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Sample records for oral contraceptive tablets

  1. Oral contraceptives.

    PubMed

    Maclennan, A H

    1987-12-01

    Over 60 million women use highly efficient and safe modern combined oral contraceptives (OCs) every day. A women who takes the oral contraceptive for 5 years before the age of 30 will actually live 12 days longer, although a woman taking the pill for the 1st time for 5 years after the age of 30 will have her life span reduced on the average by 80 days. OC related morbidity and mortality mostly occur in women over 35 who smoke. Combined low dose OCs are safe for women who do not smoke, at least to 45 years of age and probably to the menopause. The prescription of OCs is also safe to the young adolescent. The pill does not interfere with maturation of the hypothalamic-pituitary ovarian axis and does not increase the incidence of amenorrhoea, oligomenorrhoea or infertility in later life. Patients with contraindications to estrogen therapy are excluded from OC use (history of thromboembolism, major heart disease, liver disease, breast cancer). Low-dose (30-35 mcg estrogen-containing monophasic or triphasic) pills are recommended. Combined oral contraceptives contain either ethinyl estradiol (1.7 to 2 times more potent) or mestranol. After absorption the progestagens, norethisterone acetate, ethynodiol diacetate and lynoestrenol are all metabolized to norethisterone. The progestagen-only pill has about a 2% failure rate and poorer cycle control than the combined pill, but it lacks estrogenic, progestagenic and androgenic side effects. This pill is suitable for the lactating mother, for smokers over 35, for hypertensive patients, and for those with a history of thrombosis. The efficacy of the progestagen-only pill is restored in 3 days of pill taking. Postcoital contraception is an alternative: treatment can be given for at least 72 hours after intercourse. The Yuzpe method calls for the patient to take 2 combined oral contraceptive tablets containing levonorgestrel and ethinyl estradiol (Eugynon or Ovral) followed by a further 2 tablets 12 hours later. This regimen

  2. Oral contraceptives.

    PubMed

    Oesterheld, Jessica R; Cozza, Kelly; Sandson, Neil B

    2008-01-01

    Nearly 50 years ago, the introduction of Enovid (norethynodrel 10 microg and mestranol 150 microg), which provided convenient and reliable contraception, revolutionized birth control. Reports of interactions between oral contraceptives (OCs) and other drugs began to trickle into the literature. At first, these drug interactions appeared to be random and unrelated. Increased understanding of P450 enzymes and phase II reactions of sulfation and glucuronidation has permitted preliminary categorization and assessment of the clinical relevance of these drug interactions.

  3. Oral contraceptives.

    PubMed

    Ellsworth, A J; Leversee, J H

    1990-09-01

    Management of oral contraception requires an understanding of the relationships between the method's effectiveness, noncontraceptive benefits, and hormonal adverse effects. The new multiphasic combinations or OCs containing 35 micrograms of ethinyl estradiol and 0.5-1.0 mg of norethindrone or equivalent result in a maximum combination of efficacy and safety for the patient with minimal annoying problems for the patient and the prescriber. Patient education regarding early warning symptoms of adverse effects, breakthrough bleeding, and lack of withdrawal bleeding adds an additional margin of safety and reduces patient questions and uncertainties.

  4. Oral steroid contraception.

    PubMed

    Sech, Laura A; Mishell, Daniel R

    2015-11-01

    Oral steroid contraception is a popular method of family planning worldwide. Over the past several decades, this method of contraception has changed significantly by decreasing the estrogen dose, changing the progestin component, and reducing the hormone free interval. Despite the popularity of oral steroid contraception, there has been much criticism regarding the associated risks of venous thromboembolism and stroke. Despite these established, yet uncommon risks, oral steroid contraception has many important health benefits. This review highlights the available formulations of oral contraceptives along with their evidence-based associated risks and benefits. Highlights regarding future directions for development of novel oral contraceptives are also addressed.

