879279

  3. Duration of oral contraceptive use predicts women's initial and subsequent subjective responses to sexual stimuli.

    PubMed

    Renfro, Kaytlin J; Rupp, Heather; Wallen, Kim

    2015-09-01

    Recent work suggests that a woman's hormonal state when first exposed to visual sexual stimuli (VSS) modulates her initial and subsequent responses to VSS. The present study investigated whether women's initial hormonal state was related to their subjective ratings of VSS, and whether this relationship differed with VSS content. We reanalyzed previously collected data from 14 naturally cycling (NC) women and 14 women taking oral contraceptives (OCs), who subjectively rated VSS at three hormonal time-points. NC women's ratings of 216 unique sexual images were collected during the menstrual, periovulatory, and luteal phases of their menstrual cycles, and OC women's ratings were collected at comparable time-points across their pill-cycles. NC women's initial hormonal state was not related to their ratings of VSS. OC women's initial hormonal state predicted their ratings of VSS with minimal contextual information and of images depicting female-to-male oral sex. Specifically, women who entered the study in the third week of their pill-cycle (OC-3 women) rated such images as less attractive at all testing sessions than did all other women. OC-3 women were also the only women to rate decontextualized VSS as unattractive at all testing sessions. These results corroborate previous studies in which women's initial hormonal state was found to predict subsequent interest in sexual stimuli. Future work, with larger samples, should more directly investigate whether OC-3 women's negative assessment of specific types of VSS reflects a reaction to the laboratory environment or a broader mechanism, wherein OC women's sexual interests decrease late in their pill-cycle.

  4. Contraceptives for teenagers.

    PubMed

    Bullough, B; Bullough, V

    1991-01-01

    The contraceptive options suitable for teenagers are presented and discussed. Condoms have the advantage of preventing the spread of sexually transmitted diseases, and oral contraceptives are probably the most effective in preventing pregnancy. Other options include the barrier contraceptives available to women, spermicides, sponges, intrauterine devices, periodic abstinence, and the morning after pill.

  5. Development of orally disintegrating tablets comprising controlled-release multiparticulate beads

    PubMed Central

    2012-01-01

    Melperone is an atypical antipsychotic agent that has shown a wide spectrum of neuroleptic properties, particularly effective in the treatment of senile dementia and Parkinson’s-associated psychosis, and is marketed in Europe as an immediate-release (IR) tablet and syrup. An orally disintegrating tablet (ODT) dosage form would be advantageous for patients who experience difficulty in swallowing large tablets or capsules or those who experience dysphagia. Controlled-release (CR) capsule and ODT formulations containing melperone HCl were developed with target in vitro release profiles suitable for a once-daily dosing regimen. Both dosage forms allow for the convenient production of dose-proportional multiple strengths. Two ODT formulations exhibiting fast and medium release profiles and one medium release profile capsule formulation (each 50 mg) were tested in vivo using IR syrup as the reference. The two medium release formulations were shown to be bioequivalent to each other and are suitable for once-daily dosing. Based on the analytical and organoleptic test results, as well as the blend uniformity and in-process compression data at various compression forces using coated beads produced at one-tenth (1/10) commercial scale, both formulations in the form of CR capsules and CR ODTs have shown suitability for progression into further clinical development. PMID:22356215

  6. Preparation and evaluation of unpleasant taste-masked pioglitazone orally disintegrating tablets.

    PubMed

    Nakano, Yoshinori; Maeda, Arisa; Uchida, Shinya; Namiki, Noriyuki

    2013-03-25

    This study aimed to evaluate the taste and mouth feel of newly designed orally disintegrating tablets (ODTs) of pioglitazone, which is a typical type 2 diabetes medicine with an unpleasant taste, using a visual analog scale (VAS) analysis. The ODTs were subjected to either of these 2 taste-masking procedures: a physical masking procedure that included coating the inactive core granules with mixture of pioglitazone and Eudragit(®) E PO, followed by mixing the granules with aspartame and other excipients to form the tablet (physical masking ODT); or a gustatory masking procedure that involved blending pioglitazone with both sodium chloride and aspartame, followed by mixing the blend with other excipients to form the tablet (gustatory masking ODT). From the results of the VAS analysis, physical masking could suppress the bitterness but not the astringent; therefore, the overall palatability of the ODT was considered not improved. In contrast, gustatory masking significantly suppressed both the bitterness and astringent, and offered a slight sweetness; therefore, the overall palatability of the ODT was considered improved. In conclusion, VAS is a useful tool to evaluate the taste of ODTs and that gustatory masking can effectively mask the unpleasant taste of pioglitazone ODT.

  7. Maltodextrin: a novel excipient used in sugar-based orally disintegrating tablets and phase transition process.

    PubMed

    Elnaggar, Yosra Shaaban R; El-Massik, Magda A; Abdallah, Ossama Y; Ebian, Abd Elazim R

    2010-06-01

    The recent challenge in orally disintegrating tablets (ODT) manufacturing encompasses the compromise between instantaneous disintegration, sufficient hardness, and standard processing equipment. The current investigation constitutes one attempt to fulfill this challenge. Maltodextrin, in the present work, was utilized as a novel excipient to prepare ODT of meclizine. Tablets were prepared by both direct compression and wet granulation techniques. The effect of maltodextrin concentrations on ODT characteristics--manifested as hardness and disintegration time--was studied. The effect of conditioning (40 degrees C and 75% relative humidity) as a post-compression treatment on ODT characteristics was also assessed. Furthermore, maltodextrin-pronounced hardening effect was investigated using differential scanning calorimetry (DSC) and X-ray analysis. Results revealed that in both techniques, rapid disintegration (30-40 s) would be achieved on the cost of tablet hardness (about 1 kg). Post-compression conditioning of tablets resulted in an increase in hardness (3 kg), while keeping rapid disintegration (30-40 s) according to guidance of the FDA for ODT. However, direct compression-conditioning technique exhibited drawbacks of long conditioning time and appearance of the so-called patch effect. These problems were, yet, absent in wet granulation-conditioning technique. DSC and X-ray analysis suggested involvement of glass-elastic deformation in maltodextrin hardening effect. High-performance liquid chromatography analysis of meclizine ODT suggested no degradation of the drug by the applied conditions of temperature and humidity. Overall results proposed that maltodextrin is a promising saccharide for production of ODT with accepted hardness-disintegration time compromise, utilizing standard processing equipment and phenomena of phase transition. PMID:20405257

  8. Maltodextrin: a novel excipient used in sugar-based orally disintegrating tablets and phase transition process.

    PubMed

    Elnaggar, Yosra Shaaban R; El-Massik, Magda A; Abdallah, Ossama Y; Ebian, Abd Elazim R

    2010-06-01

    The recent challenge in orally disintegrating tablets (ODT) manufacturing encompasses the compromise between instantaneous disintegration, sufficient hardness, and standard processing equipment. The current investigation constitutes one attempt to fulfill this challenge. Maltodextrin, in the present work, was utilized as a novel excipient to prepare ODT of meclizine. Tablets were prepared by both direct compression and wet granulation techniques. The effect of maltodextrin concentrations on ODT characteristics--manifested as hardness and disintegration time--was studied. The effect of conditioning (40 degrees C and 75% relative humidity) as a post-compression treatment on ODT characteristics was also assessed. Furthermore, maltodextrin-pronounced hardening effect was investigated using differential scanning calorimetry (DSC) and X-ray analysis. Results revealed that in both techniques, rapid disintegration (30-40 s) would be achieved on the cost of tablet hardness (about 1 kg). Post-compression conditioning of tablets resulted in an increase in hardness (3 kg), while keeping rapid disintegration (30-40 s) according to guidance of the FDA for ODT. However, direct compression-conditioning technique exhibited drawbacks of long conditioning time and appearance of the so-called patch effect. These problems were, yet, absent in wet granulation-conditioning technique. DSC and X-ray analysis suggested involvement of glass-elastic deformation in maltodextrin hardening effect. High-performance liquid chromatography analysis of meclizine ODT suggested no degradation of the drug by the applied conditions of temperature and humidity. Overall results proposed that maltodextrin is a promising saccharide for production of ODT with accepted hardness-disintegration time compromise, utilizing standard processing equipment and phenomena of phase transition.

  9. [Advances in hormonal contraception].

    PubMed

    Villanueva Egan, Luis Alberto; Pichardo Cuevas, Mauricio

    2007-01-01

    This review provides an update regarding newer options in hormonal contraception that include the progestin-releasing intrauterine system, the contraceptive patch and ring, the single rod progestin-releasing implant, extended and emergency oral contraception and recent advances in hormonal male contraception. These methods represent a major advancement in this field, allowing for the development of more acceptable, safety and effective birth control regimens.

  10. Effects of Food Thickeners on the Inhibitory Effect of Voglibose Oral-disintegrating Tablets on Post-prandial Elevation of Blood Sugar Levels.

    PubMed

    Tomita, Takashi; Goto, Hidekazu; Sumiya, Kenji; Yoshida, Tadashi; Tanaka, Katsuya; Kohda, Yukinao

    2016-01-01

    The aim of this study was to examine the effects of food thickeners on the pharmacodynamics of voglibose, an α-glucosidase inhibitor. The pharmacodynamics of voglibose were examined in an open-label study in 9 healthy participants after the ingestion of a single oral dose of a voglibose oral-disintegrating tablet, with and without food thickener immersion. The area under the incremental blood sugar concentration-time curve was larger and the rate of increments in the blood sugar concentration was higher with the voglibose oral-disintegrating tablets immersed in the food thickener than with the tablets that were not immersed. Immersing the voglibose oral-disintegrating tablets in the food thickener possibly delayed their disintegration rate. This suggests that commercially available food thickeners may be associated with changes in the disintegration of voglibose oral-disintegrating tablets and should therefore be used carefully in certain clinical situations. PMID:27477734

  11. Review of newer contraceptive agents.

    PubMed

    Qureshi, M; Attaran, M

    1999-06-01

    Advances in contraceptive technology have made birth control more effective, convenient, and safe. We review the newer products and some under development, including the latest oral contraceptives, injectable progesterone, subdermal progestin implants, progesterone-releasing IUDs, emergency contraception, and male contraception.

  12. The 1998 Canadian Contraception Study.

    ERIC Educational Resources Information Center

    Fisher, William A.; Boroditsky, Richard; Bridges, Martha L.

    1999-01-01

    Describes the 1998 Canadian Contraception Study, a mailed survey which asked women about contraceptive practices past, present, and future (including use of oral contraceptives, condoms, and sterilization); familiarity with and opinion about different contraception methods; and general sexual and reproductive health. The paper also examines…

  13. Cycle scheduling for in vitro fertilization with oral contraceptive pills versus oral estradiol valerate: a randomized, controlled trial

    PubMed Central

    2013-01-01

    Background Both oral contraceptive pills (OCPs) and estradiol (E2) valerate have been used to schedule gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles and, consequently, laboratory activities. However, there are no studies comparing treatment outcomes directly between these two pretreatment methods. This randomized controlled trial was aimed at finding differences in ongoing pregnancy rates between GnRH antagonist IVF cycles scheduled with OCPs or E2 valerate. Methods Between January and May 2012, one hundred consecutive patients (nonobese, regularly cycling women 18–38 years with normal day 3 hormone levels and <3 previous IVF/ICSI attempts) undergoing IVF with the GnRH antagonist protocol were randomized to either the OCP or E2 pretreatment arms, with no restrictions such as blocking or stratification. Authors involved in data collection and analysis were blinded to group assignment. Fifty patients received OCP (30 μg ethinyl E2/150 μg levonorgestrel) for 12–16 days from day 1 or 2, and stimulation was started 5 days after stopping OCP. Similarly, 50 patients received 4 mg/day oral E2 valerate from day 20 for 5–12 days, until the day before starting stimulation. Results Pretreatment with OCP (mean±SD, 14.5±1.7 days) was significantly longer than with E2 (7.8±1.9 days). Stimulation and embryological characteristics were similar. Ongoing pregnancy rates (46.0% vs. 44.0%; risk difference, –2.0% [95% CI –21.2% to 17.3%]), as well as implantation (43.5% vs. 47.4%), clinical pregnancy (50.0% vs. 48.0%), clinical miscarriage (7.1% vs. 7.7%), and live birth (42.0% vs. 40.0%) rates were comparable between groups. Conclusions This is the first study to directly compare these two methods of cycle scheduling in GnRH antagonist cycles. Our results fail to show statistically significant differences in ongoing pregnancy rates between pretreatment with OCP and E2 for IVF with the GnRH antagonist protocol. Although the

  14. Effects of oral contraceptive and estrogen administration on plasma calcitonin in pre- and postmenopausal women.

    PubMed

    Hurley, D L; Tiegs, R D; Barta, J; Laakso, K; Heath, H

    1989-02-01

    Estrogen (E) therapy and administration of oral contraceptives (OC) reportedly increase plasma calcitonin (CT) concentrations in women, effects said to mediate in part the beneficial actions of E on bone. To further examine this theory, we tested the effects of three cycles of OC therapy in 12 young women, comparing them to 10 healthy women before and after three normal menstrual cycles. We also determined the effects of 3 months of E therapy (ethinyl estradiol, 20 micrograms/day, 25 of 30 days) in 14 healthy postmenopausal women, using a crossover design (studied after 3 months with and 3 months without E). We determined CT by radioimmunoassay (antiserum G-1701) in whole plasma (iCT) and silica cartridge extracts of plasma (exCT) after overnight fasting, after calcium (Ca) infusion (2 mg Ca/kg over 5 minutes), and during a normal day at 0800, 1200, 1700, and 2000 h. In no control study was there a significant diurnal change in iCT or exCT, and neither OC nor E therapy altered this. Similarly, OC administration did not affect basal CT levels or the normal iCT and exCT responses to Ca infusion. E therapy induced expected changes in serum Ca, phosphorus, and alkaline phosphatase and urinary Ca and cAMP excretion; basal and diurnal plasma exCT levels were decreased significantly, consonant with the decrement in serum Ca. E did not alter normal iCT and exCT responses to Ca infusion. Thus, administration of either OC or E has no stimulatory effect on CT secretion, which suggests that the beneficial actions of E on bone are not mediated through CT-induced inhibition of bone resorption.(ABSTRACT TRUNCATED AT 250 WORDS)

  15. Oral Contraceptive Use and Colorectal Cancer in the Nurses’ Health Study I and II

    PubMed Central

    Charlton, Brittany M.; Wu, Kana; Zhang, Xuehong; Giovannucci, Edward L.; Fuchs, Charles S.; Missmer, Stacey A.; Rosner, Bernard; Hankinson, Susan E.; Willett, Walter C.; Michels, Karin B.

    2015-01-01

    Background It remains unclear if oral contraceptive (OC) use is associated with the incidence of colorectal cancer. Few studies have examined this association by duration of OC use, time since last OC use, and different cancer subsites. Methods Among 88,691 participants of the Nurses’ Health Study I (NHSI) and 93,080 participants of the Nurses’ Health Study II (NHSII), we assessed OC use every 2 years between 1976-2010 and categorized it as ever use, duration of use, and time since last use. We included incident colorectal cancer cases through 2010 (NHSI: age at diagnosis=36-88, N=1,764, NHSII: age at diagnosis=33-64, N=206). Multivariable hazard ratios and 95% confidence intervals [HR (95% CIs)] were estimated using Cox proportional hazards regression models. Results Ever OC use was not associated with colorectal cancer in NHSI [1.01 (0.91, 1.12)] nor NHSII [1.03 (0.69, 1.53)]. In NHSII, when compared to never-users, longer durations (5+ years) of OC use were inversely associated with the risk of colon cancers (test for trend p=0.02) but the number of endpoints was limited. No other colorectal cancer subsites were associated with OC durations or times since last OC use in either cohort. Conclusions In two large prospective cohorts, we found little evidence that OC use may be protective for colorectal cancer, except potentially with longer durations of use among younger women. Impact Our results do not support the previous initial studies that reported an inverse association of recent OC use with colorectal cancer but instead support newer, larger studies demonstrating no such association. PMID:26063479

  16. Oral contraceptive cycle phase does not affect 200-m swim time trial performance.

    PubMed

    Rechichi, Claire; Dawson, Brian

    2012-04-01

    The purpose of this study was to examine whether swimming performance was affected by acute hormonal fluctuation within a monophasic oral contraceptive (OC) cycle. Six competitive swimmers and water polo players completed a 200-m time trial at 3 time points of a single OC cycle: during the consumption phase (CONS), early (WITH1), and late in the withdrawal phase (WITH2). Split times and stroke rate were recorded during the time trial, and heart rate, blood lactate, glucose, and pH were measured after each performance test. Resting endogenous serum estradiol and progesterone concentrations were also assessed. No significant differences were observed between phases for body composition, 200-m swim time, mean stroke rate, peak heart rate, or blood glucose (p > 0.05). The mean peak blood lactate was significantly lower during WITH2 (9.9 ± 3.0 mmol·L(-1)) compared with that of CONS (12.5 ± 3.0 mmol·L(-1)) and mean pH higher during WITH2 (7.183 ± 0.111) compared with that of CONS (7.144 ± 0.092). Serum estradiol levels were significantly greater during WITH2 compared with that during WITH1 and CONS, but there was no difference in serum progesterone levels. These results demonstrate that for monophasic OC users, cycle phase does not impact the 200-m swimming performance. There was a reduction in blood lactate and an increase in pH during the withdrawal phase, possibly because of an increase in fluid retention, plasma volume, and cellular alkalosis. Therefore, female 200-m swimmers taking a monophasic OC need not be concerned by the phase of their cycle with regard to competition and optimizing performance. However, coaches and scientists should exercise caution when interpreting blood lactate results obtained from swimming tests and consider controlling for cycle phase for athletes taking an OC. PMID:22446669

  17. Heart rate variability across the menstrual cycle in young women taking oral contraceptives.

    PubMed

    Teixeira, André L; Ramos, Plínio S; Vianna, Lauro C; Ricardo, Djalma R

    2015-11-01

    Previous studies have shown that resting heart rate variability (HRV) is modified by different phases of the menstrual cycle in nonusers of oral contraceptive pills (OCP); however, the effect of OCP on autonomic control of the heart remains unclear. The purpose of this study was to investigate HRV during the low hormone (LH-not taking OCP) and during the high hormone (HH-active OCP use) phases of the menstrual cycle in young women. Seventeen healthy women (19-31 years) taking OCP for at least 6 consecutive months were enrolled in this study. Plasma estradiol and progesterone were verified at each visit. HRV was assessed by using one-lead electrocardiography in time and frequency domains, in which participants rested in the supine position for a 20-min period with a breathing rate of 15 cycles/min. In addition, resting heart rate, and systolic and diastolic blood pressure were obtained. Both plasma estradiol (LH: 19.8 ± 4.2 pg/mL vs. HH: 12.4 ± 1.5 pg/mL; p > .05) and progesterone (LH: 0.247 ± 0.58 ng/mL vs. HH: 0.371 ± 0.08 ng/mL; p > .05) (mean ± SE) levels were similar in both phases. No significant difference was obtained for any component of HRV, heart rate, or blood pressure between the LH and HH phases (p > .05). These results provide preliminary evidence that use of OCP does not affect HRV during the menstrual cycle in healthy women.

  18. Use of Simulated Patients to Evaluate Combined Oral Contraceptive Dispensing Practices of Community Pharmacists

    PubMed Central

    Obreli-Neto, Paulo Roque; Pereira, Leonardo Régis Leira; Guidoni, Camilo Molino; Baldoni, André de Oliveira; Marusic, Srecko; de Lyra-Júnior, Divaldo Pereira; de Almeida, Kelsen Luis; Pazete, Ana Claudia Montolezi; do Nascimento, Janaina Dutra; Kos, Mitja; Girotto, Edmarlon; Cuman, Roberto Kenji Nakamura

    2013-01-01

    Background Combined oral contraceptive (COC) use is the most commonly used reversible method of birth control. The incorrect use of COCs is frequent and one of the most common causes of unintended pregnancies. Community pharmacists (CPs) are in a strategic position to improve COC use because they are the last health professional to interact with patients before drug use. Objective To evaluate the COC dispensing practices of CPs in a developing country. Method A cross-sectional study was conducted in community pharmacies of Assis and Ourinhos microregions, Brazil, between June 1, 2012, and October 30, 2012. Four simulated patients (SPs) (with counseled audio recording) visited community pharmacies with a prescription for Ciclo 21® (a COC containing ethinyl estradiol 30 mcg + levonorgestrel 15 mcg). The audio recording of every SP visit was listened to independently by 3 researchers to evaluate the COC dispensing practice. The percentage of CPs who performed a screening for safe use of COCs (i.e., taking of patients’ medical and family history, and measuring of blood pressure) and provided counseling, as well as the quality of the screening and counseling, were evaluated. Results Of the 185 CPs contacted, 41 (22.2%) agreed to participate in the study and finished the study protocol. Only 3 CPs asked the SP a question (1 question asked by each professional), and all of the questions were closed-ended, viz., “do you smoke?” (n = 2) and “what is your age?” (n = 1). None of the CPs measured the patient’s blood pressure. Six CPs provided counseling when dispensing COCs (drug dosing, 5 CPs; possible adverse effects, 2 CPs), and one CP provided counseling regarding both aspects. Conclusion The CPs evaluated did not dispense COC appropriately and could influence in the occurrence of negatives therapeutic outcomes such as adverse effects and treatment failure. PMID:24324584

  19. Mood changes as reported by women taking the oral contraceptive pill.

    PubMed

    Chang, A M; Chick, P; Milburn, S

    1982-05-01

    In an effort to clarify the nature of emotional side effects frequently reported by women using oral contraceptives (OCs), an exploratory study was undertaken of the verbal descriptions of side effects provided by a sample of young, healthy, sexually active women attending the Family Planning Association of Queensland clinics in Brisbane; they had been using OCs for at least 6 months. The adjectives used in unstructured interviews by 20 women happy with pills and 20 complaining of side effects formed the basis for a questionnaire comparing occurrence of emotions before and after pill use. 3 consecutive sets of adjectives were tested using Principle Factor Analysis and orthogonal rotation. The final questionnaire along with questions concerning social variables were given to 100 women and the scores from different subgroups were compared using the t test. 4 distinct, specific, and uncorrelated factors containing 53 adjectives were identified, of which "annoyed" and "tiredness" suggest negative emotional effects and "passionate" and "reassured" suggest positive effects. The distribution of factor scores in subgroups with statistically significant differences indicate that increases in "annoyed" and "tiredness" scores are found mainly in women who complain of emotional side effects, who were bothered by remembering to take the pill, worried about pill-related dangers, and gained excessive weight. Increases in "passionate" scores were found in noncohabiting women with steady sexual relationships, and increases in "reassured" were universal. The results demonstrate the multidimensional nature of reported emotional side effects from the pill and indicate that highly specific and unique mood changes which do not fit into existing notions of depression or anxiety are reported by women taking the pill.

  20. Oral contraceptive-induced menstrual migraine. Clinical aspects and response to frovatriptan.

    PubMed

    Allais, Gianni; Bussone, Gennaro; Airola, Gisella; Borgogno, Paola; Gabellari, Ilaria Castagnoli; De Lorenzo, Cristina; Pavia, Elena; Benedetto, Chiara

    2008-05-01

    Oral contraceptive-induced menstrual migraine (OCMM) is a poorly defined migraine subtype mainly triggered by the cyclic pill suspension. In this pilot, open-label trial we describe its clinical features and evaluate the efficacy of frovatriptan in the treatment of its acute attack. During the first 3 months of the study 20 women (mean age 32.2+/-7.0, range 22-46) with a 6-month history of pure OCMM recorded, in monthly diary cards, clinical information about their migraine. During the 4th menstrual cycle they treated an OCMM attack with frovatriptan 2.5 mg. The majority of attacks were moderate/severe and lasted 25-72 h or more, in the presence of usual treatment. Generally an OCMM attack appeared within the first 5 days after the pill suspension, but in 15% of cases it started later. After frovatriptan administration, headache intensity progressively decreased (2.4 at onset, 1.6 after 2 h, 1.1 after 4 h and 0.8 after 24 h; p=0.0001). In 55% of patients pain relief was reported after 2 h. Ten percent of subjects were pain-free subjects after 2 h, 35% after 4 h and 60% after 24 h (p=0.003 for trend); 36% relapsed within 24 h. Rescue medication was needed by 35% of patients; 50% of frovatriptan-treated required a second dose. Concomitant nausea and/or vomiting, photophobia and phonophobia decreased significantly after drug intake. OCMM is a severe form of migraine; actually its clinical features are not always exactly identified by the ICHD-II classification. However, treatment with frovatriptan 2.5 mg might be effective in its management.

  1. Long-term effects of oral contraceptives on ovarian cancer risk.

    PubMed

    Bosetti, Cristina; Negri, Eva; Trichopoulos, Dimitrios; Franceschi, Silvia; Beral, Valerie; Tzonou, Anastasia; Parazzini, Fabio; Greggi, Stefano; La Vecchia, Carlo

    2002-11-20

    Several epidemiologic studies have reported a protective effect of oral contraceptives (OCs) on ovarian cancer. However, there remain open issues, including better quantification of time-related factors such as time since last use, age at first use and time since first use. We performed a collaborative reanalysis of 6 case-control studies conducted between 1978 and 1999 in the United Kingdom, Greece and Italy, including a total of 2,768 incident, histologically confirmed cases of epithelial ovarian cancer and 6,274 hospital controls under age 70 years. A reduced risk of ovarian cancer was found for ever- compared to never-users [odds ratio (OR) = 0.66, 95% confidence interval (CI) 0.56-0.79], and a stronger reduction was observed for women who had used OCs for > or =5 years (OR = 0.50, 95% CI 0.33-0.76) compared to those who had used them for <5 years. The protective effect of OCs on ovarian cancer was consistent across strata of age, parity, menopausal status and family history of breast or ovarian cancer. After allowance for duration of use, no other time factor was related to ovarian cancer risk: the reduced risk was similar for women who stopped OC use > or =20 years before compared to <10 years; likewise, no significant modification of risk reduction was observed for age at first OC use and time since first OC use. The present analysis indicates that, after taking into account duration of OC use, the OC protection from ovarian cancer persists for a long time after stopping use. PMID:12397647

  2. Retrospective Comparison of Posaconazole Levels in Patients Taking the Delayed-Release Tablet versus the Oral Suspension.

    PubMed

    Durani, Urshila; Tosh, Pritish K; Barreto, Jason N; Estes, Lynn L; Jannetto, Paul J; Tande, Aaron J

    2015-08-01

    While posaconazole prophylaxis decreases the risk of invasive fungal infection compared to fluconazole, low bioavailability of the oral-suspension formulation limits its efficacy. A new delayed-release tablet formulation demonstrated an improved pharmacokinetic profile in healthy volunteers. However, serum levels for the two formulations have not been compared in clinical practice. This study compared achievement of therapeutic posaconazole levels in patients taking the delayed-release tablet to those taking the oral suspension. This retrospective cohort study included 93 patients initiated on posaconazole between 2012 and 2014 and had at least one serum posaconazole level measured. The primary measure was the proportion of patients achieving an initial therapeutic level (>700 ng/ml). An initial therapeutic posaconazole level was seen in 29 of 32 (91%) patients receiving tablets and 37 of 61 (61%) patients receiving suspension (P = 0.003). Among patients with a steady-state level measured 5 to 14 days after initiation, a therapeutic level was observed in 18 of 20 (90%) patients receiving tablets and 25 of 43 (58%) patients receiving suspension (P = 0.01). In these patients, the median posaconazole level of the tablet cohort (1655 ng/ml) was twice that of the suspension cohort (798 ng/ml) (P = 0.004). In this cohort study, the improved bioavailability of delayed-release posaconazole tablets translates into a significantly higher proportion of patients achieving therapeutic serum levels than in the cohort receiving the oral suspension. The results of this study strongly support the use of delayed-release tablets over suspension in patients at risk for invasive fungal infection.

  3. Effect of oral contraceptives on the rat brain and pituitary beta-endorphin.

    PubMed

    Tejwani, G A; Vaswani, K K; Barbacci, J C; Richard, C W; Bianchine, J R

    1983-01-01

    The purpose of this study was to investigate the effect of oral administration of progesterone (15 micrograms norethindrone, NE) in presence and absence of estradiol (1 microgram ethinyl estradiol, EE2) on the CNS levels of beta-endorphin like immunoreactivity (beta-EI) in female rats. In acute study (5 days), NE alone did not change beta-EI significantly in pituitary. NE and EE2 together decreased beta-EI by 37% (47% at 10X dose). In chronic study (7 weeks), 2NE had no significant effect on pituitary beta-EI, however, NE and EE2 together at 10X dose decreased it by 14%. In the hypothalamus, NE alone or in presence of EE2 had no significant effect on beta-EI, but 10X dose of NE+ EE2 caused 50 and 76% decrease in beta-EI in acute and chronic study. Striatum was the only tissue where NE alone caused a decrease of 82% in beta-EI when given acutely and 52% when given chronically. EE2 had some protective effect on this decrease since when given together (NE+EE2) the decrease in beta-EI was 21% in acute and 43% in chronic study. Thus our results, along with other studies on the regulation of gonadotropin levels by opioids, suggest that oral contraceptives alter the level of beta-EI and in turn may regulate the release of gonadotropins. Morphine and endogenous opioids have been shown to decrease gonadotropin secretion in various species including humans, apparently by suppressing the release of LH-RH from the hypothalamus (1-5). The opiate antagonist naloxone not only causes up to 10-fold increase in the secretion of gonadotropins (1,3, 6-9) but also opposes the negative feedback effect of steroids on the hypothalamic-pituitary-gonadotropin axis (8), suggesting a regulatory interaction between the endogenous opioids, gonadotropins and gonadal steroids. Like ACTH, the secretion of beta-endorphin is inhibited by glucocorticoids (10). Naloxone induced release of LH is facilitated by estradiol in humans (11) suggesting an antagonistic effect of estradiol on the endogenous

  4. Oral contraception does not alter single dose saquinavir pharmacokinetics in women

    PubMed Central

    Fröhlich, Margit; Burhenne, Jürgen; Martin-Facklam, Meret; Weiss, Johanna; von Wolff, Michael; Strowitzki, Thomas; Walter-Sack, Ingeborg; Haefeli, Walter E

    2004-01-01

    Aims Women experience more adverse drug reactions (ADR) to antiretroviral therapy than men. This may be attributed to higher plasma concentrations of protease inhibitors due to pharmacokinetic interactions with hormonal preparations. Thus, in the present study we aimed to investigate the influence of oral contraceptives (OC) on the pharmacokinetics of the protease inhibitor saquinavir. Methods Saquinavir was administered in a hard gelatin capsule formulation (Invirase®) to rule out confounding by pharmaceutical aids of the more frequently used soft gelatin capsule. After an overnight fast, eight healthy female participants ingested a single oral dose of 600 mg saquinavir immediately before and after the 19th dose of a combined, low dose OC (0.03 mg ethinylestradiol, 0.075 mg gestodene) in a prospective, fixed sequence study design. The first saquinavir application was scheduled on day 1, 2, or 3 of the individual menstrual cycle. Plasma concentrations of saquinavir and relative concentrations of its M2&M3-hydroxy metabolites were determined by LC/MS/MS for 48 h. Results Intake of OC resulted in a significant decrease in morning serum concentrations (before intake of OC, compared to day 19 of OC therapy) of 17β-estradiol by −23.4 pg ml−1 (57%, 95%CI: −76% to −37.4%); progesterone by −0.25 ng ml−1 (33%, 95%CI: −45.3% to −21.5%); follicle-stimulating hormone by −4.06 U l−1 (82%, 95%CI: −96.5% to −67.7%); and luteinizing hormone by −3.49 U l−1 (74%, 95%CI: −93 to −54.6%). Conversely, sexual hormone binding globulin serum concentrations increased by 83.6 nmol l−1 (205%, 95%CI: 32.2% to 377%). Pharmacokinetic parameters of saquinavir (AUC, Cmax, tmax, t1/2, CLR) were not affected by OC, nor was the relative metabolic ratio of saquinavir/M2&M3-hydroxy saquinavir. Furthermore, there was no association of serum hormone concentrations or MDR1-polymorphisms (C3435T and G2677T) with pharmacokinetic parameters of saquinavir. Conclusions There

  5. Development and optimization of taste-masked orally disintegrating tablets (ODTs) of clindamycin hydrochloride.

    PubMed

    Cantor, Stuart L; Khan, Mansoor A; Gupta, Abhay

    2015-01-01

    The purpose of this research was to develop an orally disintegrating tablet (ODT) dosage form containing taste-masked beads of clindamycin HCl. Several formulation strategies were evaluated and a taste-masked ODT of clindamycin HCl was prepared without the use of a waxy cushioning agent. Clindamycin HCl (ca. 46% w/w) was coated onto microcrystalline cellulose beads (Cellets® 200) followed by the addition of a taste-masking layer of amino methacrylate copolymer, NF (Eudragit EPO® (EPO)) coating suspension. The efficiency of both the drug coating process and the taste-masking polymer coating process, as well as the taste masking ODTs was determined using potency and drug release analysis. Magnesium stearate was found to be advantageous over talc in improving the efficiency of the EPO coating suspension. A response surface methodology using a Box-Behnken design for the tablets revealed compression force and levels of both disintegrant and talc to be the main factors influencing the ODT properties. Blending of talc to the EPO-coated beads was found to be the most critical factor in ensuring that ODTs disintegrate within 30 s. The optimized ODTs formulation also showed negligible (<0.5%) drug release in 1 min using phosphate buffer, pH 6.8 (which is analogous to the residence time and pH in the oral cavity). By carefully adjusting the levels of coating polymers, the amounts of disintegrant and talc, as well as the compression force, robust ODTs can be obtained to improve pediatric and geriatric patient compliance for clindamycin oral dosage forms. PMID:25000481

  6. Comparison of Postprandial Lipemia between Women who are on Oral Contraceptive Methods and Those who are not

    PubMed Central

    Petto, Jefferson; Vasques, Leila Monique Reis; Pinheiro, Renata Leão; Giesta, Beatriz de Almeida; dos Santos, Alan Carlos Nery; Gomes Neto, Mansueto; Ladeia, Ana Marice Teixeira

    2014-01-01

    Background: Postprandial Lipemia (PPL) is a physiological process that reflects the ability of the body to metabolize lipids. Even though the influence of oral contraceptives (OC) on PPL is not known, it is a known fact that their use increases fasting lipid values. Objective: To compare the PPL between women who are on OC and those who are not. Methods: A prospective analytical study which assessed eutrophic women, aged between 18 and 28 years old, who were irregularly active and with fasting triglycerides ≤150 mg/dL. They were divided into two groups: oral contraceptive group (COG) and non-oral contraceptive group (NCOG). Volunteers were submitted to the PPL test, in which blood samples were collected in time 0 (12-hour fasting) and after the intake of lipids in times 180 and 240 minutes. In order to compare the triglyceride deltas, which reflect PPL, the two-tailed Mann-Whitney test was used for independent samples between fasting collections and 180 minutes (∆1) and between fasting and 240 minutes (∆2). Results: Forty women were assessed and equally divided between groups. In the fasting lipid profile, it was observed that HDL did not present significant differences and that triglycerides in COG were twice as high in comparison to NCOG. Medians of ∆1 and ∆2 presented significant differences in both comparisons (p ≤0.05). Conclusion: The results point out that women who are irregularly active and use OC present more PPL in relation to those who do not use OC, which suggests that in this population, its chronic use increases the risk of heart conditions. PMID:25317941

  7. Evidence-Based Nanoscopic and Molecular Framework for Excipient Functionality in Compressed Orally Disintegrating Tablets

    PubMed Central

    Al-khattawi, Ali; Alyami, Hamad; Townsend, Bill; Ma, Xianghong; Mohammed, Afzal R.

    2014-01-01

    The work investigates the adhesive/cohesive molecular and physical interactions together with nanoscopic features of commonly used orally disintegrating tablet (ODT) excipients microcrystalline cellulose (MCC) and D-mannitol. This helps to elucidate the underlying physico-chemical and mechanical mechanisms responsible for powder densification and optimum product functionality. Atomic force microscopy (AFM) contact mode analysis was performed to measure nano-adhesion forces and surface energies between excipient-drug particles (6-10 different particles per each pair). Moreover, surface topography images (100 nm2–10 µm2) and roughness data were acquired from AFM tapping mode. AFM data were related to ODT macro/microscopic properties obtained from SEM, FTIR, XRD, thermal analysis using DSC and TGA, disintegration testing, Heckel and tabletability profiles. The study results showed a good association between the adhesive molecular and physical forces of paired particles and the resultant densification mechanisms responsible for mechanical strength of tablets. MCC micro roughness was 3 times that of D-mannitol which explains the high hardness of MCC ODTs due to mechanical interlocking. Hydrogen bonding between MCC particles could not be established from both AFM and FTIR solid state investigation. On the contrary, D-mannitol produced fragile ODTs due to fragmentation of surface crystallites during compression attained from its weak crystal structure. Furthermore, AFM analysis has shown the presence of extensive micro fibril structures inhabiting nano pores which further supports the use of MCC as a disintegrant. Overall, excipients (and model drugs) showed mechanistic behaviour on the nano/micro scale that could be related to the functionality of materials on the macro scale. PMID:25025427

  8. Formulation and Evaluation of a Novel Matrix-Type Orally Disintegrating Ibuprofen Tablet

    PubMed Central

    Tayebi, Hoda; Mortazavi, Seyed Alireza

    2011-01-01

    Orally disintegrating tablets (ODTs) are capable of turning quickly into a liquid dosage form in contact with the saliva, thus possessing the advantages of both the solid dosage forms particularly stability and liquid dosage forms specially ease of swallowing and pre-gastric absorption of drug. The aim of this study was to prepare a novel matrix-type buccal fast disintegrating ibuprofen tablet formulation using special polymers, water soluble excipients, super-disintegrants and quickly soluble granules. For this purpose different tablet formulations of ibuprofen were prepared. The amount of ibuprofen in each formulation was 100 mg. Eight groups of formulation were prepared (A-H series), accounting for a total number of 45 formulations. Formulations prepared were examined in terms of different physicochemical tests including powder/granule flowability, appearance, thickness, uniformity of weight, hardness, friability and disintegration time. Results of formulation F22a (in series F), was found to be acceptable, making it the chosen formulation for further studies. Then, by adding various flavorants and sweeteners to this formulation, complementary series of formulations, named G and H, were prepared. Following the comparison of their taste with each other through asking 10 volunteers, the most suitable formulation regarding the taste, being formulation F22s, was chosen as the ultimate formulation. This formulation had PVP, ibuprofen and croscarmellose as the intra-granular components and xylitol and saccharin as the extra-granular ingredients. Formulation F22s was found to be acceptable in terms of physicochemical tests conducted, showing quick disintegration within the buccal cavity, appropriate hardness and rather low friability. Hence formulation F22s was selected as the final formulation. PMID:24250378

  9. Sex of offspring of women using oral contraceptives, rhythm, and other methods of birth control around the time of conception.

    PubMed

    Shiono, P H; Harlap, S; Ramcharan, S

    1982-03-01

    Sex ratios were studied in a cohort of 33,205 newborns whose mothers had been questioned in early pregnancy about contraceptive use around the time of conception., The proportion of males was 0.517 (95% confidence limits [CL], 0.512 to 0.522). In the 9279 offspring of women who had used oral contraceptives (OC) in the 5 months prior to conception the sex ratio was 0.517 (0.507 to 0.527). There are sufficient numbers available for study for us to be 95% certain that OC causes no shift in sex ratio of 1% or more. Women who conceived within 2 months of stopping the pill had a small excess of males (0.528; 95% CL, 0.510 to 0.546), but this excess was probably due to chance. OC failures were followed by a raised sex ratio in the offspring (0.543; 95% CL, 0.509 to 0.577), and this excess of males was observed consistently in subgroups of maternal age, parity, race, and education. Failures of rhythm contraception were also associated with a consistent excess of male births (0.567; 95% CL, 0.514 to 0.620). No changes were observed after failures of IUDs, barrier, or chemical methods.

  10. Effect of granule properties on rough mouth feel and palatability of orally disintegrating tablets.

    PubMed

    Kimura, Shin-Ichiro; Uchida, Shinya; Kanada, Ken; Namiki, Noriyuki

    2015-04-30

    In this study, we evaluated the palatability of orally disintegrating tablets (ODTs) containing core granules with different particle sizes, coating, and types of materials using visual analog scales (VAS). Tableting the core granules into ODTs reduced rough mouth feel and improved overall palatability compared to the ingestion of core granules alone. Moreover, the evaluation performed immediately after spitting out ODTs demonstrated differences in rough mouth feel between ODTs containing placebo and core granules. Rough mouth feel was found to be significantly more intense with core granules with particle sizes ≥ 200 μm. Since ODTs may contain taste-masked particles, palatability of ODTs containing coated core granules was also evaluated. Although coating with polymers impairs palatability, it was improved by coating the outer layer with d-mannitol. The effects on palatability of materials constituting core granules were also evaluated, with reduced rough mouth feel observed with core granules composed of water-soluble additives. Based on these data, receiver operating characteristic analysis was performed to determine the threshold VAS scores at which the subjects felt roughness and discomfort. In addition, the threshold particle size of the core granule contained within the ODT required for feeling roughness was determined to be 244 μm. This study elucidated the effect of the properties of masking particles on the rough mouth feel and palatability of ODTs.

  11. Mucoadhesive elementary osmotic pump tablets of trimetazidine for controlled drug delivery and reduced variability in oral bioavailability.

    PubMed

    Alam, Naushad; Beg, Sarwar; Rizwan, Mohammad; Ahmad, Akifa; Ahmad, Farhan Jalees; Ali, Asgar; Aqil, Mohammad

    2015-04-01

    The objectives of this work was preparation and evaluation of the mucoadhesive elementary osmotic pump tablets of trimetazidine hydrochloride to achieve desired controlled release action and augmentation of oral drug absorption. The drug-loaded core tablets were prepared employing the suitable tableting excipients and coated with polymeric blend of ethyl cellulose and hydroxypropyl methylethylcellulose E5 (4:1). The prepared tablets were characterized for various quality control tests and in vitro drug release. Evaluation of drug release kinetics through model fitting suggested the Fickian mechanism of drug release, which was regulated by osmosis and diffusion as the predominant mechanism. Evaluation of mucoadhesion property using texture analyzer suggested good mucoadhesion potential of the developed osmotic systems. Solid state characterization using Fourier-transform infrared spectroscopy, differential scanning calorimetry and powder X-ray diffraction spectroscopy confirmed the absence of any physiochemical incompatibilities between drug and excipients. Scanning electron microscopy analysis showed the smooth surface appearance of the coated tablets with intact polymeric membrane without any fracture. In vivo pharmacokinetic studies in rabbits revealed 3.01-fold enhancement in the oral bioavailability vis-à-vis the marketed formulation (Vastarel MR®). These studies successfully demonstrate the bioavailability enhancement potential of the mucoadhesive elementary osmotic pumps as novel therapeutic systems for other drugs too. PMID:24669975

  12. Impact of obesity on oral contraceptive pharmacokinetics and hypothalamic-pituitary-ovarian activity

    PubMed Central

    Edelman, Alison B; Carlson, Nichole E; Cherala, Ganesh; Munar, Myrna Y.; Stouffer, Richard L; Cameron, Judy L; Stanczyk, Frank Z.; Jensen, Jeffrey T

    2009-01-01

    Objective This study was conducted to determine whether increased body mass index (BMI) affects oral contraceptive (OC) pharmacokinetics and suppression of hypothalamic-pituitary-ovarian (HPO) axis activity. Study design Ovulatory reproductive-age women of normal (< 25 kg/m2; n = 10) and obese (> 30 kg/m2; n = 10) BMI received OCs for two cycles (prospective cohort). Subjects were admitted for two 48-h inpatient stays at the beginning and end of the hormone-free interval. Ethinyl estradiol (EE) and levonorgestrel (LNG) levels were evaluated during both inpatient stays. Gonadotropin pulsatility (FSH and LH) was measured during the second inpatient stay. Estradiol (E2) and progesterone (P) were measured daily during inpatient stays and twice per week in Cycle 2. Results BMI was greater in the obese, compared to the normal BMI group [37.3 kg/m2 (SD 6.0) versus 21.9 kg/m2 (SD 1.6); p < 0.05]. The LNG half-life was significantly longer in the obese group (52.1 ± 29.4 h versus 25.6 ± 9.3 h, p < 0.05) which correlated with a lower maximum LNG concentration on Cycle 2, Day 1 [1.9 ng/mL (SD 0.5) versus 2.5 ng/mL (SD 0.7)] and a longer time to reach steady-state (10 versus 5 days), in obese women. There were no significant differences in volume of distribution between groups. LH pulse parameters did not differ statistically between groups but trended towards greater HPO activity in the obese group. Additionally, more obese (6/10 versus 3/10 normal BMI, p > 0.05) women exhibited E2 levels consistent with development of a dominant follicle, and P levels consistent with ovulation (2/10 versus 1/10) during Cycle 2. Conclusions Compared to women of normal BMI, obese women exhibit differences in OC pharmacokinetics that are associated with greater HPO activity. PMID:19631786

  13. Oral contraception following abortion: A systematic review and meta-analysis.

    PubMed

    Che, Yan; Liu, Xiaoting; Zhang, Bin; Cheng, Linan

    2016-07-01

    Oral contraceptives (OCs) following induced abortion offer a reliable method to avoid repeated abortion. However, limited data exist supporting the effective use of OCs postabortion. We conducted this systematic review and meta-analysis in the present study reported immediate administration of OCs or combined OCs postabortion may reduce vaginal bleeding time and amount, shorten the menstruation recovery period, increase endometrial thickness 2 to 3 weeks after abortion, and reduce the risk of complications and unintended pregnancies.A total of 8 major authorized Chinese and English databases were screened from January 1960 to November 2014. Randomized controlled trials in which patients had undergone medical or surgical abortions were included. Chinese studies that met the inclusion criteria were divided into 3 groups: administration of OC postmedical abortion (group I; n = 1712), administration of OC postsurgical abortion (group II; n = 8788), and administration of OC in combination with traditional Chinese medicine postsurgical abortion (group III; n = 19,707).In total, 119 of 6160 publications were included in this analysis. Significant difference was observed in group I for vaginal bleeding time (P = 0.0001), the amount of vaginal bleeding (P = 0.03), and menstruation recovery period (P < 0.00001) compared with the control groups. Group II demonstrated a significant difference in vaginal bleeding time (P < 0.00001), the amount of vaginal bleeding (P = 0.0002), menstruation recovery period (P < 0.00001), and endometrial thickness at 2 (P = 0.003) and 3 (P < 0.00001) weeks postabortion compared with the control group. Similarly, a significant difference was observed in group III for reducing vaginal bleeding time (P < 0.00001) and the amount of vaginal bleeding (P < 0.00001), shortening the menstruation recovery period (P < 0.00001), and increasing endometrial thickness 2 and 3 weeks after surgical abortion (P < 0.00001, all

  14. [Frequency and reasons for switching/stopping use of oral contraceptives. Results of the German Cohort Study on Women Health].

    PubMed

    Heinemann, L A; Thiel, C; Assmann, A; Möhner, S

    2001-10-01

    Frequency and reasons for switching/stopping use of oral contraceptives. Results of the German Cohort Study on Women Health. Use of oral contraceptives is the safest and most commonly used method of contraception. The frequency of use underscores the importance of research on benefits, risks, and acceptability of long-term use. - An interim analysis of the German Cohort Study on Women's Health (aged 15-65 years) was performed to analyse frequency and reason of switching or stop of OC-use. We got for this analysis over 10 000 women with almost 100 000 years of observation from first to last (or current) OC use. - The prevalence of ever use of OCs was 85.5 % in our cohort. Switching or stop of OC use was observed in 93 % of the women. The frequency of switching increased with age and duration of use. Social parameter such as education, employment status, and living in the old or the new Federal States were not materially associated with the frequency of switching or stopping OC use. Satisfaction with general health, psychic stability, and sexual life was slightly associated with the frequency of switching: The better satisfaction the lower frequency of switching, but the sequence of cause and consequence is unclear. The most frequent categories of reasons for switching were observed side effects and personal reasons. Desire to get pregnant was the number one single reason, followed by headache/migraine, and bleeding problems. The frequency of more than 50 single reasons is listed. - The frequency and the knowledge of reason for switching or stopping OC use underlines the need for a good collaboration between physician and treated woman. However, also research on long-term compliance is required and the development of OCs with even less side effects. PMID:11753811

  15. Comparison of efficacy of metformin and oral contraceptive combination of ethinyl estradiol and drospirenone in polycystic ovary syndrome

    PubMed Central

    Suvarna, Yashasvi; Maity, Nivedita; Kalra, Pramila; Shivamurthy, MC

    2016-01-01

    Objective The 2013 Endocrine Society guidelines state that hormonal contraceptives should be used for treating both menstrual irregularity and hirsutism in patients with polycystic ovary syndrome (PCOS). Metformin should be reserved for the treatment of women presenting with only menstrual irregularity because it has limited benefits in treating hyperandrogenism associated with PCOS. A high prevalence of insulin resistance is noted among the South Asians, and these guidelines may not hold good for this population. Thus, this study was conducted to investigate and compare the effects of metformin and an oral contraceptive containing drospirenone on menstrual pattern, body mass index, serum testosterone levels, and dehydroepiandrosterone sulfate (DHEAS) levels at baseline to 6 months of therapy in the treatment groups. Material and Methods This was a prospective observational study that was conducted over a year in patients visiting the Endocrinology outpatient department at a tertiary care center in a south Indian city. Forty-six subjects diagnosed with PCOS as per the Rotterdam criteria were included. They received either metformin twice daily or an oral contraceptive containing drospirenone once daily as a monthly regimen for 6 months. Results Metformin regularized menstrual cycles in 72% of patients who were followed up at 6 months. No significant difference was observed between the two treatment groups with respect to decreasing the body mass index, serum testosterone levels, and DHEAS levels (p=0.40, p=0.65, and p=0.22, respectively). Conclusion Metformin is effective in regularizing menstrual cycles, decreasing body mass index, and treating hyperandrogenism in Indian women diagnosed with PCOS. PMID:27026772

  16. Maternal use of oral contraceptives and risk of hypospadias - a population-based case-control study.

    PubMed

    Wogelius, Pia; Horváth-Puhó, Erzsébet; Pedersen, Lars; Nørgaard, Mette; Czeizel, Andrew E; Sørensen, Henrik Toft

    2006-01-01

    The aim of this population-based case-control study was to examine the risk of isolated hypospadias in boys born to mothers who have used oral contraceptives in early pregnancy. The study was based on data from the Hungarian Case-Control Surveillance of Congenital Abnormalities from 1980 to 1996, and included 3,038 boys with hypospadias (cases), 24,799 boys without congenital abnormalities (CA-free controls), and 11,881 boys with abnormalities other than hypospadias. We used unconditional logistic regression to adjust for birth order, maternal age, maternal employment status, maternal diabetes, and pre-eclampsia. When comparing cases with CA-free controls the OR for maternal use of OC was 1.21 (95% CI: 0.67-2.17). When comparing cases with boys with other abnormalities, the OR for maternal use of OC was 0.83 (95% CI: 0.46-1.50). Our data showed that self-reported maternal use of oral contraceptives during pregnancy was not associated with an increased risk of hypospadias in the offspring.

  17. Latin America's contributions to contraceptive development.

    PubMed

    Coutinho, E M

    1993-08-01

    The contributions of Latin Americans to contraceptive research began in 1951 when the Mexican chemist, Miramontes, invented norethisterone (norethindrone). Early studies on the use of this drug with ethinyl estradiol in an oral contraceptive (OC) pill were conducted in Puerto Rico. Publication of these studies was the second milestone in contraceptive development. While the leaders of this work, Pincus and Rock, were widely acknowledged, the many doctors who carried out the trials and reported their observations have been forgotten. The next milestone was the introduction of the estrogen-free OC by Martinez-Manautou and his collaborators in 1966. That same year Coutinho, de Souza, and Csapo reported on the contraceptive effect of medroxyprogesterone acetate (MPA) based on work done in Brazil. Also from Brazil came the proposal to use MPA in combination with estrogen in a monthly contraceptive injectable. The development of Depo-Provera and other injectables also took place mostly in Latin America. The first norgestrel-containing pill was also developed in Brazil, and successful efforts to reduce the dosage to a half tablet prefigured the development of low-dose OCs. Norplant was developed in Brazil, with the first clinical trails taking place in Chile. Other proposals followed during the late 1970s, including efforts to develop a male contraceptive. The first clinical trials with gossypol outside of China took place in Brazil. A Latino, Zipper, also proposed the use of copper in IUDs which increased the acceptability of this method. In addition to the researchers cited here, many others have contributed decisively to contraceptive development. The fact that they are not receiving the recognition they deserve is disappointing since the only real reward for their dedicated work would be recognition of their results.

  18. Expanding the application of the tablet processing workstation to support the sample preparation of oral suspensions.

    PubMed

    Opio, Alex Manuel; Nickerson, Beverly; Xue, Gang; Warzeka, John; Norris, Ken

    2011-06-01

    Sample preparation is the most time-consuming part of the analytical method for powder for oral suspension (POS) assay, purity, and preservative analysis, as this involves multiple dilution and filtration steps. The Tablet Processing Workstation (TPW) was used to automate the sample preparation of a POS formulation. Although the TPW is typically used to automate the preparation of solid oral dosage forms and powders, it contains all of the necessary components to perform POS sample preparation. The TPW exhibited acceptable repeatability in testing 3 lots using 10 replicate preparations per lot. Acceptable linearity of the drug and preservative in the presence of excipients was demonstrated over the range corresponding to 50-150% of intent. Accuracy showed suitable recoveries for all points evaluated. TPW results were shown to correlate to results obtained with the manual method. The TPW method was used to prepare samples in support of manufacturing scale-up efforts. With the efficiencies gained using the TPW, it was possible to analyze a large number of samples generated during process development activities for the POS formulation with minimal human intervention. The extensive data enabled trending of the manufacturing development runs and helped to identify optimization strategies for the process.

  19. Formulation strategy and evaluation of nanocrystal piroxicam orally disintegrating tablets manufacturing by freeze-drying.

    PubMed

    Lai, Francesco; Pini, Elena; Corrias, Francesco; Perricci, Jacopo; Manconi, Maria; Fadda, Anna Maria; Sinico, Chiara

    2014-06-01

    Piroxicam (PRX) is a non-steroidal anti-inflammatory drug characterized by a poor water solubility and consequently by a low oral bioavailability. In this work, different nanocrystal orally disintegrating tablets (ODT) were prepared to enhance piroxicam dissolution rate and saturation solubility. PRX nanocrystals were prepared by means of high pressure homogenization technique using poloxamer 188 as stabilizer. Three different ODTs were prepared with the same nanosuspension using different excipients in order to study their effect on the PRX dissolution properties. PRX nanocrystal size and zeta potential were determined by photon correlation spectroscopy. Additional characterization of PRX nanocrystal ODT was carried out by infrared spectroscopy, X-ray powder diffractometry, differential scanning calorimetry. Dissolution study was performed in distilled water (pH 5.5) and compared with PRX coarse suspension ODT, PRX/poloxamer 188 physical mixture, bulk PRX samples and a PRX commercial ODT. All PRX nanocrystal ODT formulations showed a higher drug dissolution rate than coarse PRX ODT. PRX nanocrystal ODT prepared using gelatin or croscarmellose as excipient showed a higher PRX dissolution rate compared with the commercial formulation and ODT prepared using xanthan gum. Overall results confirmed that improved PRX dissolution rate is due to the increased surface-to-volume ratio due to the nanosized drug particle but also revealed the important role of different excipients used.

  20. Emergency contraception with a Copper IUD or oral levonorgestrel: an observational study of 1-year pregnancy rates

    PubMed Central

    Turok, David K.; Jacobson, Janet C.; Dermish, Amna I.; Simonsen, Sara E.; Gurtcheff, Shawn; McFadden, Molly; Murphy, Patricia A.

    2014-01-01

    Objective We investigated the one-year pregnancy rates for emergency contraception (EC) users who selected the copper T380 IUD or oral levonorgestrel (LNG) for EC. Study Design This prospective study followed women for 1 year after choosing either the copper T380 IUD or oral LNG for EC. The study was powered to detect a 6% difference in pregnancy rates within the year after presenting for EC. Results Of the 542 women who presented for EC, agreed to participate in the trial, and meet inclusion criteria, 215 (40%) chose the copper IUD and 327 (60%) chose oral LNG. In the IUD group, 127 (59%) were nulligravid. IUD insertion failed in 42 women (19%). The 1-year follow-up rate was 443/542 (82%); 64% of IUD users contacted at 1 year still had their IUDs in place. The 1-year cumulative pregnancy rate in women choosing the IUD was 6.5% vs. 12.2% in those choosing oral LNG (HR= 0.53, 95% CI: 0.29–0.97, p=0.041). By type of EC method actually received, corresponding values were 5.2% for copper IUD users vs. 12.3% for oral LNG users, HR 0.42 (95% CI: 0.20–0.85, p= 0.017). A multivariable logistic regression model controlling for demographic variables demonstrates that women who chose the IUD for EC had fewer pregnancies in the following year than those who chose oral LNG (HR 0.50, 95% CI: 0.26–0.96, p=0.037). Conclusion One year after presenting for EC women choosing the copper IUD for EC were half as likely to have a pregnancy compared to those choosing oral LNG. PMID:24332433

  1. A novel spray-dried nanoparticles-in-microparticles system for formulating scopolamine hydrobromide into orally disintegrating tablets

    PubMed Central

    Li, Feng-Qian; Yan, Cheng; Bi, Juan; Lv, Wei-Lin; Ji, Rui-Rui; Chen, Xu; Su, Jia-Can; Hu, Jin-Hong

    2011-01-01

    Scopolamine hydrobromide (SH)-loaded microparticles were prepared from a colloidal fluid containing ionotropic-gelated chitosan nanoparticles using a spray-drying method. The spray-dried microparticles were then formulated into orally disintegrating tablets (ODTs) using a wet granulation tablet formation process. A drug entrapment efficiency of about 90% (w/w) and loading capacity of 20% (w/w) were achieved for the microparticles, which ranged from 2 μm to 8 μm in diameter. Results of disintegration tests showed that the formulated ODTs could be completely dissolved within 45 seconds. Drug dissolution profiles suggested that SH is released more slowly from tablets made using the microencapsulation process compared with tablets containing SH that is free or in the form of nanoparticles. The time it took for 90% of the drug to be released increased significantly from 3 minutes for conventional ODTs to 90 minutes for ODTs with crosslinked microparticles. Compared with ODTs made with noncrosslinked microparticles, it was thus possible to achieve an even lower drug release rate using tablets with appropriate chitosan crosslinking. Results obtained indicate that the development of new ODTs designed with crosslinked microparticles might be a rational way to overcome the unwanted taste of conventional ODTs and the side effects related to SH’s intrinsic characteristics. PMID:21720502

  2. Well-being, sleep, exercise patterns, and the menstrual cycle: a comparison of natural hormones, oral contraceptives and depo-provera.

    PubMed

    Brown, Susan G; Morrison, Lynn A; Larkspur, Louona M; Marsh, Ariel L; Nicolaisen, Nicola

    2008-01-01

    Overall well-being, sleep and exercise patterns were investigated in women between the ages of 18 and 36 years with natural hormone profiles (n = 12), and women using oral contraceptives (n = 12) or Depo-Provera (n = 12) from January 18, 2005 to December 7, 2005. Daily questionnaires on the above variables were obtained across 3 menstrual cycles (108 cycles). Women using hormonal contraception reported more overall negative well-being than women with natural hormone profiles (p = .038). Positive well-being at mid-cycle was positively correlated with increased sleep by the natural hormone (p < .05) and oral contraception groups (p < .05) but not by the Depo-Provera group. Women with natural hormone profiles walked more when they reported decreased well-being. Our findings indicate that the use of Depo-Provera interferes with the natural relations between sleep, cycle phase and well-being.

  3. Contraception and Diabetes.

    PubMed

    Afsana, Faria

    2016-09-01

    Contraception for women with diabetes mellitus is an important issue mainly as the pregnancy outcome depends on glycaemic control before conception among women with diabetes. Type of diabetes as type 1 or type 2 Diabetes, women with history of gestational diabetes and breast feeding diabetic mothers may be a consideration in selecting a contraceptive .On the other hand presence of diabetic complications is a significant determinant. Different methods of contraception as oral, injectable, implant, intrauterine devices are available. Patient\\'s choice and health issues both should be considered while prescribing a contraceptive to a woman with diabetes. Emergency contraception is sometimes required in situations where there is chance of contraceptive failure. This review article highlights different contraceptive methods, their use and limitations and will guide to make a rational choice for a woman with diabetes. PMID:27582166

  4. A Pharmacokinetic Study Comparing Eslicarbazepine Acetate Administered Orally as a Crushed or Intact Tablet in Healthy Volunteers.

    PubMed

    Sunkaraneni, Soujanya; Kharidia, Jahnavi; Schutz, Ralph; Blum, David; Cheng, Hailong

    2016-07-01

    The relative bioequivalence of crushed versus intact eslicarbazepine acetate (ESL) tablets (800 mg) administered orally in healthy adults was evaluated in an open-label, randomized, 2-period crossover study with a 5-day washout between treatments. Sample blood levels of eslicarbazepine and (R)-licarbazepine were determined; pharmacokinetic parameters were derived for eslicarbazepine. Bioequivalence was established if the 90% confidence intervals (CIs) for the geometric mean treatment ratios of eslicarbazepine AUC(0-∞) and Cmax were within the prespecified 80%-125% range. Twenty-seven subjects in the intent-to-treat population (n = 28) completed both treatment periods. Eslicarbazepine exposure measures were similar for crushed versus intact ESL tablets: average Cmax , 11 700 versus 11 500 ng/mL; AUC(0-∞) , 225 000 versus 234 000 ng·h/mL; AUC(0-last) , 222 000 versus 231 000 ng·h/mL, respectively. Geometric least squares mean ratios (90%CIs) comparing eslicarbazepine exposure measures were within the 80%-125% range (Cmax , 102.63% [97.07%-108.51%]; AUC(0-∞) , 96.72% [94.36%-99.13%]; AUC0-last , 96.69% [94.24%-99.21%]). In conclusion, ESL administered orally as a crushed tablet sprinkled on applesauce, or intact were bioequivalent in healthy subjects. Eslicarbazepine bioavailability was not significantly altered by crushing, indicating that ESL tablets can be administered intact or crushed. PMID:27249205

  5. Oral contraceptives, hormone replacement therapy, thrombophilias and risk of venous thromboembolism: a systematic review. The Thrombosis: Risk and Economic Assessment of Thrombophilia Screening (TREATS) Study.

    PubMed

    Wu, Olivia; Robertson, Lindsay; Langhorne, Peter; Twaddle, Sara; Lowe, Gordon D O; Clark, Peter; Greaves, Mike; Walker, Isobel D; Brenkel, Ivan; Regan, Lesley; Greer, Ian A

    2005-07-01

    Combined oral contraceptives, oral hormone replacement therapy and thrombophilias are recognised risk factors for venous thromboembolism in women. The objective of this study was to assess the risk of thromboembolism among women with thrombophilia who are taking oral contraceptives or hormone replacement therapy, conducting a systematic review and metaanalysis. Of 201 studies identified, only nine met the inclusion criteria. Seven studies included pre-menopausal women on oral contraceptives and two studies included peri-menopausal women on hormone replacement therapy. For oral contraceptive use, significant associations of the risk of venous thromboembolism were found in women with factor V Leiden (OR 15.62; 95%CI 8.66 to 28.15); deficiencies of antithrombin (OR 12.60; 95%CI 1.37 to 115.79), protein C (OR 6.33; 95%CI 1.68 to 23.87), or protein S (OR 4.88; 95%CI 1.39 to 17.10), elevated levels of factor VIIIc (OR 8.80; 95%CI 4.13 to 18.75); and factor V Leiden and prothrombin G20210A (OR 7.85; 95%CI 1.65 to 37.41). For hormone replacement therapy, a significant association was found in women with factor V Leiden (OR 13.16; 95%CI 4.28 to 40.47). Although limited by the small number of studies, the findings of this study support the presence of interaction between thrombophilia and venous thromboembolism among women taking oral contraceptives. However, further studies are required to establish with greater confidence the associations of these, and other, thrombophilias with venous thromboembolism among hormone users.

  6. Gastrointestinal transit of model mini-tablet controlled release oral dosage forms in fasted human volunteers.

    PubMed

    Podczeck, F; Course, N; Newton, J M; Short, M B

    2007-07-01

    The aim of this study was to compare the gastrointestinal transit of multiple unit, small diameter (3.2 mm), non-disintegrating tablets of differing densities with results previously reported in the same volunteers in the fasted state for larger diameter (6.6 and 12.2 mm) tablets. The gastrointestinal transit was observed with gamma-scintigraphy at various intervals over a 9-h period to give an accurate assessment of the transit characteristics. The value for the median emptying time of the first light tablet was significantly shorter than that for the dense tablet, but the total emptying time and the time for the last tablet to empty for both sets of tablets were not statistically different. The value of the median time for initial and final emptying of the small tablets from the stomach was significantly longer than that for the larger diameter tablets. The 9-h time limit of the observations limited the estimation of the time taken to enter the caecum and consequently the small intestine transit times. There was clear evidence that for the dense tablets of all sizes, the value for the small intestine transit time was longer than the 3-4 h reported in the literature. The only tablet system to enter the caecum within the time limit of the study was the normal density 12.2-mm tablets. PMID:17637188

  7. Metabolism and pharmacokinetics of major polyphenol components in rat plasma after oral administration of total flavonoid tablet from Anemarrhenae Rhizoma.

    PubMed

    Xie, Yuan-Yuan; Wang, Xiu-Ming; Wang, Si-Huan; Wang, Yi-Ming; Tian, Hui-Fang; Yuan, Yong-Sheng; Li, Hong-Yan; Liang, Qiong-Lin; Luo, Guo-An

    2016-07-15

    Total flavonoid tablet from Anemarrhenae Rhizoma (Zhimu tablet), which was made of total polyphenol components extracted from the dried rhizome of Anemarrhena asphodeloides Bge. (Zhimu in Chinese), is a novel traditional Chinese medicine prescribed for the treatment of diabetes. Mangiferin (MF) and neomangiferin (NMF) are the two main components detected and determined in Zhimu tablet, accounting for 8.9% of the total weight of each tablet. In the present study, high performance liquid chromatography (HPLC) coupled with time-of-flight (TOF) tandem mass spectrometry (MS) was applied to characterize the metabolites of MF and NMF in rat plasmas collected at different time points after oral administration of Zhimu tablet at a dose of 3.63g/kg (corresponding to 270mg/kg MF). Accurate mass measurement was used to determine the elemental composition of metabolites and thus to confirm the proposed structures of identified metabolites. Time points of appearance of some metabolites, such as isomers, were also taken into account during the structure confirmation. A total of 21 potential metabolites were found in rat plasma at different time points, and the metabolic pathways in vivo were involved in hydrolysis, methylation, glucuronide conjugation, glycoside conjugation, sulphation, dehydration and isomerisation. Furthermore, a selective and accurate LC-MS assay method was developed and validated for the quantification of MF in plasma. Semi-quantification of main conjugated metabolites was also performed in order to describe the dynamic metabolism profiles of polyphenol components in Zhimu tablet. MF concentration in plasma reached 1.36±0.47μgmL(-1) about 5.0h after oral administration of Zhimu tablet, which showed a 3.24- and 4.91-fold increase in plasma maximum concentration and area under the concentration-time curve (AUC) from 0 to 24h of MF compared with those for rats administered with free MF, respectively. The results indicated that the pharmacokinetic processes and

  8. Plasma cinnarizine levels resulting from oral administration as capsule or tablet formulation investigated by gas-liquid chromatography.

    PubMed Central

    Morrison, P J; Bradbrook, I D; Rogers, H J

    1979-01-01

    1 A gas chromatographic assay for the estimation of therapeutic concentrations of cinnarizine in plasma is described. 2 Cinnarizine (75 mg) was administered orally to twelve healthy subjects in the form of capsules and tablets on two separate occasions. No difference was found in the plasma levels or absorption of cinnarizine from these formulations. 3 The mean plasma elimination half-life of cinnarizine was 3.24 h. PMID:444354

  9. [The statement of Polish Gynecological Society experts on oral use of contraceptive 75 microg desogestrel minipill in different clinical cases--state of art in 2008].

    PubMed

    Debski, Romuald; Kotarski, Jan; Paszkowski, Tomasz; Pawelczyk, Leszek; Skrzypulec, Violetta; Tomaszewski, Jacek

    2009-01-01

    Recent epidemiologic studies indicate that use of combined oral contraception is associated with a increase in the incidence of cardiovascular disease (venous thromboembolism, pulmonary embolism, myocardial infarction and stroke). The risk of cardiovascular disease is strongly related to estrogen dose, progestogen type and other factors for example thrombogenic mutations and cigarette smoking among female over age 35. The progestogen only contraception is safe alternative to combined hormonal contraception. Progestogen only pill (POP) has different levels of action (local and/or central) which may vary from one drug to another. As for the cardiovascular disease risk, progestogens are not considered to be risk factors. Desogestrel containing POP is advised in the following cases: bad tolerance of exogenous oestrogens; in order to counteract an endogenous hyperoestrogenosis; medical, metabolic or cardiovascular contraindications to estroprogestogen contraception. Lastly, POP should be used as a prime contraception in some particular situations (breast feeding, endometriosis, adenomyosis, cigarette smoking, contraception for older women). These recommendations present the actual system of care in that population of women in Poland.

  10. Oral contraceptive use after conception in relation to the risk of congenital urinary tract anomalies.

    PubMed

    Li, D K; Daling, J R; Mueller, B A; Hickok, D E; Fantel, A G; Weiss, N S

    1995-01-01

    The authors conducted a case-control study of the relation of OC use after conception to the occurrence of congenital urinary tract anomalies (CUTAs). Singleton CUTA cases with no known chromosomal abnormality from seven counties in western Washington State born during the period January 1, 1990-December 31, 1991 were identified through the Washington State Birth Defect Registry. Controls without birth defects were randomly selected from singleton births that occurred in the same year as the cases in five large hospitals in King County. Mothers of the 118 cases and 369 controls were interviewed to obtain their contraceptive history as well as other information. Mothers of nine cases (7.6%) and eight controls (2.2%) had taken OCs at some time during the pregnancy. After adjustment for birth year and county of maternal residence, OC use after conception was associated with an almost five-fold increased risk of having a baby with a CUTA [odds ratio (OR) = 4.8, 95 percent confidence interval (CI), 1.6-14.1] relative to no contraception at or after conception. Use of other contraceptive methods after conception was not related to the risk of CUTAs. OC use during the 3 or 6 months prior to the conception also was not associated with the risk of CUTAs. Further adjustment for sociodemographic factors, reproductive history, perinatal exposure to exogenous agents, and past OC use did not change the results, nor did restricting the analysis to residents of King County.(ABSTRACT TRUNCATED AT 250 WORDS)

  11. Nomegestrol acetate/estradiol hormonal oral contraceptive and breast cancer risk.

    PubMed

    Del Pup, Lino; Berretta, Massimiliano; Di Francia, Raffaele; Cavaliere, Carla; Di Napoli, Marilena; Facchini, Gaetano; Fiorica, Francesco; Mileto, Mario; Schindler, Adolf E

    2014-08-01

    Combined hormonal contraceptives (CHCs) contain estrogen and progestin, which can stimulate estrogen-sensitive and/or progesterone-sensitive breast cancer growth. Until recently, ethinylestradiol had been almost the only estrogen used for decades, and its dose has been greatly reduced over time. The first generations of birth control pills contained approximately five times more estrogen and four times more progestin than the latest contraceptives. Newer CHCs also contain steroids that more closely mimic the physiological estradiol (E2) and progesterone effects. The newer CHC formulations are thus expected to have less influence on the breast, although it is very difficult to demonstrate any difference among the recent available preparations in human studies. Recently, nomegestrol acetate (NOMAC), a neutral, nonandrogenic, progesterone-like profile progestin, has become available in combination with the 'natural' estrogen, E2. According to the literature, NOMAC/E2 is expected to have either a lesser stimulating effect or a neutral effect on estrogen-sensitive breast cancers. We performed an analysis of the available studies and a bibliographical review. The endocrine and metabolic effects of NOMAC/E2 formulation might lead to a lesser breast tissue stimulation. The data reported, confirmed through clinical studies, should be considered when choosing a hormonal contraceptive, especially when breast stimulation is a concern.

  12. Emergency Contraception.

    PubMed

    Batur, Pelin; Kransdorf, Lisa N; Casey, Petra M

    2016-06-01

    Emergency contraception (EC) may help prevent pregnancy in various circumstances, such as contraceptive method failure, unprotected sexual intercourse, or sexual assault, yet it remains underused. There are 4 approved EC options in the United States. Although ulipristal acetate requires a provider's prescription, oral levonorgestrel (LNG) is available over the counter for women of all ages. The most effective method of EC is the copper intrauterine device, which can be left in place for up to 10 years for efficacious, cost-effective, hormone-free, and convenient long-term primary contraception. Ulipristal acetate tends to be more efficacious in pregnancy prevention than is LNG, especially when taken later than 72 hours postcoitus. The mechanism of action of oral EC is delay of ovulation, and current evidence reveals that it is ineffective postovulation. Women who weigh more than 75 kg or have a body mass index greater than 25 kg/m(2) may have a higher risk of unintended pregnancy when using oral LNG EC; therefore, ulipristal acetate or copper intrauterine devices are preferable in this setting. Providers are often unaware of the range of EC options or are unsure of how to counsel patients regarding the access and use of EC. This article critically reviews current EC literature, summarizes recommendations, and provides guidance for counseling women about EC. Useful tips for health care providers are provided, with a focus on special populations, including breast-feeding women and those transitioning to long-term contraception after EC use. When treating women of reproductive age, clinicians should be prepared to counsel them about EC options, provide EC appropriately, and, if needed, refer for EC in a timely manner. PMID:27261868

  13. New contraceptive choices across reproductive life.

    PubMed

    Foran, Therese M

    2003-06-16

    The range of contraceptive options and consumer awareness of new contraceptive methods have both increased significantly over the past 10 years. New methods available in Australia include lower-dose oral contraceptive pills, new oral progestogens, progestogen implants, a progestogen-bearing intrauterine device and polyurethane female condoms. Contraceptive options which may soon be introduced in Australia include novel methods of administering combined (oestrogen-progestogen) contraception, such as dermal patches and vaginal rings.

  14. Combination effect of physical and gustatory taste masking for propiverine hydrochloride orally disintegrating tablets on palatability.

    PubMed

    Matsui, Rakan; Uchida, Shinya; Namiki, Noriyuki

    2015-01-01

    Orally disintegrating tablets (ODTs) containing propiverine hydrochloride (which is extremely bitter and leaves a feeling of numbness in the mouth) were prepared with a combined use of physical and organoleptic taste masking. Propiverine-loaded masking particles (PLMPs) were prepared with different amounts of gastric-soluble coatings as physical masking. ODTs without organoleptic masking were prepared by mixing each group of PLMPs with Ludiflash®, crospovidone, and magnesium stearate. ODTs with organoleptic masking were also prepared by addition of L-menthol, aspartame, thaumatin, and cinnamon. Fifteen-minute dissolution of propiverine in solutions with pH 1.2 was ≥ 85% for all ODTs, whereas that in pH 6.8 solutions was ≤ 85% and increased with physical masking. A single blind randomized crossover trial was conducted. Ten healthy volunteers were asked to quantify the bitterness, numbness, and overall palatability using a 100-mm visual analog scale (VAS) at the period of disintegration as well as 1 and 5 min later. VAS scores of bitterness, numbness, and overall palatability improved along with increasing amounts of physical masking, and the effects persisted for 5 min. VAS scores for numbness increased over time regardless of the amount of physical masking. Bitterness, numbness, and overall palatability were significantly improved by organoleptic masking if the amount of physical masking was small. Combined use of physical and organoleptic masking is useful for improving palatability of ODTs containing propiverine. PMID:25744453

  15. Famotidine orally disintegrating tablets: bitterness comparison of original and generic products.

    PubMed

    Tokuyama, Emi; Matsunaga, Chiharu; Yoshida, Koichi; Mifsud, Jean-Christophe; Irie, Tetsumi; Yoshida, Miyako; Uchida, Takahiro

    2009-04-01

    The purpose of the present study was to compare the palatability of the original and eight generic versions of famotidine orally disintegrating tablets by means of human gustatory sensation tests, a comparison of the release profiles, and using an automated taste sensor, the alpha-Astree Electronic Tongue. In the gustatory sensation test, the original product (Gaster D, 10 mg) showed the lowest bitterness intensity. Among the eight generic products tested, the variance in the sweetness intensity was not great, but there were large variances in the intensity of bitterness, some of the generic products being significantly more bitter than that of the original product. On the other hand, some generic products show similar bitterness level as the original product. In a study of release profiles, the original product had the lowest release rates of both famotidine and aspartame; in comparison, some of the generic products had high release rates of famotidine and aspartame, even in the initial stages. Whereas some generic products had low release rates of famotidine and aspartame. Finally, sample solutions were analysed using the taste sensor. There was a good correlation between the taste predicted by principal component analysis and the Euclidean distance obtained by the taste sensor, and bitterness intensities obtained in the human gustatory tests.

  16. Combination effect of physical and gustatory taste masking for propiverine hydrochloride orally disintegrating tablets on palatability.

    PubMed

    Matsui, Rakan; Uchida, Shinya; Namiki, Noriyuki

    2015-01-01

    Orally disintegrating tablets (ODTs) containing propiverine hydrochloride (which is extremely bitter and leaves a feeling of numbness in the mouth) were prepared with a combined use of physical and organoleptic taste masking. Propiverine-loaded masking particles (PLMPs) were prepared with different amounts of gastric-soluble coatings as physical masking. ODTs without organoleptic masking were prepared by mixing each group of PLMPs with Ludiflash®, crospovidone, and magnesium stearate. ODTs with organoleptic masking were also prepared by addition of L-menthol, aspartame, thaumatin, and cinnamon. Fifteen-minute dissolution of propiverine in solutions with pH 1.2 was ≥ 85% for all ODTs, whereas that in pH 6.8 solutions was ≤ 85% and increased with physical masking. A single blind randomized crossover trial was conducted. Ten healthy volunteers were asked to quantify the bitterness, numbness, and overall palatability using a 100-mm visual analog scale (VAS) at the period of disintegration as well as 1 and 5 min later. VAS scores of bitterness, numbness, and overall palatability improved along with increasing amounts of physical masking, and the effects persisted for 5 min. VAS scores for numbness increased over time regardless of the amount of physical masking. Bitterness, numbness, and overall palatability were significantly improved by organoleptic masking if the amount of physical masking was small. Combined use of physical and organoleptic masking is useful for improving palatability of ODTs containing propiverine.

  17. Association Between Long-term Oral Contraceptive Use and Risk of Crohn’s Disease Complications in a Nationwide Study

    PubMed Central

    Khalili, Hamed; Granath, Fredrik; Smedby, Karin E.; Ekbom, Anders; Neovius, Martin; Chan, Andrew T.; Olen, Ola

    2016-01-01

    BACKGROUND & AIMS Use of exogenous hormones, in the form of oral contraceptives (OCs), has been linked consistently to risk of Crohn’s disease (CD). Nonetheless, it is not clear how OCs might contribute to the progression of CD. METHODS We conducted a prospective study of female patients with CD (age, 16–51 y), identified from the inpatient and outpatient care components of the Swedish National Patient Register from January 2002 through December 2013. Information on current OC use was obtained from the Prescribed Drug Register starting in July of 2005 and updated until December of 2013. Primary outcomes were defined as first CD-related surgery and first steroid prescription. We used Cox proportional hazard modeling with time-varying covariates to estimate multivariable-adjusted hazard ratios (MV-adjusted HRs). RESULTS We identified 482 incident cases of surgery among 4036 patients with CD, with a median follow-up period of 58 months. Compared with nonusers, the MV-adjusted HRs for surgery were 1.14 (95% confidence interval [CI], 0.80–1.63) for past users and 1.30 (95% CI, 0.89–1.92) for current users. The risk of surgery increased with longer duration of use (Ptrend = .036) and higher prescribed daily dose (Ptrend = .016). Specifically, for women with more than 3 years of OC use, the MV-adjusted HR for surgery was 1.68 (95% CI, 1.06–2.67). The association was confined to the combination type of OC. We estimated that for every 83 patients with CD receiving the combination type of oral contraceptives for at least 1 year, 1 extra surgery is required. The rate of steroid prescriptions did not appear to increase with past or current use of OCs, compared with patients who have not taken OCs (all Pcomparisons > .20). CONCLUSIONS In a nationwide analysis of patients in Sweden, long-term use of OCs, particularly the combination type, was associated with an increased risk of surgery among women with established CD. Clinicians carefully should evaluate and monitor

  18. Efficacy, tolerability, and preference of mirtazapine orally disintegrating tablets in depressed patients: a 17-week naturalistic study in Lithuania.

    PubMed

    Danileviciūte, Vita; Sveikata, Audrius; Adomaitiene, Virginija; Gumbrevicius, Gintautas; Fokas, Vidmantas; Sveikatiene, Renata

    2009-01-01

    Mirtazapine is an established antidepressant with well-documented efficacy demonstrated in controlled clinical trials. However, the gap between the results obtained in controlled clinical trials and everyday clinical practice exists. Therefore, the importance of naturalistic studies in psychiatry is becoming recognized. The aim of present naturalistic study was to acquire data on efficacy, safety, and preference of mirtazapine orally disintegrating tablets during a 17-week treatment of depression. This prospective, open-label, multicenter study in patients with mild to severe depression was conducted at 47 mental health centers of Lithuania by 78 psychiatrists. Patients were initially given 15 mg or 30 mg of mirtazapine orally disintegrating tablets; the maximum allowed dose was 45 mg per day. The primary efficacy measure was the total score on the Hamilton Depression Rating Scale-17 (HAMD-17), the Clinical Global Impression-Severity (CGI-S), and Clinical Global Impression-Improvement (CGI-I) scales. Tolerability was primarily measured by assessing the incidence of treatment-emergent adverse events. Patients were evaluated at baseline, at weeks 1, 5, 9, 13, and 17. A total of 779 patients (595 women [76.4%] with a mean [SD] age of 50.2 [13.65] and 184 men [23.6%] with a mean [SD] age of 52.4 [14.6] years) were enrolled into the study; 687 (88.2%) patients completed the study. The mean (SD) daily dose of mirtazapine orally disintegrating tablets was 29.0 (3.8) mg. The mean total (SD) HAMD-17 score improved significantly from 25.7 (4.6) to 7.3 (4.3) (P<0.005). At each visit, the mean HAMD-17 score was significantly lower than that at the preceding visit. At week 17, remission (HAMD-17 score < or =7) was observed in 436 (56%) patients. The mean (SD) CGI-S score improved significantly from 4.9 (1.0) at baseline to 1.5 (0.6) at endpoint (P<0.001). According to the CGI-I assessments, 621 patients (89.4%) improved and improved very much. The vast majority of patients (80

  19. Lack of a clinically important pharmacokinetic interaction between sofosbuvir or ledipasvir and hormonal oral contraceptives norgestimate/ethinyl estradiol in HCV-uninfected female subjects.

    PubMed

    German, P; Moorehead, L; Pang, Phillip; Vimal, M; Mathias, A

    2014-11-01

    This study evaluated the potential for a drug-drug interaction between HCV direct-acting antivirals sofosbuvir or ledipasvir and oral hormonal contraceptive (OC) norgestimate/ethinyl estradiol (norgestimate 0.18/0.215/0.25 mg with ethinyl estradiol 25 μg). This was a 112-day, open-label, fixed-sequence pharmacokinetic (PK) study in healthy female subjects that included a lead-in cycle (OC only; N = 21), cycle 1 (OC only; N = 15), cycle 2 (OC + sofosbuvir; N = 15), and cycle 3 (OC + ledipasvir; N = 15). Administration of sofosbuvir with OC did not alter PK of norelgestromin (primary norgestimate metabolite) or ethinyl estradiol. Small increases in norgestrel (secondary norgestimate metabolite) AUC(tau) (19%) and C(tau) (23%) with sofosbuvir were noted. Ledipasvir did not impact PK of norelgestromin or norgestrel but modestly increased ethinyl estradiol C(max) (40%). Sofosbuvir, GS- 331007 (predominant circulating metabolite of SOF), and ledipasvir PK were similar to historical data. Pharmacodynamic markers luteinizing hormone, follicle-stimulating hormone, and progesterone values were generally comparable in all cycles. No loss in contraceptive efficacy is expected upon administration of sofosbuvir or ledipasvir/sofosbuvir with oral contraceptives containing norgestimate and ethinyl estradiol. The use of sofosbuvir or ledipasvir/sofosbuvir FDC with oral contraceptives is permitted.

  20. [Electronmicroscopical aspects of endometrial distrophy induced by oral contraceptives (author's transl)].

    PubMed

    Gonzalez-Gómez, F; Merchan, J; Caballero-Peregrin, P; Aldama Magnet, J

    1975-01-01

    An electron-optical study on the endometrium of 5 controls and 25 patients subjected during 3-12 months to 0.25 mg norgestrel + 0.05 mg etinil-estradiol association treatment is performed. The most prominent electronmicroscopical features of endometrial changes are described, such as the asynchronical maturation of the epithelium and the stroma, the shorthening of the proliferative and secretory phases and the epithelial involution towards the last days of the cycle. Special emphasis is placed on the zonal distribution of these changes. An increase of the nostocitosis phenomena is reported and its significance as a complementary contraceptive mechanism is discussed.

  1. High-Amylose Sodium Carboxymethyl Starch Matrices: Development and Characterization of Tramadol Hydrochloride Sustained-Release Tablets for Oral Administration

    PubMed Central

    Nabais, Teresa; Leclair, Grégoire

    2014-01-01

    Substituted amylose (SA) polymers were produced from high-amylose corn starch by etherification of its hydroxyl groups with chloroacetate. Amorphous high-amylose sodium carboxymethyl starch (HASCA), the resulting SA polymer, was spray-dried to obtain an excipient (SD HASCA) with optimal binding and sustained-release (SR) properties. Tablets containing different percentages of SD HASCA and tramadol hydrochloride were produced by direct compression and evaluated for dissolution. Once-daily and twice-daily SD HASCA tablets containing two common dosages of tramadol hydrochloride (100 mg and 200 mg), a freely water-soluble drug, were successfully developed. These SR formulations presented high crushing forces, which facilitate further tablet processing and handling. When exposed to both a pH gradient simulating the pH variations through the gastrointestinal tract and a 40% ethanol medium, a very rigid gel formed progressively at the surface of the tablets providing controlled drug-release properties. These properties indicated that SD HASCA was a promising and robust excipient for oral, sustained drug-release, which may possibly minimize the likelihood of dose dumping and consequent adverse effects, even in the case of coadministration with alcohol. PMID:25006518

  2. Application of water-insoluble polymers to orally disintegrating tablets treated by high-pressure carbon dioxide gas.

    PubMed

    Ito, Yoshitaka; Maeda, Atsushi; Kondo, Hiromu; Iwao, Yasunori; Noguchi, Shuji; Itai, Shigeru

    2016-09-10

    The phase transition of pharmaceutical excipients that can be induced by humidifying or heating is well-known to increase the hardness of orally disintegrating tablets (ODTs). However, these conditions are not applicable to drug substances that are chemically unstable against such stressors. Here, we describe a system which enhances the hardness of tablets containing water-insoluble polymers by using high-pressure carbon dioxide (CO2). On screening of 26 polymeric excipients, aminoalkyl methacrylate copolymer E (AMCE) markedly increased tablet hardness (+155N) when maintained in a high-pressure CO2 environment. ODTs containing 10% AMCE were prepared and treatment with 4.0MPa CO2 gas at 25°C for 10min increased the hardness to +30N, whose level corresponded to heating at 70°C for 720min. In addition, we confirmed the effects of CO2 pressure, temperature, treatment time, and AMCE content on the physical properties of ODTs. Optimal pressure of CO2 gas was considered to be approximately 3.5MPa for an AMCE formula, as excessive pressure delayed the disintegration of ODTs. Combination of high-pressure CO2 gas and AMCE is a prospective approach for increasing the tablet hardness for ODTs, and can be conducted without additional heat or moisture stress using a simple apparatus. PMID:27374202

  3. Enhancement of the Oral Bioavailability of Fexofenadine Hydrochloride via Cremophor® El-Based Liquisolid Tablets

    PubMed Central

    Yehia, Soad Ali; El-Ridi, Mohamed Shafik; Tadros, Mina Ibrahim; El-Sherif, Nolwa Gamal

    2015-01-01

    Purpose: The current work aimed to develop promising Fexofenadine hydrochloride (FXD) liquisolid tablets able to increase its oral bioavailability and shorten time to reach maximum plasma concentrations (Tmax). Methods: Eighteen liquisolid powders were developed based on 3 variables; (i) vehicle type [Propylene glycol (PG) or Cremophor® EL (CR)], (ii) carrier [Avicel® PH102] to coat [Aerosil® 200] ratio (15, 20, 25) and (iii) FXD concentration in vehicle (30, 35, 40 %, w/w). Pre-compression studies involved identification of physicochemical interactions and FXD crystallinity (FT-IR, DSC, XRD), topographic visualization (SEM) and estimation of flow properties (angle of repose, Carr’s index, Hausner’s ratio). CR-based liquisolid powders were compressed as liquisolid tablets (LST 9 – 18) and evaluated for weight-variation, drug-content, friability-percentage, disintegration-time and drug-release. The pharmacokinetics of LST-18 was evaluated in healthy volunteers relative to Allegra® tablets. Results: Pre-compression studies confirmed FXD dispersion in vehicles, conversion to amorphous form and formation of liquisolid powders. CR-based liquisolid powders showed acceptable-to-good flow properties suitable for compaction. CR-based LSTs had appropriate physicochemical properties and short disintegration times. Release profile of LST-18 showed a complete drug release within 5 min. Conclusion: LST-18 succeeded in increasing oral FXD bioavailability by 62% and reducing Tmax to 2.16 h. PMID:26819931

  4. RP-HPLC analytical method development and optimization for quantification of donepezil hydrochloride in orally disintegrating tablet.

    PubMed

    Liew, Kai Bin; Peh, Kok Khiang; Fung Tan, Yvonne Tze

    2013-09-01

    An easy, fast and validated RV-HPLC method was invented to quantify donepezil hydrochloride in drug solution and orally disintegrating tablet. The separation was carried out using reversed phase C-18 column (Agilent Eclipse Plus C-18) with UV detection at 268 nm. Method optimization was tested using various composition of organic solvent. The mobile phase comprised of phosphate buffer (0.01M), methanol and acetonitrile (50:30:20, v/v) adjusted to pH 2.7 with phosphoric acid (80%) was found as the optimum mobile phase. The method showed intraday precision and accuracy in the range of 0.24% to -1.83% and -1.83% to 1.99% respectively, while interday precision and accuracy ranged between 1.41% to 1.81% and 0.11% to 1.90% respectively. The standard calibration curve was linear from 0.125 μg/mL to 16 μg/mL, with correlation coefficient of 0.9997±0.00016. The drug solution was stable under room temperature at least for 6 hours. System suitability studies were done. The average plate count was > 2000, tailing factor <1, and capacity factor of 3.30. The retention time was 5.6 min. The HPLC method was used to assay donepezil hydrochloride in tablet and dissolution study of in-house manufactured donepezil orally disintegrating tablet and original Aricept.

  5. Influence of Prosolv and Prosolv:Mannitol 200 direct compression fillers on the physicomechanical properties of atorvastatin oral dispersible tablets.

    PubMed

    Gowda, Veeran; Pabari, Ritesh M; Kelly, John G; Ramtoola, Zebunnissa

    2015-06-01

    The objective of the present study was to evaluate the influence of Prosolv® and Prosolv®: Mannitol 200 direct compression (DC) fillers on the physicomechanical characteristics of oral dispersible tablets (ODTs) of crystalline atorvastatin calcium. ODTs were formulated by DC and were analyzed for weight uniformity, hardness, friability, drug content, disintegration and dissolution. Three disintegration time (DT) test methods; European Pharmacopoeia (EP) method for conventional tablets (Method 1), a modification of this method (Method 2) and the EP method for oral lyophilisates (Method 3) were compared as part of this study. All ODTs showed low weight variation of <2.5%. Prosolv® only ODTs showed the highest tablet hardness of ∼ 73 N, hardness decreased with increasing mannitol content. Friability of all formulations was <1% although friability of Prosolv®:Mannitol ODTs was higher than for pure Prosolv®. DT of all ODTs was <30 s. Method 2 showed the fastest DT. Method 3 was non-discriminatory giving a DT of 13-15 s for all formulations. Atorvastatin dissolution from all ODTs was >60% within 5 min despite the drug being crystalline. Prosolv® and Prosolv®:Mannitol-based ODTs are suitable for ODT formulations by DC to give ODTs with high mechanical strength, rapid disintegration and dissolution.