  5. Oral contraceptives: current status.

    PubMed

    Burkman, R T

    2001-03-01

    During the past four decades, oral contraceptives have remained a safe and effective method of birth control. Reductions in the estrogen and progestin dosages have significantly decreased the incidence of cardiovascular complications. The association between oral contraceptives and breast cancer appears to be primarily because of detection bias or possibly a promotional effect. Despite the changes in formulation, the problems related to side effects have not been totally solved. Because compliance and successful use is strongly affected by side effects, improvement in this area is probably the biggest challenge faced by developers of oral contraceptives. It is also clear that there are a growing number of significant noncontraceptive benefits that accrue in oral contraceptive users. Unfortunately, many women do not know about these benefits. Thus, one of the issues that providers need to continue to address is how to provide better information about oral contraceptives and contraception in general to patients.

  6. Potencies of oral contraceptives.

    PubMed

    Edgren, R A; Sturtevant, F M

    1976-08-15

    Oral contraceptives are combinations of estrogens and progestogens or, in the case of the mini-pills, progestogens alone. With specific test procedures in laboratory animals or human subjects, it is possible to assign potency evaluations to the components relative to the progestational, estrogenic, or antiestrogenic activities of the progestogen or to the estrogenic potencies of the estrogenic component. It might even be possible to quantify the synergistic effects of the estrogen on the progestational agent. Unfortunately, however, it is impossible now to amalgamate such assay results into single estimates of the potencies of the combinations (either the combination products per se or the combination tablets of sequential products). For example, an over-all estrogenic potency of a combination preparation would involve the integration of contributions form the estrogen itself plus the estrogenic products of metabolism of the progestogen minus the antagonistic effect of the progestational agent, if any. These factors cannot now be quantified independently, much less merged into a single figure of clinical significance. Further, even if it were possible to produce such an estimate, it is unlikely that the evaluation would be meaningful in relation to any putative side effect or adverse reaction, i.e., the alleged thrombogenic effects of oral contraceptives cannot currently be related directly to any measure of potency that will allow prediction of these clinical conditions from laboratory models. Any evaluation of the potential of a given contraceptive to produce a specific side effect will depend upon data generated with specific regard to that adverse reaction and the individual product in question.

  7. 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 ...

  8. Oral contraception and sexuality.

    PubMed

    Dennerstein, L; Burrows, G

    1976-05-22

    A search of the literature has been carried out to determined how oral contraceptives affect sexuality in women. Some studies featured a high incidence of loss of libido. This could perhaps be attributed to preparations containing progestational compounds. However, no adequate double-blind trial has confirmed this observation. Some psychological and pharmacological aspects of contraceptions are discussed. More research is needed to ascertain why women often lose their sexual interest when taking oral contraceptives.

  9. Migraine and oral contraceptives.

    PubMed

    Mousa, G Y

    1982-10-01

    Migraine is a common complaint in optometric practice. Three cases of migrainous patients taking oral contraceptives are presented in this report. The role of oral contraceptives in triggering a migraine attack and possibly elevating the risk of a stroke in a patient with migraine is discussed. The counseling an optometrist can provide in such cases in discussed.

  10. Oral contraceptives in migraine.

    PubMed

    Allais, Gianni; Gabellari, Ilaria Castagnoli; De Lorenzo, Cristina; Mana, Ornella; Benedetto, Chiara

    2009-03-01

    Combined oral contraceptives are a safe and highly effective method of birth control, but they can also raise problems of clinical tolerability and/or safety in migraine patients. It is now commonly accepted that, in migraine with aura, the use of combined oral contraceptives is always contraindicated, and that their intake must also be suspended by patients suffering from migraine without aura if aura symptoms appear. The newest combined oral contraceptive formulations are generally well tolerated in migraine without aura, and the majority of migraine without aura sufferers do not show any problems with their use; nevertheless, the last International Classification of Headache Disorders identifies at least two entities evidently related to the use of combined oral contraceptives: exogenous hormone-induced headache and estrogen-withdrawal headache. As regards the safety, even if both migraine and combined oral contraceptive intake are associated with an increased risk of ischemic stroke, migraine without aura per se is not a contraindication for combined oral contraceptive use. Other risk factors (tobacco use, hypertension, hyperlipidemia, obesity and diabetes) must be carefully considered when prescribing combined oral contraceptives in migraine without aura patients, in particular in women aged over 35 years. Furthermore, the exclusion of a hereditary thrombophilia and of alterations of coagulative parameters should precede any decision of combined oral contraceptive prescription in migraine patients.

  11. Oral contraceptives and hypertension.

    PubMed

    Friedman, G D

    1977-01-01

    A variety of studies have noted that the use of oral contraceptives generally leads to mild increases in blood pressure which are usually reversible when the medication is discontinued. Representative data from the Walnut Creek Contraceptive Drug Study and the Royal College of General Practitioners Study concerning the magnitude of excess risk and relation to duration of use and pull content are shown. Preliminary data from women, aged 25-34 years, taking multiphasic health checkups in Oakland and San Francisco, suggest that black as well as white women are susceptible to this side effect of oral contraceptives. A method is given for estimating the proportion of hypertensives among a population of young women that is attributable to oral contraceptive use. Although the risk of pull-induced hypertension is small for the average user, oral contraceptives appear to be an important identifiable cause of hypertension in samples of women studied.

  12. 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.

  13. Oral contraceptives: a reassessment.

    PubMed

    Derman, R

    1989-09-01

    Cardiovascular risks attributable to oral contraceptive use may now be subdivided into those that appear to be secondary to the estrogen component, i.e., venous thrombosis, pulmonary embolism, and those linked to the progestin component, i.e., small vessel disease including myocardial infarction and cerebrovascular accident. It appears that venous risk is attributable to subtle changes in clotting factors, while arterial risk may be secondary to changes in glucose and lipid metabolism. In order to determine which women are at greatest risk from oral contraceptive use, Spellacy et al. has developed a risk scoring form that aids in the screening process. After excluding women with an absolute contraindication to pill use, women at greatest risk for cardiovascular disease related to oral contraceptive use are those with a family history of hyperlipidemia, gestational or overt diabetics, hypertensives, and smokers over the age of 35. The gradual reduction by manufacturers of the steroid content of oral contraceptives appears to have lessened the incidence of adverse effects. Our current knowledge of risk factors permits the clinician to reduce exposure to oral contraceptive-related mortality by as much as 86 per cent. As we continue to search for ways to reduce risk among oral contraceptive users, it is important to note that more than 25 per cent of women are still taking formulations containing 50 micrograms of estrogen. It becomes the responsibility of the practicing physician to "step-down" these patients to lower-dose preparations such as the multiphasics. Such preparations also represent optimal therapy for first-time pill users.

  14. [Oral contraceptives (author's transl)].

    PubMed

    Kopera, H

    1976-11-26

    A short review of the endocrinological basis of reproduction in the female is followed by a critical survey of the oral contraceptive methods in current use. The composition of the preparations, their use, their biological and use-effectiveness and mode of action are discussed.The importance is emphasized of complying with the basic principles of drug testing in the evaluation of effects of oral contraceptiveson health. Other effects than merely the contraceptive actions of these preparations are described in detail, including not only the undesirable, frequently neglected, yet very important beneficial effects on the drug-users, their children and families.