  6. Single, Escalating Dose Pharmacokinetics, Safety and Food Effects of a New Oral Androgen Dimethandrolone Undecanoate in Man: A prototype oral male hormonal contraceptive

    PubMed Central

    Swerdloff, Ronald S.; Nya-Ngatchou, Jean Jacques; Liu, Peter Y.; Amory, John K.; Leung, Andrew; Hull, Laura; Blithe, Diana L.; Woo, Jason; Bremner, William J.; Wang, Christina

    2014-01-01

    The novel androgen, dimethandrolone (DMA) has both androgenic and progestational activities, properties that may maximize gonadotropin suppression. We assessed the pharmacokinetics of dimethandrolone undecanoate (DMAU), an orally bioavailable, longer-acting ester of DMA, for male contraceptive development. Our objective was to examine the safety and pharmacokinetics of single, escalating doses of DMAU (powder in capsule formulation) administered orally with or without food in healthy men. We conducted a randomized, double-blind Phase 1 study. For each dose of DMAU (25 to 800 mg), ten male volunteers received DMAU and two received placebo at two academic medical centers. DMAU was administered both fasting and after a high fat meal (200–800 mg doses). Serial serum samples were collected over 24h following each dose. DMAU was well tolerated without significant effects on vital signs, safety laboratory tests or electrocardiograms. When administered while fasting, serum DMA (active compound) was detectable in only 4/10 participants after the 800mg dose. When administered with a 50% fat meal, serum DMA was detectable in all participants given 200mg DMAU and showed a dose-incremental increase up to 800mg, with peak levels 4 to 8h after taking the dose. Serum gonadotropins and sex hormone concentrations were significantly suppressed 12h after DMAU administration with food at doses above 200mg. This first-in-man study demonstrated that a single, oral dose of DMAU up to 800 mg is safe. A high-fat meal markedly improved DMAU/DMA pharmacokinetics. PMID:24789057

  7. [Contraception and adolescence].

    PubMed

    Amate, P; Luton, D; Davitian, C

    2013-06-01

    The mean age of first sexual intercourse is still around 17 in France, but a lot of teenagers are concerned by contraception before, with approximately 25% of sexually active 15-year-old girls. The contraceptive method must take into consideration some typical features of this population, as sporadic and non-planned sexual activity, with several sexual partners in a short period of time. In 2004, the "Haute Autorité de santé" has recommended, as first-line method, combined oral contraceptive (COC) pills, in association with male condoms. Copper-containing intrauterine contraceptive devices (IUCD) and etonogestrel-containing subcutaneous implant have been suggested but not recommended. However, oral contraceptive pill, as a user-based method, carries an important typical-use failure rate, because remembering taking a daily pill, and dealing with stop periods, may be challenging. Some easier-to-use method should be kept in mind, as 28-day COC packs, transdermal contraceptive patches, and vaginal contraceptive rings. Moreover, American studies have shown that long-acting reversible contraceptives (LARC), i.e. IUCD and implant, have many advantages for teenagers: very effective, safe, invisible. They seem well-fitted for this population, with high satisfaction and continuation rates, as long as side effects are well explained. Thus, LARC methods should be proposed more widely to teenagers. Anyway, before prescribing a contraceptive method, it is important to determine the specific situation of every teenager, to let them choose the method that they consider as appropriate in their own case, and to think about the availability of the chosen method. It is necessary to explain how to handle mistakes or misses with user-based contraceptive methods, and emergency contraception can be anticipated and prescribed in advanced provision. The use of male condoms should be encouraged for adolescents, with another effective contraceptive method, in order to reduce the high risk

  8. Pharmacokinetic profile of rizatriptan 10-mg tablet and 10-mg orally disintegrating tablet administered with or without water in healthy subjects: an open-label, randomized, single-dose, 3-period crossover study.

    PubMed

    Swan, Suzanne K; Alcorn, Harry; Rodgers, Anthony; Hustad, Carolyn M; Ramsey, Karen E; Woll, Susan; Skobieranda, Franck

    2006-02-01

    This open-label, 3-period crossover study compared the plasma concentration profiles of rizatriptan tablet, orally disintegrating tablet with water (ODTc), and ODT without water (ODTs) in 24 healthy volunteers aged 18 to 45 years. At each period, subjects received a single dose of either 10-mg rizatriptan tablet, 10-mg rizatriptan ODTs, or 10-mg rizatriptan ODTc. The authors hypothesized that ODTc has a greater geometric mean AUC(0-2h) than ODTs and that ODTc has a greater geometric mean AUC(0-1h) than tablet. A secondary end point was to compare the time of occurrence of the maximum rizatriptan plasma concentration (t(max)) of each dosing method. ODTc had a statistically significantly greater geometric mean AUC(0-2h) compared with ODTs (33.84 h x ng/mL vs 18.83 h x ng/mL; P < .001). ODTc had a slightly, but not statistically significantly, greater geometric mean AUC(0-1h) compared with rizatriptan tablet (17.07 h x ng/mL vs 13.32 h x ng/mL). The median t(max) was 0.67 hours for ODTc and tablet and 1.33 hours for ODTs. ODTc showed a slightly, but not significantly, faster rate of absorption compared with tablet. ODTs with water had a faster rate of absorption than ODTc. Future studies are needed to determine whether this pharmacokinetic difference produces differential efficacy in a clinical setting. PMID:16432269

  9. Putting a finger on potential predictors of oral contraceptive side effects: 2D:4D and middle-phalangeal hair.

    PubMed

    Oinonen, Kirsten A

    2009-06-01

    Many women experience emotional or physical side effects when taking oral contraceptives (OCs). Despite the potential impact on women's health and well-being, there are no valid methods to screen women for their risk of OC side effects. The present paper presents the results of two studies where anthropometric indicators of androgen exposure, 2D:4D and middle-phalangeal hair, were examined for their potential as predictors of OC side effects. In study 1, 2D:4D was associated with women's reports of a history of: (a) negative mood side effects; (b) discontinuation due to negative mood side effects; (c) specific mood side effects (i.e., crying, sadness, and altered trust in one's partners) and (d) specific physical side effects (i.e., headaches, fatigue, and decreased sex drive). In study 2, 2D:4D and/or middle-phalangeal hair was/were associated with a reported history of: (a) discontinuation due to negative mood side effects; (b) specific mood-related side effects (i.e., negative mood, disrupted sleep, increased aggression, and altered trust in one's partner) and (c) specific physical side effects (i.e., headaches, decreased menstrual cramps, and increased sex drive/arousal). The general pattern was that adverse OC side effects were experienced by women with lower 2D:4D and fewer middle-phalangeal hairs. Almost all relationships remained significant when response bias was controlled. These results suggest a possible role for prenatal testosterone exposure and both androgen action and sensitivity in women's experience of OC side effects. Furthermore, these two digit measures may be useful predictors of hormonal contraceptive side effects in women. PMID:19131172

  10. [Effect of xuebijing oral effervescent tablet on endotoxin induced fever and disseminated intravascular coagulation rabbit model].

    PubMed

    Guo, Shan-Shan; Gao, Ying-Jie; Tian, Xue-Chuan; Jin, Ya-Hong; Liu, Fang-Zhou; Cui, Xiao-Lan

    2013-08-01

    In order to discover the mechanism of Xuebijing oral effervescent tablet (XBJOET) to treat infectious diseases, the effect of XBJOET on endotoxin induced rabbit fever and disseminated intravascular coagulation (DIC) was investigated. Auricle microcirculation in rabbit was detected by laser speckle blood perfusion imager system; coagulation function was measured by coagulation analyzer, fibrinolytic system was quantified by Elisa assay and micro thrombosis in tissues was observed with HE staining under light microscope. The results demonstrated that the body temperature of rabbit decreased significantly at 1-3 h after administration with 4.8, 2.4 and 1.2 g x kg(-1) XBJOET to endotoxin induced DIC rabbit model, the auricle microcirculation blood flow in model group (54.45 +/- 14.53) PU was lower than that in control group (77.18 +/- 12.32) PU. The auricle microcirculation blood flow increased markedly and there was significant difference between model group and 1.2 g x kg(-1) XBJOET group. There was significant difference between model group and control group in the content of PAI1 and FIB. The PAI1 levels in model and control groups were (30.48 +/- 2.46) ng x mL(-1) and (20.93 +/- 3.25) ng x mL(-1), respectively. The FIB levels in model and control group were (3.34 +/- 1.09) g x L(-1) and (4.84 +/- 1.10) g x L(-1), respectively. The content of PAI1 in rabbit plasma decreased notably, there were significant differences between model group and 4.8, 2.4 g x kg(-1) XBJOET groups. On the contrary the content of FIB increased. XBJOET possessed pharmacological activities of curing infectious fever and DIC, the mechanism of which is related to amelioration of microcirculation disturbance, inhibition of fibrinolytic system activation and coagulation and micro thrombosis elimination.

  11. Pharmacokinetics and pharmacodynamics of an orally disintegrating tablet formulation of dexlansoprazole

    PubMed Central

    Kukulka, Michael; Nudurupati, Sai; Perez, Maria Claudia

    2016-01-01

    Background: The pharmacokinetics and pharmacodynamics of a novel orally disintegrating tablet (ODT) formulation of delayed-release dexlansoprazole 30 mg was evaluated versus the dexlansoprazole 30 mg capsule in this phase I, open-label, multiple-dose, randomized, two-period crossover study. Methods: Healthy adults received daily doses of 30 mg dexlansoprazole ODT or 30 mg dexlansoprazole delayed-release capsule for 5 days during two treatment periods, separated by a 7-day washout interval. Blood samples for dexlansoprazole plasma concentrations and intragastric pH measurements were collected through 24 hours postdose on days 1 and 5 of each period. Results: Bioequivalence between the 30 mg ODT and 30 mg capsule dosage forms was demonstrated by the primary endpoints of dexlansoprazole peak concentration (Cmax) and systemic exposure (AUC) values contained within the prespecified 90% confidence interval (CI) range of 0.80–1.25. Additional primary endpoints of intragastric mean pH values and percentage of time with pH > 4 over the 24-hour postdose interval were equivalent for dexlansoprazole ODT and dexlansoprazole capsule. Treatment-emergent adverse events were reported in 23% and 28% of participants receiving the ODT and capsule formulations, respectively. Headache was the most common adverse event in both treatment regimens (5.8% with ODT and 6.0% with capsule). Conclusions: Administration of dexlansoprazole 30 mg ODT or 30 mg capsule provided equivalent plasma exposure when either was administered as a single dose or as once daily doses for 5 days. Pharmacodynamic equivalence between the two formulations was demonstrated by similar intragastric pH parameters on both day 1 and day 5. No effect of day on dexlansoprazole pharmacokinetics was observed. Dexlansoprazole ODT and dexlansoprazole capsule were both well tolerated. PMID:27803731

  12. The role of drugs, particularly oral contraceptives, in triggering thrombosis in congenital defects of coagulation inhibitors: a study of six patients.

    PubMed

    Girolami, A; Simioni, P; Girolami, B; Zanardi, S

    1991-10-01

    It is well established that pregnancy and puerperium, surgery and trauma may often trigger thrombotic events even in the normal population. On the other hand, patients with congenital deficiency of clotting inhibitors may develop spontaneous thrombotic episodes, although they become often symptomatic when one of the above-mentioned triggering factors is present. We found this to be true in 40 out of 81 symptomatic patients with congenital defects of coagulation inhibitors. In six (15%) of these cases medications (mainly oral contraceptives) triggered the thrombotic event. The incidence of pharmacological factors as a cause of thrombosis is commonly maintained to be low. This study indicates that this is not so and underlines the potential importance of drugs, particularly oral contraceptives, in the pathogenesis of thrombotic events in patients with congenital defects of clotting inhibitors.

  13. Preparation and characterisation of Kolliphor® P 188 and P 237 solid dispersion oral tablets containing the poorly water soluble drug disulfiram.

    PubMed

    Ramadhani, Nisrina; Shabir, Mehwish; McConville, Christopher

    2014-11-20

    The oral route of administration is the most common and preferred route of drug delivery due to its ease of administration, cost-effectiveness and flexibility in design. However, limited aqueous solubility of the active pharmaceutical ingredient can result in poor bioavailability, which is a major issue for the pharmaceutical industry. Increasing numbers of new drugs are falling into class II of the Biopharmaceutical Classification System (BCS), where they have a low solubility and high tissue permeability, meaning that bioavailability is solubility dependent. Here we demonstrate the development and characterisation of solid dispersion oral tablets, containing the poorly water-soluble drug disulfiram, prepared using both the hot melt and solvent evaporation methods and manufactured from two different polymers, Kolliphor(®) P 188 and P 237, specifically designed for the manufacture of solid dispersions. This paper demonstrates that the disulfiram solid dispersions tablets have an enhanced release rate of disulfiram compared to the control tablets. The Kolliphor(®) P 188 polymer control tablets released approximately 48.8% of their disulfiram content over 8h, with the solvent evaporated tablets releasing approximately 65.8%, while the 60 and 80 °C hot melt tablets released approximately 73.2 and 100% of their disulfiram content respectively. A similar trend was seen with Kolliphor(®) P 237 as the control tablets released approximately 50.5% of their disulfiram content over 8h, while the solvent evaporated tablets released approximately 79.5% and the 60 and 80 °C hot melt tablets released 100.2 and 100.3% respectively. Depending on what method and polymer is used to manufacture the solid dispersions the disulfiram is either maintained completely or partially in its amorphous state and it is this which enhances its solubility and release rate from the tablets. The disulfiram in the Kolliphor(®) P 188 solvent evaporated and 60 °C hot melt tablets retained 50

  14. Preparation of Orally Disintegrating Tablets Containing Powdered Tea Leaves with Enriched Levels of Bioactive Compounds by Means of Microwave Irradiation Technique.

    PubMed

    Tanaka, Hironori; Iwao, Yasunori; Izumikawa, Masahiro; Sano, Syusuke; Ishida, Hitoshi; Noguchi, Shuji; Itai, Shigeru

    2016-01-01

    In the present study, a microwave treatment process has been applied to prepare orally disintegrating tablets (ODTs) containing powdered tea leaves with enriched levels of the anti-inflammatory compounds such as chafuroside A (CFA) and chafuroside B (CFB). The use of distilled water as the adsorbed and granulation solvents in this preparation process afforded tablets with a long disintegration time (more than 120 s). The CFA and CFB contents of these tablets did not also change after 4 min of microwave irradiation due to the tablet temperature, which only increased to 100°C. In contrast, the tablet temperature increased up to 140°C after 3 min of microwave irradiation when a 1.68 M Na2HPO4 solution instead of distilled water. Notably, the disintegration time of these tablets was considerably improved (less than 20 s) compared with the microwave-untreated tablets, and there were 7- and 11-fold increases in their CFA and CFB contents. In addition, the operational conditions for the preparation of the tablets were optimized by face-centered composite design based on the following criteria: tablet hardness greater than 13 N, disintegration time less than 30 s and friability less than 0.5%. The requirements translated into X1 (the amount of granulation solvent), X2 (tableting pressure) and X3 (content of the powdered tea leaves) values of 45%, 0.43 kN and 32%, respectively, and the ODTs containing powdered tea leaves prepared under these optimized conditions were found to show excellent tablet properties and contain enriched levels of CFA and CFB. PMID:27581633

  15. Emergency contraception

    MedlinePlus

    Morning-after pill; Postcoital contraception; Birth control - emergency; Plan B; Family planning - emergency contraception ... Emergency contraception most likely prevents pregnancy in the same way as regular birth control pills: By preventing or delaying ...

  16. Emergency Contraception

    MedlinePlus

    ... contraception are available: emergency contraceptive pills and the copper-containing intrauterine device (IUD). Emergency contraceptive pills include ... for emergency use, talk to your doctor. The copper-containing IUD (brand name: Paragard) is a small, ...

  17. Emergency Contraception

    MedlinePlus

    f AQ FREQUENTLY ASKED QUESTIONS FAQ114 CONTRACEPTION Emergency Contraception • What is emergency contraception (EC)? • How does EC work? • What are the different types of EC? • What is the most ...

  18. Contraception in the perimenopause.

    PubMed

    Sparrow, M

    1992-12-01

    Most clinicians advise women to continue using contraception for 12 months after menstruation has ceased. Some recommend that women less than 45 years old continue contraception for 2 years after menstruation has ceased. A fertility specialist says that women can stop taking nonhormonal methods after 6 months of amenorrhea if women experience hot flushes. If there are no classic menopausal symptoms, however, they should wait for 12 months before stopping contraception use. Hormonal methods may mask menopausal signs. If a woman has no contraindications, she can use them safely until age 50, however. Women should still use contraception after menopause because irregular ovulation may occur. In older women, the most useful measure of ovarian history is perhaps a good menstrual history rather than a high level of follicle stimulating hormone. A woman needs to consider her age, health status, menstrual history, sexuality, risk of sexually transmitted diseases, past contraception use, lifestyle, obstetric history, and attitude toward abortion when choosing a contraceptive method during the perimenopausal years. Options may include male or female sterilization, combined oral contraceptives, the progestogen-only pill, Depo-Provera, IUD, female barrier methods (diaphragm, cervical cap, contraceptive sponge, and female condom), condoms, spermicides, and postcoital contraception. Assuming the mucus signs can be reliably determined, natural family planning is an alternative for some older women. Depending on coitus interruptus can be stressful for older women because it is not easy to distinguish between a possible pregnancy and an irregular menses.

  19. Acute effects of bright light and caffeine on nighttime melatonin and temperature levels in women taking and not taking oral contraceptives

    NASA Technical Reports Server (NTRS)

    Wright, K. P. Jr; Myers, B. L.; Plenzler, S. C.; Drake, C. L.; Badia, P.; Czeisler, C. A. (Principal Investigator)

    2000-01-01

    Caffeine and bright light effects on nighttime melatonin and temperature levels in women were tested during the luteal phase of the menstrual cycle (n=30) or the pseudo luteal phase for oral contraceptive users (n=32). Participants were randomly assigned to receive either bright (5000 lux) or dim room light (<88 lux) between 20:00 and 08:00 h under a modified constant routine protocol. Half the subjects in each lighting condition were administered either caffeine (100 mg) or placebo in a double-blind manner at 20:00, 23:00, 02:00 and 05:00 h. Results showed that the combination of bright light and caffeine enhanced nighttime temperature levels to a greater extent than did either caffeine or bright light alone. Both of the latter groups had higher temperature levels relative to the dim light placebo condition and the two groups did not differ. Temperature levels in the bright light caffeine condition were maintained at near peak circadian levels the entire night in the luteal and pseudo luteal phase. Melatonin levels were reduced throughout the duration of bright light exposure for all women. Caffeine reduced the onset of melatonin levels for women in the luteal phase, but it had little effect on melatonin levels for oral contraceptive users. The results for women in the luteal phase of the menstrual cycle are consistent with our previous findings in men. The results also suggest that oral contraceptives may alter the effects of caffeine on nighttime melatonin levels.

  20. Intrinsic clotting factors in dependency of age, sex, body mass index, and oral contraceptives: definition and risk of elevated clotting factor levels.

    PubMed

    Luxembourg, Beate; Schmitt, Joern; Humpich, Marek; Glowatzki, Matthias; Seifried, Erhard; Lindhoff-Last, Edelgard

    2009-10-01

    Elevated clotting factors have been demonstrated to be a risk factor for venous thromboembolism (VTE). The aim of our study was to investigate the impact of age, sex, body mass index, and oral contraceptives on the clotting factor activities of factors VIII, IX, XI, and XII and their impact on the cutoff definition and risk of VTE associated with elevated clotting factors. Factor VIII, IX, XI, and XII activities were measured in 499 blood donors and 286 patients with VTE. Age and body mass index predicted significantly and independently the clotting factor activities of factors VIII, IX, and XI, whereas use of oral contraceptives predicted factor IX, XI, and XII levels. Percentiles of clotting factor activities, which are often used for the cutoff definition of elevated clotting factors, varied due to the effect of age, body mass index, and oral contraceptives. The adjusted odds ratios for VTE were 10.3 [95% confidence interval (CI) 5.1-20.7], 6.1 (95% CI 3.1-12.0), and 3.3 (95% CI 1.9-5.8) for elevated factors VIII, IX, and XI, respectively. Furthermore, our study demonstrates for the first time that elevated factor XII is associated with an increased risk of VTE (adjusted odds ratio 2.9, 95% CI 1.6-5.3).

  1. Male contraception

    PubMed Central

    Mathew, Vivek; Bantwal, Ganapathi

    2012-01-01

    Contraception is an accepted route for the control of population explosion in the world. Traditionally hormonal contraceptive methods have focused on women. Male contraception by means of hormonal and non hormonal methods is an attractive alternative. Hormonal methods of contraception using testosterone have shown good results. Non hormonal reversible methods of male contraception like reversible inhibition of sperm under guidanceare very promising. In this article we have reviewed the current available options for male contraception. PMID:23226635

  2. 21 CFR 310.501 - Patient package inserts for oral contraceptives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.501..., Division of Reproductive and Urologic Products, Food and Drug Administration, 10903 New Hampshire Ave... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Patient package inserts for oral...

  3. Risk factors for venous thromboembolism in women under combined oral contraceptive. The PILl Genetic RIsk Monitoring (PILGRIM) Study.

    PubMed

    Suchon, Pierre; Al Frouh, Fadi; Henneuse, Agathe; Ibrahim, Manal; Brunet, Dominique; Barthet, Marie-Christine; Aillaud, Marie-Françoise; Venton, Geoffroy; Alessi, Marie-Christine; Trégouët, David-Alexandre; Morange, Pierre-Emmanuel

    2016-01-01

    Identifying women at risk of venous thromboembolism (VTE) is a major public health issue. The objective of this study was to identify environmental and genetic determinants of VTE risk in a large sample of women under combined oral contraceptives (COC). A total of 968 women who had had one event of VTE during COC use were compared to 874 women under COC but with no personal history of VTE. Clinical data were collected and a systematic thrombophilia screening was performed together with ABO blood group assessment. After adjusting for age, family history, and type and duration of COC use, main environmental determinants of VTE were smoking (odds ratio [OR] =1.65, 95% confidence interval [1.30-2.10]) and a body mass index higher than 35 kg.m⁻² (OR=3.46 [1.81-7.03]). In addition, severe inherited thrombophilia (OR=2.13 [1.32-3.51]) and non-O blood groups (OR=1.98 [1.57-2.49]) were strong genetic risk factors for VTE. Family history poorly predicted thrombophilia as its prevalence was similar in patients with or without first degree family history of VTE (29.3% vs 23.9%, p=0.09). In conclusion, this study confirms the influence of smoking and obesity and shows for the first time the impact of ABO blood group on the risk of VTE in women under COC. It also confirms the inaccuracy of the family history of VTE to detect inherited thrombophilia.

  4. Efficacy of Acupuncture versus Combined Oral Contraceptive Pill in Treatment of Moderate-to-Severe Dysmenorrhea: A Randomized Controlled Trial

    PubMed Central

    Sriprasert, Intira; Suerungruang, Suparerk; Athilarp, Porntip; Matanasarawoot, Anuchart; Teekachunhatean, Supanimit

    2015-01-01

    This open-label randomized controlled trial was designed to compare the efficacy of acupuncture and combined oral contraceptive (COC) pill in treating moderate-to-severe primary dysmenorrhea. Fifty-two participants were randomly assigned to receive either acupuncture (n = 27) or COC (n = 25) for three menstrual cycles. Mefenamic acid was prescribed as a recue analgesic drug with both groups. The statistical approach used for efficacy and safety assessments was intention-to-treat analysis. By the end of the study, both treatments had resulted in significant improvement over baselines in all outcomes, that is, maximal dysmenorrhea pain scores, days suffering from dysmenorrhea, amount of rescue analgesic used, and quality of life assessed by SF-36 questionnaire. Over the three treatment cycles, COC caused greater reduction in maximal pain scores than acupuncture, while improvements in the remaining outcomes were comparable. Responders were defined as participants whose maximal dysmenorrhea pain scores decreased at least 33% below their baseline. Response rates following both interventions at the end of the study were not statistically different. Acupuncture commonly caused minimal local side effects but did not cause any hormone-related side effects as did COC. In conclusion, acupuncture is an alternative option for relieving dysmenorrhea, especially when COC is not a favorable choice. PMID:26346199

  5. The influence of endogenous and exogenous sex hormones in adolescents with attention to oral contraceptives and anabolic steroids.

    PubMed

    Lane, J R; Connor, J D

    1994-12-01

    The endogenous sex hormones produce dispositional changes in the developing child as well as imparting unique male and female dispositional patterns. Age-related changes have been observed for digoxin disposition and caffeine and theophylline metabolism. These age-related dispositional changes have led to age-dependent dosing recommendations. Studies with caffeine and antipyrine indicate that this change in drug disposition occurs over a short period of time, is seen earlier in girls than in boys, and is related to pubertal (Tanner) stage and the "growth spurt". Significant changes in endogenous sex hormone concentrations occur during the menstrual cycle and during pregnancy, leading to alterations in drug binding, distribution, and clearance. Oral contraceptives (OCs) inhibit the metabolism of certain drugs resulting in toxicity or lack of efficacy. Rifampin induces the OC metabolism, resulting in decreased clinical effectiveness. Most studies did not examine these kinetic and dynamic interactions between adult and adolescent users. It is estimated that there are over 45 anabolic steroid compounds available for abuse by athletes, and their use is increasing among male and female adolescents. Although the adolescent is at increased risk of developing adverse effects from these agents, a systematic evaluation of the long-term effects of anabolic steroid abuse has not been undertaken in this population. Further research is needed regarding the influence of endogenous and exogenous hormones on adolescent drug kinetics and dynamics. Because of their frequency of use among adolescents, OCs and anabolic steroids require particular emphasis.

  6. Effects of prior oral contraceptive use and soy isoflavonoids on estrogen-metabolizing cytochrome P450 enzymes

    PubMed Central

    Scott, LM; Durant, P; Leone-Kabler, S; Wood, CE; Register, TC; Townsend, A; Cline, JM

    2009-01-01

    Estrogen exposure and metabolism may play an important role in the development of estrogen-sensitive cancers in postmenopausal women. In this study we investigated whether past oral contraceptive (OC) administration or current dietary isoflavonoids (IF) affected expression and/or activity of steroid hormone-metabolizing cytochrome P450 (CYP) enzymes using complementary primate and cell culture models. One-hundred-eighty-one female cynomolgus macaques were randomized to receive OC or nothing for 26 months premenopausally, then ovariectomized and randomized to one of three diets for 36 months: an IF-depleted soy protein isolate (Soy−) diet, a Soy diet with IF (Soy+), or a Soy− diet supplemented with conjugated equine estrogens (CEE). Prior OC-treatment significantly reduced CYP gene expression in the mammary gland (≤60% of OC−). Dietary IFs had no effect on CYP expression, while CEE-treatment decreased CYP1A1 and increased CYP3A4 mRNA in a tissue-specific manner. For in vitro studies, we measured effects of the isoflavonoids genistein, daidzein and equol on CYP activity using intact V79 cells stably transfected to express CYP1A1, CYP1B1, or CYP3A4. All three IFs significantly altered CYP activity in a dose-dependent and isoform-specific manner (20–95% inhibition vs. controls). These results suggest potential mechanisms for prior OC and dietary IF effects on cancer risk in estrogen-responsive tissues. PMID:18955142

  7. Risk of Inflammatory Bowel Disease with Oral Contraceptives and Menopausal Hormone Therapy: Current Evidence and Future Directions.

    PubMed

    Khalili, Hamed

    2016-03-01

    Crohn's disease (CD) and ulcerative colitis (UC), collectively known as inflammatory bowel diseases, are archetypical inflammatory disorders of the gastrointestinal tract with rising incidence worldwide. Although the role of genetic factors in disease development has been highlighted by genome-wide association studies, environmental risk factors likely play a pivotal role in development of CD and UC. Prior observational studies have suggested a link between exogenous hormone use and risk of CD and UC. Specifically, studies have shown an association between oral contraceptive use and risk of CD and menopausal hormone therapy and risk of UC. Although the exact mechanism of these associations is largely unknown, a number of hypotheses have been proposed. First, oral estrogen has been shown to modify intestinal permeability, a critical step in the pathophysiology of inflammatory bowel disease. Second, exogenous hormone use through its effect on endogenous levels of hormones may enhance the development of Th1- and Th2-mediated inflammatory diseases. Lastly, recent data have linked modification in the gut microbiome to endogenous levels of androgens, which are also known to be altered with exogenous hormone use and influence the development of autoimmune diseases. This supports the intriguing hypothesis that the gut microbiome lies at the crossroads of pathways linking exogenous hormone use with innate and adaptive immunity. Future studies should therefore focus on bridging these epidemiologic findings to disease pathogenesis through comprehensive understanding of the complex interaction between exogenous hormone use, sex steroid biomarkers, genetic risk loci, and alterations in the intestinal microbial environment in the etiology of CD and UC.

  8. [Male contraception].

    PubMed

    Demoulin, A

    1984-04-01

    Among the reasons why male hormonal contraception has lagged behind female methods are the necessity of preserving virility, the fact that spermatogenesis is a continuous process, the need to control secondary effects and toxicity, and the requirement that modes of administration be acceptable to both partners. Among currently available reversible mehtods, withdrawal is undoubtedly the most ancient. It is still widespread but cannot be recommended because of its limited effectiveness. The condom is used by about 10% of couples worldwide as a principal or temporary method, but its inter-ference with sensation has limited its acceptance. Condoms are nevertheless highly effective when used with a spermicide. Various androgens are currently under investigation. High doses of testosterone can induce azoospermia without affecting libido but their side effects may be serious. The use of combinations of steroids permits doses to be reduced and offers promise for the future. The combination of oral medroxyprogesterone acetate and percutaneous testosterone is one of the better approaches; the combination is effective and nontoxic but has the disadvantage of percutaneous administration. Gossypol, a pigment extracted from the cotton plant, has been used as a contraceptive in China with a reported efficacy of 99.89%, recovery of fertility within 3 months, and no effect on future fertility. However, its toxicity appears to be significant in the animal and its reversibility is uncertain. A search is on for analogs which would preserve the contraceptive effects while eliminating toxic effects. Several gonadotropin releasing hormone (GnRH) analogs under investigation for their interference with spermatogenesis have given promising results. Several chemicals tested for contraceptive effects have had unacceptably high toxicity. Chinese investigators have reported good results with various physical methods of interfering with sperm production, but their reversibility and innocuity

  9. Cardiovascular risk in Egyptian healthy consumers of different types of combined oral contraceptives pills: A comparative study.

    PubMed

    El-Haggar, Sahar M; Mostafa, Tarek M

    2015-08-01

    This study aimed to evaluate the associated cardiovascular risk in Egyptian healthy consumers of different types of combined oral contraceptives pills (COCPs) via determination of lipids profiles, Castelli index I, leptin, adiponectin, and resistin concentrations as cardiovascular risk factors. In this cross-sectional study, the study groups consisted of control group that represented by 30 healthy married women who were not on any contraceptive mean or any hormonal therapy and had normal menstrual cycles, group two consisted of 30 women who were users of Levonorgesterl 0.15 mg plus Ethinylestradiol 0.03 mg as 21 days cycle, group three consisted of 30 women who were users of Gestodene 0.075 mg plus Ethinylestradiol 0.03 mg as 21 days cycle, and group four consisted of 30 women who were users of Drospirenone 3 mg plus Ethinylestradiol 0.03 mg as 21 days cycle. One-way analysis of variance followed by LSD post hoc test was used for comparison of variables. P value <0.05 was considered to be significant. The comparison of the studied groups revealed that COCPs containing levonorgestrel plus ethinylestradiol resulted in significantly lower adiponectin level, and significantly higher leptin and resistin levels with more atherogenic lipid profile presented by significantly higher LDL-C, significantly lower HDL-C concentrations, and significantly higher atherogenic index. Formulation containing ethinylestradiol combined with gestodene neither altered adipose tissue function nor showed deleterious effect on lipid panel. Formulation containing ethinylestradiol combined with drospirenone resulted in significantly higher HDL-C and adiponectin concentrations. In conclusion, the uptake of COCPs containing levonorgestrel plus ethinylestradiol is associated with high cardiovascular risk since this formulation showed significantly lower adiponectin concentration, significantly higher leptin, resistin, and atherogenic index as compared to other studied groups. By contrast, the

  10. Cardiovascular risk in Egyptian healthy consumers of different types of combined oral contraceptives pills: A comparative study.

    PubMed

    El-Haggar, Sahar M; Mostafa, Tarek M

    2015-08-01

    This study aimed to evaluate the associated cardiovascular risk in Egyptian healthy consumers of different types of combined oral contraceptives pills (COCPs) via determination of lipids profiles, Castelli index I, leptin, adiponectin, and resistin concentrations as cardiovascular risk factors. In this cross-sectional study, the study groups consisted of control group that represented by 30 healthy married women who were not on any contraceptive mean or any hormonal therapy and had normal menstrual cycles, group two consisted of 30 women who were users of Levonorgesterl 0.15 mg plus Ethinylestradiol 0.03 mg as 21 days cycle, group three consisted of 30 women who were users of Gestodene 0.075 mg plus Ethinylestradiol 0.03 mg as 21 days cycle, and group four consisted of 30 women who were users of Drospirenone 3 mg plus Ethinylestradiol 0.03 mg as 21 days cycle. One-way analysis of variance followed by LSD post hoc test was used for comparison of variables. P value <0.05 was considered to be significant. The comparison of the studied groups revealed that COCPs containing levonorgestrel plus ethinylestradiol resulted in significantly lower adiponectin level, and significantly higher leptin and resistin levels with more atherogenic lipid profile presented by significantly higher LDL-C, significantly lower HDL-C concentrations, and significantly higher atherogenic index. Formulation containing ethinylestradiol combined with gestodene neither altered adipose tissue function nor showed deleterious effect on lipid panel. Formulation containing ethinylestradiol combined with drospirenone resulted in significantly higher HDL-C and adiponectin concentrations. In conclusion, the uptake of COCPs containing levonorgestrel plus ethinylestradiol is associated with high cardiovascular risk since this formulation showed significantly lower adiponectin concentration, significantly higher leptin, resistin, and atherogenic index as compared to other studied groups. By contrast, the

  11. A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using levonorgestrel 1.5 mg

    PubMed Central

    Festin, Mario P.R.; Bahamondes, Luis; Nguyen, Thi My Huong; Habib, Ndema; Thamkhantho, Manopchai; Singh, Kuldip; Gosavi, Arundhati; Bartfai, Gyorgy; Bito, Tamas; Bahamondes, M. Valeria; Kapp, Nathalie

    2016-01-01

    STUDY QUESTION Will the use of levonorgestrel (LNG) 1.5 mg taken at each day of coitus by women who have relatively infrequent sex be an efficacious, safe and acceptable contraceptive method? SUMMARY ANSWER Typical use of LNG 1.5 mg taken pericoitally, before or within 24 h of sexual intercourse, provides contraceptive efficacy of up to 11.0 pregnancies per 100 women-years (W-Y) in the primary evaluable population and 7.1 pregnancies per 100 W-Y in the evaluable population. WHAT IS KNOWN ALREADY LNG 1.5 mg is an effective emergency contraception following unprotected intercourse. Some users take it repeatedly, as their means of regular contraception. STUDY DESIGN, SIZE, DURATION This was a prospective, open-label, single-arm, multicentre Phase III trial study with women who have infrequent coitus (on up to 6 days a month). Each woman had a follow-up visit at 2.5, 4.5 and 6.5 months after admission or until pregnancy occurs if sooner, or she decided to interrupt participation. The study was conducted between 10 January 2012 and 15 November 2014. PARTICIPANTS/MATERIALS, SETTING, METHODS A total of 330 healthy fertile women aged 18–45 years at risk of pregnancy who reported sexual intercourse on up to 6 days a month, were recruited from four university centres located in Bangkok, Thailand; Campinas, Brazil; Singapore and Szeged, Hungary to use LNG 1.5 mg pericoitally (24 h before or after coitus) as their primary method of contraception. The participants were instructed to take one tablet every day she had sex, without taking more than one tablet in any 24-h period, and to maintain a paper diary for recording date and time for every coital act and ingestion of the study tablet, use of other contraceptive methods and vaginal bleeding patterns. Anaemia was assessed by haemoglobin evaluation. Pregnancy tests were performed monthly and pregnancies occurring during product use were assessed by ultrasound. At the 2.5-month and final visit at 6.5 months, acceptability

  12. Depo medroxyprogesterone acetate (DMPA) and combined oral contraceptives and cervical carcinoma in-situ in women aged 50 years and under.

    PubMed

    Hoyo, C; Cousins, D S; Bisgrove, E Z; Gaines, M M; Schwingl, P J; Fortney, J A

    2004-12-01

    Most low-resource settings depend on hormonal contraceptives for their family planning programmes and cervical cancer occurs in higher frequency in these populations. To determine whether hormonal contraception use increases cervical carcinoma in-situ (CIS) risk, a case-control study was conducted in the Kingston and St Andrew Corporate area of Jamaica, using 119 cases from the Jamaica Tumour Registry and 304 population controls matched on year of Papanicolaou (Pap) smear and clinic where Pap smear was obtained. While CIS cases were more likely to have 'ever used' combined oral contraceptives (COC) (OR = 1.4, 95% CI: 0.8, 2.5), depo-medroxyprogesterone acetate (DMPA) use was similar. Compared to women who never used hormonal contraceptives, the risk of CIS was elevated in: women who had used COCs five years or more (OR = 2.1, 95% CI: 1.0, 4.6), women who first used COC for less than 10 years prior to the interview (OR = 1.8, 95% CI: 0.9, 3.7) and women who were 18 to 24 years old when they first used COCs (OR = 1.8, 95% CI: 0.9, 3.4). Similarly, compared to women who never used DMPA, the risk of CIS was elevated in: women using DMPA five years or more (OR = 1.9, 95% CI: 0.7, 4.8), women reporting use within a year prior to interview (OR = 2.8, 95% CI: 0.7, 10.7) and women who initiated use of DMPA when they were 20 and 24 years old (OR = 1.4, 95% CI: 0.7, 3.1). These results suggest that if hormonal contraceptive use confers any risk of CIS, it is confined to long-term users. Increased risk in some groups, however, warrant further study. PMID:15816269

  13. Depo medroxyprogesterone acetate (DMPA) and combined oral contraceptives and cervical carcinoma in-situ in women aged 50 years and under.

    PubMed

    Hoyo, C; Cousins, D S; Bisgrove, E Z; Gaines, M M; Schwingl, P J; Fortney, J A

    2004-12-01

    Most low-resource settings depend on hormonal contraceptives for their family planning programmes and cervical cancer occurs in higher frequency in these populations. To determine whether hormonal contraception use increases cervical carcinoma in-situ (CIS) risk, a case-control study was conducted in the Kingston and St Andrew Corporate area of Jamaica, using 119 cases from the Jamaica Tumour Registry and 304 population controls matched on year of Papanicolaou (Pap) smear and clinic where Pap smear was obtained. While CIS cases were more likely to have 'ever used' combined oral contraceptives (COC) (OR = 1.4, 95% CI: 0.8, 2.5), depo-medroxyprogesterone acetate (DMPA) use was similar. Compared to women who never used hormonal contraceptives, the risk of CIS was elevated in: women who had used COCs five years or more (OR = 2.1, 95% CI: 1.0, 4.6), women who first used COC for less than 10 years prior to the interview (OR = 1.8, 95% CI: 0.9, 3.7) and women who were 18 to 24 years old when they first used COCs (OR = 1.8, 95% CI: 0.9, 3.4). Similarly, compared to women who never used DMPA, the risk of CIS was elevated in: women using DMPA five years or more (OR = 1.9, 95% CI: 0.7, 4.8), women reporting use within a year prior to interview (OR = 2.8, 95% CI: 0.7, 10.7) and women who initiated use of DMPA when they were 20 and 24 years old (OR = 1.4, 95% CI: 0.7, 3.1). These results suggest that if hormonal contraceptive use confers any risk of CIS, it is confined to long-term users. Increased risk in some groups, however, warrant further study.

  14. Users of withdrawal method in the Islamic Republic of Iran: are they intending to use oral contraceptives? Applying the theory of planned behaviour.

    PubMed

    Rahnama, P; Hidarnia, A; Shokravi, F A; Kazemnejad, A; Montazeri, A; Najorkolaei, F R; Saburi, A

    2013-09-01

    Many couples in the Islamic Republic of Iran rely on coital withdrawal for contraception. The purpose of this cross-sectional study was to use the theory of planned behaviour to explore factors that influence withdrawal users' intent to switch to oral contraception (OC). Participants were 336 sexually active, married women, who were current users of withdrawal and were recruited from 5 public family planning clinics in Tehran. A questionnair included measures of the theory of planned behaviour: attitude (behavioural beliefs, outcome evaluations), subjective norms (normative beliefs, motivation to comply), perceived behaviour control, past behaviour and behavioural intention. Linear regression analyses showed that past behaviour, perceived behaviour control, attitude and subjective norms accounted for the highest percentage of total variance observed for intention to use OC (36%). Beliefs-based family planning education and counsellingshould to be designed for users of the withdrawal method.

  15. Users of withdrawal method in the Islamic Republic of Iran: are they intending to use oral contraceptives? Applying the theory of planned behaviour.

    PubMed

    Rahnama, P; Hidarnia, A; Shokravi, F A; Kazemnejad, A; Montazeri, A; Najorkolaei, F R; Saburi, A

    2013-09-01

    Many couples in the Islamic Republic of Iran rely on coital withdrawal for contraception. The purpose of this cross-sectional study was to use the theory of planned behaviour to explore factors that influence withdrawal users' intent to switch to oral contraception (OC). Participants were 336 sexually active, married women, who were current users of withdrawal and were recruited from 5 public family planning clinics in Tehran. A questionnair included measures of the theory of planned behaviour: attitude (behavioural beliefs, outcome evaluations), subjective norms (normative beliefs, motivation to comply), perceived behaviour control, past behaviour and behavioural intention. Linear regression analyses showed that past behaviour, perceived behaviour control, attitude and subjective norms accounted for the highest percentage of total variance observed for intention to use OC (36%). Beliefs-based family planning education and counsellingshould to be designed for users of the withdrawal method. PMID:24313039

  16. Development and characterisation of sustained release solid dispersion oral tablets containing the poorly water soluble drug disulfiram.

    PubMed

    Shergill, Mandip; Patel, Mina; Khan, Siraj; Bashir, Ayesha; McConville, Christopher

    2016-01-30

    Administration of drugs via the oral route is the most common and preferred route due to its ease of administration, cost-effectiveness and flexibility in design. However, if the drug being administered has limited aqueous solubility it can result in poor bioavailability. Furthermore, the low pH of the stomach as well as enzymatic activity can result in drugs delivered via the oral route being rapidly metabolised and degraded. Here we demonstrate the development and characterisation of sustained release solid dispersion oral tablets, containing the poorly water-soluble drug disulfiram (DSF). The tablets, which are manufactured from two different polymers (Kolliphor(®) P 188 and P 237) specifically designed for the manufacture of solid dispersions and two different polymers (Kollidon(®) SR and HPMC) specifically designed to provide sustained release, can enhance the solubility of DSF, sustain its release, while protecting it from degradation in simulated gastric fluid (SGF). The paper demonstrates that when using the hot melt method at 80°C the DSF loading capacity of the Kolliphor(®) P 188 and P 237 polymers is approximately 43 and 46% respectively, with the DSF completely in an amorphous state. The addition of 80% Kollidon(®) SR to the formulation completely protected the DSF in SGF for up to 70 min with 16% degradation after 120 min, while 75% degradation occurred after 120 min with the addition of 80% HPMC. The release rate of DSF can be manipulated by both the loading and type of sustained release polymer used, with HPMC providing for a much faster release rate compared to Kollidon(®) SR.

  17. Development and characterisation of sustained release solid dispersion oral tablets containing the poorly water soluble drug disulfiram.

    PubMed

    Shergill, Mandip; Patel, Mina; Khan, Siraj; Bashir, Ayesha; McConville, Christopher

    2016-01-30

    Administration of drugs via the oral route is the most common and preferred route due to its ease of administration, cost-effectiveness and flexibility in design. However, if the drug being administered has limited aqueous solubility it can result in poor bioavailability. Furthermore, the low pH of the stomach as well as enzymatic activity can result in drugs delivered via the oral route being rapidly metabolised and degraded. Here we demonstrate the development and characterisation of sustained release solid dispersion oral tablets, containing the poorly water-soluble drug disulfiram (DSF). The tablets, which are manufactured from two different polymers (Kolliphor(®) P 188 and P 237) specifically designed for the manufacture of solid dispersions and two different polymers (Kollidon(®) SR and HPMC) specifically designed to provide sustained release, can enhance the solubility of DSF, sustain its release, while protecting it from degradation in simulated gastric fluid (SGF). The paper demonstrates that when using the hot melt method at 80°C the DSF loading capacity of the Kolliphor(®) P 188 and P 237 polymers is approximately 43 and 46% respectively, with the DSF completely in an amorphous state. The addition of 80% Kollidon(®) SR to the formulation completely protected the DSF in SGF for up to 70 min with 16% degradation after 120 min, while 75% degradation occurred after 120 min with the addition of 80% HPMC. The release rate of DSF can be manipulated by both the loading and type of sustained release polymer used, with HPMC providing for a much faster release rate compared to Kollidon(®) SR. PMID:26608620

  18. [Post-abortion contraception: effects of contraception services and reproductive intention].

    PubMed

    Borges, Ana Luiza Vilela

    2016-02-01

    Contraceptive counseling and the supply of contraceptive methods are part of post-abortion care and positively influence the subsequent use of contraceptive methods. Studies showing such evidence have been conducted predominantly in countries with no legal restrictions on abortion and with adequate care for women that terminate a pregnancy. However, little is known about contraceptive practices in contexts where abortion is illegal, as in Brazil, in which post-abortion contraceptive care is inadequate. The objective of this study was to analyze the effect of contraceptive care on male condom use and oral and injectable contraceptives in the six months post-abortion, considering reproductive intention. The results showed that contraceptive care only has a positive effect on the use of oral contraceptives in the first six months post-abortion, as long as the woman had a medical consultation in the same month in which she received information on contraception. One or the other intervention alone had no significant impact.

  19. MDM2 polymorphism associated with the development of cervical lesions in women infected with Human papillomavirus and using of oral contraceptives

    PubMed Central

    2014-01-01

    Background The MDM2 gene is the major negative regulator of p53, a tumor suppressor protein. Single nucleotide polymorphism in promoter region of MDM2 gene leads to increased expression resulting in higher levels of MDM2 protein. This event increases the attenuation of the p53 pathway. Polymorphisms in this gene can interfere in the regulation of cellular proliferation. We evaluated whether MDM2 SNP309 (rs2278744) associated or not with the use of oral contraceptive can heighten susceptibility to development of cervical lesions in women HPV infected. Methods MDM2 SNP309 (rs2278744) was genotyped in a total of 287 patients using the PCR-RFLP technique. The results were analyzed by UNPHASED v.3.121 and SNPStats programs. Results The three groups (SIL, LSIL and HSIL) showed no significant differences in either genotype or allelic frequencies for MDM2 polymorphisms, except when HSIL was compared with LSIL (p = 0.037; OR = 1.81). Furthermore, in the analysis of contraceptives, a significant association was found between the use of contraceptives and the MDM2 variant in the development of high-grade cervical lesions for the TG genotype (p = 0.019; OR = 2.21) when HSIL was compared with control. When HSIL was compared with LSIL (p = 0.006; OR = 2.27). Conclusion The results of this study suggest that MDM2 SNP309 might be a good marker for assessing the progression of LSIL to HSIL. In addition, they also show that oral contraceptives alone, did not have any effect on the progression or development of cervical lesions. However, they may act synergistically with MDM2 SNP309 (rs2278744) and HPV infection in the development of cervical lesions. PMID:25075210

  20. The effect of combination oral contraceptives on smoking-related symptomatology during short-term smoking abstinence.

    PubMed

    Hinderaker, Katie; Allen, Alicia M; Tosun, Nicole; al'Absi, Mustafa; Hatsukami, Dorothy; Allen, Sharon S

    2015-02-01

    Although an estimated 25% of premenopausal smokers report using oral contraceptives (OC), little is known about how OC use may influence smoking cessation. The purpose of this study was to examine the difference in smoking-related symptomatology during acute smoking abstinence between women on a standardized combination OC (Tri-Sprintec(™)) compared to women not on OCs (no-OC). Participants were women aged 18-40 who smoked ≥5 cigarettes/day and reported regular menstrual cycles. Using a controlled cross-over design, participants completed two six-day testing weeks: Low Progesterone Week (LPW; Follicular (F) phase in no-OC or 1st week of pills in OC) and High Progesterone Week (HPW; Luteal (L) phase in no-OC or 3rd week of pills in OC). Each testing week included daily assessment of symptomatology and biochemical confirmation of smoking status. During smoking abstinence, the OC group (n=14) reported significantly lower levels of positive affect (21.56±7.12 vs. 24.57±6.46; β=3.63, p=0.0323) than the no-OC group (n=28). Further significant interactions between group and testing week were observed as follows: Smoking satisfaction was higher during LPW in the OC group (LPW: 4.29±1.30 vs. HPW: 4.10±1.37) but higher during HPW in the no-OC group (LPW: 3.91±1.30 vs. HPW: 4.23±1.30; β=-0.5499, p<0.0001). Similar interactions were noted in negative affect and psychological reward of smoking. These results suggest that women on OCs may have different patterns of smoking-related symptomatology during short-term smoking abstinence as compared to women not on OCs. Additional work is needed to examine how this may affect smoking cessation efforts.

  1. Aesthetic and incentive salience of cute infant faces: studies of observer sex, oral contraception and menstrual cycle.

    PubMed

    Sprengelmeyer, Reiner; Lewis, Jennifer; Hahn, Amanda; Perrett, David I

    2013-01-01

    Infant cuteness can influence adult-infant interaction and has been shown to activate reward centres in the brain. In a previous study, we found men and women to be differentially sensitive to small differences in infant facial cuteness, with reproductive hormone status as the potential underlying cause. It is unclear, however, whether reproductive hormone status impacts on the aesthetic and incentive salience of infant faces. To address this question, we conducted two interlinked studies. We used static images of the same smiling and neutral-looking infant faces in both a rating task, in which participants had to rate the cuteness of infant faces (aesthetic salience - 'liking'), and a key-press task, in which participants could prolong or shorten viewing time of infant faces by rapid alternating key-presses (incentive salience - 'wanting'). In a first study, we compared the performance of men, women who are taking oral contraceptives, and regularly cycling women. In this study, we found a significant correlation between cuteness ratings within and between groups, which implies that participants had the same concept of cuteness. Cuteness ratings and effort to look at faces was linked regardless of sex and reproductive hormone status, in that cute faces were looked at for longer than less cute faces. A happy facial expression contributed only marginally to the incentive salience of the face. To explore the potential impact of reproductive hormone status in more detail, we followed a subset of regularly cycling women during the menstrual, follicular and luteal phases of their cycle. The aesthetic and incentive salience of infant faces did not change across the menstrual cycle. Our findings suggest that reproductive hormone status does not modulate the aesthetic and incentive value of infant faces.

  2. Timing within the menstrual cycle, sex, and the use of oral contraceptives determine adrenergic suppression of NK cell activity

    PubMed Central

    Shakhar, K; Shakhar, G; Rosenne, E; Ben-Eliyahu, S

    2000-01-01

    Physiological responses that involve adrenergic mechanisms, such as stress-induced changes in cardiovascular indices, were reported to fluctuate along the menstrual cycle. Metastatic development following surgery was also reported to vary according to the menstrual phase during which a primary breast tumour was removed. Natural killer (NK) cells are believed to play an important role in controlling metastases. Our recent studies in rats demonstrated that adrenergic suppression of NK activity and of resistance to metastasis is more profound during oestrous phases characterized by high levels of oestradiol. In the current study in humans, we examined the in vitro impact of a β-adrenergic agonist, metaproterenol (MP), on NK activity, comparing blood drawn from (a) women tested at 3–4 different phases of their menstrual cycle (n = 10), (b) women using oral contraceptives (OC) (n = 10), and (c) men (n = 7). NK activity in each blood sample was assessed in the presence of 5 different concentrations of MP (10–8M to 10–6M), and in its absence (baseline). The results indicated marked group differences in the magnitude of NK suppression by MP: EC 50 was 2.6-fold lower in the luteal phase compared to the follicular phase, and 1.8-fold lower in OC users compared to men, who were least susceptible to the effects of MP. No significant group differences or menstrual effects in baseline levels of NK activity were evident. These findings provide the first empirical evidence for menstrual regulation of adrenergic impact on cellular immune competence. Relevance of these findings to the relation between the timing of breast cancer excision within the menstrual cycle and survival rates is discussed. © 2000 Cancer Research Campaign http://www.bjcancer.com PMID:11104557

  3. Past Oral Contraceptive Use and Current Dietary Soy Isoflavones Influence Estrogen Metabolism in Postmenopausal Monkeys (Macaca fascicularis)

    PubMed Central

    Scott, Latanya M.; Xu, Xia; Veenstra, Timothy D.; Tooze, Janet A.; Wood, Charles E.; Register, Thomas C.; Kock, Nancy D.; Cline, J. Mark

    2009-01-01

    Estrogen metabolism may play an important role in mammary carcinogenesis in postmenopausal women. We evaluated the effects of prior oral contraceptive (OC) treatment and current soy isoflavone consumption on endogenous estrogen metabolite concentration and biomarkers of tissue estrogen exposure in a monkey model. One hundred eighty-one female cynomolgus macaques were randomized to receive OC or placebo for 26 months premenopausally, then ovariectomized and randomized to one of three diets for 36 months: an isoflavone-depleted soy protein isolate (Soy−) diet, a diet containing soy protein isolate with a human equivalent of 129 mg isoflavone/d (Soy+), or a Soy− diet supplemented with conjugated equine estrogens (CEE+) at a human equivalent dose of 0.625 mg/d. Reverse-phase high-performance liquid chromatography directly coupled with tandem mass spectrometry was used to measure the concentrations of estrogen species in urine samples. Generally, prior OC treatment was associated with significantly reduced urinary estrogen metabolites (25–55% reduction; P < 0.05 for each versus OC−). Animals that consumed isoflavones postmenopausally had increased urinary 2-hydroxyestrone and 16α-hydroxyestrone (50% and 56% increases, respectively), but reduced levels of 2-hydroxyestradiol, 2-methoxyestradiol, and 17-epiestriol (92%, 63%, and 66%, respectively), compared with animals fed a Soy− diet. Isoflavones did not have widespread effects on uterine or mammary proliferation biomarkers, whereas prior OC significantly reduced two of three proliferation end points in the endometrium. Premenopausal OCs may have long-term systemic effects on response to estrogen and its metabolism whereas postmenopausal dietary isoflavones may alter endogenous estrogen metabolism in a modest but selective manner. PMID:18843000

  4. Effects of ovarian hormones and oral contraceptive pills on cardiac vagal withdrawal at the onset of dynamic exercise.

    PubMed

    Teixeira, André L; Ramos, Plinio S; Vianna, Lauro C; Ricardo, Djalma R

    2015-01-01

    The purpose of this study was to investigate the effects of the ovarian hormones and the use of oral contraceptive pills (OCP) on cardiac vagal withdrawal at the onset of dynamic exercise. Thirty physically active women aged 19-32 years were divided into two groups: OCP users (n = 17) and non-OCP users (n = 13). Participants were studied randomly at three different phases of the menstrual cycle: early follicular (day 3.6 ± 1.2; range 1-5), ovulatory (day 14.3 ± 0.8; range 13-16) and midluteal (day 21.3 ± 0.8; range 20-24), according to endogenous (in non-OCP users) or exogenous (in OCP users) estradiol and progesterone variations. The cardiac vagal withdrawal was represented by the cardiac vagal index (CVI), which was obtained by the 4-s exercise test. Additionally, resting heart rate, systolic (SBP) and diastolic blood pressure (DBP) were obtained. The CVI was not significantly different between the three phases of the menstrual cycle in either the non-OCP users (early follicular: 1.58 ± 0.1; ovulatory: 1.56 ± 0.1; midluteal: 1.58 ± 0.1, P > 0.05) or OCP users (early follicular: 1.47 ± 0.1; ovulatory: 1.49 ± 0.1; midluteal: 1.47 ± 0.1, P > 0.05) (mean ± SEM). Resting cardiovascular responses were not affected by hormonal phase or OCP use, except that the SBP was higher in the OCP users than non-OCP users in all phases of the cycle (P < 0.05). In summary, our results demonstrate that cardiac vagal withdrawal at the onset of dynamic exercise was not impacted by the menstrual cycle or OCP use in physically active women.

  5. Impact of oral contraceptive use and menstrual phases on patellar tendon morphology, biochemical composition, and biomechanical properties in female athletes.

    PubMed

    Hansen, Mette; Couppe, Christian; Hansen, Christina S E; Skovgaard, Dorthe; Kovanen, Vuokko; Larsen, Jytte O; Aagaard, Per; Magnusson, S Peter; Kjaer, Michael

    2013-04-01

    Sex differences exist with regards to ligament and tendon injuries. Lower collagen synthesis has been observed in exercising women vs. men, and in users of oral contraceptives (OC) vs. nonusers, but it is unknown if OC will influence tendon biomechanics of women undergoing regular training. Thirty female athletes (handball players, 18-30 yr) were recruited: 15 long-term users of OC (7.0 ± 0.6 yr) and 15 nonusers (>5 yr). Synchronized values of patellar tendon elongation (obtained by ultrasonography) and tendon force were sampled during ramped isometric knee extensor maximum voluntary contraction to estimate mechanical tendon properties. Furthermore, tendon cross-sectional area and length were measured from MRI images, and tendon biopsies were obtained for analysis of tendon fibril characteristics and collagen cross-linking. Overall, no difference in tendon biomechanical properties, tendon fibril characteristics, or collagen cross-linking was observed between the OC users and nonusers, or between the different phases of the menstrual cycle. In athletes, tendon cross-sectional area in the preferred jumping leg tended to be larger than that in the contralateral leg (P = 0.09), and a greater absolute (P = 0.01) and normalized tendon stiffness (P = 0.02), as well as a lower strain (P = 0.04), were observed in the jumping leg compared with the contralateral leg. The results indicate that long-term OC use or menstrual phases does not influence structure or mechanical properties of the patellar tendon in female team handball athletes. PMID:23429870

  6. Safety of Hormonal Replacement Therapy and Oral Contraceptives in Systemic Lupus Erythematosus: A Systematic Review and Meta-Analysis

    PubMed Central

    Rojas-Villarraga, Adriana; Torres-Gonzalez, July-Vianneth; Ruiz-Sternberg, Ángela-María

    2014-01-01

    Background There is conflicting data regarding exogenous sex hormones [oral contraceptives (OC) and hormonal replacement therapy (HRT)] exposure and different outcomes on Systemic Lupus Erythematosus (SLE). The aim of this work is to determine, through a systematic review and meta-analysis the risks associated with estrogen use for women with SLE as well as the association of estrogen with developing SLE. Methods and Findings MEDLINE, EMBASE, SciElo, BIREME and the Cochrane library (1982 to July 2012), were databases from which were selected and reviewed (PRISMA guidelines) randomized controlled trials, cross-sectional, case-control and prospective or retrospective nonrandomized, comparative studies without language restrictions. Those were evaluated by two investigators who extracted information on study characteristics, outcomes of interest, risk of bias and summarized strength of evidence. A total of 6,879 articles were identified; 20 full-text articles were included. Thirty-two meta-analyses were developed. A significant association between HRT exposure (Random model) and an increased risk of developing SLE was found (Rate Ratio: 1.96; 95%-CI: 1.51–2.56; P-value<0.001). One of eleven meta-analyses evaluating the risk for SLE associated with OC exposure had a marginally significant result. There were no associations between HRT or OC exposure and specific outcomes of SLE. It was not always possible to Meta-analyze all the available data. There was a wide heterogeneity of SLE outcome measurements and estrogen therapy administration. Conclusion An association between HRT exposure and SLE causality was observed. No association was found when analyzing the risk for SLE among OC users, however since women with high disease activity/Thromboses or antiphospholipid-antibodies were excluded from most of the studies, caution should be exercised in interpreting the present results. To identify risk factors that predispose healthy individuals to the development of SLE who

  7. Effects of Ovarian Hormones and Oral Contraceptive Pills on Cardiac Vagal Withdrawal at the Onset of Dynamic Exercise

    PubMed Central

    Teixeira, André L.; Ramos, Plinio S.; Vianna, Lauro C.; Ricardo, Djalma R.

    2015-01-01

    The purpose of this study was to investigate the effects of the ovarian hormones and the use of oral contraceptive pills (OCP) on cardiac vagal withdrawal at the onset of dynamic exercise. Thirty physically active women aged 19–32 years were divided into two groups: OCP users (n = 17) and non-OCP users (n = 13). Participants were studied randomly at three different phases of the menstrual cycle: early follicular (day 3.6 ± 1.2; range 1–5), ovulatory (day 14.3 ± 0.8; range 13–16) and midluteal (day 21.3 ± 0.8; range 20–24), according to endogenous (in non-OCP users) or exogenous (in OCP users) estradiol and progesterone variations. The cardiac vagal withdrawal was represented by the cardiac vagal index (CVI), which was obtained by the 4-s exercise test. Additionally, resting heart rate, systolic (SBP) and diastolic blood pressure (DBP) were obtained. The CVI was not significantly different between the three phases of the menstrual cycle in either the non-OCP users (early follicular: 1.58 ± 0.1; ovulatory: 1.56 ± 0.1; midluteal: 1.58 ± 0.1, P > 0.05) or OCP users (early follicular: 1.47 ± 0.1; ovulatory: 1.49 ± 0.1; midluteal: 1.47 ± 0.1, P > 0.05) (mean ± SEM). Resting cardiovascular responses were not affected by hormonal phase or OCP use, except that the SBP was higher in the OCP users than non-OCP users in all phases of the cycle (P < 0.05). In summary, our results demonstrate that cardiac vagal withdrawal at the onset of dynamic exercise was not impacted by the menstrual cycle or OCP use in physically active women. PMID:25785599

  8. Glutathione peroxidase activity in a healthy Canadian population. Effects of age, smoking and drinking habits, exercise and oral contraceptive use.

    PubMed

    L'abbe, M R; Collins, M W; Trick, K D; Laffey, P J

    1992-01-01

    The activity of the enzyme glutathione peroxidase (SeGSHPx) has been suggested as an indicator of selenium status. The purpose of this study was to measure the activity of this enzyme in a large sample of healthy, free-living Canadians to determine normal distributions and the effects of age, smoking, and drinking habits, exercise, and the use of oral contraceptives (OCs) or estrogen replacement therapy. The population consisted of 386 self-selected subjects between the ages of 24 and 75. Erythrocyte SeGSHPx activity was 21.5 +or- 7 (Mean +or- SD) and 33.6 +or- 8U/g Hb and plasma activity was 226 +or- 31 and 214 +or- 38 U/L for males (n=239) and females (n=147), respectively. Erythrocyte activity was significantly higher in females and males (p0.01). The Se form of GSHPx accounted for 76% and 54% of total activity in plasma and erythrocytes, respectively. No differences due to age were seen in males, although plasma SeGSHPx, non-SeGSHPx, and total GSHPx activities were elevated in females 65 years of age and older. Cigarette smoking significantly elevated erythrocyte SeGSHPx and total activity in male subjects. This elevation did not vary with the amount smoked and was not seen in ex-smokers. Drinking elevated erythrocyte non-SeGSHPx and total activity in male subjects with the highest activity seen in drinkers who also smoked. No significant differences were seen with level of exercise except for a slight elevation with vigorous exercise. Estrogen use significantly elevated erythrocyte SeGSHPx, non-SeGSHPx, and total activities in both pre- and postmenopausal women. These data suggest that some lifestyle factors can have small but significant effects of GSHPx activity and must be controlled for when population-based surveys are being conducted.

  9. The effect of combination oral contraceptives on smoking-related symptomatology during short-term smoking abstinence.

    PubMed

    Hinderaker, Katie; Allen, Alicia M; Tosun, Nicole; al'Absi, Mustafa; Hatsukami, Dorothy; Allen, Sharon S

    2015-02-01

    Although an estimated 25% of premenopausal smokers report using oral contraceptives (OC), little is known about how OC use may influence smoking cessation. The purpose of this study was to examine the difference in smoking-related symptomatology during acute smoking abstinence between women on a standardized combination OC (Tri-Sprintec(™)) compared to women not on OCs (no-OC). Participants were women aged 18-40 who smoked ≥5 cigarettes/day and reported regular menstrual cycles. Using a controlled cross-over design, participants completed two six-day testing weeks: Low Progesterone Week (LPW; Follicular (F) phase in no-OC or 1st week of pills in OC) and High Progesterone Week (HPW; Luteal (L) phase in no-OC or 3rd week of pills in OC). Each testing week included daily assessment of symptomatology and biochemical confirmation of smoking status. During smoking abstinence, the OC group (n=14) reported significantly lower levels of positive affect (21.56±7.12 vs. 24.57±6.46; β=3.63, p=0.0323) than the no-OC group (n=28). Further significant interactions between group and testing week were observed as follows: Smoking satisfaction was higher during LPW in the OC group (LPW: 4.29±1.30 vs. HPW: 4.10±1.37) but higher during HPW in the no-OC group (LPW: 3.91±1.30 vs. HPW: 4.23±1.30; β=-0.5499, p<0.0001). Similar interactions were noted in negative affect and psychological reward of smoking. These results suggest that women on OCs may have different patterns of smoking-related symptomatology during short-term smoking abstinence as compared to women not on OCs. Additional work is needed to examine how this may affect smoking cessation efforts. PMID:25452059

  10. Preparation and evaluation of orally disintegrating tablets of taste masked phencynonate HCl using ion-exchange resin.

    PubMed

    Ge, Zhenzhong; Yang, Meiyan; Wang, Yuli; Shan, Li; Gao, Chunsheng

    2015-06-01

    This study was intended to design an orally disintegrating tablet (ODT) formulation that can mask the extremely bitter and metallic taste of phencynonate HCl by novel ion-exchange resins. The drug-resin complexes (DRCs) were prepared and characterized by scanning electron microscopy, X-ray powder diffraction and differential scanning calorimetry. In vitro properties (dissolution, wetting time and disintegration time) and in vivo behavior (disintegration time and taste-masking effect) in healthy volunteers of the prepared ODTs were also investigated. The drug was changed from the crystal structure to the amorphous form in the DRC. Compared with commercial tablets, the in vitro and in vivo disintegration of optimized DRC-loaded ODTs with a drug-resin ratio of 1:1 was greatly improved and better palatability with a low bitterness index (0.33) was obtained. The current DRC-loaded ODT could promise a good way to mask the unpleasant taste of certain drugs and accordingly improve the patient compliance.

  11. Xanthan and galactomannan (from M. scabrella) matrix tablets for oral controlled delivery of theophylline.

    PubMed

    Vendruscolo, C W; Andreazza, I F; Ganter, J L M S; Ferrero, C; Bresolin, T M B

    2005-05-30

    Directly compressed theophylline tablets, containing commercial xanthan (X) (Keltrol) and a highly hydrophilic galactomannan (G) from the seeds of Mimosa scabrella (a brazilian leguminous tree called bracatinga) as release-controlling agents, were obtained. Gums were used at 4, 8, 12.5 and 25% (w/w), either alone or in mixture (X:G 1:1). During galactomannan extraction process, the biopolymer was dried in a scale up, by vacuum oven (VO) or spray dryer (SD). The in vitro drug release was evaluated at different time intervals during 8 h using apparatus 1 (USP 26) at 100 rpm. The pH of the dissolution medium (1.4) was changed to 4.0 and 6.8 after 2 and 3 h, respectively. Tablets containing G(SD) resulted in more uniform drug release than G(VO) ones, due to their smaller particle size. The drug release decreased with the increase of polymer concentration and all formulations at 25% w/w of gums showed excessive sustained release effect. The matrices made with alone X showed higher drug retention for all concentrations, compared with G matrices that released the drug too fast. The XG matrices were able to produce near zero-order drug release. The XG(SD) 8% tablets provided the required release rate (about 90% at the end of 8 h), with zero-order release kinetics. Tablets containing G(VO) in low concentration showed a complete erosion, while the others demonstrated fast hydration and swelling in contact with the dissolution medium. The release mechanism was a combination of diffusion and relaxation. The relative importance of these two processes varied with matrix composition. The XG(SD) 8% matrix showed higher contribution of polymer relaxation.

  12. Early post implantation contraceptive effects of a purified fraction of neem (Azadirachta indica) seeds, given orally in rats: possible mechanisms involved.

    PubMed

    Mukherjee, S; Garg, S; Talwar, G P

    1999-11-30

    Neem seed and leaf extracts have immunomodulators that induce cellular immune reactions. These aspects of neem were exploited in earlier studies, where the oral administration of the neem seed extracts in rodents and primates could completely abrogate pregnancy at an early post implantation stage. Complete restoration of fertility was observed in the animals treated in the subsequent cycles. For the purpose of using neem as a long term contraceptive, an activity guided fractionation, followed by identification and characterization of the biologically active fraction from neem seeds was carried out. Sequentially extracted fractions of neem seeds were tested orally at an early post implantation stage in rats. The hexane extract of the neem seeds was found to be biologically active and was the precursor for the final active fraction. The active fraction, identified as a mixture of six components, could completely abrogate pregnancy in rodents up to a concentration of 10%. No apparent toxic effects could be seen following treatment with the fraction. The treatment with the active fraction caused a specific activation of T lymphocyte cells of CD8+ subtype as well as phagocytic cells followed by elevation in cytokines gamma-interferon and TNF. The results of the present study show that a pure active fraction of neem seeds could be obtained for the purpose of early post implantation contraception when given orally, and its mechanism of action seems to be by activating cell mediated immune reactions. PMID:10617063

  13. Comparing the Therapeutic Effects of Garlic Tablet and Oral Metronidazole on Bacterial Vaginosis: A Randomized Controlled Clinical Trial

    PubMed Central

    Mohammadzadeh, Farnaz; Dolatian, Mahrokh; Jorjani, Masoome; Alavi Majd, Hamid; Borumandnia, Nasrin

    2014-01-01

    Background: Bacterial vaginosis (BV) is one of the most common gynecological infections during reproductive age. Although metronidazole is one of the most effective medications recommended as the first-line treatment, it has various side effects. Because of the side effects and contraindications of some chemical medicines, using herbs has been investigated in treating BV. Objectives: The aim of this study was to compare the effect of garlic tablet (Garsin) and oral metronidazole in clinical treatment of the BV in women referred to Resalat Health Center, affiliated with Mazandaran University of Medical Sciences, in 2013. Patients and Methods: This randomized clinical trial was conducted on 120 married women aged 18 to 44 years who were diagnosed with BV by Amsel’s clinical criteria and Gram staining. Enrolled women were randomly allocated to two groups of 60 patients and were treated with either garlic tablet or oral metronidazole for seven days. Amsel’s criteria and Gram stain were assessed seven to ten days after beginning the treatment period and side effects were registered. Results: Amsel’s criteria were significantly decreased after treatment with garlic or metronidazole (70% and 48.3%, respectively; P < 0.001). Therapeutic effects of garlic on BV were similar to that of metronidazole (63.3% and 48.3%, respectively; P = 0.141). There were significant differences between the two treatment groups in terms of side effects; metronidazole was associated with more complications (P = 0.032). Conclusions: This study reveals that garlic could be a suitable alternative for metronidazole in treatment of BV in those interested in herbal medicines or those affected by side effects of metronidazole. PMID:25237588

  14. Improvement in quality-of-life questionnaire measures in obese adolescent females with polycystic ovary syndrome treated with lifestyle changes and oral contraceptives, with or without metformin.

    PubMed

    Harris-Glocker, Miranda; Davidson, Kristin; Kochman, Lynda; Guzick, David; Hoeger, Kathleen

    2010-02-01

    We studied the effect of metformin or placebo in a lifestyle modification program combined with oral contraceptives (OC) on quality-of-life parameters measured by the polycystic ovary syndrome (PCOS) questionnaire in obese adolescent women with validated PCOS. The quality-of-life indicators were measured at baseline and conclusion for five domains on the PCOS questionnaire, with equal improvement in scores in both placebo and metformin groups, suggesting that the addition of metformin does not add improvement to quality-of-life measures above those observed with lifestyle modification and OC treatment.

  15. Contraception and headache.

    PubMed

    MacGregor, E Anne

    2013-02-01

    Most women have used at least 1 method of contraception during their reproductive years, with the majority favoring combined oral contraceptives. Women are often concerned about the safety of their method of choice and also ask about likely effects on their pre-existing headache or migraine and restrictions on using their headache medication. While there should be no restriction to the use of combined hormonal contraceptives by women with migraine without aura, the balance of risks vs benefits for women with aura are debatable. Migraine with aura, but not migraine without aura, is associated with a twofold increased risk of ischemic stroke, although the absolute risk is very low in healthy, nonsmoking women. Although ethinylestradiol has been associated with increased risk of ischemic stroke, the risk is dose-dependent. Low-dose pills currently used are considerably safer than pills containing higher doses of ethinylestradiol but they are not risk-free. This review examines the evidence available regarding the effect that different methods of contraception have on headache and migraine and identifies strategies available to minimize risk and to manage specific triggers such as estrogen "withdrawal" headache and migraine associated with combined hormonal contraceptives. The independent risks of ischemic stroke associated with migraine and with hormonal contraceptives are reviewed, and guidelines for use of contraception by women with migraine are discussed in light of the current evidence. PMID:23432442

  16. What's wrong with contraception?

    PubMed

    Rice, L; Rice, B

    1994-01-01

    A "reader's exchange" question solicited information on how readers respond when asked what is wrong with contraception. One correspondent couple wrote that their response is dependent upon their assessment of the questioner's perspective. Responses they use are 1) that the Catholic Church teaches that contraception is wrong and it is okay to accept this teaching in faith; 2) the Church teaches that every act of sexual intercourse must be open to life; 3) the God-given gift of intercourse involves pleasure and procreation, it is wrong to accept only part of the gift; 4) oral contraceptives have abortifacient properties; and 5) natural family planning involves temperance whereas contraception allows behavior which is similar to gluttony. A second correspondent wrote that the use of contraception makes humans behave like animals and allows them to be "takers" rather than "givers." A third letter-writer maintained that the use of contraception prohibits true love, total commitment, and complete acceptance on the part of a married couple. Contraception attempts to create a utopia and obviates the pain and suffering which are necessary in order to find true love and true happiness.

  17. Emergency contraception in Nairobi, Kenya: knowledge, attitudes and practices among policymakers, family planning providers and clients, and university students.

    PubMed

    Muia, E; Ellertson, C; Lukhando, M; Flul, B; Clark, S; Olenja, J

    1999-10-01

    To gauge knowledge, attitudes, and practices about emergency contraception in Nairobi, Kenya, we conducted a five-part study. We searched government and professional association policy documents, and clinic guidelines and service records for references to emergency contraception. We conducted in-depth interviews with five key policymakers, and with 93 family planning providers randomly selected to represent both the public and private sectors. We also surveyed 282 family planning clients attending 10 clinics, again representing both sectors. Finally, we conducted four focus groups with university students. Although one specially packaged emergency contraceptive (Postinor levonorgestrel tablets) is registered in Kenya, the method is scarcely known or used. No extant policy or service guidelines address the method specifically, although revisions to several documents were planned. Yet policymakers felt that expanding access to emergency contraception would require few overt policy changes, as much of the guidance for oral contraception is already broad enough to cover this alternative use of those same commodities. Participants in all parts of the study generally supported expanded access to emergency contraception in Kenya. They did, however, want additional, detailed information, particularly about health effects. They also differed over exactly who should have access to emergency contraception and how it should be provided. PMID:10640169

  18. A 13-month multicenter clinical experience of a low-dose monophasic oral contraceptive containing 20 microg ethinylestradiol and 75 microg gestodene in Latin American women.

    PubMed

    Bassol, Susana; Alvarado, Gloria; Arreola, Ranferi Gaona; Celis-Gonzalez, Cuauhtemoc; Peña, Efrain Perez; Flores, Josue Garza; Ahued, Jose R; Ricalde, Roger Lara; Lopez, Carlos R; Prieto, Gustavo; Gurucharri, Carlos; Heredia, Monica G; Ortiz, Oscar Contreras; Percossi, Gabriela; Figueroa Casas, Pedro R; Botto, Elida; Tozzini, Roberto Italo; Botti, Gustavo; Nuñez de Pierro, Anibal; Fernandez, Mirta; Lastreto, Enrique; Nañez, Monica; Carneiro de Oliveira, Hildoberto; Diogenes Holanda Yazlle, Martha E; Silva, Jaime; Salazar, German; Gomez, Jorge; Penagos, Gloria; Cifuentes, Rodrigo; Torres, Luz A; Reyes-Marquez, Roberto; Albrecht, Gerhard

    2003-05-01

    This prospective, multicenter study was conducted to evaluate the contraceptive reliability, cycle control and tolerability of a 21-day oral contraceptive regimen containing 20 microg ethinylestradiol and 75 microg gestodene in four Latin American countries (Mexico, Argentina, Brazil and Colombia). Participants took trial medication daily for 21 days. Contraceptive efficacy, cycle control and tolerability were evaluated over a period of 13 cycles. Efficacy data gathered from 5,109 treatment cycles were obtained from 393 participants. The trial medication proved to be an effective contraceptive and provided good cycle control. One pregnancy because of poor compliance was recorded. This resulted in a study Pearl index of 0.25. Forty-six percent of Latin American women reported one intracyclic spotting bleeding episode and 37.6% reported one intracyclic breakthrough bleeding (medium/excessive bleeding) episode during cycles 2-4 (primary target). Overall, intracyclic bleeding was reported in 41%. Overall, there was a trend towards a lower incidence of spotting in all the countries and this difference had statistical significance between Argentina and the others three countries (p < 0.05) during cycles 2-4. This trend was also apparent with respect to breakthrough bleeding, but again the difference did not achieve statistical significance. The discontinuation rate because of adverse events was low (3%); no serious adverse events were reported. More than 78% of the women in the four countries maintained constant body weight or lost weight (2 kg) during the study. The treatment effect on blood pressure was negligible. There were no appreciable changes in mean laboratory values over the course of the study. PMID:12742559

  19. Association of Combined Tobacco Smoking and Oral Contraceptive Use With Cervical Intraepithelial Neoplasia 2 or 3 in Korean Women

    PubMed Central

    Oh, Hea Young; Kim, Mi Kyung; Seo, Sang-Soo; Lee, Jae-Kwan

    2016-01-01

    Background Cigarette smoking and oral contraceptive (OC) use have been associated with cervical neoplasia, and the combination of smoking and OC use could influence cervical carcinogenesis. We aimed to assess the joint effect of smoking and OC use on the risk of cervical intraepithelial neoplasia (CIN). Methods From a cohort of human papillomavirus-positive subjects recruited from 6 hospitals in Korea from March 2006 to November 2012, a total of 678 subjects (411 control, 133 CIN 1, and 134 CIN 2 or 3 cases) were selected for this study (mean age, 43 years). The risk of CIN associated with smoking and OC use on additive and multiplicative scales was estimated via multinomial logistic regression after adjustment for potential confounding factors. The relative excess risk due to interaction (RERI) and the synergy index (S) were used to evaluate the additive interaction. Results OC users (odds ratio [OR] 1.98; 95% confidence interval [CI], 1.07–3.69) and long-term OC use (≥20 months; OR 2.71; 95% CI, 1.11–6.59) had a higher risk of CIN 2/3, but had no association with CIN 1, compared to non-OC users. Smokers and heavy smoking (≥8 cigarettes/day) were not associated with any CIN grade. Combined smoking and OC use (OR 4.91; 95% CI, 1.68–14.4; RERI/S, 3.77/27.4; P for multiplicative interaction = 0.003) and combined heavy smoking and long-term OC use (OR 11.5; 95% CI, 1.88–70.4; RERI/S, 9.93/18.8; P for multiplicative interaction = 0.009) had a higher risk of CIN 2/3 but had no association with CIN 1 compared to combined non-smoking and non-OC use. Conclusions OC use and smoking acted synergistically to increase the risk of CIN 2 or 3 in Korean women. PMID:26441210

  20. Age at first oral contraceptive use as a major determinant of vertebral bone mass in female endurance athletes.

    PubMed

    Hartard, Manfred; Kleinmond, Christine; Kirchbichler, Alexander; Jeschke, Dieter; Wiseman, Michael; Weissenbacher, Ernst Rainer; Felsenberg, Dieter; Erben, Reinhold G

    2004-10-01

    It was the aim of this retrospective analysis to examine the influence of low-dose monophasic oral contraceptives (OCs) on bone mineral density (BMD) of the femoral neck and of the spine in young female endurance athletes. Data on training intensity, dietary intake, menarche, menstrual cycle disorders, years of OC use, and age at first OC use were determined by a self-report questionnaire. Only athletes performing regular endurance exercise for more than 3 years with more than 3 h of exercise per week were included in this study and underwent a clinical assessment including measurement of weight, height, spine, and hip BMD by dual-energy X-ray absorptiometry, and collection of a blood sample. The data from 75 regularly exercising endurance athletes aged 18-35 years (26.5 +/- 4.8 years) were initially included in this analysis. Six athletes were later excluded due to oligo-/amenorrhea. Subjects were allocated into the OC group when they reported OC use for more than 3 years in women younger than 22 years of age, or when they reported OC use for more than 50% of the time after menarche in women aged 22-35 years. There were no differences in age, weight, height, body mass index (BMI), body fat, menarche, training intensity, age at start of training, or any serum parameters between OC users (n = 31) and control subjects (n = 38). However, OC users had 7.9% lower spine BMD and 8.8% lower proximal femur BMD (P < 0.01 for both sites). When the relationship between BMD of the spine and OC use was further analyzed by a stepwise model of multiple regression analysis using OC years, age at OC initiation, BMI, and menarche as independent variables, age at first OC use was found to be the best predictor of vertebral BMD, while the only significant predictor of femoral neck BMD was BMI. We conclude that OC use is associated with decreased BMD of the spine and the femoral neck in female endurance athletes, and that early age at initiation of OC use may be an important risk factor

  1. [Contraception in the future].

    PubMed

    Hamzaoui, R; Boukhris, M

    1994-02-01

    In the last decade, global use of contraceptive methods has increased. About 50% of couples of childbearing age use a modern contraceptive method. This evolution and a positive change in attitude towards male contraception has encouraged research in fertility regulation to enlarge and to improve acceptance of the contraceptive mix. Current injectable contraceptives interfere with the menstrual cycle. Research is exploring ways to minimize such secondary effects by reducing the total hormone dose and by changing the way the active product is delivered (e.g., microspheres). An injectable prototype is an analogue of levonorgestrel (HRP 002). A new IUD is made of leather suspended by a nylon suture which has been inserted into the uterine muscle. RU-486, often used to interrupt early pregnancy, is being tested as an oral contraceptive (OC). It inhibits secretion of gonadotropins and ovulation. It holds promise as an OC with no estrogen component. Since it also inhibits endometrial development and thus prevents implantation, it may someday be used for emergency contraception (i.e., postcoital contraception). New contraceptive implants under study include Norplant RII (2 rods of levonorgestrel lasting for 3 years), Implanon (desogestrel), and Capranor (biodegradable implant lasting 2 years). The female condom consists of a flexible polyurethane sheath with a flexible ring at each end. It has the potential to protect against sexually transmitted diseases since it covers the labial lips and is impermeable to HIV. France and Switzerland have both approved its use. It will enter the UK market at the end of the year. Approval for marketing has been sought in the US.

  2. Effect of emergency oral contraceptive use on condom utilization and sexual risk taking behaviours among university students, Northwest Ethiopia: a cross-sectional study

    PubMed Central

    2012-01-01

    Background Young people between the ages of 15 and 24 years are both the most at risk of HIV and the greatest hope for turning the tide against HIV/AIDS. Although various surveys have been done on sexual behaviour of youth in Ethiopia, studies assessing the effect of emergency oral contraceptives on condom utilization of university students are lacking. Methods A cross-sectional study was conducted in two major universities of Ethiopia from January to May 2011 using structured self administered questionnaire with the aim to assess the effect of introducing oral emergency contraceptive pills on condom utilization and sexual risk taking behaviours among female university students. Study participants were selected by simple random sampling using the list from the associate registrars of each University. Data were entered, cleaned and analyzed using SPSS version 17.0. Bivariate and multiple logistic regression analyses were used to determine factors associated with condom utilization. Results a total of 623 students out of 660 were included giving response rate of 94.4%. A total of 103(16.5%) had history of sexual intercourse and nearly half (45.6%) of them had sex before the age of 20 years. Forty (6.4%) students had history of sexually transmitted infections (STI). Sixty seven percent of students had heard about emergency oral contraceptives. One hundred and ninety one (45.7%) of students believe that EOC is effective in preventing pregnancy. Believing that EOC is effective in preventing pregnancy (adjusted Odds ratio, AOR = 0.22 95% CI 0.06, 0.87), condom prevents STI (AOR = 10.37, 95% CI 1.73, 62.24) and younger age below 20 years (AOR = 11.68 95% CI 1.25, 109.19) were statistically significantly associated with condom use. Conclusion a significant number of students had history of sexual intercourse and used emergency contraception. The belief in the effectiveness of EOC negatively affects condom use. The preference for the pill may make

  3. Deep vein thrombosis and changes in coagulation and fibrinolysis after gynaecological operations in Chinese: the effect of oral contraceptives and malignant disease.

    PubMed

    Tso, S C; Wong, V; Chan, V; Chan, T K; Ma, H K; Todd, D

    1980-12-01

    Of 154 Chinese patients who underwent gynaecological operations, four showed a positive 125I fibrinogen leg scan for venous thrombosis, and overall incidence of 2 . 6%. In those who were on oral contraceptives and had major pelvic surgery for benign conditions, the incidence was 10 . 5%; in those who had Wertheim hysterectomy for carcinoma of cervix, it was 6 . 7%. This confirms the rarity of post-operative thromboembolism in the Chinese. Fragment E showed a biphasic rise after major operation due to tissue injury and venous thrombosis. In patients with malignancy, the postoperative 'fibrinolytic shutdown', represented by decreased plasminogen activator together with increased alpha 1 antitrypsin and C1- inhibitor levels, was more marked. In addition, alpha 2 macroglobulin level was lower and fell significantly after operation. In patients on oral contraceptives, fragment E levels were higher after surgery and there was no decrease in plasminogen activator levels. Antithrombin III levels did not fall except in three of the four patients with venous thrombosis. A marked increase in fragment E level and a decrease in antithrombin III level might be useful diagnostic markers for postoperative venous thrombosis.

  4. Postpartum contraception.

    PubMed

    Sober, Stephanie; Schreiber, Courtney A

    2014-12-01

    As birth spacing has demonstrated health benefits for a woman and her children, contraception after childbirth is recognized as an important health issue. The potential risk of pregnancy soon after delivery underscores the importance of initiating postpartum contraception in a timely manner. The contraceptive method initiated in the postpartum period depends upon a number of factors including medical history, anatomic and hormonal factors, patient preference, and whether or not the woman is breastfeeding. When electing a contraceptive method, informed choice is paramount. The availability of long-acting reversible contraceptive methods immediately postpartum provides a strategy to achieve reductions in unintended pregnancy. PMID:25264698

  5. [Pharmaceutical formulations and adherence to pharmacological treatment in psychiatry: the example of oral disintegrating tablet of olanzapine].

    PubMed

    Cecchi, Cristiana; Canonico, Pier Luigi

    2012-01-01

    Adherence to treatment in psychiatric as in other chronic or recurrent conditions, is often suboptimal. A high proportion of relapses is due to non-adherence to prescribed treatment. Adherence to treatment is a potent predictor of effectiveness, both in clinical trials and cohort studies, therefore is a very relevant area where any improving tool is looked forward. Orally Disintegrating Tablets (ODT) were developed with the aim to improve patient's compliance due to their fast oral absorption. They are particularly useful in psychiatric patients who often simulate drug assumption or experience difficulties in taking pills. ODT formulations have been developed for many antypsychotics including olanzapine. The ODT formulations of olanzapine show to be significantly different one from the other in the dissolution time, thus having a potential impact on compliance. In this review, the results of different studies consistently highlight the positive risk/benefit profile, the contribution to patient's compliance and their preference while using ODT formulation of olanzapine produced throughout the ZYDIS technology (Velotab). Moreover, the differences between olanzapine ODT (Velotab) and the standard formulation of olanzapine and other antipsychotics are described focusing on in efficacy, safety, patient acceptance and health economic impact. The ODT formulation of olanzapine (Velotab) seems to ameliorate patient's adherence thus improving psychiatrist/caregiver/patient alliance.

  6. Safety of fluralaner chewable tablets (BravectoTM), a novel systemic antiparasitic drug, in dogs after oral administration

    PubMed Central

    2014-01-01

    Background Fluralaner is a novel systemic insecticide and acaricide that provides long acting efficacy in dogs after a single oral treatment. This study investigated the safety of oral administration of fluralaner in chewable tablets to dogs at the highest recommended treatment dose and at multiples of this dose. Methods Thirty-two (16 male and 16 female) healthy 8-week old Beagle dogs weighing 2.0 - 3.6 kg at first administration were included in the study. Fluralaner was administered on three occasions at 8-week intervals at doses of up to 56, 168, and 280 mg fluralaner/kg body weight, equivalent to 1, 3, and 5 times the highest recommended treatment dose of fluralaner; sham dosed dogs served as controls. During the study, all dogs were clinically observed, and their health was carefully monitored including body weight development, food consumption and measurement of hematology, coagulation, clinical chemistry (including measurement of levels of ACTH and C-reactive protein) and urinalysis. Following euthanasia of the dogs, complete gross post mortem examination, including organ weight determination, and histopathological examination of multiple tissues were conducted. Results There were no clinical findings related to fluralaner treatment. Statistically significant differences between the treated groups and the control group were observed for some clinical pathology parameters and organ weights; none of these findings were considered to be of clinical relevance. Conclusions Oral administration of fluralaner at the highest recommended treatment dose (56 mg/kg) at 8-week intervals is well tolerated and has a safety margin of more than five in healthy dogs eight weeks of age or older and weighing at least 2 kg. PMID:24606886

  7. Contraceptive options for adolescents.

    PubMed

    Moriarty, A L

    1997-01-01

    Data on national trends of sex behavior indicate that adolescents in the US are initiating sexual activity at younger ages than in the past several decades. The 1996 Centers for Disease Control Youth Behavior Survey found that 36.9% of 9th graders and 66.4% of 12th graders had been sexually active. Of those, 37.9% were sexually active within the 3 months preceding the survey. 12.7% of the sexually active boys and 4.9% of the sexually active girls reported beginning sexual activity before age 13 years. 72% of individuals aged 15-17 years and 84% of those aged 18-19 report using some form of contraception. However, many use contraception inconsistently. The most popular and effective methods of contraception chosen by adolescents are condoms, oral contraception, and depot medroxyprogesterone acetate (DMPA). These methods are discussed. Before either oral contraceptive pill or DMPA use is initiated, a detailed health history should be taken and a complete physical examination conducted which includes a pelvic examination.

  8. Contraception: traditional and religious attitudes.

    PubMed

    Schenker, J G; Rabenou, V

    1993-04-01

    Humans have tried to control fertility for centuries. Primitive, preliterate societies practiced infanticide and abortion. When primitive women understood the advantages of conception control, they tried, when possible, to use contraception. In the 4th century B.C., Plato and Aristotle advocated a one-child family. Greek medical literature reported a hollow tube inserted through the cervix into the uterus and a potion as contraceptives. Islamic physicians had much knowledge about conception control. The attitudes toward contraception. In the 5th century B.C., Saint Augustine condemned contraception, even among married couples. The condom emerged in the early modern period. Yet, they were usually worn to protect against disease, e.g., bilharzia in Egypt and syphilis in Europe. The cervical cap and the diaphragm are examples of occlusive pessaries. By 1880, contraceptives and spermicides were advertised. In 1928, the IUD joined the existing contraceptives. Today we have combined oral contraceptives. Judaic law requires husbands to fulfill their wives sexual needs, separate from their duty to procreate. It also calls men, not women, to procreate and forbids men from masturbating, thus Judaic law does not forbid women from practicing contraception. The Roman Catholic church forbids contraceptive use because it is a sin against nature. Some Protestant denominations have allowed contraceptive use. Islamic law states that children are gifts from Allah. Some Moslems believe that they must have many children, but Allah and the Prophet state that children have rights to education and future security. These rights allow couples to prevent pregnancy. Neither Hinduism nor Buddhism prohibit contraceptive use. Differences in husband-wife communication, sex roles, access to contraceptives, and traditional family values will have more of an effect on contraceptive use and fertility than theological barriers or the social class of religious groups.

  9. The effect of combined oral contraception on testosterone levels in healthy women: a systematic review and meta-analysis

    PubMed Central

    Zimmerman, Y.; Eijkemans, M.J.C.; Coelingh Bennink, H.J.T.; Blankenstein, M.A.; Fauser, B.C.J.M.