  15. Antibiotics and oral contraceptives.

    PubMed

    DeRossi, Scott S; Hersh, Elliot V

    2002-10-01

    With the exception of rifampin-like drugs, there is a lack of scientific evidence supporting the ability of commonly prescribed antibiotics, including all those routinely employed in outpatient dentistry, to either reduce blood levels and/or the effectiveness of oral contraceptives. To date, all clinical trials studying the effects of concomitant antibiotic therapy (with the exception of rifampin and rifabutin) have failed to demonstrate an interaction. Like all drugs, oral contraceptives are not 100% effective with the failure rate in the typical United States population reported to be as high as 3%. It is thus possible that the case reports of unintended pregnancies during antibiotic therapy may simply represent the normal failure rate of these drugs. Considering that both drug classes are prescribed frequently to women of childbearing potential, one would expect a much higher rate of oral contraceptive failure in this group of patients if a true drug:drug interaction existed. On the other hand, if the interaction does exist but is a relatively rare event, occurring in, say, 1 in 5000 women, clinical studies such as those described in this article would not detect the interaction. The pharmacokinetic studies of simultaneous antibiotic and oral contraceptive ingestion, and the retrospective studies of pregnancy rates among oral contraceptive users exposed to antibiotics, all suffer from one potential common weakness, i.e., their relatively small sample size. Sample sizes in the pharmacokinetic trials ranged from 7 to 24 participants, whereas the largest retrospective study of pregnancy rates still evaluated less than 800 total contraceptive users. Still, the incidence of such a rare interaction would not differ from the accepted normal failure rate of oral contraceptive therapy. The medico-legal ramifications of what looks like at best a rare interaction remains somewhat "murky." On one hand, we have medico-legal experts advising the profession to exercise caution

  16. History (of oral contraceptives).

    PubMed

    1978-02-01

    This article summarizes the interest and research in oral contraceptives, with particular attention given to recent discoveries in the field. Development of the present day pill was impossible until scientific discoveries of female ovarian hormones during pregnancy. Scientific work in the 1920s identified the 2 hormones, estrogen and progesterone, and scientists showed that use of the 2 together influenced ovulation and eased dysmenorrhea. It was not until 1944 that a scientist produced progesterone from a plant steroid; today synthetic steroids are available. Margaret Sanger, a pioneer in the American Family Planning Movement, financed and encouraged early human volunteer trials and later clinical trials with contraceptive pills. By 1957, the pills were approved by the FDA for use in treating menstrual disorders. In January 1962, they were released on the market as contraceptives. By 1976-77, the pill was used by 80-100 million women around the world. A dated table summarizes the information in the article in a timetable fashion.

  17. Potencies of oral contraceptives.

    PubMed

    Chihal, H J; Peppler, R D; Dickey, R P

    1978-02-01

    This letter is a response to the discussion by Edgren and Sturtevant (125:1029, 1976) on potencies of oral contraceptives (OCs). It is agreed that the results of studies in animal models on OC potencies may not necessarily reflect true potencies in human subjects, however, these animal models do allow the evaluation of the biological effects and interactions of the components of OCs. Data obtained in animal studies are acknowledged to be valuable aids in the study of human diseases. Likewise, mouse uterine response to contraceptive steroids is 1 criterion to be used in evaluating steroid potency. As previously reported, the importance of the mouse uterine response is that the contribution of the progestin component to the total estrogenic potency of the OC is demonstrated.

  18. Depressive Symptoms and Oral Contraceptives

    PubMed Central

    Herzberg, Brenda N.; Johnson, Anthony L.; Brown, Susannah

    1970-01-01

    Of 261 women who completed a self-rating scale for measuring depression, 168 were taking oral contraceptives and 93 were using physical methods of contraception. Of the group of women taking oral contraceptives 6·6% were more severely depressed than any of the control group. There was a significant variation in the depth of depression related to the day of the menstrual cycle in the control group. This association was not found in the oral contraceptive group, where premenstrual depression was limited to the one or two days preceding menstruation. Women taking a contraceptive containing lynoestrenol 2·5 mg. and mestranol 0·075 mg. showed a significantly increased incidence of pessimism, feelings of dissatisfaction, crying, and tension, compared with women taking other oral contraceptives and the control group. PMID:5475818