    2014-01-01

    BACKGROUND Combined oral contraceptives (COCs) reduce levels of androgen, especially testosterone (T), by inhibiting ovarian and adrenal androgen synthesis and by increasing levels of sex hormone-binding globulin (SHBG). Although this suppressive effect has been investigated by numerous studies over many years, to our knowledge no systematic review concerning this issue had been performed. This systematic review and meta-analysis was performed to evaluate the effect of COCs on concentrations of total T, free T and SHBG in healthy women and to evaluate differences between the various types of COCs (e.g. estrogen dose, type of progestin) and the assays used to assess total T and free T. METHODS A review of the literature was performed using database searches (MEDLINE, EMBASE and the Cochrane Central Register of Clinical Trials) and all publications (from inception date until July 2012) investigating the effect of COCs on androgen levels in healthy women were considered eligible for selection. Three reviewers were involved in study selection, data extraction and critical appraisal. For the meta-analysis, data on total T, free T and SHBG were extracted and combined using random effects analysis. Additional subgroup analyses were performed to evaluate differences between the various types of COCs (e.g. estrogen dose, type of progestin) and the assays used to assess total T or free T. RESULTS A total of 151 records were identified by systematic review and 42 studies with a total of 1495 healthy young women (age range: 18–40 years) were included in the meta-analysis. All included studies were experimental studies and 21 were non-comparative. Pooling of the results derived from all the included papers showed that total T levels significantly decreased during COC use [mean difference (MD) (95% confidence interval, CI) −0.49 nmol/l (−0.55, −0.42); P < 0.001]. Significantly lower levels of free T were also found [relative change (95% CI) 0.39 (0.35, 0.43); P < 0

  10. [Test your knowledge: contraceptives].

    PubMed

    1998-06-01

    A brief self-administered quiz on contraceptive knowledge is presented. The 7 questions ask the reader to explain the mechanism of action of combined oral contraceptives, and why estrogens are used with progestins, and to indicate the main secondary effects of Depo-Provera and implants and the dosage of the "morning-after pill." A multiple-choice question concerns absolute contraindications to combined OC use. One clinical case involves selection of OCs for a woman with a family history of breast cancer and the other requires development of a strategy for reducing high-risk pregnancies and risk of AIDS.

  11. Low dose oestrogen combined oral contraception and risk of pulmonary embolism, stroke, and myocardial infarction in five million French women: cohort study

    PubMed Central

    Dalichampt, Marie; Raguideau, Fanny; Ricordeau, Philippe; Blotière, Pierre-Olivier; Rudant, Jérémie; Alla, François; Zureik, Mahmoud

    2016-01-01

    Objective To assess the risk of pulmonary embolism, ischaemic stroke, and myocardial infarction associated with combined oral contraceptives according to dose of oestrogen (ethinylestradiol) and progestogen. Design Observational cohort study. Setting Data from the French national health insurance database linked with data from the French national hospital discharge database. Participants 4 945 088 women aged 15-49 years, living in France, with at least one reimbursement for oral contraceptives and no previous hospital admission for cancer, pulmonary embolism, ischaemic stroke, or myocardial infarction, between July 2010 and September 2012. Main outcome measures Relative and absolute risks of first pulmonary embolism, ischaemic stroke, and myocardial infarction. Results The cohort generated 5 443 916 women years of oral contraceptive use, and 3253 events were observed: 1800 pulmonary embolisms (33 per 100 000 women years), 1046 ischaemic strokes (19 per 100 000 women years), and 407 myocardial infarctions (7 per 100 000 women years). After adjustment for progestogen and risk factors, the relative risks for women using low dose oestrogen (20 µg v 30-40 µg) were 0.75 (95% confidence interval 0.67 to 0.85) for pulmonary embolism, 0.82 (0.70 to 0.96) for ischaemic stroke, and 0.56 (0.39 to 0.79) for myocardial infarction. After adjustment for oestrogen dose and risk factors, desogestrel and gestodene were associated with statistically significantly higher relative risks for pulmonary embolism (2.16, 1.93 to 2.41 and 1.63, 1.34 to 1.97, respectively) compared with levonorgestrel. Levonorgestrel combined with 20 µg oestrogen was associated with a statistically significantly lower risk than levonorgestrel with 30-40 µg oestrogen for each of the three serious adverse events. Conclusions For the same dose of oestrogen, desogestrel and gestodene were associated with statistically significantly higher risks of pulmonary embolism but not arterial

  12. [Method for the evaluation of the stability and usability after opening packages of orally disintegrating tablets: case of amlodipine besilate products].

    PubMed

    Hori, Katsuhito; Yoshida, Naoko; Okumura, Tomonori; Okamura, Yasufumi; Kawakami, Junichi

    2010-08-01

    Orally disintegrating (OD) tablets are widely used in clinical practice. However, drug information on the choice and dispensing based on their stability after opening packages and usability in patients and dispensaries is not sufficient. The aim of this study was to investigate possible evaluation methods of the stability and usability of amlodipine OD tablets. Additives of the brand were changed in April 2009, and therefore the previous and current forms and two generics, current and newly marketed (in November 2009) products of different firms, were used. OD tablets were stored at 25 degrees C and 75% relative humidity for 3 months after opening the packages, and their physicochemical properties were evaluated. Their weight, diameter, thickness, and color difference increased slightly from the initial state. The extent of the change in their hardness, disintegration time, and friability was different among products. These physicochemical changes were acceptable in dispensary practice. Storage after opening the packages did not affect their dissolution rate. The dissolution rate at the initial state of the current brand was slower than that of the previous one. All products used were able to be dispensed by an automatic tablet-packing machine and applied to the so-called simple suspension method for intubational administration. Sensory evaluation tests revealed no major difference in the oral disintegration time, taste, impression, and preference among products. In conclusion, the stability and usability of amlodipine OD tablets used in this study were examined using several methods, and they can be used equivalently from the stability and usability viewpoints. PMID:20686207

  13. Non-prescription dispensing of emergency oral contraceptives: Recommendations from the German Federal Chamber of Pharmacists [Bundesapothekerkammer

    PubMed Central

    Goebel, Ralf; Zagermann-Muncke, Petra

    2016-01-01

    Background: Emergency hormonal contraceptives (EHC) are contraceptives used to prevent unintended pregnancy following unprotected sexual intercourse (USI) or contraceptive failure. The EHCs available without a prescription include medicines containing levonorgestrel (LNG) in more than 80 countries and, recently, based on an EU-switch ellaOne®, which contains ulipristal acetate (UPA). EHCs work by stopping or delaying ovulation. Those containing LNG can be used up to 72 hours after USI or contraceptive failure, while UPA can be used up to 120 hours. In the context of the UPA implementation process, Germany switched LNG to non-prescription status as well. Objectives: To develop recommendations, a protocol, and a continuing education program for pharmacists to assure quality when giving advice and dispensing EHCs in community pharmacies without a medical prescription. Methods: The recommendations were developed by an iterative process of drafting, recognizing, and discussing comments and proposals for amendments as well a seeking agreement with a number of stakeholders such as the Federal Ministry of Health (BMG), Federal Institute for Drugs and Medical Devices (BfArM), Federal Chamber of Physicians (BÄK), Drug Commission of German Physicians (AkdÄ), professional organizations/associations of gynaecologists, pharmaceutical OTC-industry as well as government-controlled, private, and church-based organizations and centres providing advice on sex education and family planning. Results: The recommendations were eventually endorsed by the BMG in consultation with the BfArM. Conclusions: The recommendations were made public, published in the professional journal and used in an uncounted number of continuing education programs based on the curriculum and provided by the State Chambers of Pharmacists. PMID:27785169

  14. Injectable contraception.

    PubMed

    Kaunitz, A M

    1989-06-01

    The most effective, convenient, reversible method of birth control is considered to be long-acting progestogen injections. Used by over 90 countries, Depot medroxy-progesterone acetate (DMPA, Depo-Provera, Upjohn) has yet to be approved by the U.S. Food and Drug Administration. The reluctance of the FDA to approve DMPA and much of the controversy surrounding this method revolve around the results of testing done on animals who were given large doses of the progestogen over a long period of time and developed tumors. However, the large body of research and records on this method that have been compiled over the past 30 years is positive. The injectable method works like oral contraceptives, inhibiting ovulation. Changes in menstruation have been the chief complaint of women who use this method; however, the duration and frequency of spotting and bleeding diminish over time. Other side effects of DMPA and Norethindrone enanthate (NET EN, Noristerat, Schering) are discussed. Also discussed is the history of development and testing for the 2 methods and subdermal implants, specifically Norplant.

  15. Pharmaceutical development of an oral tablet formulation containing a spray dried amorphous solid dispersion of docetaxel or paclitaxel.

    PubMed

    Sawicki, Emilia; Beijnen, Jos H; Schellens, Jan H M; Nuijen, Bastiaan

    2016-09-25

    Previously, it was shown in Phase I clinical trials that solubility-limited oral absorption of docetaxel and paclitaxel can be drastically improved with a freeze dried solid dispersion (fdSD). These formulations, however, are unfavorable for further clinical research because of limitations in amorphicity of SD and scalability of the production process. To resolve this, a spray drying method for an SD (spSD) containing docetaxel or paclitaxel and subsequently drug products were developed. Highest saturation solubility (Smax), precipitation onset time (Tprecip), amorphicity, purity, residual solvents, yield/efficiency and powder flow of spSDs were studied. Drug products were monitored for purity/content and dissolution during 24 months at +15-25°C. Docetaxel spSD Smax was equal to that of fdSD but Tprecip was 3 times longer. Paclitaxel spSD Smax was 30% increased but Tprecip was equal to fdSD. spSDs were fully amorphous, >99% pure, <5% residual solvents, mean batch yield was 100g and 84%. spSDs had poor powder flow characteristics, which could not be resolved by changing settings, but by using 75% lactose as diluent. The drug product was a tablet with docetaxel or paclitaxel spSD and was stable for at least 24 months. Spray drying is feasible for the production of SD of docetaxel or paclitaxel for upcoming clinical trials.

  16. Preliminary buprenorphine sublingual tablet pharmacokinetic data in plasma, oral fluid and sweat during treatment of opioid-dependent pregnant women

    PubMed Central

    Concheiro, Marta; Jones, Hendreé E.; Johnson, Rolley E.; Choo, Robin; Huestis, Marilyn A.

    2011-01-01

    Background Buprenorphine is currently under investigation as a pharmacotherapy to treat pregnant women for opioid dependence. This research evaluates buprenorphine (BUP), norbuprenophine (NBUP), buprenorphine-glucuronide (BUP-Gluc) and norbuprenorphine-glucuronide (NBUP-Gluc) pharmacokinetics after high dose (14–20 mg) BUP sublingual tablet administration in three opioid-dependent pregnant women. Methods Oral fluid and sweat specimens were collected in addition to plasma specimens for 24 h during gestation weeks 28 or 29 and 34, and 2 months after delivery. Tmax was not affected by pregnancy; however, BUP and NBUP Cmax and AUC0–24h tended to be lower during pregnancy compared to postpartum levels. Results Statistically significant but weak positive correlations were found for BUP plasma and OF concentrations, and BUP/NBUP ratios in plasma and OF. Conclusion Statistically significant negative correlations were observed for times of specimen collection and BUP and NBUP OF/plasma ratios. BUP-Gluc and NBUP-Gluc were detected in only 5% of OF specimens. In sweat, BUP and NBUP were detected in only 4 of 25 (12 or 24 h) specimens in low concentrations (<2.4 ng/patch). These preliminary data describe BUP and metabolite pharmacokinetics in pregnant women and suggest that, like methadone, upward dose adjustments may be needed with advancing gestation. PMID:21860340

  17. The practical approach to the evaluation of methods used to determine the disintegration time of orally disintegrating tablets (ODTs)

    PubMed Central

    Brniak, Witold; Jachowicz, Renata; Pelka, Przemyslaw

    2015-01-01

    Even that orodispersible tablets (ODTs) have been successfully used in therapy for more than 20 years, there is still no compendial method of their disintegration time evaluation other than the pharmacopoeial disintegration test conducted in 800–900 mL of distilled water. Therefore, several alternative tests more relevant to in vivo conditions were described by different researchers. The aim of this study was to compare these methods and correlate them with in vivo results. Six series of ODTs were prepared by direct compression. Their mechanical properties and disintegration times were measured with pharmacopoeial and alternative methods and compared with the in vivo results. The highest correlation with oral disintegration time was found in the case of own-construction apparatus with additional weight and the employment of the method proposed by Narazaki et al. The correlation coefficients were 0.9994 (p < 0.001), and 0.9907 (p < 0.001) respectively. The pharmacopoeial method correlated with the in vivo data much worse (r = 0.8925, p < 0.05). These results have shown that development of novel biorelevant methods of ODT’s disintegration time determination is eligible and scientifically justified. PMID:27134547

  18. Enhancement of Solubility of Lamotrigine by Solid Dispersion and Development of Orally Disintegrating Tablets Using 32 Full Factorial Design

    PubMed Central

    Singh, Jatinderpal; Garg, Rajeev; Gupta, Ghanshyam Das

    2015-01-01

    Present investigation deals with the preparation and evaluation of orally disintegrating tablets (ODTs) of lamotrigine using β-cyclodextrin and PVP-K30 as polymers for the preparation of solid dispersion which help in enhancement of aqueous solubility of this BCS CLASS-II drug and sodium starch glycolate (SSG) and crospovidone as a superdisintegrating agent, to reduce disintegration time. The ODTs were prepared by direct compression method. Nine formulations were developed with different ratios of superdisintegrating agents. All the formulations were evaluated for disintegration time, weight variation, hardness, friability, drug content uniformity, wetting time, and in vitro drug release study. In vitro drug release study was performed using United States Pharmacopoeia (USP) type 2 dissolution test apparatus employing paddle stirrer at 50 rpm using 900 mL of 0.1 N HCl maintained at 37°C ± 0.5°C as the dissolution medium. On the basis of evaluation parameters formulations were prepared using β-CD 1 : 1 solid dispersion. Then 32 full factorial design was applied using SSG and crospovidone in different ratios suggested by using design expert 8.0.7.1 and optimized formulation was prepared using amount of SSG and crospovidone as suggested by the software. The optimized formulation prepared had disintegrating time of 15 s, wetting time of 24 s, and % friability of 0.55. PMID:26634173

  19. Mefenamic acid taste-masked oral disintegrating tablets with enhanced solubility via molecular interaction produced by hot melt extrusion technology

    PubMed Central

    Alshehri, Sultan M.; Park, Jun-Bom; Alsulays, Bader B.; Tiwari, Roshan V.; Almutairy, Bjad; Alshetaili, Abdullah S.; Morott, Joseph; Shah, Sejal; Kulkarni, Vijay; Majumdar, Soumyajit; Martin, Scott T.; Mishra, Sanjay; Wang, Lijia; Repka, Michael A.

    2015-01-01

    The objective of this study was to enhance the solubility as well as to mask the intensely bitter taste of the poorly soluble drug, Mefenamic acid (MA). The taste masking and solubility of the drug was improved by using Eudragit® E PO in different ratios via hot melt extrusion (HME), solid dispersion technology. Differential scanning calorimetry (DSC) studies demonstrated that MA and E PO were completely miscible up to 40% drug loads. Powder X-ray diffraction analysis indicated that MA was converted to its amorphous phase in all of the formulations. Additionally, FT-IR analysis indicated hydrogen bonding between the drug and the carrier up to 25% of drug loading. SEM images indicated aggregation of MA at over 30% of drug loading. Based on the FT-IR, SEM and dissolution results for the extrudates, two optimized formulations (20% and 25% drug loads) were selected to formulate the orally disintegrating tablets (ODTs). ODTs were successfully prepared with excellent friability and rapid disintegration time in addition to having the desired taste-masking effect. All of the extruded formulations and the ODTs were found to be physically and chemically stable over a period of 6 months at 40°C/75% RH and 12 months at 25°C/60% RH, respectively. PMID:25914727

  20. Influence of food on the oral bioavailability of deramciclane from film-coated tablet in healthy male volunteers.

    PubMed

    Drabant, Sándor; Nemes, Katalin Balogh; Horváth, Viola; Tolokán, Antal; Grézal, Gyula; Anttila, Markku; Gachályi, Béla; Kanerva, Harri; Al-Behaisi, Samar; Horvai, George; Klebovich, Imre

    2004-11-01

    The effect of a high-fat meal on the oral bioavailability of deramciclane 30 mg tablet was evaluated in 18 healthy male volunteers in a randomised, single dose, two-way crossover study. The drug was administered following an overnight fast or a standardised high-fat breakfast. The plasma concentrations of deramciclane and N-desmethylderamciclane were determined by using a validated HPLC-MS -MS/MS method. An effect of food on the bioavailability was indicated if the 90% confidence interval (CI) for the ratio of geometric means of fed and fasted treatments was not contained in the equivalence limit of 0.8-1.25 for AUC and C(max). The ratios of the mean C(max) and AUC(0-infinity) values of deramciclane were 1.24 (90% CI 1.12-1.38) and 1.31 (90% CI 1.21-1.41) in fed versus fasted subjects, which overlapped but exceeded the equivalence limit. In contrast to the parent compound, the 90% CI of the mean ratios for AUC(0-infinity) and C(max) of N-desmethylderamciclane were within the predefined range. The 24 and 31% increase in C(max) and AUC(0-infinity) of deramciclane, respectively, under fed condition is modest and probably has no clinical significance since it is relatively small compared to the inter-individual variability of these parameters.

  1. Improved migraine management in primary care: results of a patient treatment experience study using zolmitriptan orally disintegrating tablet

    PubMed Central

    SHAPERO, G; DOWSON, A; LACOSTE, J-P; ALMQVIST, P

    2006-01-01

    The ‘Zomig Appropriate for Primary care’ programme was developed to address the needs of primary care physicians (PCPs) to improve migraine management. As part of the programme, an international, open-label, 6-month clinical study was performed. The study included new and tangible outcome variables relevant to PCPs and recruited patients presenting in primary care with an established migraine diagnosis. Patients treated up to three migraine attacks per month with zolmitriptan orally disintegrating tablet (ODT) 2.5 mg. All other migraine attacks occurring during the study period were treated with the patient's usual migraine medication (including other triptans). Questionnaires were used to record patient treatment experiences at the study end. The primary end-point was the proportion of patients wanting to continue using zolmitriptan ODT. Some 595 patients treated 7171 migraine attacks with zolmitriptan ODT. Of the 504 patients who completed the 6-month questionnaire, 380 (75.4%) wished to continue using zolmitriptan ODT. The results of the study indicate that patient-orientated end-points are more motivational and meaningful to physicians than traditional end-points used in controlled clinical trials, allowing them to make informed decisions regarding migraine management. PMID:17109663

  2. Pharmaceutical development of an oral tablet formulation containing a spray dried amorphous solid dispersion of docetaxel or paclitaxel.

    PubMed

    Sawicki, Emilia; Beijnen, Jos H; Schellens, Jan H M; Nuijen, Bastiaan

    2016-09-25

    Previously, it was shown in Phase I clinical trials that solubility-limited oral absorption of docetaxel and paclitaxel can be drastically improved with a freeze dried solid dispersion (fdSD). These formulations, however, are unfavorable for further clinical research because of limitations in amorphicity of SD and scalability of the production process. To resolve this, a spray drying method for an SD (spSD) containing docetaxel or paclitaxel and subsequently drug products were developed. Highest saturation solubility (Smax), precipitation onset time (Tprecip), amorphicity, purity, residual solvents, yield/efficiency and powder flow of spSDs were studied. Drug products were monitored for purity/content and dissolution during 24 months at +15-25°C. Docetaxel spSD Smax was equal to that of fdSD but Tprecip was 3 times longer. Paclitaxel spSD Smax was 30% increased but Tprecip was equal to fdSD. spSDs were fully amorphous, >99% pure, <5% residual solvents, mean batch yield was 100g and 84%. spSDs had poor powder flow characteristics, which could not be resolved by changing settings, but by using 75% lactose as diluent. The drug product was a tablet with docetaxel or paclitaxel spSD and was stable for at least 24 months. Spray drying is feasible for the production of SD of docetaxel or paclitaxel for upcoming clinical trials. PMID:27480397

  3. [Historical survey of modern reversible contraceptive methods].

    PubMed

    Mbabajende, V

    1986-04-01

    Because of contraception, pregnancy need not be viewed by women as punishment for sexual activity but as a planned and desired event. Most of the contraceptive methods used in developing countries at present were introduced during the 1960s, but use of contraception has a long history and some methods date back to antiquity. Contraceptive pills were already used around 2000 BC in the form of mercury and arsenic tablets. Their effectiveness was questionable. The role of hormones in human reproduction began to be understood only in the early 1900s. The discovery of progesterone in a Mexican iguana in the 1940s permitted production of progesterone on a large scale. Estrogens had been identified around 1930. Human trials of a contraceptive pill beginning in 1956 in Puerto Rico demonstrated that progestins could prevent pregnancy by suppressing ovulation. Later on, estrogen was added to reduce menstrual irregularities. The 1st generation of combined oral contraceptives contained very high levels of hormones associated with high rates of side effects. Numerous formulations with lower hormonal contents became available beginning around 1970 and constitute the principal formulations in use today. A number of long acting hormonal methods based on progestins have been developed, including injectables, some IUDs and vaginal rings, and implants. The 1st commercially available injectable, norethisterone enanthate, did not acquire the wide distribution of medroxyprogesterone acetate, sold as Depo Provera and used to treat various pathological conditions as well as for contraception. The 1st true IUDs were small stones placed within the uteri of camels by nomads to prevent pregnancy during long caravans. An IUD was developed in 1909 by Richter, and the 2 most widely used models before 1960 were the Grafenberg and Ota silver rings. Use of the 2 rings became rare for medical reasons after 1935 despite their efficacy. Safe plastic IUDs which appeared beginning in the early 1960s

  4. 21 CFR 520.2150a - Stanozolol tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Administered orally to cats and small breeds of dogs, 1/2 to 1 tablet twice daily for several weeks; to large breeds of dogs, 1 to 2 tablets twice daily for several weeks. The tablets may be crushed and...

  5. A survey of contraception in five west European countries.

    PubMed

    Riphagen, F E; Lehert, P

    1989-01-01

    In 1984 and 1985, a survey was conducted of 7696 women aged 15-44 living in Italy, France, Great Britain, Spain and the Federal Republic of Germany. The aim of the study was to examine the use of contraceptive methods, the differences in contraceptive use, knowledge of fertility, communication about contraception, motives for choice and the perceptions held by women regarding contraceptive methods, particularly oral contraception. The results show important differences between the countries studied.

  6. A prospective comparison of bone density in adolescent girls receiving depot medroxyprogesterone acetate (Depo-Provera), levonorgestrel (Norplant), or oral contraceptives.

    PubMed

    Cromer, B A; Blair, J M; Mahan, J D; Zibners, L; Naumovski, Z

    1996-11-01

    In Ohio, data on 31 postmenarcheal women, 12-21 years old and using hormonal contraception (Norplant = 7, Depo Provera = 15, and oral contraceptives [OCs] = 9) were compared with data on 17 controls of similar age to prospectively examine lumbar bone density in girls before and after 1 and 2 years of hormonal contraceptive use and to compare the results with young women not using hormonal contraceptives. The subjects attended a general adolescent clinic at Children's Hospital in Columbus. There was an insufficient number of OC users at 2 years, so they were not included in second year analyses. Initial height and weight were significantly associated with bone density values (p 0.05). Weight accounted for the most variance both at baseline (p 0.001) and after 1 year of treatment (p 0.01). At baseline and 1 year, bone density values between patient groups were not significantly different. At 2 years, however, Norplant users had higher bone density than Depo- Provera users and controls (1.308 vs. 1.004 and 1.087, respectively; p 0.01). After 1 year, Depo-Provera users experienced a decrease (1.53%) in bone density while Norplant users, OC users, and controls experienced an increase in bone density (2.46%, 1.52%, and 2.85%, respectively). The change in bone density between Depo-Provera users and controls was significant (p 0.02). At 2 years, Depo Provera users experienced a decrease in bone density while Norplant users and controls experienced an increase (-3.12% vs. 9.33% and 9.49%, respectively; p 0.0001). This study is important because 50% of adult bone mass is accrued during adolescence. In fact, bone mass peaks during adolescence. It is not known whether bone loss during Depo Provera use is reversible after treatment discontinuation. These findings show that Depo Provera inhibits skeletal bone mineralization in adolescents, at least temporarily, while Norplant and OCs appear to increase bone density.

  7. Ovarian hyperstimulation syndrome prevention strategies: oral contraceptive pills-dual gonadotropin-releasing hormone agonist suppression with step-down gonadotropin protocols.

    PubMed

    Damario, Mark A

    2010-11-01

    The identification of patients at high risk for excessive responses to ovarian stimulation for in vitro fertilization and embryo transfer is essential in the tailoring of safe and effective treatment strategies. Known factors associated with increased sensitivity to gonadotropins include polycystic ovary syndrome, young age, prior ovarian hyperstimulation syndrome (OHSS), high baseline antral follicle count, and high baseline ovarian volume. Although several treatment strategies have been proposed for these patients, this report describes the experience using the dual suppression with gonadotropin step-down protocol. This protocol uses oral contraceptive pretreatment in combination with a long gonadotropin-releasing hormone agonist followed by a programmed step-down in gonadotropin dosing. Hormonal characteristics of dual suppression include an improved luteinizing hormone-to-follicle-stimulating hormone ratio and lower serum androgens, particularly dehydroepiandrosterone sulfate. Clinical characteristics of the protocol include a lower cancellation rate and favorable clinical and ongoing pregnancy rates per initiated cycle while mitigating the risk of OHSS.

  8. Comparison of Rates of and Charges from Pregnancy Complications in Users of Extended and Cyclic Combined Oral Contraceptive (COC) Regimens: A Brief Report

    PubMed Central

    Howard, Brandon; Trussell, James; Grubb, ElizaBeth; Lage, Maureen J.

    2014-01-01

    Objective Evaluate pregnancy complication rates and related charges in users of 84/7, 21/7, and 24/4 combined oral contraceptives (COCs). Study Design Data were obtained from the i3 InVision Data Mart™ retrospective claims database. Subjects were aged 15–40 years; first prescribed a COC between 1/1/2006 and 4/1/2011; and continuously insured for ≥1 year. 84/7 users were matched 1:1 to 21/7 and 24/4 users. Results Pregnancy-related complication rates and associated charges were significantly lower with 84/7 vs. 21/7 and 24/4 regimens. Conclusion Preliminary data suggest 84/7 regimens may be associated with fewer pregnancy complications and lower related charges. PMID:24457060

  9. Combined administration of low-dose gossypol acetic acid with desogestrel/mini-dose ethinylestradiol/testosterone undecanoate as an oral contraceptive for men.

    PubMed

    Yang, Zhan-Jun; Ye, Wei-San; Cui, Guang-Hui; Guo, Yan; Xue, She-Pu

    2004-09-01

    To evaluate the efficacy and feasibility of a new regimen of low-dose gossypol acetic acid (GA) combined with desogestrel/ethinylestradiol and testosterone undecanoate (DSG/E/TU) as a male contraceptive, adult male rats were fed orally with GA (12.5 mg/kg/day) and DSG (0.125 mg/kg)/E (0.025 mg/kg)/TU (100 mg/kg) daily for 8 weeks as loading dose until infertility, and a similar low dose of GA alone for infertility maintenance. Control animals were administered a single low dose of GA (12.5 mg/kg/day) or DSG (0.125 mg/kg)/E (0.025 mg/kg)/TU (100 mg/kg), and vehicle, respectively. Results demonstrated that the combined dosage regimen could damage epididymal sperm motility and density, and induce infertility within 8 weeks in rats; the infertility could be consistently sustained by giving single GA (12.5 mg/kg/day), and was reversible in about 8 weeks following withdrawal of gossypol. The regimen rendered treated male rats with spermiation failure within a period of 6-20 weeks of treatment. Also, the serum luteinizing hormone, follicle-stimulating hormone and testicular interstitial fluid testosterone levels showed a transient decrease at the end of 6 or 8 weeks, which returned to control levels after 8 weeks of recovery phase. No hypokalemia or other adverse effects in viscera were observed. These results provide a promising approach to using the new regimen for the development of an effective and reversible oral male contraceptive. PMID:15325889

  10. Contraceptive Evaluation.

    ERIC Educational Resources Information Center

    Hulka, Barbara S.; And Others

    The objective of research in contraceptive evaluation is to improve the ability of individuals to choose contraceptive methods best suited to their needs and circumstances and to provide information that will lead to the development of safer and more effective methods. There are usually three considerations in judging the importance of a method of…

  11. Formulation development of oral controlled release tablets of hydralazine: optimization of drug release and bioadhesive characteristics.

    PubMed

    Singh, Bhupinder; Pahuja, Sonia; Kapil, Rishi; Ahuja, Naveen

    2009-03-01

    The current study involves development of oral bioadhesive hydrophilic matrices of hydralazine hydrochloride, and optimization of their in vitro drug release profile and ex vivo bioadhesion against porcine gastric mucosa. A 32 central composite design was employed to systematically optimize the drug delivery formulations containing two polymers, viz., carbomer and hydroxypropyl methyl cellulose. Response surface plots were drawn and optimum formulations were selected by brute force searches. Validation of the formulation optimization study indicated a very high degree of prognostic ability. The study successfully undertook the development of an optimized once-a-day formulation of hydralazine with excellent bioadhesive and controlled release characteristics.

  12. Contraception choices in women with underlying medical conditions.

    PubMed

    Bonnema, Rachel A; McNamara, Megan C; Spencer, Abby L

    2010-09-15

    Primary care physicians often prescribe contraceptives to women of reproductive age with comorbidities. Novel delivery systems (e.g., contraceptive patch, contraceptive ring, single-rod implantable device) may change traditional risk and benefit profiles in women with comorbidities. Effective contraceptive counseling requires an understanding of a woman's preferences and medical history, as well as the risks, benefits, adverse effects, and contraindications of each method. Noncontraceptive benefits of combined hormonal contraceptives, such as oral contraceptive pills, include regulated menses, decreased dysmenorrhea, and diminished premenstrual dysphoric disorder. Oral contraceptive pills may be used safely in women with a range of medical conditions, including well-controlled hypertension, uncomplicated diabetes mellitus, depression, and uncomplicated valvular heart disease. However, women older than 35 years who smoke should avoid oral contraceptive pills. Contraceptives containing estrogen, which can increase thrombotic risk, should be avoided in women with a history of venous thromboembolism, stroke, cardiovascular disease, or peripheral vascular disease. Progestin-only contraceptives are recommended for women with contraindications to estrogen. Depo-Provera, a long-acting injectable contraceptive, may be preferred in women with sickle cell disease because it reduces the frequency of painful crises. Because of the interaction between antiepileptics and oral contraceptive pills, Depo-Provera may also be considered in women with epilepsy. Implanon, the single-rod implantable contraceptive device, may reduce symptoms of dysmenorrhea. Mirena, the levonorgestrel-containing intrauterine contraceptive system, is an option for women with menorrhagia, endometriosis, or chronic pelvic pain. PMID:20842989

  13. Contraception choices in women with underlying medical conditions.

    PubMed

    Bonnema, Rachel A; McNamara, Megan C; Spencer, Abby L

    2010-09-15

    Primary care physicians often prescribe contraceptives to women of reproductive age with comorbidities. Novel delivery systems (e.g., contraceptive patch, contraceptive ring, single-rod implantable device) may change traditional risk and benefit profiles in women with comorbidities. Effective contraceptive counseling requires an understanding of a woman's preferences and medical history, as well as the risks, benefits, adverse effects, and contraindications of each method. Noncontraceptive benefits of combined hormonal contraceptives, such as oral contraceptive pills, include regulated menses, decreased dysmenorrhea, and diminished premenstrual dysphoric disorder. Oral contraceptive pills may be used safely in women with a range of medical conditions, including well-controlled hypertension, uncomplicated diabetes mellitus, depression, and uncomplicated valvular heart disease. However, women older than 35 years who smoke should avoid oral contraceptive pills. Contraceptives containing estrogen, which can increase thrombotic risk, should be avoided in women with a history of venous thromboembolism, stroke, cardiovascular disease, or peripheral vascular disease. Progestin-only contraceptives are recommended for women with contraindications to estrogen. Depo-Provera, a long-acting injectable contraceptive, may be preferred in women with sickle cell disease because it reduces the frequency of painful crises. Because of the interaction between antiepileptics and oral contraceptive pills, Depo-Provera may also be considered in women with epilepsy. Implanon, the single-rod implantable contraceptive device, may reduce symptoms of dysmenorrhea. Mirena, the levonorgestrel-containing intrauterine contraceptive system, is an option for women with menorrhagia, endometriosis, or chronic pelvic pain.

  14. Intrauterine contraception.

    PubMed

    Whaley, Natalie S; Burke, Anne E

    2015-11-01

    Intrauterine devices (IUDs) are effective, reversible forms of contraception with high patient satisfaction and continuation. IUDs can be safely used by most women and should be considered the first-line method of contraception for all women. This descriptive review will discuss the clinical issues associated with IUDs - including management of side effects, noncontraceptive uses and insertion and removal. When the burdens of cost are removed, women are more likely to select and IUDs. Health policy changes that increase insurance coverage for contraception will improve access to IUDs. IUDs remain an underutilized form of contraception in USA and efforts to improve availability and access to long-acting reversible contraception methods is needed to optimize their use.

  15. Contraceptive Equity

    PubMed Central

    Temkin, Elizabeth

    2007-01-01

    The Equity in Prescription Insurance and Contraceptive Coverage Act, introduced in Congress in 1997 and still unpassed, seeks to redress health insurers’ failure to pay for birth control as they pay for other prescription drugs, most paradoxically Viagra. In 1936 the International Workers Order (IWO), a fraternal society, became the first insurer to include contraception in its benefits package. A forerunner in the movement for prepaid medical care, the IWO offered its members primary care and contraceptive services for annual flat fees. Founded at a time when the legal status of contraception was in flux, the IWO’s Birth Control Center was the only such clinic to operate on an insurance system. Recent state laws and judicial actions have revived the IWO’s groundbreaking view of contraception as a basic preventive service deserving of insurance coverage. PMID:17761562

  16. Oral heroin in opioid-dependent patients: pharmacokinetic comparison of immediate and extended release tablets

    PubMed Central

    Perger, Ludwig; Rentsch, Katharina M.; Kullak-Ublick, Gerd A.; Verotta, Davide; Fattinger, Karin

    2009-01-01

    In diacetylmorphine prescription programs for heavily dependent addicts, diacetylmorphine is usually administered intravenously, but this may not be possible due to venosclerosis or when heroin abuse had occurred via non-intravenous routes. Since up to 25% of patients administer diacetylmorphine orally, we characterised morphine absorption after single oral doses of immediate and extended release diacetylmorphine in 8 opioid addicts. Plasma concentrations were determined by liquid chromatography-mass spectrometry. Non-compartmental methods and deconvolution were applied for data analysis. Mean (±SD) immediate and extended release doses were 719 ± 297 mg and 956 ± 404 mg, with high absolute morphine bioavailabilities of 56% to 61%, respectively. Immediate release diacetylmorphine caused rapid morphine absorption, peaking at 10 to 15 min. Morphine absorption was considerably slower and more sustained for extended release diacetylmorphine, with only ~30% of maximal immediate release absorption being reached after 10 min and maintained for 3 to 4 h, with no relevant food interaction. The relative extended to immediate release bioavailability was calculated to be 86% by non-compartmental analysis and 93% by deconvolution analysis. Thus, immediate and extended release diacetylmorphine produce the intended morphine exposures. Both are suitable for substitution treatments. Similar doses can be applied if used in combination or sequentially. PMID:19084595

  17. [Chronic illness and contraception].

    PubMed

    Saarikoski, S

    1987-01-01

    In recent years sterilization that can cause problems of the psyche and marital life has been recommended much less frequently with respect to chronic diseases. As regards heart and hypertensive diseases pregnancy is always contraindicated in case of 3rd and 4th disease categories and sterilization is recommended according to the New York Heart Association. As far as 1st and 2nd category patients are concerned if the load carrying capacity is normal pregnancy could be undertaken. Combination pills are not recommended for contraception because they can cause fluid retention or increase the risk of thrombosis. If the patient has a higher-than-normal risk of developing thrombosis or infection, for instance, those who wear pacemakers only tablets containing progesterone or subdermal capsule implants can be used. In those with blood pressure problems the additional use of the IUD is also advised. Among diseases of neurological and psychic origin the effect of hormonal contraceptives is weakened by antiepileptics, but even in such cases older combination pills of larger doses of active ingredients can be employed. Migraine is exacerbated in 1/3 of patients; here IUDs can be used. Even the contraceptive tablets themselves can induce depression. In psychosis methods requiring regular attention can be easily forgotten, therefore the IUD is the most suitable device. In diabetes progesterone and other progestogens reduce insulin response, harm carbohydrate metabolism; therefore in young people the IUD is preferred an in older women with children even sterilization can be employed. Hormonal tablets must not be used in hyperlipidemia and liver diseases. Caution must be exercised in hyperthyroidism and in endocrine disorders (e.g., Cushing's syndrome); if it is accompanied by blood pressure disorders appropriate treatment is required. In kidney diseases pregnancy is contraindicated if it is accompanied by blood pressure increase or a higher level of creatine. On the other hand

  18. 21 CFR 520.1284 - Sodium liothyronine tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Sodium liothyronine tablets. 520.1284 Section 520... liothyronine tablets. (a) Specifications. Sodium liothyronine tablets consist of tablets intended for oral administration which contain liothyronine at 60 or 120 micrograms per tablet, as the sodium salt. (b)...

  19. 21 CFR 520.1284 - Sodium liothyronine tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Sodium liothyronine tablets. 520.1284 Section 520... liothyronine tablets. (a) Specifications. Sodium liothyronine tablets consist of tablets intended for oral administration which contain liothyronine at 60 or 120 micrograms per tablet, as the sodium salt. (b)...

  20. Contraceptive implants.

    PubMed

    McDonald-Mosley, Raegan; Burke, Anne E

    2010-03-01

    Implantable contraception has been extensively used worldwide. Implants are one of the most effective and reversible methods of contraception available. These devices may be particularly appropriate for certain populations of women, including women who cannot use estrogen-containing contraception. Implants are safe for use by women with many chronic medical problems. The newest implant, Implanon (Organon International, Oss, The Netherlands), is the only device currently available in the United States and was approved in 2006. It is registered for 3 years of pregnancy prevention. Contraceptive implants have failure rates similar to tubal ligation, and yet they are readily reversible with a return to fertility within days of removal. Moreover, these contraceptive devices can be safely placed in the immediate postpartum period, ensuring good contraceptive coverage for women who may be at risk for an unintended pregnancy. Irregular bleeding is a common side effect for all progestin-only contraceptive implants. Preinsertion counseling should address possible side effects, and treatment may be offered to women who experience prolonged or frequent bleeding.

  1. Development of dimethandrolone 17beta-undecanoate (DMAU) as an oral male hormonal contraceptive: induction of infertility and recovery of fertility in adult male rabbits.

    PubMed

    Attardi, Barbara J; Engbring, Jean A; Gropp, David; Hild, Sheri Ann

    2011-01-01

    Dimethandrolone undecanoate (DMAU: 7α,11β-dimethyl-19-nortestosterone 17β-undecanoate) is a potent orally active androgen with progestational activity that is in development for therapeutic uses in men. We hypothesized that because of its dual activity, DMAU might have potential as a single-agent oral hormonal contraceptive. To test this possibility, adult male rabbits (5/group) of proven fertility were treated orally with vehicle or DMAU at 1.0, 2.5, 5.0, or 10.0 mg/kg/d for 12 or 13 weeks. Semen and blood samples were collected every other week through week 30. Sperm were decreased (P < .05) in semen samples from DMAU-treated rabbits at 2.5 and 5.0 mg/kg/d at weeks 12, 14, 16, 18, and 20 compared to week 0 (prior to treatment). The percentage of forward progressive motile sperm in those rabbits that still had measurable sperm was also reduced by DMAU treatment at 2.5 mg/kg/d at weeks 14, 16, 18, and 20 and at 5.0 mg/kg/d at week 18 (P < .05). At 1.0 mg/kg/d only 1 rabbit had reduced sperm numbers and motility. A mating trial was performed at week 15. The number of bred males that were fertile was 4 of 4 in the vehicle-treated group and 4 of 5, 0 of 4, and 2 of 5 in the 1.0, 2.5, and 5.0 mg/kg/d DMAU treatment groups. By week 22, sperm numbers and forward progressive motility increased, and they returned to pretreatment levels in all DMAU-treated rabbits by week 30. All bred males were fertile at week 31. Serum levels of testosterone, follicle-stimulating hormone (FSH), and luteinizing hormone (LH) were significantly suppressed in DMAU (1.0, 2.5, or 5.0 mg/kg/d)-treated rabbits during the 12-week dosing interval, but were comparable to pretreatment levels after cessation of dosing. These data indicate that DMAU suppressed the hypothalamic-pituitary-gonadal axis, resulting in severe oligospermia in the majority of rabbits in the 2.5 and 5.0 mg/kg/d dosing groups. Infertility was observed when sperm numbers decreased to about 10% of pretreatment levels. In

  2. Development of dimethandrolone 17beta-undecanoate (DMAU) as an oral male hormonal contraceptive: induction of infertility and recovery of fertility in adult male rabbits.

    PubMed

    Attardi, Barbara J; Engbring, Jean A; Gropp, David; Hild, Sheri Ann

    2011-01-01

    Dimethandrolone undecanoate (DMAU: 7α,11β-dimethyl-19-nortestosterone 17β-undecanoate) is a potent orally active androgen with progestational activity that is in development for therapeutic uses in men. We hypothesized that because of its dual activity, DMAU might have potential as a single-agent oral hormonal contraceptive. To test this possibility, adult male rabbits (5/group) of proven fertility were treated orally with vehicle or DMAU at 1.0, 2.5, 5.0, or 10.0 mg/kg/d for 12 or 13 weeks. Semen and blood samples were collected every other week through week 30. Sperm were decreased (P < .05) in semen samples from DMAU-treated rabbits at 2.5 and 5.0 mg/kg/d at weeks 12, 14, 16, 18, and 20 compared to week 0 (prior to treatment). The percentage of forward progressive motile sperm in those rabbits that still had measurable sperm was also reduced by DMAU treatment at 2.5 mg/kg/d at weeks 14, 16, 18, and 20 and at 5.0 mg/kg/d at week 18 (P < .05). At 1.0 mg/kg/d only 1 rabbit had reduced sperm numbers and motility. A mating trial was performed at week 15. The number of bred males that were fertile was 4 of 4 in the vehicle-treated group and 4 of 5, 0 of 4, and 2 of 5 in the 1.0, 2.5, and 5.0 mg/kg/d DMAU treatment groups. By week 22, sperm numbers and forward progressive motility increased, and they returned to pretreatment levels in all DMAU-treated rabbits by week 30. All bred males were fertile at week 31. Serum levels of testosterone, follicle-stimulating hormone (FSH), and luteinizing hormone (LH) were significantly suppressed in DMAU (1.0, 2.5, or 5.0 mg/kg/d)-treated rabbits during the 12-week dosing interval, but were comparable to pretreatment levels after cessation of dosing. These data indicate that DMAU suppressed the hypothalamic-pituitary-gonadal axis, resulting in severe oligospermia in the majority of rabbits in the 2.5 and 5.0 mg/kg/d dosing groups. Infertility was observed when sperm numbers decreased to about 10% of pretreatment levels. In

  3. Massive pulmonary embolism associated with Factor V Leiden, prothrombin, and methylenetetrahydrofolate reductase gene mutations in a young patient on oral contraceptive pills: a case report.

    PubMed

    Charafeddine, Khalil M; Mahfouz, Rami A; Ibrahim, Georges Y; Taher, Ali T; Hoballah, Jamal J; Taha, Assad M

    2010-10-01

    Factor V Leiden (Factor V G1691A), prothrombin gene mutation G20210A, and homozygous C677T mutation in the methylenetetrahydrofolate reductase (MTHFR) gene are known to predispose venous thromboembolism (VTE). We present herein a rare case of a young woman heterozygous for these mutations and taking oral contraceptive pills for less than 2 months, diagnosed to have massive deep venous thrombosis and bilateral pulmonary embolism. The patient was managed for 10 days in the hospital and discharged home on oral anticoagulants. This case suggests that screening for these factors in people with family history of thrombosis and in relatives of patients with these mutations is highly recommended to prevent fatal consequences. In addition, a new guideline for treatment and prophylaxis with anticoagulant for these patients and others who are at risk of developing VTE (American College of Chest Physicians [ACCP] guidelines-Chest 2008) has been published recently. Our recommendation is to promote for the internationally published algorithms through their application, where necessary, to prevent any future thrombotic morbidity or mortality incidents. PMID:19520679

  4. Contraception-21.

    PubMed

    Fathalla, M F

    1999-12-01

    A Contraception-21 strategy was adopted by the Rockefeller Foundation in 1993. The objective of the strategy is to mobilize and lift up the whole field of contraceptive research, to develop novel contraceptive approaches for the next century. The premise of the strategy is that, in spite of technological advances in the past few decades, current contraceptive choices are still inadequate to meet present and rapidly expanding future needs, particularly in developing countries. The central theme of the strategy is that it should be driven by the unmet needs of women, and not by a demographic imperative or by scientific opportunity alone. Two essential requirements are: mobilization of the science, particularly the new advances in cell and molecular biology, to provide the needed tools; and mobilization of industry to provide the needed resources.

  5. Advances in Male Contraception

    PubMed Central

    Page, Stephanie T.; Amory, John K.; Bremner, William J.

    2008-01-01

    Despite significant advances in contraceptive options for women over the last 50 yr, world population continues to grow rapidly. Scientists and activists alike point to the devastating environmental impacts that population pressures have caused, including global warming from the developed world and hunger and disease in less developed areas. Moreover, almost half of all pregnancies are still unwanted or unplanned. Clearly, there is a need for expanded, reversible, contraceptive options. Multicultural surveys demonstrate the willingness of men to participate in contraception and their female partners to trust them to do so. Notwithstanding their paucity of options, male methods including vasectomy and condoms account for almost one third of contraceptive use in the United States and other countries. Recent international clinical research efforts have demonstrated high efficacy rates (90–95%) for hormonally based male contraceptives. Current barriers to expanded use include limited delivery methods and perceived regulatory obstacles, which stymie introduction to the marketplace. However, advances in oral and injectable androgen delivery are cause for optimism that these hurdles may be overcome. Nonhormonal methods, such as compounds that target sperm motility, are attractive in their theoretical promise of specificity for the reproductive tract. Gene and protein array technologies continue to identify potential targets for this approach. Such nonhormonal agents will likely reach clinical trials in the near future. Great strides have been made in understanding male reproductive physiology; the combined efforts of scientists, clinicians, industry and governmental funding agencies could make an effective, reversible, male contraceptive an option for family planning over the next decade. PMID:18436704

  6. Is oral contraceptive-induced headache dependent on patent foramen ovale? Clinical dynamics, evidence-based hypothesis and possible patient-oriented management.