  19. Adolescents and oral contraceptives.

    PubMed

    Sanfilippo, J S

    1991-01-01

    Oral contraceptive (OC) options for adolescents are provides. Clarification for those desiring a birth control method is necessary and the benefits of decreased acne and dysmenorrhea with low dose OCs should be stressed along with the importance of compliance. A community effort is suggested to communicate the sexual and contraceptive alternatives, including abstinence and outercourse (sexual stimulation to orgasm without intercourse). Attention is given to concerns associated with teenage sexual activity, prevention of adolescent pregnancy, contraceptive options for the adolescent patient, adolescent attitudes toward birth control OCs, management of the adolescent OC user, manipulation of steroid components of OCs to respond to adolescent concerns, and other hormonal contraceptive options such as minipills or abstinence. The text is supplemented with tables: the % of US women by single years of age for 1971, 1976, 1979, and 1982; comparative pregnancy and abortion rates for the US and 5 other countries; federal cost for teen childbearing; adolescent nonhormonal contraceptive methods (advantages, disadvantages, and retail cost); checklist to identify those at risk for noncompliance with OCs; hormonal side effects of OCs; risks from OCs to adolescents; and benefits of OCs. Concern about adolescent pregnancy dates back to Aristotle. A modern profile shows girls form single-parent families are sexually active at an earlier age, adolescent mothers produce offspring who repeat the cycle, victims of sexual abuse are more likely to be sexually active, and teenagers in foster care are 4 times more likely to be sexually active and 8 times more likely to become pregnant. Prevention involves a multifaceted approach. OCs are the most appropriate contraceptive choice for adolescents. Frequency of intercourse is closely associated with OC use after approximately 15 months of unprotected sexual activity. At risk for noncompliance variables are scales of personality development

  20. A systematic review of effectiveness and safety of different regimens of levonorgestrel oral tablets for emergency contraception.

    PubMed

    Shohel, Mohammad; Rahman, Mohammad Mahfuzur; Zaman, Asif; Uddin, Mir Muhammad Nasir; Al-Amin, Md Mamun; Reza, Hasan Mahmud

    2014-04-04

    Unintended pregnancy is a complex phenomenon which raise to take an emergency decision. Low contraceptive prevalence and high user failure rates are the leading causes of this unexpected situation. High user failure rates suggest the vital role of emergency contraception to prevent unplanned pregnancy. Levonorgestrel - a commonly used progestin for emergency contraception. However, little is known about its pharmacokinetics and optimal dose for use. Hence, there is a need to conduct a systematic review of the available evidences. Randomized, double-blind trials were sought, evaluating healthy women with regular menstrual cycles, who requested emergency contraception within 72 h of unprotected coitus, to one of three regimens: 1.5 mg single dose levonorgestrel, two doses of 0.75 mg levonorgestrel given 12 h apart or two doses of 0.75 mg levonorgestrel given 24 h apart. The primary outcome was unintended pregnancy; other outcomes were side-effects and timing of next menstruation. Every trial under consideration successfully established the contraceptive effectiveness of levonorgestrel for preventing unintended pregnancy. Moreover, a single dose of levonorgestrel 1.5 mg for emergency contraception supports its safety and efficacy profile. If two doses of levonorgestrel 0.75 mg are intended for administration, the second dose can positively be taken 12-24 h after the first dose without compromising its contraceptive efficacy. The main side effect was frequent menstrual irregularities. No serious adverse events were reported. The review shows that, emergency contraceptive regimen of single-dose levonorgestrel is not inferior in efficacy to the two-dose regimen. All the regimens studied were very efficacious for emergency contraception and prevented a high proportion of pregnancies if taken within 72 h of unprotected coitus. Single levonorgestrel dose (1.5 mg) can substitute two 0.75 mg doses 12 or 24 h apart. With either regimen, the earlier the treatment is given

  1. A systematic review of effectiveness and safety of different regimens of levonorgestrel oral tablets for emergency contraception