    PubMed

    Chiofalo, Benito; Laganà, Antonio Simone; Imbesi, Giovanna; Vitale, Salvatore Giovanni; Catena, Ursula; Campolo, Federica; Lanzo, Gabriele; Centini, Gabriele; Triolo, Onofrio

    2016-09-01

    Secondary headache is one of the most common side effect during oral contraceptive (OC) treatment and it leads many patients to stop the therapy. Patent foramen ovale (PFO) is an interatrial communication that spontaneously closes at birth in about 75% of the population. However, in the rest of adults PFO maintains a direct communication between the right and left side of circulation. In these patients PFO is a tunnel-like structure that could allow a blood clot to pass from the right to the left side of circulation, thus can cause paradoxical embolization. Although an increased frequency of PFO in patients with migraine was already reported, the relationship between PFO and migraine remains uncertain. In patients with migraine, the prevalence of moderate or large PFO is 35% and seems not associated with the presence of aura or the frequency of headache. Basing on these assumptions, we hypothesize that asymptomatic PFO could play a role in secondary headache due to OC. The procoagulant effect of OC improves the production of microemboli that through the POF could pass from the right to the left atrium and than to the brain, where they could be responsible of secondary headache. If our hypothesis would be confirmed in future studies, it would be possible to identify high-risk patients for developing OC-induced headache and other cerebrovascular major diseases through transcranial Doppler and transesophageal echocardiography. This scenario may radically change the management of reproductive-age woman who have to undergo OC therapy for contraception or other medical conditions. PMID:27515209

  7. [Chorea and the use of contraceptives].

    PubMed

    Despland, P A; Dufresne, J J; Regli, F

    1976-08-01

    A 20-year-old nullipara without previous history of chorea or rheumatic fever developed unilateral chorea 11 months after first taking oral contraceptives. All laboratory findings were normal except for considerable elevation of the triglycerides. Complete remission of the extrapyramidal disorder occurred within 4 months of discontinuing the contraceptive preparation. It is suggested that the contraceptive steroids may influence some metabolic events which produce vascular changes. PMID:1006233

  8. The Effects of Screw Configuration and Polymeric Carriers on Hot-Melt Extruded Taste-Masked Formulations Incorporated into Orally Disintegrating Tablets

    PubMed Central

    Morott, Joseph T.; Pimparade, Manjeet; Park, Jun-Bom; Worley, Chelsea P.; Majumdar, Soumyajit; Lian, Zhuoyang; Pinto, Elanor; Bi, Yunxia; Durig, Thomas; Repka, Michael A.

    2015-01-01

    The primary aim of this research was to produce successfully taste masked formulations of Sildenafil Citrate (SC) using hot-melt extrusion (HME) technology. Multiple screw configurations and polymeric carriers were evaluated for their effects on taste masking efficiency, which was assessed by both E-tongue analysis and in vitro dissolution in simulated salivary fluid (SSF, pH 6.8 artificial saliva). The screw configurations were further assessed for their effects on the morphology of the API using PXRD, FT-IR and mid-infrared chemical imaging. It was determined that the screw configuration had a profound effect on the taste masking efficiency of the formulations as a result of altering the physical state of the API. Selected extruded formulations using ethylcellulose (EC) with a pore former were further formulated into orally disintegrating tablets (ODTs), which were optimized by varying the grade and percentage of the superdisintegrant used. An optimized disintegration time of approximately 8 seconds was achieved. The final ODT formulation exhibited excellent taste masking properties with over 85% drug release in gastric media as well as physical tablet properties. Interestingly, friability, which tends to be a common concern when formulating ODTs, was well within the acceptable limits (<1%) for common tablets. PMID:25410968

  9. Improvement of Meloxicam Solubility Using a β-Cyclodextrin Complex Prepared via the Kneading Method and Incorporated into an Orally Disintegrating Tablet

    PubMed Central

    Ainurofiq, Ahmad; Choiri, Syaiful; Azhari, Muhamad Ali; Siagian, Chaterin Romauli; Suryadi, Bambang Budi; Prihapsara, Fea; Rohmani, Sholichah

    2016-01-01

    Purpose: The aim of this research was to formulate and develop an orally disintegrating tablet (ODT) that incorporated a MEL/β-CD complex, using a quality by design (QbD) approach to enhance solubility and drug release. Methods: Multiple regression linear analysis was conducted to develop the kneading process and ODT formulation. Mixing time and amount of solvent were used as independent variables in kneading process optimisation, while the superdisintegrants were used to obtain the desired formulation. Fourier transform infrared spectroscopy and differential scanning calorimetry were performed for complex characterization. Results: MEL/β-CD complexation was successful in enhancing MEL solubility. The results suggest that increasing the amount of solvent and mixing time enhances drug loading and drug release. However, increased solvent amounts present the problem of removing the solvent. Primojel and Polyplasdone had a significant effect on the water wicking and tablet disintegration process (p<0.05), although Polyplasdone negatively affected tablet hardness. Both an optimized KN process and ODT formulation were obtained using a QbD approach. Conclusion: Incorporation of the MEL/β-CD complex during ODT formulation using the QbD approach serves as a model for ODT product development, with optimal product performance based on the specification of quality target product profiles. To understand more specific phenomena, one point in the middle of the design for each factor should be added to more powerfully estimate this effect and avoid the lack of estimate due to an inadequate equation. PMID:27766224

  10. Emerging Options for Emergency Contraception

    PubMed Central

    Koyama, Atsuko; Hagopian, Laura; Linden, Judith

    2013-01-01

    Emergency post-coital contraception (EC) is an effective method of preventing pregnancy when used appropriately. EC has been available since the 1970s, and its availability and use have become widespread. Options for EC are broad and include the copper intrauterine device (IUD) and emergency contraceptive pills such as levonorgestrel, ulipristal acetate, combined oral contraceptive pills (Yuzpe method), and less commonly, mifepristone. Some options are available over-the-counter, while others require provider prescription or placement. There are no absolute contraindications to the use of emergency contraceptive pills, with the exception of ulipristal acetate and mifepristone. This article reviews the mechanisms of action, efficacy, safety, side effects, clinical considerations, and patient preferences with respect to EC usage. The decision of which regimen to use is influenced by local availability, cost, and patient preference. PMID:24453516

  11. Simultaneous LC-MS/MS determination of five tripterygium pyridine alkaloids in dog plasma and its application to their pharmacokinetic study after oral administration of tripterygium glycosides tablets.

    PubMed

    Su, Meng-xiang; Song, Min; Yang, Da-song; Shi, Jin-fang; Di, Bin; Hang, Tai-jun

    2015-05-15

    A sensitive and selective liquid chromatography tandem mass spectrometric method was developed and validated for the simultaneous determination of five pyridine alkaloids contained in tripterygium glycosides tablets (triptolide, wilforine, wilforgine, wilfording and wilfortrine) in dog plasma. The analysis was carried out on a Sepax GP-Phenyl column using a mixture of methanol and 10mmol/L ammonium formate buffer solution containing 0.1% formic acid (75:25, v/v) as the mobile phase pumped at a flow-rate of 1.0mL/min. All MS data were obtained in the positive ESI mode with selective multiple reaction monitoring of ion transitions. The method was fully validated to be accurate and precise with a linear range of 0.2-1000ng/mL for triptolide and 0.05-1000ng/mL for the other four pyridine alkaloids. The intra-day and inter-day precisions (relative standard deviation, RSD, %) were within 10.6% and 14.0%, respectively, and the relative error (RE, %) were all less than 13.1%. The method was successfully applied to multi-components pharmacokinetic study of the five pyridine alkaloids in beagle dogs after a single oral administration of 3mg/kg and 30mg/kg tripterygium glycosides tablets, respectively, and a multiple oral administration of 30mg/kg for 6 consecutive days. PMID:25855315

  12. Male contraception.

    PubMed

    Chao, Jing; Page, Stephanie T; Anderson, Richard A

    2014-08-01

    Clear evidence shows that many men and women would welcome new male methods of contraception, but none have become available. The hormonal approach is based on suppression of gonadotropins and thus of testicular function and spermatogenesis, and has been investigated for several decades. This approach can achieve sufficient suppression of spermatogenesis for effective contraception in most men, but not all; the basis for these men responding insufficiently is unclear. Alternatively, the non-hormonal approach is based on identifying specific processes in sperm development, maturation and function. A range of targets has been identified in animal models, and targeted effectively. This approach, however, remains in the pre-clinical domain at present. There are, therefore, grounds for considering that safe, effective and reversible methods of contraception for men can be developed. PMID:24947599

  13. Male contraception

    PubMed Central

    Chao, Jing; Page, Stephanie T.; Anderson, Richard A.

    2015-01-01

    Clear evidence shows that many men and women would welcome new male methods of contraception, but none have become available. The hormonal approach is based on suppression of gonadotropins and thus of testicular function and spermatogenesis, and has been investigated for several decades. This approach can achieve sufficient suppression of spermatogenesis for effective contraception in most men, but not all; the basis for these men responding insufficiently is unclear. Alternatively, the nonhormonal approach is based on identifying specific processes in sperm development, maturation and function. A range of targets has been identified in animal models, and targeted effectively. This approach, however, remains in the pre-clinical domain at present. There are, therefore, grounds for considering that safe, effective and reversible methods of contraception for men can be developed. PMID:24947599

  14. Contraceptive use, amenorrhea, and breastfeeding in postpartum women.

    PubMed

    Laukaran, V H; Winikoff, B

    1985-01-01

    Data from a 1981-1982 survey of infant feeding practices in four developing countries are used to analyze the relationship of amenorrhea, lactation, and time since childbirth with contraceptive use. The relationship was first explored using contingency table analysis. Logistic regression analysis was then performed to control for the effects of background variables. Models were tested separately for oral contraceptive users and users of other methods. Analysis showed a strong, independent, and consistent negative relationship between amenorrhea and contraceptive use. Women who were less than four months postpartum were also less likely to use contraceptives. The strength of the association with amenorrhea outweighed all other variables, including demographic correlates of contraceptive use. A negative relationship between breastfeeding and contraceptive use was found only for users of oral contraceptives. It is possible that women in the immediate postpartum period, especially those who are lactating and amenorrheic, are not as highly motivated to use contraception as had been supposed.

  15. The 'nonmenstrual woman' in the new millennium? Discourses on menstrual suppression in the first decade of extended cycle oral contraception use in Canada.

    PubMed

    Granzow, Kara

    2014-06-01

    In the early-twenty-first century, extended cycle oral contraception (ECOC) became available by physician prescription in North America. Researchers speculate that this drug, with its capacity to reduce or eliminate menstrual bleeding, may shift not only women's biological processes but also their experiences of menstruation. In this paper, I discuss women's experiences of menstrual suppression drawing on findings from a qualitative study conducted before ECOC was available, and examine these findings against recently published research on menstrual suppression in an ECOC era. Findings suggest that the body as a natural entity figures strongly in women's discourses on suppression. They further suggest that suppression is a contingent, paradoxical and practical achievement, not a securely or fully realised embodied state. This paper reads women's accounts of menstrual suppression prior to ECOC as a challenge to the modern artifice of a mind/body split, and questions whether this challenge is perhaps made less discernible in an ECOC era, where attention may no longer be paid to the daily practices of menstrual suppression. Hence, a case is made for the varied political effects of ongoing non-menstruation versus event-specific practices of non-menstruation.

  16. WWOX CNV-67048 Functions as a Risk Factor for Epithelial Ovarian Cancer in Chinese Women by Negatively Interacting with Oral Contraceptive Use

    PubMed Central

    Chen, Yongxiu; Tan, Xiaochang; Ding, Yongli; Mai, Bi; Huang, Xiaowen; Hu, Guiying

    2016-01-01

    Copy number variations (CNVs) have attracted increasing evidences to represent their roles as cancer susceptibility regulators. However, little is known about the role of CNV in epithelia ovarian cancer (EOC). Recently, the CNV-67048 of WW domain-containing oxidoreductase (WWOX) was reported to alter cancer risks. Considering that WWOX also plays a role in EOC, we hypothesized that the CNV-67048 was associated with EOC risk. In a case-control study of 549 EOC patients and 571 age (±5 years) matched cancer-free controls, we found that the low copy number of CNV-67048 (1-copy and 0-copy) conferred a significantly increased risk of EOC (OR = 1.346, 95% CI = 1.037–1.747) and it determined the risk by means of copy number-dependent dosage effect (P = 0.009). Data from TCGA also confirmed the abovementioned association as the frequency of low copies in EOC group was 3.68 times more than that in healthy group (P = 0.023). The CNV also negatively interacted with oral contraceptive use on EOC risk (P = 0.042). Functional analyses further showed a lower mRNA level of WWOX in tissues with the 0-copy or 1-copy than that in those with the 2-copy (P = 0.045). Our data suggested the CNV-67048 to be a risk factor of EOC in Chinese women. PMID:27190995

  17. Oral contraceptive pretreatment does not improve outcome in microdose gonadotrophin-releasing hormone agonist protocol among poor responder intracytoplasmic sperm injection patients

    PubMed Central

    Berker, Bulent; Turhan, Nilgun Ozturk; Satiroglu, Hakan

    2008-01-01

    Purpose To compare oral contraceptive (OC) pretreatment plus microdose GnRH-a in flare-up protocol and non-OC microdose GnRH-a in flare-up protocol among poor responder ICSI patients. Methods A retrospective analysis of poor responder ICSI patients. Patients were divided into two groups according to used microdose protocol. Precycle treatment with OC followed by follicular phase administration of 40 μg sc leuprolide acetate (LA) every 12 h beginning on after 2 day pill-free period and rFSH administration was begun on the third day of LA administration (OC-Group, n = 26). Alternatively on day 2 after menses, patients were administered similar stimulation regime (non-OC Group, n = 27). Results There were no significant differences between groups in the number of oocytes, peak estradiol levels, endometrial thickness, fertilization rates and embryo quality. Implantations and pregnancy rates per embryo transfer were similar. Conclusion OC pretreatment plus microdose GnRHa in flare-up protocol does not offer advantages over non-OC microdose GnRHa in flare-up protocol among poor responder ICSI patients. PMID:18253823

  18. Young women's attitudes toward continuous use of oral contraceptives: the effect of priming positive attitudes toward menstruation on women's willingness to suppress menstruation.

    PubMed

    Rose, Jennifer Gorman; Chrisler, Joan C; Couture, Samantha

    2008-08-01

    The present study investigated American women's attitudes toward menstrual suppression and the effect of priming attitudes toward menstruation on women's willingness to suppress menstruation. One hundred college women randomly were assigned to either a positive priming group or a negative priming group. The positive priming group first completed the menstrual joy questionnaire (MJQ) followed by a willingness to suppress menstruation (WSM) questionnaire, the beliefs and attitudes toward menstruation (BATM) questionnaire, the menstrual distress questionnaire (MDQ), and a demographic questionnaire. The negative priming group completed, in the following order: the MDQ, WSM, BATM, MJQ, and demographics. Priming affected women's reports of positive cycle-related changes on the MDQ, but not women's willingness to suppress menstruation. Higher scores on the MJQ, positive attitudes toward menstrual suppression, and previous oral contraceptive (OC) use were predictors of women's willingness to suppress menstruation. Women's primary source of information about menstrual suppression was "media," and their primary concern was "safety." Thus, researchers should continue to investigate the long-term effects of continuous OC use and to analyze information about menstrual suppression in the popular press.

  19. Effects of oral contraceptive use on the salivary testosterone and cortisol responses to training sessions and competitions in elite women athletes.

    PubMed

    Crewther, Blair T; Hamilton, Dave; Casto, Kathleen; Kilduff, Liam P; Cook, Christian J

    2015-08-01

    This study examined the salivary testosterone (T) and cortisol (C) responses of elite women hockey players across 4 activities (light and heavy training, club and International competitions). The players formed an oral contraceptive (OC) group (n=10) and a Non-OC (n=19) group for analysis. The Non-OC group had higher T levels (by 31-52%) across all activities, whilst the OC group showed signs of reduced T and C reactivity when data were pooled. As a squad, positive T and C changes occurred with heavy training (45%, 46%), club competitions (62%, 80%) and International competitions (40%, 27%), respectively. Our results confirm that OC use lowers T levels in women athletes whilst reducing the T and C responses to training and competition activities within the sporting environment. Differences in the physical and/or psychological demands of the sporting activity could be contributing factors to the observed hormone responses. These factors require consideration when applying theoretical models in sport, with broader implications for women around exercising behaviours and stress physiology.

  20. Effects of oral contraceptive use on the salivary testosterone and cortisol responses to training sessions and competitions in elite women athletes.

    PubMed

    Crewther, Blair T; Hamilton, Dave; Casto, Kathleen; Kilduff, Liam P; Cook, Christian J

    2015-08-01

    This study examined the salivary testosterone (T) and cortisol (C) responses of elite women hockey players across 4 activities (light and heavy training, club and International competitions). The players formed an oral contraceptive (OC) group (n=10) and a Non-OC (n=19) group for analysis. The Non-OC group had higher T levels (by 31-52%) across all activities, whilst the OC group showed signs of reduced T and C reactivity when data were pooled. As a squad, positive T and C changes occurred with heavy training (45%, 46%), club competitions (62%, 80%) and International competitions (40%, 27%), respectively. Our results confirm that OC use lowers T levels in women athletes whilst reducing the T and C responses to training and competition activities within the sporting environment. Differences in the physical and/or psychological demands of the sporting activity could be contributing factors to the observed hormone responses. These factors require consideration when applying theoretical models in sport, with broader implications for women around exercising behaviours and stress physiology. PMID:25866255

  1. Prospective multicenter randomized intermediate biomarker study of oral contraceptive versus depo-provera for prevention of endometrial cancer in women with Lynch syndrome.

    PubMed

    Lu, Karen H; Loose, David S; Yates, Melinda S; Nogueras-Gonzalez, Graciela M; Munsell, Mark F; Chen, Lee-May; Lynch, Henry; Cornelison, Terri; Boyd-Rogers, Stephanie; Rubin, Mary; Daniels, Molly S; Conrad, Peggy; Milbourne, Andrea; Gershenson, David M; Broaddus, Russell R

    2013-08-01

    Women with Lynch syndrome have a 40% to 60% lifetime risk for developing endometrial cancer, a cancer associated with estrogen imbalance. The molecular basis for endometrial-specific tumorigenesis is unclear. Progestins inhibit estrogen-driven proliferation, and epidemiologic studies have shown that progestin-containing oral contraceptives (OCP) reduce the risk of endometrial cancer by 50% in women at general population risk. It is unknown whether they are effective in women with Lynch syndrome. Asymptomatic women ages 25 to 50 with Lynch syndrome were randomized to receive the progestin compounds Depo-Provera (depo-MPA) or OCP for three months. An endometrial biopsy and transvaginal ultrasound were conducted before and after treatment. Endometrial proliferation was evaluated as the primary endpoint. Histology and a panel of surrogate endpoint biomarkers were evaluated for each endometrial biopsy as secondary endpoints. A total of 51 women were enrolled, and 46 completed treatment. Two of the 51 women had complex hyperplasia with atypia at the baseline endometrial biopsy and were excluded from the study. Overall, both depo-MPA and OCP induced a dramatic decrease in endometrial epithelial proliferation and microscopic changes in the endometrium characteristic of progestin action. Transvaginal ultrasound measurement of endometrial stripe was not a useful measure of endometrial response or baseline hyperplasia. These results show that women with Lynch syndrome do show an endometrial response to short-term exogenous progestins, suggesting that OCP and depo-MPA may be reasonable chemopreventive agents in this high-risk patient population.

  2. Effect of oral contraceptive use on the incidence of dry socket in females following impacted mandibular third molar extraction: a meta-analysis.

    PubMed

    Xu, J-L; Sun, L; Liu, C; Sun, Z-H; Min, X; Xia, R

    2015-09-01

    The aim of this comprehensive meta-analysis was to provide evidence-based data to test whether oral contraceptive (OC) use can promote the incidence of dry socket (DS) in females following impacted mandibular third molar extraction. PubMed, the Cochrane Library, and Elsevier Science Direct databases were searched. The pooled risk ratio (RR) with 95% confidence interval (CI) was calculated using fixed-effects or random-effects model analysis. Heterogeneity among studies was evaluated with the Cochran test and I(2) statistic. Study quality was assessed with the Newcastle-Ottawa scale. Of 70 articles identified in the search, 12 reporting 16 clinical controlled trials were included in this study. The incidence of DS was significantly greater in the OC groups than in the control groups (RR 1.80, 95% CI 1.33-2.43). Subgroup analyses showed that the unit assessed (tooth or patient), the region in which the study was conducted, and the intervention were not related to the incidence of DS in females taking OC after impacted mandibular third molar extraction. The sensitivity analysis showed no significant change when any one study was excluded. Publication bias was also not detected. This study suggests that OC use may promote the incidence of DS in females following impacted mandibular third molar extraction.

  3. Intrauterine Contraception.

    PubMed

    Hsia, Jennifer K; Creinin, Mitchell D

    2016-05-01

    Currently, there are only two basic types of intrauterine devices (IUDs): copper and hormonal. However, other types of IUDs are under development, some of which are in clinical trials around the world. Continued development has focused on increasing efficacy, longer duration of use, and noncontraceptive benefits. This review discusses currently available intrauterine contraceptives, such as the Cu380A IUD and levonorgestrel-releasing intrauterine systems; novel intrauterine contraceptives that are available in select parts of the world including the intrauterine ball, low-dose copper products, frameless devices, and intrauterine delivery systems impregnated with noncontraceptive medication; and novel products currently in development. PMID:26947701

  4. 21 CFR 520.1451 - Moxidectin tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Moxidectin tablets. 520.1451 Section 520.1451 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1451 Moxidectin tablets. (a) Specifications. Each tablet contains 30,...

  5. 21 CFR 520.1288 - Lufenuron tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Lufenuron tablets. 520.1288 Section 520.1288 Food... DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1288 Lufenuron tablets. (a) Specifications—(1) Tablets containing 45, 90, 204.9, or 409.8 milligrams (mg) lufenuron for use as in...

  6. Emergency contraception - Potential for women's health

    PubMed Central

    Mittal, Suneeta

    2014-01-01

    Emergency contraception (EC) is a safe and effective method which is used to prevent unwanted pregnancy after unprotected sexual intercourse. Many of the unwanted pregnancies end in unsafe abortions. The search for an ideal contraceptive, which does not interfere with spontaneity or pleasure of the sexual act, yet effectively controls the fertility, is still continuing. Numerous contraceptive techniques are available, yet contraceptive coverage continues to be poor in India. Thus, even when not planning for a pregnancy, exposure to unprotected sex takes place often, necessitating the use of emergency contraception. This need may also arise due to failure of contraceptive method being used (condom rupture, diaphragm slippage, forgotten oral pills) or following sexual assault. Emergency contraception is an intervention that can prevent a large number of unwanted pregnancies resulting from failure of regular contraception or unplanned sexual activity, which in turn helps in reducing the maternal mortality and morbidity due to unsafe abortions. However, a concern has been expressed regarding repeated and indiscriminate usage of e-pill, currently the rational use of emergency contraception is being promoted as it is expected to make a significant dent in reducing the number of unwanted pregnancies and unsafe abortions. In fact, since the introduction of emergency contraception, the contribution of unsafe abortion towards maternal mortality has declined from 13 to 8 per cent. PMID:25673542

  7. Emergency contraception - potential for women's health.

    PubMed

    Mittal, Suneeta

    2014-11-01

    Emergency contraception (EC) is a safe and effective method which is used to prevent unwanted pregnancy after unprotected sexual intercourse. Many of the unwanted pregnancies end in unsafe abortions. The search for an ideal contraceptive, which does not interfere with spontaneity or pleasure of the sexual act, yet effectively controls the fertility, is still continuing. Numerous contraceptive techniques are available, yet contraceptive coverage continues to be poor in India. Thus, even when not planning for a pregnancy, exposure to unprotected sex takes place often, necessitating the use of emergency contraception. This need may also arise due to failure of contraceptive method being used (condom rupture, diaphragm slippage, forgotten oral pills) or following sexual assault. Emergency contraception is an intervention that can prevent a large number of unwanted pregnancies resulting from failure of regular contraception or unplanned sexual activity, which in turn helps in reducing the maternal mortality and morbidity due to unsafe abortions. However, a concern has been expressed regarding repeated and indiscriminate usage of e-pill, currently the rational use of emergency contraception is being promoted as it is expected to make a significant dent in reducing the number of unwanted pregnancies and unsafe abortions. In fact, since the introduction of emergency contraception, the contribution of unsafe abortion towards maternal mortality has declined from 13 to 8 per cent. PMID:25673542

  8. Effect of filtration on morphine and particle content of injections prepared from slow-release oral morphine tablets

    PubMed Central

    2009-01-01

    Background Injections of mixtures prepared from crushed tablets contain insoluble particles which can cause embolisms and other complications. Although many particles can be removed by filtration, many injecting drug users do not filter due to availability, cost or performance of filters, and also due to concerns that some of the dose will be lost. Methods Injection solutions were prepared from slow-release morphine tablets (MS Contin®) replicating methods used by injecting drug users. Contaminating particles were counted by microscopy and morphine content analysed by liquid chromatography before and after filtration. Results Unfiltered tablet extracts contained tens of millions of particles with a range in sizes from < 5 μm to > 400 μm. Cigarette filters removed most of the larger particles (> 50 μm) but the smaller particles remained. Commercial syringe filters (0.45 and 0.22 μm) produced a dramatic reduction in particles but tended to block unless used after a cigarette filter. Morphine was retained by all filters but could be recovered by following the filtration with one or two 1 ml washes. The combined use of a cigarette filter then 0.22 μm filter, with rinses, enabled recovery of 90% of the extracted morphine in a solution which was essentially free of tablet-derived particles. Conclusions Apart from overdose and addiction itself, the harmful consequences of injecting morphine tablets come from the insoluble particles from the tablets and microbial contamination. These harmful components can be substantially reduced by passing the injection through a sterilizing (0.22 μm) filter. To prevent the filter from blocking, a preliminary coarse filter (such as a cigarette filter) should be used first. The filters retain some of the dose, but this can be recovered by following filtration with one or two rinses with 1 ml water. Although filtration can reduce the non-pharmacological harmful consequences of injecting tablets, this remains an unsafe practice due

  9. Contraception technology: past, present and future.

    PubMed

    Sitruk-Ware, Regine; Nath, Anita; Mishell, Daniel R

    2013-03-01

    Steady progress in contraception research has been achieved over the past 50 years. Hormonal and nonhormonal modern contraceptives have improved women's lives by reducing different health conditions that contributed to considerable morbidity. However, the contraceptives available today are not suitable to all users, and the need to expand contraceptive choices still exists. Novel products such as new implants, contraceptive vaginal rings, transdermal patches and newer combinations of oral contraceptives have recently been introduced in family planning programs, and hormonal contraception is widely used for spacing and limiting births. Concerns over the adverse effects of hormonal contraceptives have led to research and development of new combinations with improved metabolic profile. Recent developments include use of natural compounds such as estradiol and estradiol valerate with the hope to decrease thrombotic risk, in combination with newer progestins derived from the progesterone structure or from spirolactone, in order to avoid the androgenic effects. Progesterone antagonists and progesterone receptor modulators are highly effective in blocking ovulation and preventing follicular rupture and are undergoing investigations in the form of oral pills and in semi-long-acting delivery systems. Future developments also include the combination of a contraceptive with an antiretroviral agent for dual contraception and protection against sexually transmitted diseases, to be used before intercourse or on demand, as well as for continuous use in dual-protection rings. Although clinical trials of male contraception have reflected promising results, limited involvement of industry in that area of research has decreased the likelihood of having a male method available in the current decade. Development of nonhormonal methods is still at an early stage of research, with the identification of specific targets within the reproductive system in ovaries and testes, as well as

  10. A simple, rapid and sensitive UFLC-MS/MS method for the quantification of oral contraceptive norgestrel in human plasma and its pharmacokinetic applications.

    PubMed

    Batta, N; Pigili, R K; Pallapothu, L M K; Yejella, R P

    2014-09-01

    A simple, rapid and sensitive ultra flow liquid chromatography-tandem mass spectrometry (UFLC-MS/MS) assay for the determination of norgestrel in human plasma was developed using levonorgestrel D6 as an internal standard (IS). Norgestrel and IS were extracted from human plasma via liquid-liquid extraction. Chromatographic separation was achieved on a Zorbax XDB-Phenyl column under isocratic conditions. Detection was done by tandem mass spectrometry, operating in positive ion mode. The protonated precursor to product ion transitions monitored for norgestrel and IS were at m/z 313.30→245.40 and 319.00→251.30 respectively. The method was fully validated as per current regulatory guidelines. Anticoagulant counter ion effect was also assessed with K2EDTA and K3EDTA. The method was validated with a linearity range of 304.356-50 807.337 pg/mL having run time of 2.0 min per sample. The method has shown tremendous reproducibility with intra- and inter-day precision (%CV) less than 11.0% and intra- and inter-day accuracy less than 9.0% of nominal values. The validated method was applied to a pharmacokinetic study in human plasma samples generated after administrating a single oral dose of 0.3 mg norgestrel tablets to healthy female volunteers and has proved to be highly reliable for the analysis of clinical samples. PMID:24310360

  11. 21 CFR 520.1284 - Sodium liothyronine tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Sodium liothyronine tablets. 520.1284 Section 520...) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1284 Sodium liothyronine tablets. (a) Specifications. Sodium liothyronine tablets consist of tablets intended for...

  12. Oral Contraceptive Use, Micronutrient Deficiency, and Obesity among Premenopausal Females in Korea: The Necessity of Dietary Supplements and Food Intake Improvement

    PubMed Central

    Park, Boyoung; Kim, Jeongseon

    2016-01-01

    This study addressed the associations between oral contraceptive (OC) use and obesity as measured by recording the body mass index (BMI) of premenopausal females, and possible interactions with micronutrient intake were considered. A group of 39,189 premenopausal females aged 35–59 were included in the analysis; they were in the Health Examinee cohort. Participant BMIs were calculated from anthropometric measurements, and females with a BMI≥25kg/m2 were considered obese. Individual OC use, age at first OC use, duration of OC use, nutrient intake, and other covariates were measured with a structured questionnaire. A multivariate logistic regression with an interaction term was applied to identify the odds ratio (OR) and 95% confidence intervals (CI) between OC use and obesity along with consideration of micronutrient intake interactions. OC use is associated with an increased risk of obesity (OR = 1.12, 95% CI = 1.04–1.20), and females who used OCs for more than 6 months over their lifetimes were more likely to be obese (OR = 1.15, 95% CI = 1.01–1.32) compared with those who used OCs for <6 months. There were interaction effects between phosphorus, potassium, vitamin A, vitamin B1, vitamin B2, niacin, vitamin C intake and total duration of OC use on being obesity (P-value<0.05). When stratified by micronutrient intake, the associations between total OC use duration and obesity were present only among those with calcium, phosphorus, potassium, vitamin A, B1, B2, C, niacin, and folate intakes below the recommended levels. Efforts to estimate nutrient intake and prevent micronutrient depletion with supplements or food should be considered by clinicians for females who take OC for a long period. PMID:27348598

  13. Long-term effects of oral contraceptives on the prevalence of diabetes in post-menopausal women: 2007-2012 KNHANES.

    PubMed

    Kim, Sung-Woo; Jeon, Jae-Han; Lee, Won-Kee; Lee, Sungwoo; Kim, Jung-Guk; Lee, In-Kyu; Park, Keun-Gyu

    2016-09-01

    There is little information on whether past use of oral contraceptives (OCs) at child-bearing age influences the incidences of diabetes and insulin resistance (IR) after menopause. This study aimed to evaluate the association of past use of OCs with the development of diabetes and IR in post-menopausal women. This cross-sectional study was based on data from the Korea National Health and Nutrition Examination Survey carried out from 2007 to 2012. Of the 50405 participants, 6554 post-menopausal women were included in the analysis. The associations of OC use with the prevalence of diabetes in post-menopausal women were examined using multivariate logistic analysis. In addition, fasting glucose and insulin levels were measured in 3338 nondiabetic post-menopausal women, and the association between IR and OCs was examined by the analysis of covariance. The prevalence of diabetes was significantly higher in post-menopausal participants who had taken OCs for more than 6 months than in those who had never taken OCs. The association remained significant after adjusting for multiple confounding factors (odd ratio 1.379; 95 % CI 1.115-1.707; P = 0.003). The duration of OC use was also positively associated with the prevalence of diabetes. Furthermore, taking OCs for more than 6 months led to a significant increase in fasting insulin levels and HOMA-IR in nondiabetic participants. Past use of OCs for more than 6 months led to a significant increase in the prevalence of diabetes in post-menopausal women, and increased IR in nondiabetic participants. These results suggested that the prolonged use of OCs at reproductive age may be an important risk factor for developing diabetes in post-menopausal women.

  14. Effects of oral contraceptives on diurnal profiles of insulin, insulin-like growth factor binding protein-1, growth hormone and cortisol in endurance athletes with menstrual disturbance

    PubMed Central

    Rickenlund, A.; Thorén, M.; Nybacka, Å.; Frystyk, J.; Hirschberg, A. Lindén

    2010-01-01

    BACKGROUND Menstrual disturbances in female athletes are often explained as a consequence of energy deficiency. Oral contraceptive (OC) treatment may have favorable metabolic effects. We evaluated effects of OCs on diurnal secretions of insulin, insulin-like growth factor binding protein 1 (IGFBP-1), growth hormone (GH) and cortisol in relation to changes in body composition in athletes with menstrual disturbance compared with regularly menstruating athletes and controls. METHODS Age- and BMI-matched groups of endurance athletes with menstrual disturbance (OAM, n = 9) and regularly cycling athletes (RM, n = 8) and sedentary controls (CTRL, n = 8) were examined, and hormone levels measured, before and after 8 months of treatment with a low-dose combined OC (30 µg ethinyl estradiol + 150 µg levonorgestrel). RESULTS Before OC treatment, the diurnal profile of insulin was lower (P < 0.01) and levels of IGFBP-1 (P < 0.05) and cortisol (P < 0.05) were higher in OAM athletes than in CTRL, whereas GH secretion was higher than in RM athletes (P < 0.05). After treatment, diurnal secretions of these hormones were similar between groups with an increase of IGFBP-1 in the regularly menstruating subjects only (P < 0.001). OC treatment increased body fat mass in OAM athletes (P < 0.01 versus baseline). The change in total fat mass correlated positively with pretreatment diurnal levels of GH (rs = 0.67, P < 0.01) and cortisol (rs = 0.64, P < 0.01). CONCLUSIONS OC treatment in endurance athletes with menstrual disturbance increases body fat mass and results in diurnal levels of insulin, IGFBP-1, GH and cortisol that are comparable to those in regularly menstruating subjects. These results suggest that OCs improve metabolic balance in OAM athletes. PMID:19840988

  15. Emergency contraception

    PubMed Central

    Langille, Donald B.; Allen, Michael; Whelan, Anne Marie

    2012-01-01

    Abstract Objective To determine the extent to which Nova Scotian FPs prescribe and provide emergency contraceptive pills (ECPs) and to explore their knowledge of and attitudes toward ECPs. Design Survey of Nova Scotian FPs using a modified Dillman method. Setting All regions of Nova Scotia. Participants Family physicians registered with Dalhousie University’s Division of Continuing Medical Education. Main outcome measures Sex differences in the provision of ECPs and knowledge and attitudes about the ECP Plan B. Results Of 913 eligible FPs, 155 (17.0%) participated in the survey. Respondents resembled the sampling frame closely. Most physicians (64.0%) had prescribed ECPs in the previous year (mean number of prescriptions, 4.92); only 12.9% provided ECPs in advance of need. Knowledge about Plan B was quite good, except for knowledge of the time frame for potential effectiveness; only 29.2% of respondents answered that question correctly. Respondents generally supported nonprescription availability of ECPs, but 25.0% of FPs were concerned that this could lead to less use of more effective methods of contraception, and 39.2% believed that it would encourage repeat use. Younger FPs provided ECPs more often than their older colleagues, while female respondents had better knowledge about Plan B. In multivariate analysis being younger than 40 years was marginally associated with prescribing Plan B and with prescribing any form of ECP. Conclusion Most Nova Scotian FPs provided ECPs and had generally good knowledge about and attitudes toward providing such contraception without prescription. However, FPs were poorly informed about the length of time that Plan B can be effective, which could potentially affect use when patients consult several days after unprotected sex. There were some concerns about nonprescription availability of ECPs, which could have implications for recommending it to patients. Rarely were ECPs prescribed for advance use, which might represent a lost

  16. Contraceptive practices.

    PubMed

    Morgenthau, J E; Rao, P S

    1976-08-01

    A family life education program (FLEP) providing contraceptive services within a comprehensive health care organization for low-income, inner-city adolescents is described. Each female patient attending in the July 1-September 30, 1974, period was included in a study undertaken to identify and serve the unmet needs of the teen-age population in the community of East Harlem. Of the 334 females interviewed, almost 1/2 were black, 37% were Hispanic, 12% were white, and 2% were Oriental, totals representative of the surrounding community. The questionnaire included information on demographic and social background, sexual history, reproductive history, and contraceptive experience. Comparisons are made on the answers between groups. Personal contacts and school outreach were the 2 main sources of referral to the clinic. Sexual history was found to be associated with social background rather than physiological factors. More than 1/2 the teen-agers had never used contraception prior to their 1st clinic visit and another 1/4 of the girls were using unreliable methods. The study indicated that teen-agers will use good programs which are designed to meet their needs. For teen-agers, a free-standing clinic offering comprehensive health care is the ideal situation. PMID:1066531

  17. Emergency Contraception Website

    MedlinePlus

    Text Only Full media Version Get Emergency Contraception NOW INFO about Emergency Contraception Q&A about Emergency Contraception Español | Arabic Find a Morning After Pill Provider Near You This website is ...

  18. Knowledge and Beliefs about Reproductive Anatomy and Physiology among Mexican-Origin Women in the U.S.A: Implications for Effective Oral Contraceptive Use

    PubMed Central

    Amastae, Jon; Potter, Joseph E.; Hopkins, Kristine; Grossman, Daniel

    2013-01-01

    Inherent in many reproductive health and family planning programmes is the problematic assumption that the body, its processes, and modifications to it are universally experienced in the same way. This paper addresses contraceptive knowledge and beliefs among Mexican-origin women, based upon data gathered by the qualitative component of the Border Contraceptive Access Study. Open-ended interviews explored the perceived mechanism of action of the pill, side effects, non-contraceptive benefits, and general knowledge of contraception. Findings revealed complex connections between traditional and scientific information. Use of medical terms (“hormone”) illustrated attempts to integrate new information with existing knowledge and belief systems. Conclusions address concerns that existing information and services may not be sufficient if population-specific knowledge and beliefs are not assessed and addressed. Findings can contribute to the development of effective education, screening, and reproductive health services. PMID:23464742

  19. "Pregnancy and labour cause more deaths than oral contraceptives": The debate on the pill in the Spanish press in the 1960s and 1970s.

    PubMed

    Ortiz-Gómez, Teresa; Ignaciuk, Agata

    2015-08-01

    From 1941 to 1978, Franco's regime in Spain banned all contraceptive methods. The pill started circulating in Spain from the 1960s, officially as a drug used in gynaecological therapy. However, in the following decade it was also increasingly used and prescribed as a contraceptive. This paper analyses debates about the contraceptive pill in the Spanish daily newspaper ABC and in two magazines, Blanco y Negro and Triunfo, in the 1960s and 1970s. It concludes that the debate on this contraceptive method was much more heterogeneous than might be expected given the Catholic-conservative character of the dictatorship. The daily press focused on the adverse effects of the drug and magazines concentrated on the ethical and religious aspects of the pill and discussed it in a generally positive light. Male doctors and Catholic authors dominated the debate.

  20. Ampicillin Oral

    MedlinePlus

    ... capsule, liquid, and pediatric drops to take by mouth. It is usually taken every 6 hours (four ... blood thinners') such as warfarin (Coumadin), atenolol (Tenormin), oral contraceptives, probenecid (Benemid), rifampin, sulfasalazine, and vitamins.tell ...

  1. The mechanism of action of hormonal contraceptives and intrauterine contraceptive devices.

    PubMed

    Rivera, R; Yacobson, I; Grimes, D

    1999-11-01

    Modern hormonal contraceptives and intrauterine contraceptive devices have multiple biologic effects. Some of them may be the primary mechanism of contraceptive action, whereas others are secondary. For combined oral contraceptives and progestin-only methods, the main mechanisms are ovulation inhibition and changes in the cervical mucus that inhibit sperm penetration. The hormonal methods, particularly the low-dose progestin-only products and emergency contraceptive pills, have effects on the endometrium that, theoretically, could affect implantation. However, no scientific evidence indicates that prevention of implantation actually results from the use of these methods. Once pregnancy begins, none of these methods has an abortifacient action. The precise mechanism of intrauterine contraceptive devices is unclear. Current evidence indicates they exert their primary effect before fertilization, reducing the opportunity of sperm to fertilize an ovum.

  2. Venous thromboembolism in women taking hormonal contraceptives.

    PubMed

    Blanco-Molina, Angeles; Monreal, Manuel

    2010-02-01

    Hormonal contraceptives are a popular method of contraception, but their use has been associated with an increased risk for venous thromboembolism. In order to reduce such risk, these compounds have been changed in their dosage, chemical composition and route of administration. The absolute risk of death from pulmonary embolism in contraceptive users has been estimated to be 10.5 (95% CI: 6.2-16.6) per million woman-years. The safest option is an oral contraceptive containing levonorgestrel combined with a low dose of estrogen. Identifying women at increased risk for venous thromboembolism is difficult, and greater use of thromboprophylaxis during immobility or minor surgery should be warranted. Several authors have called for all women to be screened for thrombophilia before prescription of hormonal contraceptives, but its cost-effectiveness remains uncertain.

  3. 21 CFR 520.2150b - Stanozolol chewable tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... treatment in dogs. (2) Administered orally to small breeds of dogs, 1/2 to 1 tablet twice daily for several weeks; to large breeds of dogs, 1 to 2 tablets twice daily for several weeks. (3) Federal law...

  4. 21 CFR 520.2150b - Stanozolol chewable tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... treatment in dogs. (2) Administered orally to small breeds of dogs, 1/2 to 1 tablet twice daily for several weeks; to large breeds of dogs, 1 to 2 tablets twice daily for several weeks. (3) Federal law...

  5. Controversies in contraception for women with epilepsy.

    PubMed

    Thomas, Sanjeev V

    2015-01-01

    Contraception is an important choice that offers autonomy to women with regard to prevention of unintended pregnancies. There is wide variation in the contraceptive practices between continents, countries, and societies. The medical eligibility for contraception for sexually active women with epilepsy (WWE) is determined by the type of anti-epileptic drugs (AEDs) that they use. Enzyme inducing AEDs such as phenobarbitone, phenytoin, carbamazepine, and oxcarbazepine increase the metabolism of orally administered estrogen (and progesterone to a lesser extent). Estrogen can increase the metabolism of certain AEDs, such as lamotrigine, leading to cyclical variation in its blood level with resultant adverse effect profile or seizure dyscontrol. AEDs and sex hormones can increase the risk of osteoporosis and fracture in WWE. The potential interactions between AEDs and hormonal contraception need to be discussed with all women in reproductive age-group. The alternate options of oral contraception such as intrauterine copper device, intrauterine levonorgestrel release system, and supplementary protection with barriers need to be presented to them. World Health Organization has recommended to avoid combination contraceptive pills containing estrogen and progesteron in women who desire contraception and in breastfeeding mothers. Care providers need to consider the option of non-enzyme-inducing AEDs while initiating long-term treatment in adolescent and young WWE. PMID:26425002

  6. Controversies in contraception for women with epilepsy

    PubMed Central

    Thomas, Sanjeev V.

    2015-01-01

    Contraception is an important choice that offers autonomy to women with regard to prevention of unintended pregnancies. There is wide variation in the contraceptive practices between continents, countries, and societies. The medical eligibility for contraception for sexually active women with epilepsy (WWE) is determined by the type of anti-epileptic drugs (AEDs) that they use. Enzyme inducing AEDs such as phenobarbitone, phenytoin, carbamazepine, and oxcarbazepine increase the metabolism of orally administered estrogen (and progesterone to a lesser extent). Estrogen can increase the metabolism of certain AEDs, such as lamotrigine, leading to cyclical variation in its blood level with resultant adverse effect profile or seizure dyscontrol. AEDs and sex hormones can increase the risk of osteoporosis and fracture in WWE. The potential interactions between AEDs and hormonal contraception need to be discussed with all women in reproductive age-group. The alternate options of oral contraception such as intrauterine copper device, intrauterine levonorgestrel release system, and supplementary protection with barriers need to be presented to them. World Health Organization has recommended to avoid combination contraceptive pills containing estrogen and progesteron in women who desire contraception and in breastfeeding mothers. Care providers need to consider the option of non-enzyme-inducing AEDs while initiating long-term treatment in adolescent and young WWE. PMID:26425002

  7. Contraceptive counseling for adolescents.

    PubMed

    Potter, Julia; Santelli, John S

    2015-11-01

    The majority of adolescents become sexually active during their teenage years, making contraceptive counseling an important aspect of routine adolescent healthcare. However, many healthcare providers express discomfort when it comes to counseling adolescents about contraceptive options. This Special Report highlights the evidence supporting age-appropriate contraceptive counseling for adolescents and focuses on best practices for addressing adolescents' questions and concerns about contraceptive methods.

  8. In vitro and in vivo correlation of disintegration and bitter taste masking using orally disintegrating tablet containing ion exchange resin-drug complex.

    PubMed

    Kim, Jong-Il; Cho, Sang-Min; Cui, Jing-Hao; Cao, Qing-Ri; Oh, Euichaul; Lee, Beom-Jin

    2013-10-15

    Although the taste-masking of bitter drug using ion exchange resin has been recognized, in vitro testing using an electronic tongue (e-Tongue) and in vivo bitterness test by human panel test was not fully understood. In case of orally disintegrating tablet (ODT) containing bitter medicine, in vitro and in vivo disintegration is also importance for dosage performance. Donepezil hydrochloride was chosen as a model drug due to its bitterness and requires rapid disintegration for the preparation of ODT. In this study, ion exchange resin drug complex (IRDC) at three different ratios (1:2, 1:1, 2:1) was prepared using a spray-drying method and then IRDC-loaded ODT containing superdisintegrants (crospovidone, croscarmellose sodium, and sodium starch glycolate) were prepared by the direct compression method. The physical properties and morphologies were then characterized by scanning electron microscopy (SEM), X-ray powder diffraction (PXRD) and electrophoretic laser scattering (ELS), respectively. The in vitro taste-masking efficiency was measured with an electronic tongue (e-Tongue). In vivo bitterness scale was also evaluated by human volunteers and then we defined new term, "bitterness index (BI)" to link in vitro e-Tongue. There was a good correlation of IRDC between in vitro e-Tongue values and in vivo BI. Furthermore, IRDC-loaded ODT showed good in vitro/in vivo correlation in the disintegration time. The optimal IRDC-loaded ODTs displayed similar drug release profiles to the reference tablet (Aricept(®) ODT) in release media of pH 1.2, pH 4.0, pH 6.8 and distilled water but had significantly better palatability in vivo taste-masking evaluation. The current IRDC-loaded ODT according to the in vitro and in vivo correlation of disintegration and bitter taste masking could provide platforms in ODT dosage formulations of donepezil hydrochloride for improved patient compliances. PMID:23933050

  9. [The enantioselective pharmacokinetic study of desvenlafaxine sustained release tablet in Chinese healthy male volunteers after oral administration].

    PubMed

    Chen, Yin-xia; Du, Jiang-bo; Zhang, Yi-fan; Chen, Xiao-yan; Zhong, Da-fang

    2015-04-01

    A chiral LC-MS/MS method for the simultaneous analysis of desvenlafaxine (DVS) enantiomers in human plasma was developed and applied to a pharmacokinetic study on 12 Chinese healthy volunteers. d6-Desvenlafaxine was used as internal standard (IS). Chromatographic separation was performed on the Astec Chirobiotic V chiral column (150 mm x 4.6 mm, 5 μm). The assay was linear over the concentration range of 0.500-150 ng x mL(-1) for both enantiomers (r2 > 0.99). The method was successfully applied to a stereoselective pharmacokinetic study of 100 mg desvenlafaxine sustained release tablets on 12 Chinese healthy volunteers under fasting conditions. The results showed that the pharmacokinetic parameters were similar to both enantiomers in Chinese healthy volunteers. The AUC(0-t), and C(max) of the two enantiomers were about 1.5 times higher than those of blacks and whites reported in the literature.

  10. Underage contraception.

    PubMed

    Southgate, L

    1985-12-01

    This article discusses the ethical and legal dilemmas confronting general practitioners in regard to contraceptive advice for adolescents. When a teenage girl comes to a physician for advice, she alone is the patient and the physician has an obligation to her. However, this obligation must be reconociled with the obligation to her parents. A UK parent, Victoria Gillick, sought declarations in the High Court against a National Health Service Notice concerning family planning services for adolescents. She argued: 1) that physicians who give family planning advice to girls under 16 years of age witout parental consent are guilty of causing or encouraging unlawful sexual intercourse; and 2) the doctor's actions interfere with the rights of the child's parents and undermine their ability to carry out their duties of supervising the physical and moral welfare of their children. If Gillick's position is adopted by society, no minor will be able to consult a physician without the parent being present. In practice, many physicians consulted by teenagers under 16 attempt to determine whether the girl has reached a stage in her development where she is capable of behaving as an autonomous agent, with the rights and responsibilities this entails. In the US, the concept of the mature minor doctrine has been developed. This approach recognizes that some teenagers mature more rapidly than others, and leaves it to the judgment of the physician to determine whether a given adolescent has reached a stage at which she can be considered competent to make decisions about her health care. Moreover, it is noted that when young teenagers ask for contraception, they are likely to be already sexually active and at risk for pregnancy. Given the difficult issues involved, physicians who want to respect an adolescent's autonomy yet consider her parents' feelings must be clear about the ethical basis on which they practice.

  11. New approaches to male non-hormonal contraception.

    PubMed

    Nya-Ngatchou, Jean-Jacques; Amory, John K

    2013-03-01

    A non-hormonal male contraceptive is a contraceptive that does not involve the administration of hormones or hormone blockers. This review will focus on the use of lonidamine derivatives and inhibitors of retinoic acid biosynthesis and function as approaches to male non-hormonal contraception. Two current lonidamine derivatives, adjudin and H2-gamendazole, are in development as male contraceptives. These potent anti-spermatogenic compounds impair the integrity of the apical ectoplasmic specialization, resulting in premature spermiation and infertility. Another approach to male contraceptive development is the inhibition of retinoic acid in the testes, as retinoic acid signaling is necessary for spermatogenesis. The administration of the retinoic acid receptor antagonist BMS-189453 reversibly inhibits spermatogenesis in mice. Similarly, oral dosing of WIN 18,446, which inhibits testicular retinoic acid biosynthesis, effectively contracepts rabbits. Hopefully, one of these approaches to non-hormonal male contraception will prove to be safe and effective in future clinical trials.

  12. Contraception and irregular menses.

    PubMed

    Hopayian, K; Houston, A; Cooke, I

    1989-03-22

    A fictitious patient with obesity, hirsutism and polycystic ovary syndrome is discussed by 3 British general practitioners to illuminate management of this type of case. The patient is 24 years old, expects to marry next year, has irregular menses averaging 6 weeks apart, and is requesting an explanation for her irregular periods as well as oral contraception. The 1st physician would exclude hypothyroidism, then evaluate polycystic ovary syndrome by assaying testosterone, LH, FSH and prolactin, next find out the significance of the patient's questions in her mind and finally prescribe a triphasic pill. The 2nd doctor would withhold the pill on the grounds that it might compromise future fertility if she has a primary endocrine imbalance. She would check rubella status, assay progesterone, LH, FSH, prolactin and testosterone on Day 19 of the cycle, and probably prescribe Marvelon oral contraceptives. The 3rd doctor would use a hirsutism score, investigate the polycystic ovary syndrome by ultrasound and an essay of sex hormone binding globulin and the LH:FSH and prolactin, next find out the significance of the patient's questions in her mind and finally prescribe a triphasic pill. The 2nd doctor would withhold the pill on the ground that it might compromise future fertility if she has a primary endocrine imbalance. She would check rubella status, assay progesterone, LH, FSH, prolactin and testosterone on Day 19 of the cycle, and probably prescribe Marvelon oral contraceptives. The 3rd doctor would use a hirsutism score, investigate the polycystic ovary syndrome by ultrasound and an assay of sex hormone binding globulin and the LH:FSH ration between Days 2-6 of the cycle, and rule out congenital adrenal hyperplasia with an assay for 17-alpha-OH-progesterone. Since the patient might be anovulatory because of obesity, major long-term weight lose is a priority. Prescription of pills would depend on family history, smoking, and the degree of hirsutism and endocrine status

  13. Update on contraception: benefits and risks of the new formulations.

    PubMed

    Batur, Pelin; Elder, Julie; Mayer, Mark

    2003-08-01

    Several new contraceptives have become available to women in recent years. These new agents include ultra-low-dose oral contraceptives as well as injectable, vaginal, and patch formulations. We review these, with emphasis on the Yasmin pill (which contains a new progestin), the Lunelle once-a-month injection, the Ortho Evra patch, the NuvaRing vaginal ring, the Mirena intrauterine device, and emergency contraceptive kits. Patient education regarding these options is essential for patient compliance and satisfaction.

  14. [Young men's contraceptive habits].

    PubMed

    Kaiser, A H; Nielsen, B B; Hansen, K; Johansen, J B; Nielsen, M B

    1992-10-01

    A total of 379 men from the greater Copenhagen area were invited to fill out a questionnaire about sexual habits and use of contraception in connection with conscription for military duty. A total of 334 (88%) answered the questionnaire. In the autumn of 1988, a total of 27 men answered the test questionnaire, while in the spring of 1989, when the real study was conducted, 307 men answered it. The median age of 334 participants was 18 years (range of 17-29 years). 33% of the group stated that they had used condoms during first intercourse, while 47% had not. 1 person reported to be exclusively attracted sexually to men, 5 persons were attracted both to men and women, but 97% were exclusively attracted to women. 82% had had intercourse or other sexual experience with women. 1.8% had had intercourse or other sexual experience with men. 8% had no sexual experience, and 8% did not answer the question. Oral contraceptives were used by 60% and the condom by 56%. 10% had used coitus interruptus at one time or another; 15% had used no contraception; 5% used the IUD; and 5% used the diaphragm. Some gave several answers. 1% used spermicidal lotion. 60% thought that it was the responsibility of both men and women to be concerned about contraception, 12% opined that it was exclusively men's duty, and 2% that it was exclusively women's, while 26% did not answer. 68% wanted to use the condom in the future for protection, 24% did not know, but 8% did not want to use it more extensively. 64% did not think that the fear of AIDS would affect their sexual life, but 36% thought it would. Several of the subjects indicated that they would be more careful about choosing a partner, and every 10th suggested that they would use the condom with a new partner. One person (0.3%) was a drug addict, 89% had never injected drugs, but about 11% did not answer about drugs. 97% and 95%, respectively, indicated that the condom provided good protection against pregnancy and venereal diseases.

  15. The adolescent and contraception.

    PubMed

    Bonar, R W; Mcculla, D

    1981-08-01

    Coital activity is often initiated during adolescence, and adolescents, like many adults, do not behave in purely rational ways and frequently fail to protect themselves against undesired pregnancy. Public attention is focused on adolescent pregnancies because of their increasing number and because the consequences are usually catastrophic. Unplanned pregnancies can have physical, psychosocial, and prenatal effects. It is important from both the individual and societal perspective that high priority be given to the task of preventing adolescent pregnancy. The health care provider, to gain the trust of the adolescent, must be open, honest, and willing to consider the young person's feelings and motivations. In addition to historical data and physical examination, the choice of a contraceptive method is based on individual preferences involving personal, familial, religious, and societal beliefs as well as sexual practice. A decision involving birth control for the adolescent can be complicated by parental influence and involvement. The teenage years are frequently a time of embarrassment about the physical maturation and biological functioning of the body. Birth control methods which require a person to touch himself/herself or to be used at the time of sexual intercourse may be unacceptable to the teenager. Fertility awareness techniques, such as basal body temperature, rhythm, and cervical mucus methods are inexpensive but call for a high degree of personal motivation. The use of a diaphragm requires an office visit and a pelvic examination for fitting and prescription. Contraceptive foam, suppositories, and condoms can be easily obtained over-the-counter for a minimal cost, and a moderate degree of personal motivation is needed for their effective use. Though effective, abortions should not be recommended indiscriminately. Permanent contraceptive methods are not recommended for the adolescent. The IUD and oral contraceptives (OCs) are recommended for adolescents

  16. Contraceptive strategies for young women in the 21st century.

    PubMed

    Ruusuvaara, L; Johansson, E D

    1999-12-01

    Safe, effective and affordable contraceptives have been available for a few decades, yet, in many countries, the struggle for reproductive rights continues. Children, still, are forced to give birth to children in many nations. In most industrialized countries, where contraceptive counselling and abortions have been options, fertility rates have reached all time lows. Effective contraception improves health and well-being as well and may be used for conditions other than birth control. Young girls often initially take oral contraceptives primarily to reduce menstrual pain and blood loss; they also welcome a contraceptive that eliminates menstrual bleeding. Women using oral contraceptives and Norplant experience about 50% reduction in menstrual blood; 90% reduction in blood loss is achieved with the levonorgestrel intrauterine system (Mirena). Teenagers and their parents are often misinformed about the side-effects of oral contraceptives and birth control in general, which may adversely affect compliance. Adequate, user-friendly and supportive information about contraception is necessary to ensure proper use of the pill and other birth control methods. In addition, emergency contraceptives should be easily accessible. The mortality and morbidity of young women would be dramatically reduced by the global use of medical abortion as well. Only a combined effort by policy makers, educators, parents and health-care providers can enhance the reproductive (and future!) health of both young females and males.

  17. [Contraception in immigrant women: influence of sociocultural aspects on the choice of contraceptive method].

    PubMed

    Paraíso Torras, B; Maldonado Del Valle, M D; López Muñoz, A; Cañete Palomo, M L

    2013-01-01

    There are currently 6 million immigrants living in Spain. Half of them are women, the majority of whom are of childbearing age. These women, who suffer high rates of induced abortion, form a special group who require a special approach to their reproductive health. In order to study the use of contraceptive methods in this population, a review was made of 1100 clinical histories from our Sexual Health and Reproduction Clinic. Latin American women were the most prevalent group who came to seek information about contraception, followed by Eastern Europeans and Moroccans. Fewer Asian and Sub-Saharan women sought these services. The contraceptives most frequently used were the intrauterine device (used mostly by Latin American and Eastern European women), and combined oral contraception, most used by Moroccan women. It is important to advise the immigrant women about contraceptive methods, taking into account their preferences, in order to improve adherence to the method. PMID:23583187

  18. [Contraception in immigrant women: influence of sociocultural aspects on the choice of contraceptive method].

    PubMed

    Paraíso Torras, B; Maldonado Del Valle, M D; López Muñoz, A; Cañete Palomo, M L

    2013-01-01

    There are currently 6 million immigrants living in Spain. Half of them are women, the majority of whom are of childbearing age. These women, who suffer high rates of induced abortion, form a special group who require a special approach to their reproductive health. In order to study the use of contraceptive methods in this population, a review was made of 1100 clinical histories from our Sexual Health and Reproduction Clinic. Latin American women were the most prevalent group who came to seek information about contraception, followed by Eastern Europeans and Moroccans. Fewer Asian and Sub-Saharan women sought these services. The contraceptives most frequently used were the intrauterine device (used mostly by Latin American and Eastern European women), and combined oral contraception, most used by Moroccan women. It is important to advise the immigrant women about contraceptive methods, taking into account their preferences, in order to improve adherence to the method.

  19. Efficacy and safety of desmopressin orally disintegrating tablet in patients with central diabetes insipidus: results of a multicenter open-label dose-titration study.

    PubMed

    Arima, Hiroshi; Oiso, Yutaka; Juul, Kristian Vinter; Nørgaard, Jens Peter

    2013-01-01

    Central diabetes insipidus (CDI) is associated with arginine vasopressin (AVP) deficiency with resultant polyuria and polydipsia. Intranasal desmopressin provides physiological replacement but oral formulations are preferred for their ease of administration. This study aimed to demonstrate the efficacy and safety of desmopressin orally disintegrating tablet (ODT) in the treatment of Japanese patients with CDI, and confirm that antidiuresis is maintained on switching from intranasal desmopressin to desmopressin ODT. A total of 20 patients aged 6-75 years with CDI were included in this 4-week multicenter, open-label study. Following observation, patients switched from intranasal desmopressin to desmopressin ODT with titration to optimal dose over ≤5 days at the study site. Following three consecutive doses with stable patient fluid balance, patients were discharged with visits at Weeks 2 and 4. Following titration from intranasal desmopressin to ODT, the mean 24-hour urine volume was unchanged, indicating similar antidiuresis with both formulations. The proportion of patients with endpoint measurements (urine osmolality, 24-hour urine volume, hourly diuresis rate and urine-specific gravity) within normal range at Days 1-2 (intranasal desmopressin) and Week 4 (desmopressin ODT) was similar. The mean daily dose ratio of intranasal desmopressin to desmopressin ODT (Week 4) was 1:24 but a wide range was observed across individuals to maintain adequate antidiuretic effect. Hyponatraemia was generally mild and managed by dose titration. Desmopressin ODT achieved sufficient antidiuretic control compared to intranasal therapy and was well tolerated over long-term treatment. The wide range of intranasal:ODT dose ratios underline the importance of individual titration. PMID:23811987

  20. Efficacy and safety of desmopressin orally disintegrating tablet in patients with central diabetes insipidus: results of a multicenter open-label dose-titration study.

    PubMed

    Arima, Hiroshi; Oiso, Yutaka; Juul, Kristian Vinter; Nørgaard, Jens Peter

    2013-01-01

    Central diabetes insipidus (CDI) is associated with arginine vasopressin (AVP) deficiency with resultant polyuria and polydipsia. Intranasal desmopressin provides physiological replacement but oral formulations are preferred for their ease of administration. This study aimed to demonstrate the efficacy and safety of desmopressin orally disintegrating tablet (ODT) in the treatment of Japanese patients with CDI, and confirm that antidiuresis is maintained on switching from intranasal desmopressin to desmopressin ODT. A total of 20 patients aged 6-75 years with CDI were included in this 4-week multicenter, open-label study. Following observation, patients switched from intranasal desmopressin to desmopressin ODT with titration to optimal dose over ≤5 days at the study site. Following three consecutive doses with stable patient fluid balance, patients were discharged with visits at Weeks 2 and 4. Following titration from intranasal desmopressin to ODT, the mean 24-hour urine volume was unchanged, indicating similar antidiuresis with both formulations. The proportion of patients with endpoint measurements (urine osmolality, 24-hour urine volume, hourly diuresis rate and urine-specific gravity) within normal range at Days 1-2 (intranasal desmopressin) and Week 4 (desmopressin ODT) was similar. The mean daily dose ratio of intranasal desmopressin to desmopressin ODT (Week 4) was 1:24 but a wide range was observed across individuals to maintain adequate antidiuretic effect. Hyponatraemia was generally mild and managed by dose titration. Desmopressin ODT achieved sufficient antidiuretic control compared to intranasal therapy and was well tolerated over long-term treatment. The wide range of intranasal:ODT dose ratios underline the importance of individual titration.

  1. A prospective randomized trial of the antiemetic efficacy and cost-effectiveness of intravenous and orally disintegrating tablet of ondansetron in children with cancer.

    PubMed

    Corapçioglu, Funda; Sarper, Nazan

    2005-03-01

    Orally disintegrating tablet (ODT) of ondansetron is a new formulation, which instantaneously disintegrates and disperses in the saliva without need for ingestion of a liquid. This makes the formulation suitable for administration in children. The objective of this study was to compare the relative efficacy and cost of ODT and intravenous (IV) formulation of ondansetron in controlling nausea and vomiting in children receiving chemotherapy regimens without cisplatin. This prospective randomized trial was performed in a single institution to compare ODT and IV formulation of ondansetron for the prevention of acute emesis in a group of 22 children. Study agents were administered 30 min before chemotherapy and 12 hourly after chemotherapy (5 mg/m2 IV or 4-8 mg oral according to body surface area in 56 and 39 courses, respectively). After randomization, IV formulation was administered to some children instead of ODT due to unavailability of this formulation. Complete and major control of emesis was obtained in 92% of patients in the IV group and 93% of patients in the ODT group. In 56 courses with grade III-IV emetogenicity, complete response rates were not different between the two treatment arms. In the courses without corticosteroids complete response rates were not also different between the two arms. The mean costs per successfully controlled courses were 121.3 USD for the IV formulation whereas 63.2 USD for the ODT formulation. The results of this study confirmed that ODT formulation of ondansetron is a safe, well-tolerated, and cost-effective antiemetic for children during non-cisplatin-containing moderately and highly emetogenic chemotherapy.

  2. LC-MS/MS determination and urinary excretion study of seven alkaloids in healthy Chinese volunteers after oral administration of Shuanghua Baihe tablets.

    PubMed

    Cheng, Minlu; Liu, Ruijuan; Wu, Yao; Gu, Pan; Zheng, Lu; Liu, Yujie; Ma, Pengcheng; Ding, Li

    2016-01-25

    An LC-MS/MS method was developed and validated for the simultaneous determination of magnoflorine, berberrubine, jatrorrhizine, coptisine, epiberberine, palmatine and berberine in human urine. The sample preparation procedure involved the four-fold dilution of the urine samples with acetonitrile/water (1:3, v/v). The chromatographic separation was achieved on a Hedera ODS-2 column under gradient elution at a flow rate of 0.4 mL/min with acetonitrile and water containing 0.5% formic acid as the mobile phase. The mass detection was performed in the positive mode. Calibration curves of the seven alkaloids showed good linearity (correlation coefficients>0.9973) over their concentration ranges. To meet the requirements of urinary excretion study for each alkaloid in human, the lower limit of quantification was set at different values from 0.05063 ng/mL to 2.034 ng/mL for the seven alkaloids, respectively. The intra- and inter-batch precision and accuracy were all within ± 15%. No matrix effect was observed for the analytes. The validated method was applied to the excretion study for the seven alkaloids in healthy Chinese volunteers after oral administration of Shuanghua Baihe tablets. The average 72 h cumulative urinary excretion of magnoflorine, berberrubine, jatrorrhizine, coptisine, epiberberine, palmatine and berberine accounted for 1.81%, 0.27%, 0.29%, 0.046%, 0.027%, 0.010% and 0.021% of the respective administered dose.

  3. Taste-masking effect of physical and organoleptic methods on peppermint-scented orally disintegrating tablet of famotidine based on suspension spray-coating method.

    PubMed

    Sugiura, Takeshi; Uchida, Shinya; Namiki, Noriyuki

    2012-01-01

    Orally disintegrating tablets (ODTs) are useful for improving benefits for patients of various ages. Masking the unpleasant taste of a drug is an important factor in the compliance of patients who take ODTs. We evaluated the taste acceptability effects of various taste-masking methods on bitter famotidine ODTs as a clinical pharmacological study. The following methods were tested to compare taste-masking effects: physical masking by spray-coating famotidine with ethyl cellulose versus organoleptic masking with added sweetener and flavor. The ODT samples were prepared as single or combinations of each taste-masking method using a novel suspension spray-coating method including a placebo. A total of 31 healthy volunteers were enrolled in this randomized, double-blind study and asked to score their bitterness, sweetness and total palate impressions by 100 mm visual analogue scale (VAS). VAS scores were significantly improved by the physical and organoleptic methods as compared to without taste-masked ODTs. Furthermore, the combination of both taste-masking methods was most effective for improving palatability and VAS scores were similar to those of placebo ODTs. The results of this study suggest that different taste-masking mechanisms function cooperatively.

  4. Taste-masking effect of physical and organoleptic methods on peppermint-scented orally disintegrating tablet of famotidine based on suspension spray-coating method.

    PubMed

    Sugiura, Takeshi; Uchida, Shinya; Namiki, Noriyuki

    2012-01-01

    Orally disintegrating tablets (ODTs) are useful for improving benefits for patients of various ages. Masking the unpleasant taste of a drug is an important factor in the compliance of patients who take ODTs. We evaluated the taste acceptability effects of various taste-masking methods on bitter famotidine ODTs as a clinical pharmacological study. The following methods were tested to compare taste-masking effects: physical masking by spray-coating famotidine with ethyl cellulose versus organoleptic masking with added sweetener and flavor. The ODT samples were prepared as single or combinations of each taste-masking method using a novel suspension spray-coating method including a placebo. A total of 31 healthy volunteers were enrolled in this randomized, double-blind study and asked to score their bitterness, sweetness and total palate impressions by 100 mm visual analogue scale (VAS). VAS scores were significantly improved by the physical and organoleptic methods as compared to without taste-masked ODTs. Furthermore, the combination of both taste-masking methods was most effective for improving palatability and VAS scores were similar to those of placebo ODTs. The results of this study suggest that different taste-masking mechanisms function cooperatively. PMID:22382410

  5. Providing Contraception to Adolescents.

    PubMed

    Raidoo, Shandhini; Kaneshiro, Bliss

    2015-12-01

    Adolescents have high rates of unintended pregnancy and face unique reproductive health challenges. Providing confidential contraceptive services to adolescents is important in reducing the rate of unintended pregnancy. Long-acting contraception such as the intrauterine device and contraceptive implant are recommended as first-line contraceptives for adolescents because they are highly effective with few side effects. The use of barrier methods to prevent sexually transmitted infections should be encouraged. Adolescents have limited knowledge of reproductive health and contraceptive options, and their sources of information are often unreliable. Access to contraception is available through a variety of resources that continue to expand.

  6. Contraception in the prepill era.

    PubMed

    Connell, E B

    1999-01-01

    Although medical history has documented the desire to control fertility since ancient times, safe and effective contraception did not exist until this century and has not been equally available to all people. Strong moral sentiments, economic and social class factors, religious beliefs, familial and gender relations, and political as well as legal constraints have often limited the ability of physicians in favor of contraception to provide advice and methods of birth control to their patients. By the early 1900s, a constellation of factors--in particular, the large influx of poor immigrants, and feminist groups advocating women's rights--helped to move forward a birth-control movement in this country and abroad. In the early 20th century, Margaret Sanger became one of the most avid proponents of contraception in the United States. By 1950, she and Katharine McCormick had contracted with biologist Gregory Pincus to develop an effective birth control pill. A collaborative effort by Pincus and other researchers led to trials of the pill in Puerto Rico, Haiti, and Mexico between 1956 and 1957, which provided the basis for an application to the Food and Drug Administration for approval of the first oral contraceptive.

  7. Effect of hydrophilic natural gums in formulation of oral-controlled release matrix tablets of propranolol hydrochloride.

    PubMed

    Rajesh, K S; Venkataraju, M P; Gowda, D V

    2009-04-01

    In order to develop a controlled delivery of highly water-soluble propranolol hydrochloride (PPHCl) using hydrophilic natural gums (xanthan gum [X] and locust bean gum [LBG]) as cost-effective, nontoxic, easily available. The granules of PPHCl were prepared by wet granulation method using a different ratios drug: gum ratios of X, LBG and XLBG(X and LBG in 1:1 ratios). To increase the flowability and compressibility of the granules, and to prevent its adhesion to punch and die, magnesium stearate and talc were added to the granules in 1:2 ratios before punching. The tablet was analysed to determine hardness, friability, % assay and invitro release study was carried out. The release of PPHCl from a gelatinous swollen mass, which controls the diffusion of drug molecules through the polymeric material into aqueous medium. The XLBG matrice shows precise controlled release than the X and LBG matrice because of burst effect and fast release in case of X and LBG matrice respectively and there was no chemical interaction between drug and polymer in XLBG formulation as confirmed by FTIR studies. First pass effect of PPHCl can be avoided by these formulations. Matrices with XLBG show zero-order release via swelling, diffusion and relaxation mechanism. The XLBG matrice leads to more precise result than X and LBG alone by the utilization of synergistic interaction between two biopolymers and uniformity in the hydration layer in dissolution media. However, according to the similarity factor (f(2)) XLBG3 were the most similar formulations to Lol-SR as the reference standard. PMID:19339235

  8. Contraceptive pills and thrombosis: effects of the French crisis on prescriptions and consequences for medicine agencies.

    PubMed

    Emmerich, J; Thomassin, C; Zureik, M

    2014-09-01

    The higher risk of venous thromboembolism with 3rd and 4th- generations combined oral contraceptives compared to 2nd generation triggered a media crisis in France. Exposure to 3rd or 4th-generation combined oral contraceptives led to an annual excess of around 100 premature deaths in Europe. In the absence of any demonstrated additional benefit of these combined oral contraceptives, measures were taken to decrease exposure of women to this illegitimate excess of risk. As a consequence, this crisis saw a 45% decrease in the prescription of 3rd and 4th-generations combined oral contraceptives, without adverse consequences.

  9. CONTRACEPTION TECHNOLOGY: PAST, PRESENT AND FUTURE

    PubMed Central

    Sitruk-Ware, Regine; Nath, Anita; Mishell, Daniel R.

    2012-01-01

    Steady progress in contraception research has been achieved over the past 50 years. Hormonal and non-hormonal modern contraceptives have improved women’s lives by reducing different health conditions that contributed to considerable morbidity. However the contraceptives available today are not suitable to all users and the need to expand contraceptive choices still exists. Novel products such as new implants, contraceptive vaginal rings, transdermal patches and newer combinations of oral contraceptives have recently been introduced in family planning programs and hormonal contraception is widely used for spacing and limiting births. Concerns over the adverse effects of hormonal contraceptives have led to research and development of new combinations with improved metabolic profile. Recent developments include use of natural compounds such as estradiol (E2) and estradiol valerate (E2V) with the hope to decrease thrombotic risk, in combination with newer progestins derived from the progesterone structure or from spirolactone, in order to avoid the androgenic effects. Progesterone antagonists and progesterone receptor modulators are highly effective in blocking ovulation and preventing follicular rupture and are undergoing investigations in the form of oral pills and in semi long-acting delivery systems. Future developments also include the combination of a contraceptive with an antiretroviral agent for dual contraception and protection against sexually transmitted diseases, to be used before intercourse or on demand, as well as for continuous use in dual-protection rings. Alhough clinical trials of male contraception have reflected promising results, limited involvement of industry in that area of research has decreased the likelihood of having a male method available in the current decade. Development of non-hormonal methods are still at an early stage of research, with the identification of specific targets within the reproductive system in ovaries and testes, as

  10. HelpDesk answers: do hormonal contraceptives lead to weight gain?

    PubMed

    Albright, Maria; Rani, Saira; Gavagan, Thomas

    2015-06-01

    It depends. Weight doesn't appear to increase with combined oral contraception (OC) compared with nonhormonal contraception, but percent body fat may increase slightly. Depot-medroxyprogesterone acetate injection (DMPA) users experience weight gain compared with OC and nonhormonal contraception (NH) users.

  11. Access to modern contraception.

    PubMed

    Welsh, Michael J; Stanback, John; Shelton, James

    2006-06-01

    Access to modern contraception has become a recognized human right, improving the health and well-being of women, families and societies worldwide. However, contraceptive access remains uneven. Irregular contraceptive supply, limited numbers of service delivery points and specific geographic, economic, informational, psychosocial and administrative barriers (including medical barriers) undermine access in many settings. Widening the range of providers enabled to offer contraception can improve contraceptive access, particularly where resources are most scarce. International efforts to remove medical barriers include the World Health Organization's Medical Eligibility Criteria. Based on the best available evidence, these criteria provide guidance for weighing the risks and benefits of contraceptive choice among women with specific clinical conditions. Clinical job aids can also improve access. More research is needed to further elucidate the pathways for expanding contraceptive access. Further progress in removing medical barriers will depend on systems for improving provider education and promoting evidence-based contraceptive service delivery. PMID:16443395

  12. Contraception for adolescents.

    PubMed

    2014-10-01

    Contraception is a pillar in reducing adolescent pregnancy rates. The American Academy of Pediatrics recommends that pediatricians develop a working knowledge of contraception to help adolescents reduce risks of and negative health consequences related to unintended pregnancy. Over the past 10 years, a number of new contraceptive methods have become available to adolescents, newer guidance has been issued on existing contraceptive methods, and the evidence base for contraception for special populations (adolescents who have disabilities, are obese, are recipients of solid organ transplants, or are HIV infected) has expanded. The Academy has addressed contraception since 1980, and this policy statement updates the 2007 statement on contraception and adolescents. It provides the pediatrician with a description and rationale for best practices in counseling and prescribing contraception for adolescents. It is supported by an accompanying technical report.

  13. Contraception for adolescents.

    PubMed

    Ott, Mary A; Sucato, Gina S

    2014-10-01

    A working knowledge of contraception will assist the pediatrician in both sexual health promotion as well as treatment of common adolescent gynecologic problems. Best practices in adolescent anticipatory guidance and screening include a sexual health history, screening for pregnancy and sexually transmitted infections, counseling, and if indicated, providing access to contraceptives. Pediatricians' long-term relationships with adolescents and families allow them to help promote healthy sexual decision-making, including abstinence and contraceptive use. Additionally, medical indications for contraception, such as acne, dysmenorrhea, and heavy menstrual bleeding, are frequently uncovered during adolescent visits. This technical report provides an evidence base for the accompanying policy statement and addresses key aspects of adolescent contraceptive use, including the following: (1) sexual history taking, confidentiality, and counseling; (2) adolescent data on the use and side effects of newer contraceptive methods; (3) new data on older contraceptive methods; and (4) evidence supporting the use of contraceptives in adolescent patients with complex medical conditions. PMID:25266435

  14. 21 CFR 520.1870 - Praziquantel tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Praziquantel tablets. 520.1870 Section 520.1870 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1870 Praziquantel tablets....

  15. Contraceptive revolution.

    PubMed

    Segal, S J

    1994-06-01

    Global population will increase by almost 1 billion people in the 1990s, the largest 10-year increase ever recorded. In 1994 alone, population will surpass 5.7 billion. The prospect of double-digit billions of people is worrisome, especially since these numbers may affect global warming, supplies of fresh water, destruction of rain forests, industrial pollution, and sustainable development. Yet, many indicators of quality of life show that people enjoy a better quality of life today than they did 100 years ago. Between India's independence and now, life expectancy increased by 20 years, infant mortality decreased 2-fold, literacy increased, and the food supply stabilized. Even though India's population has almost tripled since 1947, its economy increased rapidly and is 1 of the world's top 10 economies. University enrollment stands at 4.5 million. Agricultural production has exceeded demand. India represents the potential for human achievement through technological advancement and social organization. If the world's first national family planning program had been more successful when it began in 1952 in an India of 350 million people, India's population would be around 500 million instead of the expected 1 billion in 2000. All countries need to achieve a sustainable balance between human numbers and needs and natural resources. Family planning is an essential, cost-effective part of any development strategy. Family planning use has reduced fertility from 6 to 3.6 in developing countries. In 1965, only 8% used contraception, while more than 50% use it now. The most remarkable family planning/fertility reduction successes are Bangladesh, Brazil, Colombia, Indonesia, Mexico, and Thailand. Sufficient investment in family planning is needed if significant declines in fertility are to occur. More than 90% of the developing world's people are in countries with official family planning programs. Cost-effective assistance by donors and developing countries implementing

  16. Contraceptive revolution.

    PubMed

    Segal, S J

    1994-06-01

    Global population will increase by almost 1 billion people in the 1990s, the largest 10-year increase ever recorded. In 1994 alone, population will surpass 5.7 billion. The prospect of double-digit billions of people is worrisome, especially since these numbers may affect global warming, supplies of fresh water, destruction of rain forests, industrial pollution, and sustainable development. Yet, many indicators of quality of life show that people enjoy a better quality of life today than they did 100 years ago. Between India's independence and now, life expectancy increased by 20 years, infant mortality decreased 2-fold, literacy increased, and the food supply stabilized. Even though India's population has almost tripled since 1947, its economy increased rapidly and is 1 of the world's top 10 economies. University enrollment stands at 4.5 million. Agricultural production has exceeded demand. India represents the potential for human achievement through technological advancement and social organization. If the world's first national family planning program had been more successful when it began in 1952 in an India of 350 million people, India's population would be around 500 million instead of the expected 1 billion in 2000. All countries need to achieve a sustainable balance between human numbers and needs and natural resources. Family planning is an essential, cost-effective part of any development strategy. Family planning use has reduced fertility from 6 to 3.6 in developing countries. In 1965, only 8% used contraception, while more than 50% use it now. The most remarkable family planning/fertility reduction successes are Bangladesh, Brazil, Colombia, Indonesia, Mexico, and Thailand. Sufficient investment in family planning is needed if significant declines in fertility are to occur. More than 90% of the developing world's people are in countries with official family planning programs. Cost-effective assistance by donors and developing countries implementing

  17. 21 CFR 520.1696d - Penicillin V tablets.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Penicillin V tablets. 520.1696d Section 520.1696d... DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1696d Penicillin V tablets. (a) Specifications. Each tablet contains penicillin V potassium equivalent to 125 milligrams...

  18. 21 CFR 520.1696d - Penicillin V tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Penicillin V tablets. 520.1696d Section 520.1696d... DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1696d Penicillin V tablets. (a) Specifications. Each tablet contains penicillin V potassium equivalent to 125 milligrams...

  19. 21 CFR 520.1331 - Meclofenamic acid tablets.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Meclofenamic acid tablets. 520.1331 Section 520...) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1331 Meclofenamic acid tablets. (a) Specifications. Each tablet contains either 10 or 20 milligrams of meclofenamic acid....

  20. 21 CFR 520.1331 - Meclofenamic acid tablets.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Meclofenamic acid tablets. 520.1331 Section 520...) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1331 Meclofenamic acid tablets. (a) Specifications. Each tablet contains either 10 or 20 milligrams of meclofenamic acid....

  1. 21 CFR 520.1331 - Meclofenamic acid tablets.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Meclofenamic acid tablets. 520.1331 Section 520...) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1331 Meclofenamic acid tablets. (a) Specifications. Each tablet contains either 10 or 20 milligrams of meclofenamic acid....

  2. Permanent contraception for women.

    PubMed

    Micks, Elizabeth A; Jensen, Jeffrey T

    2015-11-01

    Permanent methods of contraception are used by an estimated 220 million couples worldwide, and are often selected due to convenience, ease of use and lack of side effects. A variety of tubal occlusion techniques are available for female permanent contraception, and procedures can be performed using a transcervical or transabdominal approach. This article reviews currently available techniques for female permanent contraception and discusses considerations when helping patients choose a contraceptive method and tubal occlusion technique.

  3. Benefit–risk assessment of paliperidone oral extended-release tablet versus monthly injectable for maintenance treatment of schizophrenia

    PubMed Central

    Markowitz, Michael; Turkoz, Ibrahim; Fu, Dong-Jing; Gopal, Srihari; Alphs, Larry

    2016-01-01

    The purpose of this study was to conduct a post-hoc benefit–risk assessment of paliperidone palmitate once-monthly (PP1M) injectable versus oral paliperidone extended-release (ER) in schizophrenia maintenance treatment. The Benefit–Risk Action Team framework was used to structure the analysis based on patient-level data from two similar, double-blind, placebo-controlled relapse studies. Efficacy outcomes were relapse, psychiatric hospitalization, Clinical Global Impression–Severity scale, Personal and Social Performance (PSP) scale, and Positive and Negative Syndrome Scale (PANSS). Safety outcomes were extrapyramidal symptom–related adverse events, weight gain, prolactin-related adverse events, somnolence, orthostatic hypotension, anticholinergic use, fasting plasma glucose, and total cholesterol/high–density lipoprotein. For the first 8 weeks of maintenance treatment, most efficacy outcomes significantly favored PP1M compared with paliperidone ER. Per 1000 patients, there would be 165, 115, 85, and 53 fewer cases of PSP worsening, relapse, PANSS worsening, and hospitalizations, respectively. For the first 40 weeks, PSP worsening significantly favored PP1M (140 fewer cases). Relapse, PANSS, hospitalizations, and Clinical Global Impression–Severity scale showed a consistent pattern favoring PP1M but were not significant. Safety outcomes for both 8-week and 40-week periods demonstrated no statistically significant differences between groups. These analyses suggest a benefit–risk profile favoring PP1M over oral paliperidone ER throughout 40 weeks of treatment, particularly in early treatment. PMID:27434314

  4. Benefit-risk assessment of paliperidone oral extended-release tablet versus monthly injectable for maintenance treatment of schizophrenia.

    PubMed

    Levitan, Bennett; Markowitz, Michael; Turkoz, Ibrahim; Fu, Dong-Jing; Gopal, Srihari; Alphs, Larry

    2016-11-01

    The purpose of this study was to conduct a post-hoc benefit-risk assessment of paliperidone palmitate once-monthly (PP1M) injectable versus oral paliperidone extended-release (ER) in schizophrenia maintenance treatment. The Benefit-Risk Action Team framework was used to structure the analysis based on patient-level data from two similar, double-blind, placebo-controlled relapse studies. Efficacy outcomes were relapse, psychiatric hospitalization, Clinical Global Impression-Severity scale, Personal and Social Performance (PSP) scale, and Positive and Negative Syndrome Scale (PANSS). Safety outcomes were extrapyramidal symptom-related adverse events, weight gain, prolactin-related adverse events, somnolence, orthostatic hypotension, anticholinergic use, fasting plasma glucose, and total cholesterol/high-density lipoprotein. For the first 8 weeks of maintenance treatment, most efficacy outcomes significantly favored PP1M compared with paliperidone ER. Per 1000 patients, there would be 165, 115, 85, and 53 fewer cases of PSP worsening, relapse, PANSS worsening, and hospitalizations, respectively. For the first 40 weeks, PSP worsening significantly favored PP1M (140 fewer cases). Relapse, PANSS, hospitalizations, and Clinical Global Impression-Severity scale showed a consistent pattern favoring PP1M but were not significant. Safety outcomes for both 8-week and 40-week periods demonstrated no statistically significant differences between groups. These analyses suggest a benefit-risk profile favoring PP1M over oral paliperidone ER throughout 40 weeks of treatment, particularly in early treatment. PMID:27434314

  5. Intrauterine devices and other forms of contraception: thinking outside the pack.

    PubMed

    Allen, Caitlin; Kolehmainen, Christine

    2015-05-01

    A variety of contraception options are available in addition to traditional combined oral contraceptive pills. Newer long-acting reversible contraceptive (LARC) methods such as intrauterine devices and subcutaneous implants are preferred because they do not depend on patient compliance. They are highly effective and appropriate for most women. Female and male sterilization are other effective but they are irreversible and require counseling to minimize regret. The contraceptive injection, patch, and ring do not require daily administration, but their typical efficacy rates are lower than LARC methods and similar to those for combined oral contraceptive pills.

  6. Searching for Ideal Contraceptives.

    ERIC Educational Resources Information Center

    Djerassi, Carl

    1985-01-01

    Discusses the problem of adolescent pregnancy and focuses on improving contraception as a practical solution. Describes the advantages and disadvantages of existing methods (the condom, the pill, and the contraceptive sponge). Predicts that the development of a fundamentally new contraceptive, such as a monthly menses-inducer pill, will not occur…

  7. Hormonal contraception. Current status and future perspectives.

    PubMed

    Holinka, C F

    1994-09-30

    Hormonal contraception was pioneered by Gregory Pincus in the 1950s. Today, hormonal contraception is accepted as having a highly favorable benefit/risk profile. There is, however, a need for the development of new contraceptive methods to broaden the range of choices and enhance motivation and compliance in users. With the staggering rate of increase in the world's population, the number of contraceptive users in developing countries is expected to increase from 381 million in 1990 to 567 million in the year 2000. This will require substantial supplies of inexpensive contraceptives and the development of new and improved methods. The use of contraceptives is an asset to women's health, which can be jeopardized by the risks of pregnancy, as well as to the psychological and social well-being of mother and child. Oral contraceptives also have noncontraceptive health benefits such as protecting against endometrial cancer, uterine fibroids, menorrhagia, benign breast disease, anemia, ovarian cancer, functional ovarian cysts, dysmenorrhea, ectopic pregnancy, salpingitis, and bone loss. The new low-dose formulations are considered to be very safe for most healthy, nonsmoking women of reproductive age. Therefore, current research efforts are focused on new delivery methods, such as vaginal rings, rather than on the development of new hormonally active steroids. Nonoral contraceptive methods which avoid first-pass effects on the liver are being developed or improved. These include implants, vaginal rings, vaginally applied pills, and progestogen-containing IUDs. Contraceptive research is also focusing on immunologic interference with the hypothalamic-pituitary-gonadal axis in both men and women. This may spawn as yet unforseen methods of molecular modulation of sperm-ovum interactions which would result in the inhibition of implantation.

  8. Sucrose esters with various hydrophilic-lipophilic properties: novel controlled release agents for oral drug delivery matrix tablets prepared by direct compaction.

    PubMed

    Chansanroj, K; Betz, G

    2010-08-01

    Sucrose esters (SE) are esters of sucrose and fatty acids with various hydrophilic-lipophilic properties which have attracted interest from being used in pharmaceutical applications. This study aimed to gain insight into the use of SE as controlled release agents for direct compacted matrix tablets. The study focused on the effect of hydrophilic-lipophilic properties on tableting properties and drug release. Sucrose stearate with hydrophilic-lipophilic balance (HLB) values ranging from 0 to 16 was systematically tested. Tablet formulations contained SE, metoprolol tartrate as a highly soluble model drug and dibasic calcium phosphate dihydrate as a tablet formulation filler in the ratio 1:1:2. The compaction behaviour of matrix tablets was compared with the compacts of individual starting materials as reference. SE incorporation improved the plasticity, compressibility and lubricating property of powder mixtures. The hydrophilic-lipophilic properties of SE affected tableting properties, drug release rate and release mechanism. Increasing hydrophilicity corresponding to the increased monoesters in SE composition increased the relative porosity, elastic recovery and tensile strength of the tablets due to the increased hydrogen bonding between the monoesters. This also facilitated the swelling behaviour of SE, which sustained the drug release rate. A sustained release effect prevailed in tablets containing SE with HLB values of 3-16. The ability to improve the tableting properties as well as sustain the drug release rate of the highly soluble model drug via gelation of SE highlights SE as promising controlled release regulators for direct compacted matrix tablets comprising drugs with various solubilities according to the Biopharmaceutics Classification System. PMID:20132913

  9. [Resistance and compliance to contraception in adolescents].

    PubMed

    Pichot, F; Dayan-lintzer, M

    1985-10-01

    Although inadequate information on sex and contraception is frequently believed to account for contraceptive failure in adolescents, other factors including resistence to contraception or poor compliance with method requirements have been invoked to explain contraceptive failures in well-informed adolescents. Sexual relations are beginning at ever-younger ages in France; a 1980 survey indicated that 50% had their 1st sexual relations before age 17. Sexual activity is sporadic and irregular but usually occurs with the same partner. At least 50% of 1st sexual relations are unprotected by contraception, and half of adolescent pregnancies occur in the 1st 6th months of sexual activity. 6-12 months pass on average before sexually active adolescents begin to use contraception. Rates of pregnancy and abortion have increased especially among adolescents under 16, and in 1979 almost 20% of all abortions were in women under 20 years old. In 1980, only 20% of adolescents used contraception, with 17.3% using oral contraceptives. Few statistics exist on the complex phenomenon of conscious or subconscious contraceptive resistence in adolescence, and clinical experience serves as a better guide. A frequent attitude among adolescents is that sexual relations should be spontaneous and romantic, traits viewed as incompatible with contraception. "Magical thinking", failure to appreciate the real risk of pregnancy, and dissociation of sex and pregnancy are common. Adolescents who doubt their fecundity may engage in unprotected relations to reassure themselves, while some seeking to assert their femininity may use pills although they have no need for contraception. Guilt and ambivalence may be unconscious motivations for poor contraceptive use. Young girls in cold, uncaring, neglectful, or conflict-ridden homes may seek affection from a sexual partner and wish to have a baby to demonstrate their attachment. Such situations often lead to well-accepted pregnancies and may also

  10. Tablet Weaving

    ERIC Educational Resources Information Center

    Kren, Margo

    1976-01-01

    Article described a weaving technique called tablet weaving, an ancient textile process that provides opportunity for making a variety of items, such as guitar straps, belts, and decorative bands. (Author/RK)

  11. Contraception and Breastfeeding.

    PubMed

    Pieh Holder, Kelly Lynne

    2015-12-01

    Postpartum contraception is important to lengthening birth intervals and improving the health of women and children. For breastfeeding women the choice and timing of contraception may influence breastfeeding and infant growth patterns. Nonhormonal methods of contraception are the preferred choice for breastfeeding women. Progestin-only methods comprise a viable next option. Combined hormonal methods of contraception containing estrogen and progestin may be considered as a third option for birth control in breastfeeding women. The objective of this chapter is to review the current literature and recommendations for the use of hormonal and nonhormonal methods of contraception while breastfeeding.