    PubMed Central

    2014-01-01

    Background Unintended pregnancy is a complex phenomenon which raise to take an emergency decision. Low contraceptive prevalence and high user failure rates are the leading causes of this unexpected situation. High user failure rates suggest the vital role of emergency contraception to prevent unplanned pregnancy. Levonorgestrel - a commonly used progestin for emergency contraception. However, little is known about its pharmacokinetics and optimal dose for use. Hence, there is a need to conduct a systematic review of the available evidences. Methods Randomized, double-blind trials were sought, evaluating healthy women with regular menstrual cycles, who requested emergency contraception within 72 h of unprotected coitus, to one of three regimens: 1.5 mg single dose levonorgestrel, two doses of 0.75 mg levonorgestrel given 12 h apart or two doses of 0.75 mg levonorgestrel given 24 h apart. The primary outcome was unintended pregnancy; other outcomes were side-effects and timing of next menstruation. Results Every trial under consideration successfully established the contraceptive effectiveness of levonorgestrel for preventing unintended pregnancy. Moreover, a single dose of levonorgestrel 1.5 mg for emergency contraception supports its safety and efficacy profile. If two doses of levonorgestrel 0.75 mg are intended for administration, the second dose can positively be taken 12–24 h after the first dose without compromising its contraceptive efficacy. The main side effect was frequent menstrual irregularities. No serious adverse events were reported. Conclusions The review shows that, emergency contraceptive regimen of single-dose levonorgestrel is not inferior in efficacy to the two-dose regimen. All the regimens studied were very efficacious for emergency contraception and prevented a high proportion of pregnancies if taken within 72 h of unprotected coitus. Single levonorgestrel dose (1.5 mg) can substitute two 0.75 mg doses 12 or 24 h apart. With either

  2. Combined oral contraceptives: health benefits beyond contraception.

    PubMed

    Caserta, D; Ralli, E; Matteucci, E; Bordi, G; Mallozzi, M; Moscarini, M

    2014-09-01

    It has been recognized for over 50 years that combined oral contraceptives (COCs) are also capable of offering health benefits beyond contraception through the treatment and prevention of several gynaecological and medical disorders. During the last years a constant attention was given to the adverse effects of COCs, whereas their non-contraceptive benefits were underestimated. To date, most women are still unaware of the therapeutic uses of hormonal contraceptives, while on the contrary there is an extensive and constantly increasing of these non-contraceptive health benefits. This review summarizes the conditions of special interest for physicians, including dysmenorrhoea, menorrhagia, hyperandrogenism (acne, hirsutism, polycystic ovary syndrome), functional ovarian cysts, endometriosis, premenstrual syndrome, myomas, pelvic inflammatory disease, bone mineral density, benign breast disease and endometrial/ovarian and colorectal cancer. The benefits of COCs in rheumatoid arthritis, multiple sclerosis, menstrual migraine and in perimenopause have also been treated for more comprehensive information. Using COCs specifically for non-contraceptive indications is still outside the product licence in the majority of cases. We strongly believe that these aspects are not of minor relevance and they deserve a special consideration by health providers and by the mass media, which have the main responsibility in the diffusion of scientific information. Thus, counseling and education are necessary to help women make well-informed health-care decisions and it is also crucial to increase awareness among general practitioners and gynaecologists.

  3. Progestin-Only Oral Contraceptives

    MedlinePlus

    ... oral contraceptives are a very effective method of birth control, but they do not prevent the spread of ... on another day, use a backup method of birth control (such as a condom and/or a spermicide) ...

  4. Oral contraceptives and exercise.

    PubMed

    Mostardi, R A; Woebkenberg, N R; Jarrett, M T

    1980-01-01

    A laboratory study was undertaken with volunteer females (aged 20-25) to determine the effect of OCs (oral contraceptives) on hematologic and metabolic variables during exercise. 5 of the women studied were naturally cycling and 7 were taking OCs. The women worked at 2 workloads on a bicycle ergometer at 50% and 90% of their maximal aerobic capacity during 3 different phases of their menstrual cycle. There was no better time of the month for doing the 50% or the 90% workload in either group. Heartrate for the OC group was significantly higher at the 50% maximal capacity. Results of the test indicate tha women on OCs have somewhat reduced cardiac efficiency and are ventilating more to carry out a given amount of work when compared to women who are naturally cycling. Possible explanations for the higher heart rate are put forward. The main limitation of the study is that the subject numbers involved are small and the number of cycles studied is also small.