  12. Bioavailability, safety, and pharmacodynamics of delayed-release dexlansoprazole administered as two 30 mg orally disintegrating tablets or one 60 mg capsule

    PubMed Central

    Kukulka, Michael; Nudurupati, Sai; Perez, Maria Claudia

    2016-01-01

    Background: Dual delayed-release dexlansoprazole is approved for use in adults as a 30 mg orally disintegrating tablet (ODT) or as 30 mg and 60 mg capsules. The pharmacokinetics, pharmacodynamics, and safety profile of two dexlansoprazole 30 mg ODTs were compared with one dexlansoprazole 60 mg capsule in this randomized, phase I, open-label, single-center, multiple-dose, two-period crossover study. Methods: Participants were randomized in one of two treatment sequences, each comprised two 5-day treatment periods during which two dexlansoprazole 30 mg ODTs or one 60 mg capsule was administered once daily. Pharmacokinetic parameters and the mean intragastric pH profile for the 24-hour period after dosing on days 1 and 5 were described. Adverse events were monitored during study duration and followed up with a phone call 5–10 days after the last dose of study drug. Results: On day 1, peak observed plasma concentration (Cmax) values were similar between two 30 mg ODTs (1047 ng/ml) and one 60 mg capsule (1164 ng/ml). Systemic exposure, measured by the area under the plasma concentration–time curve (AUC), was approximately 25% lower after ODT administration. On day 5, mean pH after daily doses of two 30 mg ODT or one 60 mg capsule was 4.33 and 4.36, respectively; both regimens maintained intragastric pH above 4.0 for 60% of the 24-hour period. Headache was the most commonly reported adverse event (observed in 19.2% of participants); no adverse events leading to study withdrawal occurred. Conclusions: While systemic exposure (AUC) was 25% lower with ODT, peak concentrations (Cmax) after administration of two dexlansoprazole 30 mg ODTs and one 60 mg capsule were similar. The 24-hour intragastric pH control after administration of two dexlansoprazole 30 mg ODTs was equivalent to one dexlansoprazole 60 mg capsule. Both ODT and capsule were well tolerated. PMID:27803732

  13. Transdermal delivery of contraceptives.

    PubMed

    Friend, D R

    1990-01-01

    Contraceptive agents are administered to the body through a variety of routes. Research has recently been directed at examining the transdermal route for systemic delivery of contraceptive agents, including estrogens and progestins. The transdermal route has several potential advantages over the other routes of administration: (1) improved compliance, (2) once-weekly administration, (3) delivery is easily terminated, and (4) some side effects can be alleviated based on more constant delivery rates. This article reviews the permeability of skin toward contraceptive steroids and how skin permeability is evaluated. The metabolism of contraceptive steroids is also considered. Transdermal delivery systems used to deliver contraceptives are presented, followed by a detailed discussion of several delivery systems for specific contraceptive agents such as levonorgestrel and estradiol. The potential problem of skin irritation is presented as it relates to transdermal contraceptive delivery systems, all of which will be worn chronically. PMID:2272099

  14. Investigation of the Bioequivalence of Rosuvastatin 20 mg Tablets after a Single Oral Administration in Mediterranean Arabs Using a Validated LC-MS/MS Method

    PubMed Central

    Zaid, Abdel Naser; Al Ramahi, Rowa; Cortesi, Rita; Mousa, Ayman; Jaradat, Nidal; Ghazal, Nadia; Bustami, Rana

    2016-01-01

    There is a wide inter-individual response to statin therapy including rosuvastatin calcium (RC), and it has been hypothesized that genetic differences may contribute to these variations. In fact, several studies have shown that pharmacokinetic (PK) parameters for RC are affected by race. The aim of this study is to demonstrate the interchangeability between two generic RC 20 mg film-coated tablets under fasting conditions among Mediterranean Arabs and to compare the pharmacokinetic results with Asian and Caucasian subjects from other studies. A single oral RC 20 mg dose, randomized, open-label, two-way crossover design study was conducted in 30 healthy Mediterranean Arab volunteers. Blood samples were collected prior to dosing and over a 72-h period. Concentrations in plasma were quantified using a validated liquid chromatography tandem mass spectrometry method. Twenty-six volunteers completed the study. Statistical comparison of the main PK parameters showed no significant difference between the generic and branded products. The point estimates (ratios of geometric mean %) were 107.73 (96.57–120.17), 103.61 (94.03–114.16), and 104.23 (94.84–114.54) for peak plasma concentration (Cmax), Area Under the Curve (AUC)0→last, and AUC0→∞, respectively. The 90% confidence intervals were within the pre-defined limits of 80%–125% as specified by the Food and Drug Administration and European Medicines Agency for bioequivalence studies. Both formulations were well-tolerated and no serious adverse events were reported. The PK results (AUC0→last and Cmax) were close to those of the Caucasian subjects. This study showed that the test and reference products met the regulatory criteria for bioequivalence following a 20 mg oral dose of RC under fasting conditions. Both formulations also showed comparable safety results. The PK results of the test and reference in the study subjects fall within the acceptable interval of 80%–125% and they were very close to the

  15. Reduction in the volume of water for ingesting orally disintegrating tablets of solifenacin (Vesicare® OD), and the clinical disintegration time of Vesicare® OD after unit-dose packaging.

    PubMed

    Uchida, Shinya; Yoshita, Tomohiro; Namiki, Noriyuki

    2013-03-25

    This study aimed to determine the amount of water required for ingesting an orally disintegrating tablet (ODT) of solifenacin (Vesicare(®), VES) and VES conventional tablets (VES-CT). We measured the disintegration time of VES-ODT in the oral cavity (clinical disintegration time) before and after unit-dose packaging. Thirty healthy volunteers participated in this randomized crossover trial. The participants were asked to drink water during the intake placebos of VES and after the disintegration of placebos of VES-ODT in their oral cavity. The amounts of water required for ingesting placebos of VES-CT and of VES-ODT were 42.8±27.0 mL and 20.0±23.7 mL, respectively, which indicated that the amount of water required for ingesting ODTs was significantly lesser than that for ingesting CTs. Furthermore, 5 (16.7%) participants did not require water for ingesting the ODTs. Clinical disintegration time of VES-ODT was 21.4s in 10 healthy volunteers. This clinical disintegration time did not change significantly after unit-dose packaging or subsequent storage for 56 days. This study showed that the amount of water required for ingesting VES-ODT is lower than that for ingesting VES-CT.

  16. The quest for a herbal contraceptive.

    PubMed

    Chaudhury, R R

    1993-01-01

    An oral herbal contraceptive would allow couples control their fertility without consulting a health worker, which in turn would likely markedly increase the number of couples practicing family planning. Other advantages of such a contraceptive would include the familiarity rural people have with herbal medicines, the fewer side effects associated with herbal preparations, their ready availability from local sources, and protection of privacy. There are many references to plants in India with antifertility properties. Since 1966, the Indian Council of Medical Research (ICMR) has been conducting research to identify a herbal contraceptive, as have other organizations. Plants that have exhibited antifertility activity in clinical trials include Hibiscus rosasinensis (benzene extract of the flower petals suppresses implantation); Rudrapushpaka (extract of the flower petals prevents pregnancy); Embelia ribes (pregnancy prevention); Davcus carota, Butea monosperma, and Sapindus trifoliatis (seeds have an anti-implantation effect); and Mentha arvensis (leaves have anti-implantation effect). The Central Drug Research Institute in Lucknow, India, in collaboration with the US National Institutes of Health, the World Health Organization, and the ICMR confirm anti-implantation activity in Ferula jaeschkeana, Bupleurum marginatum, Lepidium capitatum, Caesalpinia sepiaria, Lonicera japonica, Juniperus communis, Lotus corniculatus, Lamium allum, and Acacia farnesiana. In China, scientists have evaluated the cotton-seed extract gossypol as a male contraceptive. They are now studying the possible antifertility effect on men of the plant Tripterygium wilfordii. From all the aforementioned plants as well as others under investigation, three possible types of contraceptives could be developed: an anti-ovulatory contraceptive; a postcoital contraceptive; and a male contraceptive. Some obstacles to their development include difficulties in obtaining adequate quantities of the herbs, a

  17. Contraceptive prevalence in Paraguay.

    PubMed

    Morris, L; Anderson, J E; Monteith, R S; Kriskovich, R; Schoemaker, J; Frutos, O

    1978-01-01

    Contraceptive use, source of contraception, history of abortion, current pregnancy intention, and fertility rates are evaluated for a national sample of women using data from the Paraguay Contraceptive Prevalence Survey, conducted in 1977. The survey found that 15.5 percent of all women aged 15--44 and 23.6 percent of ever-married women were using effective contraceptive methods. The urban/rural difference in contraceptive use paralleled fertility differentials: over 40 percent of ever-married women were using contraception in Greater Asuncion and other urban areas compared with 15 percent in rural areas. Overall, the data indicate that high-parity rural women have the greatest need for family planning services in Paraguay.

  18. Knowledge, attitude and practice of pharmacists and health-care workers regarding oral contraceptives correct usage, side-effects and contraindications.

    PubMed

    Sattari, M; Mokhtari, Z; Jabari, H; Mashayekhi, S O

    2013-06-01

    Despite the success of the Iranian family planning programme, the number of unwanted pregnancies remains high. To investigate whether health workers in Tabriz are providing correct information and counselling about OCP use, the current study was planned to examine the level of knowledge, attitude and practice of OCP providers. A sample of 150 health-care workers in health houses and 150 community/hospital pharmacists answered a questionnaire about knowledge of correct use of OCP, side-effects, contraindications, danger signs/symptoms and non-contraceptive benefits, and whether they counselled patients about these subjects. Knowledge of pharmacists and health workers was not as high as expected and in many topics they were counselling patients even when they had incorrect knowledge and in other areas they were not providing information to patients despite having the correct knowledge. Better continuing education for OCP providers and especially for pharmacists seems necessary. PMID:24975184

  19. Hormonal contraceptives and travel to high altitude.

    PubMed

    Keyes, Linda E

    2015-03-01

    Women frequently ask about the safety and efficacy of using hormonal contraception (HC), either oral contraceptive pills (OC) or other forms, when traveling to high altitude locales. What are the risks and benefits of using HC at high altitude? Does HC affect acclimatization, exercise performance, or occurrence of acute mountain sickness? This article reviews current data regarding the risks and benefits of HC at high altitude, both demonstrated and theoretical, with the aim of helping health care providers to advise women traveling above 2500 meters. Most healthy women can safely use HC when traveling to high altitude, but should be aware of the potential risks and inconveniences.

  20. Hormonal contraceptives and travel to high altitude.

    PubMed

    Keyes, Linda E

    2015-03-01

    Women frequently ask about the safety and efficacy of using hormonal contraception (HC), either oral contraceptive pills (OC) or other forms, when traveling to high altitude locales. What are the risks and benefits of using HC at high altitude? Does HC affect acclimatization, exercise performance, or occurrence of acute mountain sickness? This article reviews current data regarding the risks and benefits of HC at high altitude, both demonstrated and theoretical, with the aim of helping health care providers to advise women traveling above 2500 meters. Most healthy women can safely use HC when traveling to high altitude, but should be aware of the potential risks and inconveniences. PMID:25759908

  1. What's wrong with contraception?

    PubMed

    1994-01-01

    A "reader's exchange" question solicited information on how readers respond when asked what is wrong with contraception. One letter-writer maintained that the use of contraception prohibits true love, total commitment, and complete acceptance on the part of a married couple. Contraception attempts to create a utopia and obviates the pain and suffering which are necessary in order to find true love and true happiness.

  2. FPIA helps expand contraceptive services.

    PubMed

    Groot, H

    1984-01-01

    Since the beginning in 1971 of the Planned Parenthood Federation of America's international program, Family Planning International Assistance (FPIA), US$54 million has been contributed in direct financial support for the operation of over 300 family planning programs in 51 countries; over 3000 institutions in 115 countries have been supplied with family planning commodities, including over 600 million condoms, 120 cycles of oral contraceptives, and 4 million IUD; and about 1 million contraceptive clients were served by FPIA funded projects in 1982 aone. Since 1971, however, the world's population has increased from 3.7 billion to around 4.7 billion people. About 85 million people are added to the world each year. There is consensus that without organized family planning programs, today's world population would be even higher. FPIA measures its progress in terms of expanding the availability of contraceptive services in devloping countries. FPIA supported projects have helped make services available in areas previously lacking them, and has helped involve a wide variety of organizations, such as women's groups, youth organizations, and Red Cross Societies, in family planning services. A prime concern of FPIA, which has limited resources, is what happens to projects once FPIA support is terminated. FPIA has been paying attention to local income generation to help projects become more self-supporting and to increas staff members' management skills. The more successful income-generating schemes appear to be directly related to family planning, selling contraceptives and locally produced educational materials, and charging fees for family planning and related medical services and tuition for training courses. FPIA funded to projects use management by objectives (MBO) to help improve management skills. MBO helps grantees improve their ability to set objectives, plan, monitor, report, and do day-to-day project management.

  3. Pooled post hoc analysis of population pharmacokinetics of oxycodone and acetaminophen following a single oral dose of biphasic immediate-release/extended-release oxycodone/acetaminophen tablets.

    PubMed

    Franke, Ryan M; Morton, Terri; Devarakonda, Krishna

    2015-01-01

    This analysis evaluated the single-dose population pharmacokinetics (PK) of biphasic immediate-release (IR)/extended-release (ER) oxycodone (OC)/acetaminophen (APAP) 7.5/325 mg tablets administered under fasted conditions and the effects of a meal on their single-dose population PK. Data were pooled from four randomized, single-dose crossover trials enrolling healthy adult (18-55 years old) participants (three trials) and nondependent recreational users of prescription opioids (one trial) with a body weight of ≥59 kg. Participants received IR/ER OC/APAP 7.5/325 mg tablets in single doses of 7.5/325 mg (one tablet), 15/650 mg (two tablets), or 30/1,300 mg (four tablets) under fasted or fed conditions. Six variables were examined: sex, race, age, weight, height, and body mass index. Single-dose population PK was analyzed using first-order conditional estimation methods. A total of 151 participants were included in the analysis under fasted conditions, and 31 participants were included in the fed analysis. Under fasted conditions, a 10% change in body weight was accompanied by ~7.5% change in total body clearance (CL/F) and volume of distribution (V/F) of OC and APAP. Black participants had 17.3% lower CL/F and a 16.9% lower V/F of OC compared with white participants. Under fed conditions, the absorption rate constant of OC and APAP decreased significantly, although there was no effect on CL/F and V/F. Considering that the recommended dose for IR/ER OC/APAP 7.5/325 mg tablets is two tablets every 12 hours, adjustments of <50% are not clinically relevant. Dose adjustment may be necessary for large deviations from average body weight, but the small PK effects associated with race and consumption of a meal are not clinically relevant.

  4. Current contraceptive status among women aged 15-44: United States, 2011-2013.

    PubMed

    Daniels, Kimberly; Daugherty, Jill; Jones, Jo

    2014-12-01

    Nearly all women use contraception at some point in their lifetimes, although at any given time they may not be using contraception for reasons such as seeking pregnancy, being pregnant, or not being sexually active. Using data from the 2011-2013 National Survey of Family Growth (NSFG) on contraceptive use in the month of the interview, this report provides a snapshot of current contraceptive status among women aged 15-44 in the United States. In addition to describing use of any method by age, Hispanic origin and race, and educational attainment, patterns of use are described for the four most commonly used contraceptive methods: the oral contraceptive pill, female sterilization, the male condom, and long-acting reversible contraceptives, which include contraceptive implants and intrauterine devices.

  5. Contraception: Efficacy, Risks, Continuation Rates, and Use in High-Risk Women.

    PubMed

    Batur, Pelin; Bowersox, Natalie; McNamara, Megan

    2016-08-01

    The clinical update serves as a brief review of recently published, high-impact, and potentially practice-changing journal articles summarized for our readers. Topics include menopause, sexual dysfunction, breast health, contraception, osteoporosis, and cardiovascular disease. In this clinical update, we selected recent publications relevant to the use of contraceptive methods. We highlight articles on continuation rates of long-acting reversible contraception versus nonlong-acting methods, updated risks of intrauterine devices, use of estrogen-containing contraceptives during anticoagulation for venous thromboembolic events, and the efficacy of oral and emergency contraception in women with elevated body mass index. PMID:27438879

  6. Use of long-acting reversible contraceptives to reduce the rate of teen pregnancy.

    PubMed

    Rome, Ellen

    2015-11-01

    Long-acting reversible contraceptives (LARCs) are safe for use in adolescents and do not rely on compliance or adherence for effectiveness. Continuation rates are higher and pregnancy rates are lower for adolescent users of LARCs compared with short-acting methods such as oral contraceptives. Similarly, repeat pregnancy rates are lower when LARCs are used compared with other forms of contraception. Myths and misconceptions about LARCs and other contraceptives remain a barrier to their use. Health care providers are in a unique position to provide confidential care to adolescents, and should provide education to them about the various contraceptive options, especially LARCs.

  7. Television and contraception.

    PubMed

    Klein, L

    1986-01-01

    This article consists of excerpts from a speach made on October 19th at the 1986 annual meeting of the Association of Planned Parenthood Professionals by Dr. Luella Klein, President of the American College of Obstetricians and Gynecologists (ACOG) between 1984-85. The speaker described the reaction of US television network to the ACOG's request that the networks air a public service announcement encouraging responsible sexual behavior among the nation's young people. In 1984 the ACOG initiated a public information program aimed at reducing the high number of unwanted births among young people. The ACOG with the help of an advertising agency developed a 27-second public service announcement stressing responsible parenthood and informing young people that they could write or call for further information. A booklet, entitled "Facts," was prepared for distribution to those who inquired. It advised young people to consider postponing sexual intercourse but to use the most effective methods of contraception if they decided to be sexually active. Oral contraceptives for females and condoms for males were recommended as the most effective methods. When the 3 major television networks, i.e., the American Broadcasting Company (ABC), the National Broadcasting Company (NBC), and the Columbia Broadcasting System (CBS), were requested to carry the announcement, all 3 networks claimed the announcement was too controversial to air. These same networks do not hesitate to show blatant, irresponsible sexual behavior repeatedly during their entertainment programming, and commercials with sexual innuendos are routinely accepted for airing by the networks. In July, 1986, the ACOG called a news conference in New York City to inform the news media about the rejection of the announcement by the networks. The conference stimulated considerable interest, and the story was carried by many newspapers and by radio and television news programs. Many of the news accounts of the story contained

  8. Male Adolescent Contraceptive Utilization.

    ERIC Educational Resources Information Center

    Finkel, Madelon Lubin; Finkel, David J.

    1978-01-01

    The contraceptive utilization of a sample of sexually active, urban, high school males (Black, Hispanic, and White) was examined by anonymous questionnaire. Contraceptive use was haphazard, but White males tended to be more effective contraceptors than the other two groups. Reasons for nonuse were also studied. (Author/SJL)

  9. Social marketing of contraceptives.

    PubMed

    Schellstede, W P; Derr, B B

    1986-12-01

    Application of commercial marketing techniques has not only increased awareness, acceptability, and use of modern contraceptives in developing countries, but also overcome logistic problems in service delivery. The ability of contraceptive social marketing to reach large numbers and to treat contraceptives as common consumer products has helped to diminish social and religious constraints associated with family planning. Each contraceptive social marketing program is built around a theme tailored to meet specific cultural, social, and management requirements. The primary target populations are those who cannot afford regular commercial products and those who are not adequately reached by government programs. In countries such as Sri Lanka and Jamaica, profit is not a primary sales objective and retail prices are highly subsidized to make products affordable to low-income people. In contrast, the Colombian and Thai programs use contraceptive social marketing to help offset the operating costs of rural community-based programs and seek profits. The most impressive contraceptive social marketing sales performances have been recorded in Bangladesh, Colombia, Egypt, and Jamaica. The main reason contraceptive social marketing is more cost-efficient than other modes of contraceptive distribution is that the cost of product delivery is assumed by the commercial system. Although there has been some interest in making these programs self-sufficient financially, this step has tended to undermine the purpose of serving lower income groups. PMID:12341233

  10. 21 CFR 520.531 - Cythioate tablets.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... DRUGS, FEEDS, AND RELATED PRODUCTS ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.531 Cythioate tablets. (a) (b...) Limitations. For oral use in dogs only. Do not use in greyhounds or in animals that are pregnant, sick, under stress, or recovering from surgery. Federal law restricts this drug to use by or on the order of...

  11. Contraceptive failure in China.

    PubMed

    Wang, Duolao

    2002-09-01

    This study examines patterns and differentials of contraceptive failure rates by method and characteristics of users, using the Chinese Two-per-Thousand Fertility Survey data. The results show that contraceptive failure rates for modern methods including sterilization are some of the highest in the world. The first year failure rates are 4.2% for male sterilization, 0.7% for female sterilization, 10.3% for IUD, 14.5% for pill, and 19.0% for condom. There are also some differentials in contraceptive failure rates by users' sociodemographic and fertility characteristics. Contraceptive failure rate declines with women's age for all reversible methods. Rural women have higher sterilization, IUD, and condom contraceptive failure rates than urban women. Women with two or more children have a higher failure rate for sterilization methods but have lower failure rates for other methods.

  12. Contraception and cardiovascular disease.

    PubMed

    Roos-Hesselink, Jolien W; Cornette, Jerome; Sliwa, Karen; Pieper, Petronella G; Veldtman, Gruschen R; Johnson, Mark R

    2015-07-14

    Contraceptive counselling should begin early in females with heart disease, preferably directly after the start of menstruation. In coming to a decision about the method of contraception, the following issues should be considered: (i) the risk of pregnancy for the mother and the consequences of an unplanned pregnancy; (ii) the risks of the contraceptive method; (iii) failure rates; (iv) the non-contraceptive benefits; (v) the availability; (vi) the individual's preferences; (vii) protection against infection; and (viii) costs. In some women with heart disease, the issues may be complex and require the input of both a cardiologist and an obstetrician (or other feto-maternal expert) to identify the optimal approach. No studies have been performed in women with heart disease to investigate the relative risks and benefits of different contraceptive methods.

  13. Contraceptive product advertising.

    PubMed

    Kastor, A

    1985-07-01

    In the US, all national broadcast networks refuse to accept ads for contraceptive products. About 10 years ago, the National Association of Broadcasters (NAB), a trade association, inserted a ban on contraceptive ads in its advertising code for member stations. The ban was voluntary, but all NAB stations adhered to it. When the NAB dropped its advertising code in 1982, for legal reasons unrelated to contraceptive advertising, individual networks established their own codes. These codes continued the ban on contraceptives along with bans on ads for cigarettes, X-rated movies, sex magazines, and astrology services. In recent years, a few local radio and television stations and cable networks began accepting contraceptive ads. The ads, which are tasteful and straightforward, met with little or no public disapproval. Given that the national television networks through their programming willingly expose viewers to an estimated 9230 sexual acts or references a year, it is hard to understand why they persist in refusing to air contraceptive ads or to allow any references to contraceptive use in their programming. There are some hopeful signs. A number of national organizations are now publicly urging the networks to drop their ban. These organizations include the American College of Nurse-Midwives, the American Jewish Congress, and the Society for Adolescent Medicine. The Center for Population Options recently organized a task force to promote contraceptive advertising. The task force is composed of representatives from a wide range of national organizations, including the American Public Health Association and the National Urban League. The task force developed guidelines for the production and selection of contraceptive ads. The guidelines state that ads must provide accurate and clear information on product effectiveness, present comparisons with other products fairly, advise users to read all instructions, and inform listeners if there is an effectiveness waiting

  14. [Community marketing of contraceptives].

    PubMed

    Urrutia, J M

    1987-09-01

    The 5-year-old community contraceptive distribution program developed by PROFAMILIA, Colombia's private family planning organization, has given excellent results, but several cost-effectiveness comparisons with social marketing programs have suggested that commercial distribution programs are superior. The community contraceptive distribution program has a high content of information and education activities, which produced significant increases in knowledge and use of contraception in the communities covered. It has been a fundamental support for the social marketing program, creating much of the demand for contraceptive products that the social marketing program has filled. The social marketing program has given good results in terms of volume of sales and in cost-effectiveness since 1976, prompting calls for replacement of the community contraceptive distribution program by the social marketing program in those sectors where knowledge and use of contraception have achieved acceptable levels. An experiment in the Department of Santander in 1984 and 1985 gave very favorable results, suggesting that community contraceptive distribution programs should be replaced by social marketing programs in all more developed markets. But economic problems in 1985 and the decision of manufacturers to decrease the profit margin for PROFAMILIA jeopardized the social marketing program. The community distribution program covered about 20% of the market. Reduced profits in the social marketing program threatened its continued expansion, at the same time that potential demand was growing because of increases in the fertile aged population and increased use of contraception. To meet the need, PROFAMILIA combined the community contraceptive distribution and social marketing programs into a new entity to be called community marketing. The strategy of the community marketing program will be to maintain PROFAMILIA's participation in the market and aid the growth of demand for

  15. A (polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer)-dispersed sustained-release tablet for imperialine to simultaneously prolong the drug release and improve the oral bioavailability.

    PubMed

    Lin, Qing; Fu, Yu; Li, Jia; Qu, Mengke; Deng, Li; Gong, Tao; Zhang, Zhirong

    2015-11-15

    Imperialine, extracted from Bulbus Fritillariae Cirrhosae, is an efficient antitussive and expectorant medicine. However, its short half-life and stomach degradation limited imperialine from further clinical use. The current study was conducted to develop a sustained-release tablet for imperialine both to prolong absorption time and to improve the oral bioavailability of the drug. The tablets were prepared by a direct compression method formulated on optimized solid dispersion (SD) for imperialine based on polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (Soluplus(®)) with imperialine/Soluplus(®) ratio of 1:8 (w/w). In order to obtain the optimized formulation, factors that affected the drug release were investigated by in vitro dissolution studies in the media of pH1.2, 5.8, 7.0 and 7.4. Powder X-ray diffraction and scanning electron microscope confirmed that the imperialine in SD was amorphous instead of crystalline, and still stayed amorphous even after the direct compression. And besides, pharmacokinetic study in Beagle dogs was performed to inspect the in vivo sustained release. Plasma concentration-time curves and pharmacokinetic parameters were gained. As a result, the Cmax of imperialine was one-fold reduced and Tmax was two-fold prolonged, and the mean AUC0-24 was expressed as 89.581±21.243μgh/L, which showed that the oral bioavailability of imperialine was 2.46-fold improved. Moreover, the in vitro-in vivo correlation was recommended to carry out, demonstrating the percentages of drug release in vitro were well-correlated with the absorptive fraction in vivo with the correlation coefficients above 0.9900. By mathematically modeling and moment imaging of the drug release, Peppas equation was selected as the most fitted model for the sustained-release tablets with the diffusional coefficient in the range of 0.59-0.62, indicating the release of imperialine from the sustained-release tablets was an anomalous process involving

  16. Estradiol Valerate Pretreatment in Short Protocol GnRH-Agonist Cycles versus Combined Pretreatment with Oral Contraceptive Pills in Long Protocol GnRH-Agonist Cycles: A Randomised Controlled Trial

    PubMed Central

    Kunicki, Michal; Kuczynski, Waldemar; Pastuszek, Ewa; Jakiel, Grzegorz; Plociennik, Lukasz; Zielinski, Krzysztof; Zabielska, Judyta

    2015-01-01

    The strategy of in vitro fertilization (IVF) procedures relies on the increasing pregnancy rate and decreasing the risk of premature ovulation and ovarian hyperstimulation syndrome. They are also designed to avoid weekend oocyte retrievals. Combined oral contraceptive (OC) pills are among the medicines used to accomplish these objectives. Alternatively, estradiol can be used instead of OC to obtain similar results. The aim of our study was to compare the differences in pregnancy rates (PRs), implantation rates, and miscarriage rates between a short agonist protocol with estradiol priming and a long protocol with combined OC. Of the 298 women who participated in this study, 134 achieved clinical pregnancies (45.0%). A higher PR (58.4%, n = 80, compared to 40.3%, n = 54) was achieved in the long protocol after OC pretreatment group. The implantation rate was also higher for this group (37.8% versus 28.0%; P = 0.03). The miscarriage rate was 15.0% (n = 12) for the long protocol after OC pretreatment group and 20.4% (n = 11) for the short agonist group (P = 0.81). The short agonist protocol required a 5.7% lower human menopausal gonadotropin (hMG) dosage than the long protocol but surprisingly the number of oocytes retrieved was also smaller. PMID:25922838

  17. Investigation of the bioequivalence of montelukast chewable tablets after a single oral administration using a validated LC-MS/MS method

    PubMed Central

    Zaid, Abdel Naser; Abualhasan, Murad N; Watson, David G; Mousa, Ayman; Ghazal, Nadia; Bustami, Rana

    2015-01-01

    Background Montelukast (MT) is a leukotriene D4 antagonist. It is an effective and safe medicine for the prophylaxis and treatment of chronic asthma. It is also used to prevent acute exercise-induced bronchoconstriction and as a symptomatic relief of seasonal allergic rhinitis and perennial allergic rhinitis. Objective The aim of this study was to evaluate the bioequivalence (BE) of two drug products: generic MT 5 mg chewable tablets versus the branded drug Singulair® pediatric 5 mg chewable tablets among Mediterranean volunteers. Methods An open-label, randomized two-period crossover BE design was conducted in 32 healthy male volunteers with a 9-day washout period between doses and under fasting conditions. The drug concentrations in plasma were quantified by using a newly developed and fully validated liquid chromatography tandem mass spectrometry method, and the pharmacokinetic parameters were calculated using a non-compartmental model. The ratio for generic/branded tablets using geometric least squares means was calculated for both the MT products. Results The relationship between concentration and peak area ratio was found to be linear within the range 6.098–365.855 ng/mL. The correlation coefficient (R2) was always greater than 0.99 during the course of the validation. Statistical comparison of the main pharmacokinetic parameters showed no significant difference between the generic and branded products. The point estimates (ratios of geometric means) were 101.2%, 101.6%, and 98.11% for area under the curve (AUC)0→last, AUC0→inf, and Cmax, respectively. The 90% confidence intervals were within the predefined limits of 80.00%–125.00% as specified by the US Food and Drug Administration and European Medicines Agency for BE studies. Conclusion Broncast® pediatric chewable tablets (5 mg/tablet) are bioequivalent to Singulair® pediatric chewable tablets (5 mg/tablet), with a similar safety profile. This suggests that these two formulations can be

  18. Role of various natural, synthetic and semi-synthetic polymers on drug release kinetics of losartan potassium oral controlled release tablets

    PubMed Central

    Jayasree, J.; Sivaneswari, S.; Hemalatha, G.; Preethi, N.; Mounika, B.; Murthy, S. Vasudeva

    2014-01-01

    Objective: The objective of the present work was to formulate and to characterize controlled release matrix tablets of losartan potassium in order to improve bioavailability and to minimize the frequency of administration and increase the patient compliance. Materials and Methods: Losartan potassium controlled release matrix tablets were prepared by direct compression technique by the use of different natural, synthetic and semisynthetic polymers such as gum copal, gum acacia, hydroxypropyl methyl cellulose K100 (HPMC K100), eudragit RL 100 and carboxy methyl ethyl cellulose (CMEC) individually and also in combination. Studies were carried out to study the influence of type of polymer on drug release rate. All the formulations were subjected to physiochemical characterization such as weight variation, hardness, thickness, friability, drug content, and swelling index. In vitro dissolution studies were carried out simulated gastric fluid (pH 1.2) for first 2 h and followed by simulated intestinal fluid (pH 6.8) up to 24 h, and obtained dissolution data were fitted to in vitro release kinetic equations in order to know the order of kinetics and mechanism of drug release. Results and Discussion: Results of physiochemical characterization of losartan potassium matrix tablets were within acceptable limits. Formulation containing HPMC K100 and CMEC achieved the desired drug release profile up to 24 h followed zero order kinetics, release pattern dominated by Korsmeyer — Peppas model and mechanism of drug release by nonfickian diffusion. The good correlation obtained from Hixson-Crowell model indicates that changes in surface area of the tablet also influences the drug release. Conclusion: Based on the results, losartan potassium controlled release matrix tablets prepared by employing HPMC K100 and CMEC can attain the desired drug release up to 24 h, which results in maintaining steady state concentration and improving bioavailability. PMID:25426439

  19. Recent advances in hormonal contraception

    PubMed Central

    Li, HW Raymond

    2010-01-01

    This report reviews some of the new studies regarding new hormonal contraceptive formulations (e.g., Yaz, Qlaira®, extended-cycle or continuous combined contraceptives, subcutaneous depot medroxyprogesterone acetate, and ulipristal acetate as an emergency contraceptive). Recent data on the relationship between hormonal contraceptive use and bone health are also reviewed. PMID:21173872

  20. Contraceptive use and sexual behavior in obese women.

    PubMed

    Kaneshiro, Bliss

    2012-12-01

    Obesity and unintended pregnancy differentially affect women based on sociodemographic factors. Because of the overlap of these factors, obesity and unintended pregnancy have been described as colliding epidemics. Understanding the relationship between obesity and unintended pregnancy, contraceptive use, and sexual behavior is important in improving the reproductive health of women given the increasing weight demographic. A review of the literature reveals contraceptive use versus nonuse does not differ in women of different body weights. Obese women use oral contraceptives less than normal weight women and are more likely to use procedural methods like sterilization. No difference was noted in most types of sexual behavior for women of different body weights.

  1. Debate on the use of hormonal contraceptives during lactation.

    PubMed

    Nilsson, S; Nygren, K G

    1980-04-01

    Contraceptive steroids taken during the lactation period will, in small measure, be transferred to the milk. The side effects from estrogens administered during lactation are enough to contraindicate their use at this time. Low-dose gestagens are sufficient to achieve contraceptive effect. A study of 6-7-year-old children whose mothers took OCs (oral contraceptives) during lactation is being conducted currently to ascertain longterm side effects or possible effects outside the hypothalamic-pituitary-gonadal axis. However, at this time the minipill of 30 mcg d-norgestrel daily is considered safe for a nursing mother and her baby.

  2. Hormonal contraception and HIV acquisition: reanalysis using marginal structural modeling.

    PubMed

    Morrison, Charles S; Chen, Pai-Lien; Kwok, Cynthia; Richardson, Barbra A; Chipato, Tsungai; Mugerwa, Roy; Byamugisha, Josaphat; Padian, Nancy; Celentano, David D; Salata, Robert A

    2010-07-17

    Hormonal contraceptives are used widely worldwide; their effect on HIV acquisition remains unresolved. We reanalyzed data from the Hormonal Contraception and HIV Study using marginal structural modeling to reduce selection bias due to time-dependent confounding. Replicating our original analysis closely, we found that depo-medroxyprogesterone acetate (DMPA) but not combined oral contraceptive (COC) was associated with increased HIV acquisition. Also, young (18-24 years) but not older women who used DMPA and COCs were at increased HIV risk. PMID:20588106

  3. Evidence based contraceptive choices.

    PubMed

    Scott, Alison; Glasier, Anna

    2006-10-01

    People who attend for contraceptive advice have usually formulated an idea of the type of contraceptive that will suit them best. They may wish to use a method that is long, short or medium acting. These are defined as follows: Long-acting method requires renewal no more frequently than every 3 months (e.g. injectable or intrauterine). Short-acting method used daily or with every act of intercourse (e.g. pills, condoms) Medium-acting method requires renewal weekly or monthly (e.g. ring, patch). For men the choice is limited to condoms or vasectomy. Some women do not wish to use hormonal preparations or have an intrauterine device (IUD) or implant inserted. There may also be cultural influences making certain methods of contraception unacceptable. Each of these factors influences the final decision of which method of contraception is decided upon. In addition to taking a full medical and sexual history to identify any risks to the individual's health, which might be increased by a particular contraceptive, time must be spent discussing the options available. It is important to ensure that there is a full understanding of the advantages and disadvantages of each method. The most successful contraceptive method is likely to be the one that the woman (or man) chooses, rather than the one the clinician chooses for them. Access for women to contraception can be improved by having convenient clinic times and service developments such as nurse prescribing and Patient Group Directions.

  4. Investigation of the bioavailability of hypericin, pseudohypericin, hyperforin and the flavonoids quercetin and isorhamnetin following single and multiple oral dosing of a hypericum extract containing tablet.

    PubMed

    Schulz, Hans-Ulrich; Schürer, Michael; Bässler, Dagmar; Weiser, Dieter

    2005-01-01

    The objective of these two open phase I clinical trials was the investigation of the bioavailability of five constituents from a hypericum extract containing tablet, which are discussed as the components contributing to the antidepressant action. Each trial included 18 healthy male volunteers who received the test preparation, containing 612 mg dry extract of St John's wort (STW-3, Laif 600), either as a single oral dose or as a multiple once daily dose over a period of 14 days. Concentration/time curves were determined for hypericin, pseudohypericin, hyperforin, the flavonoid aglycone quercetin, and its methylated form isorhamnetin for 48 h after single dosing and for 24 h on day 14 at the end of 2 weeks of continuous daily dosing. After single dose intake, the key pharmacokinetic parameters were determined as follows: hypericin: area under the curve (AUC(0-infinity)) = 75.96 h x ng/ml, maximum plasma concentration (Cmax) = 3.14 ng/ml, time to reach Cmax (t(max)) = 8.1 h, and elimination half-life (t1/2) = 23.76 h; pseudohypericin: AUC(0-infinity) = 93.03 h x ng/ml, Cmax = 8.50 ng/ml, t(max) = 3.0 h, t1/2 = 25.39 h; hyperforin: AUC(0-max) = 1009.0 h x ng/ml, Cmax = 83.5 nglml, t(max) = 4.4 h, t1/2 = 19.64 h. Quercetin and isohamnetin showed two peaks of maximum plasma concentration separated by about 4 h. Quercetin: AUC(0-infinity) = 318,7 h x ng/ml, Cmax (1) = 47.7 ng/ml, t(max) (1) = 1.17 h, Cmax (2) = 43.8 ng/ml, t(max) (2) = 5.47 h, t1/2 = 4.16 h; isorhamnetin: AUC(0-infinity) = 98.0 h x ng/ml, Cmax (1) = 7.6 ng/ml, t(max) (1) = 1.53 h, Cmax (2) = 9.0 ng/ml, t(max), (2) = 6.42 h, t1/2 = 4.45 h. Under steady state conditions reached during multiple dose administration similar results were obtained. Further pharmacokinetic characteristics calculated from the obtained data were the mean residence time (MRT), the lag-time, the peak-trough fluctuation (PTF), the lowest observed plasma concentration (Cmin), and the average plasma concentration (Cav). The data

  5. Male hormonal contraception.

    PubMed

    Nieschlag, E

    2010-01-01

    The principle of hormonal male contraception based on suppression of gonadotropins and spermatogenesis has been established over the last three decades. All hormonal male contraceptives use testosterone, but only in East Asian men can testosterone alone suppress spermatogenesis to a level compatible with contraceptive protection. In Caucasians, additional agents are required of which progestins are favored. Current clinical trials concentrate on testosterone combined with norethisterone, desogestrel, etonogestrel, DMPA, or nestorone. The first randomized, placebo-controlled clinical trial performed by the pharmaceutical industry demonstrated the effectiveness of a combination of testosterone undecanoate and etonogestrel in suppressing spermatogenesis in volunteers. PMID:20839093

  6. The effects of contraception on female poverty.

    PubMed

    Browne, Stephanie P; LaLumia, Sara

    2014-01-01

    Poverty rates are particularly high among households headed by single women, and childbirth is often the event preceding these households' poverty spells. This paper examines the relationship between legal access to the birth control pill and female poverty. We rely on exogenous cross-state variation in the year in which oral contraception became legally available to young, single women. Using census data from 1960 to 1990, we find that having legal access to the birth control pill by age 20 significantly reduces the probability that a woman is subsequently in poverty. We estimate that early legal access to oral contraception reduces female poverty by 0.5 percentage points, even when controlling for completed education, employment status, and household composition.

  7. Factors that influence contraceptive use amongst women in Vanga health district, Democratic Republic of Congo

    PubMed Central

    Izale, Kangale; Fina, Jean-Pierre L.; Tumbo, John

    2014-01-01

    Abstract Background Contraception is often necessary in order to plan for children and without it there is a risk of unplanned pregnancies. In the Democratic Republic of Congo, this often results in abortions by untrained persons with resultant morbidity and mortality. Aim To investigate the factors that influence contraceptive use amongst women of childbearing age in the Vanga health zone. Methods Cross-sectional survey using interviewer-administered questionnaires. Results Of the 384 women recruited, a majority (46.1%) were in the 31–40 year age group; 52% had reached primary school and 88% did not have formal employment. One hundred and forty of the participants reported current use of contraception, with 60% of them using modern methods of contraception; 36.1% of them had begun using contraception before the age of 20; and the most common methods were oral contraceptive pills and injection, each accounting for 22.9%. There was variation in the duration of contraceptive use and the main reason for using contraception was to space children. Of the participants, 20.7% had been using contraception for more than two years. Seventy-seven (31.5%) of the women reported they did not use contraception because of a fear of side effects. Forty-four (18%) reported that they are unable to afford contraception, 38 (15.6%) had husbands who disapproved of contraceptive usage, 26 (10.6%) had a fear of infertility, 18 (7.4%) practised a religion that did not allow them to use contraception and 12 of the women (4.9%) did not use contraception because it was unavailable to them. Conclusion Barriers to contraception in our study were fears of side effects and infertility, cost, male partner's objection, unavailability of contraception and religious beliefs. PMID:26245398

  8. The use of contraception among abortion applicants.

    PubMed

    Krishnamoni, D; Jain, S C

    1985-01-01

    consisted mainly of young women whose parental attitude had deterred them from seeking help with birth control. The 181 women who had used some form of contraception within the last 6 months or earlier but not at the time of conception were mainly over age 17. More than half of them were unmarried. Less than 1/3 had elementary school education, and half had high school or more education. The complaint of side effects caused by the method was the most common reason for non-use among this group. In most instances the method complained about was oral contraception. More than half of the consistent users were married and almost 3/4 had high school or better education. The contraceptive that appears to have had the highest failure rate among the consistent users was the condom. Almost 1/3 of the women claimed that they had depended on the condom. The oral contraceptive, the IUD, and irreversible methods such as tubal ligation and vasectomy had a failure rate of 2% each. PMID:4005776

  9. Effect of Village Midwife Program on Contraceptive Prevalence and Method Choice in Indonesia

    PubMed Central

    Weaver, Emily H.; Frankenberg, Elizabeth; Fried, Bruce J.; Thomas, Duncan; Wheeler, Stephanie B.; Paul, John E.

    2014-01-01

    Indonesia established its Village Midwife Program in 1989 to combat high rates of maternal mortality. The program’s goals were to address gaps in access to reproductive health care for rural women, increase access to and use of family planning services, and broaden the mix of available contraceptive methods. In this study, we use longitudinal data from the Indonesia Family Life Survey to examine the program’s effect on contraceptive practice. We find that the program did not affect overall contraceptive prevalence but did affect method choice. Over time, for women using contraceptives, midwives were associated with increased odds of injectable contraceptive use and decreased odds of oral contraceptive and implant use. Although the Indonesian government had hoped that the Village Midwife Program would channel women into using longer-lasting methods, the women’s “switching behavior” indicates that the program succeeded in providing additional outlets for and promoting the use of injectable contraceptives. PMID:24323659

  10. Contraception and Birth Control

    MedlinePlus

    ... health, age, frequency of sexual activity, number of sexual partners, desire to have children in the future, and family history of certain diseases. Individuals should consult their health care provider to ... methods of contraception include: Barrier —physically ...

  11. Post abortion contraception.

    PubMed

    Gemzell-Danielsson, Kristina; Kopp, Helena Kallner

    2015-11-01

    A safe induced abortion has no impact on future fertility. Ovulation may resume as early as 8 days after the abortion. There is no difference in return to fertility after medical or surgical abortion. Most women resume sexual activity soon after an abortion. Contraceptive counseling and provision should therefore be an integrated part of the abortion services to help women avoid another unintended pregnancy and risk, in many cases an unsafe, abortion. Long-acting reversible contraceptive methods that includes implants and intrauterine contraception have been shown to be the most effective contraceptive methods to help women prevent unintended pregnancy following an abortion. However, starting any method is better than starting no method at all. This Special Report will give a short guide to available methods and when they can be started after an induced abortion.

  12. Post abortion contraception.

    PubMed

    Gemzell-Danielsson, Kristina; Kopp, Helena Kallner

    2015-11-01

    A safe induced abortion has no impact on future fertility. Ovulation may resume as early as 8 days after the abortion. There is no difference in return to fertility after medical or surgical abortion. Most women resume sexual activity soon after an abortion. Contraceptive counseling and provision should therefore be an integrated part of the abortion services to help women avoid another unintended pregnancy and risk, in many cases an unsafe, abortion. Long-acting reversible contraceptive methods that includes implants and intrauterine contraception have been shown to be the most effective contraceptive methods to help women prevent unintended pregnancy following an abortion. However, starting any method is better than starting no method at all. This Special Report will give a short guide to available methods and when they can be started after an induced abortion. PMID:26619082

  13. A novel male contraceptive pill-patch combination: oral desogestrel and transdermal testosterone in the suppression of spermatogenesis in normal men.

    PubMed

    Hair, W M; Kitteridge, K; O'Connor, D B; Wu, F C

    2001-11-01

    This study investigated the effect of transdermal T and oral desogestrel on the reproductive axis of healthy men. Twenty-three men were randomized to 1 of 3 treatment groups and received a daily transdermal T patch plus oral desogestrel at a dose of 75, 150, or 300 microg/d for 24 wk. Baseline blood and semen samples were obtained and then every 4 wk thereafter for 32 wk. The outcome measures were sperm density and plasma levels of FSH, LH, total and free T. The results show a dose-dependent suppression of spermatogenesis and gonadotropins. Seven of the 17 subjects became azoospermic. Desogestrel (300 microg daily) in combination with 5 mg daily transdermal T was the most effective (57% azoospermic), whereas a dose of 75 microg was ineffective (0% azoospermic). Total and free plasma T were reduced by approximately 30%. High density lipoprotein cholesterol was significantly reduced. No serious side-effects were encountered. We conclude that daily self-administered desogestrel with transdermal T is capable of suppressing the male reproductive axis, although the efficacy was less marked and less consistent than injectable regimens. The lower efficacy is likely to be due to failure of the transdermal T system to maintain circulating T levels consistently in the required range.

  14. Dilemmas of public sector contraceptive development.

    PubMed

    Zeidenstein, G

    1993-02-01

    The International Symposium on Recent Advances in Female Reproductive Health Care was organized in Helsinki, Finland. The symposium focused attention on female reproductive health care as a central element in the provision of services for moderating unwanted fertility. The most relevant aspects to biomedical scientists engaged in developing contraceptives intended primarily for use in pu