  5. Oral contraceptives and cancer.

    PubMed

    Edgren, R A

    1991-01-01

    Concerns over the safety of oral contraceptives (OCs) have led to numerous empirical studies of the relationship of OC use to normal pregnancy outcomes, pituitary effects, cardiovascular accidents, and cancer. The article reviews some of the results of studies on the effects of OC use on ovarian, uterine, cervical, and breast cancer and on hepatic cancer and melanomas. Reference is made to direct study results rather than to reviews of studies, although it is noted that the critical reviews of Goldzieher and Realini reflect appropriate critiques of the validity of the methods employed in the analysis of cancers as well as cardiovascular risks. Concern is raised for meta-analysis of pooled data. In spite of the 30 years of research on OCs there is no definitive answer to the question of cause and effect. The epidemiological articles reviewed do not meet the standards of critical editorial review boards of experimental journals; confirmation of findings is also lacking. Studies suggesting increased risks as well as those showing positive benefits are questionable. The conclusion reached is that OCs protect against ovarian and uterine cancers and do not cause mammary, cervical, or liver cancer or melanoma. This conclusion is based on inconclusive data. The conclusion on hepatic cancer is that the 3 retrospective case control studies and anecdotal reports are flawed in design, and little confidence can be placed on such a limited number of cases. Malignant melanoma conclusions are that the data are inconsistent and hover around a risk of one for long-term OC-users. There is no increased risk related to OC-use. Ovarian cancer risk seems to be decreased in about 40% of OC-users. Endometrial cancer risk seems to be decreased, except for the sequential contraceptive Oracon which is associated with increased risk. Decreased risk is related to length of usage and continues after stoppage. Cervical carcinoma results appear to confirm the finding that prolonged OC use slightly

  6. Oral contraceptive agents.

    PubMed

    Shearman, R P

    1986-02-17

    The history of the development of oral contraceptives (OCs) has been a progressive reduction in dosage to what is now probably the lowest does that is compatible with the desired therapeutic effect -- to inhibit ovluation. Yet, controversy and argument continue. A table lists the OCs that are available in Australia. Many of these preparations, although having different trade names, have an identical composition. Since the withdrawal of sequential OCs from the Australian market, there are only 2 generic types. These are the progestogen only (mini) OCs, which consist of either 30 mcg of levonorgestrel or 350 mcg of norethisterone given at the same time every day; and the combined OCs, which contain an estrogen and a progestogen. In the last 12 months, some of the older high-dose OCs have been withdrawn, and it seems likely that further withdrawals will follow. Only 2 estrogens are used in the formulation of the OC, but there is a greater variety of progestogens. Ethinyl estradiol is used in most preparations. A small minority of OCs contain mestranol, the 3-methyl ether of ethinyl estradiol. Currently, there are only 4 OC agents that are available in Australia that contain mestranol and 2 of these contain the high doses of 100 mcg. Fundamentally, there are 2 types of progestogens -- those that contain, or are metabolized to, norethisterone and those that contain norgestrel or its close relative, desogestrel. With the exception of the norgestrel group and desogestrel, all other progestins, including norethisterone itself, are effective in vivo after they have been metablized to norethisterone. Mestranol is effective in humans after demethylation to ethinyl estradiol. In the norgesterel group, since d-norgestrel is inert endocrinologically, 250 mcg of levonorgestrel and 500 mcg of dl-norgestrel are equivalent. Levonorgestrel and desogestrel are of approximately equal potency. With the combined OC agents, the overwhelming mechanism of action is by the inhibition of the

  7. [Mercilon - the optimal oral contraceptive].

    PubMed

    Rachev, E; Damianov, L; Kolarov, G; Novachkov, V; Ivanov, S

    2000-01-01

    The authors review the effect of the oral contraceptive Mercilon on menstrual cycle, contraceptive efficacy, lipid profile, safety profile and adverse effects in a group of 32 women, included in the survey. The results of the trial show excellent contraceptive effect with Pearl Index of 0.00 and good control over the menstrual cycle. No negative or unfavorable effects were seen on the lipid profile as well as on the liver kidney and coangulant system function. Minor side effects were seen in only 5% of the patients.

  8. Oral contraceptives and endocrine changes*

    PubMed Central

    Lucis, O. J.; Lucis, R.

    1972-01-01

    In groups of women taking oral contraceptives and in control groups of women, the serum levels of cortisol, protein-bound iodine, and total thyroxine were measured together with the T3 binding index. The daily excretion in the urine of free cortisol, 17-hydroxycorticosteroids, 17-ketosteroids, pregnanediol, pregnanetriol, total oestrogens, total catecholamines, and 4-hydroxy-3-methoxymandelic acid was also assayed. The frequency distribution of the values obtained indicates that oral contraceptives have a marked influence on the endocrine environment. The smallest deviations were observed in urinary excretion of total catecholamines and of 4-hydroxy-3-methoxymandelic acid. In some individuals the hormone assays were continued throughout the menstrual cycle. The morning and afternoon levels of serum cortisol tended to increase during the period when the oral contraceptive was being taken. PMID:4538188

  9. Oral contraception following abortion

    PubMed Central

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

    2016-01-01

    Abstract 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

  10. Oral contraceptives and liver function

    PubMed Central

    Hargreaves, Tom

    1969-01-01

    Oral contraceptives can cause liver damage and jaundice but this is very rare in women in the United Kingdom. The drugs are contraindicated where there is a history of recurrent intrahepatic cholestasis of pregnancy and acute or chronic disturbance of liver function which can be congenital or acquired. It is not yet known whether the oestrogenic or progestogenic components of oral contraceptives cause the hepatic abnormalities. The available data suggest that neither oestrogens nor progestogens in low doses impair hepatic excretory processes. The full implications of the continued administration of oestrogens and progestogens for many years on liver proteins are not yet known.

  11. Our knowledge of drug interactions with oral contraceptives.

    PubMed

    Seregély, G

    1989-01-01

    In the introduction the author points out the importance, mechanism and consequence of interactions between oral contraceptives and other drugs. The interactions between certain drugs with different pharmacological action and the contraceptive tablets which decrease or increase the contraceptive effect as well as the drugs whose effect may be influenced by the contraceptive tablets have been discussed. Cases in which only a few data refer to, or no clinical proof supports interaction, are also mentioned. According to interactions observed until present in women taking Anteovin, the recommended measures to be taken in these cases have been described. Finally it has been emphasized that the knowledge of interactions between drugs is just as important in family planning counselling as is when prescribing other drug treatments.

  12. Vitamin A, Pregnancy, and Oral Contraceptives

    PubMed Central

    Wild, Jennifer; Schorah, C. J.; Smithells, R. W.

    1974-01-01

    It has been shown that women receiving oral contraceptives have increased levels of serum vitamin A. High vitamin A levels may constitute a teratogenic hazard and it has been suggested that women who conceive soon after discontinuing oral contraceptive therapy may be especially at risk to this hazard. We have confirmed a significant increase in vitamin A levels in women taking oral contraceptives. During early pregnancy there is no significant difference in vitamin A levels between women who have recently been taking oral contraceptives and those who have not. We have been unable to show that either taking oral contraceptives shortly before pregnancy or a high vitamin A level during the first trimester of pregnancy, comparable to that of a woman taking oral contraceptives, has any detrimental effect on the outcome of pregnancy. It seems unlikely that women who conceive soon after discontinuing oral contraception run any teratogenic risk from increased vitamin A levels. PMID:4812394

  13. Choosing the appropriate oral contraceptive.

    PubMed

    Langer, A; Devanesan, M; Pelosi, M A

    1978-06-01

    The estrogen and progestin in most oral contraceptives, regardless of amounts, can produce undesirable side effects in any woman. The convenience and effectiveness, however, make oral contraceptives an excellent birth control method for the correctly screened patient. The use of relatively small doses of estrogen combined with a progestin complementary to the estrogenic, progestogenic, and androgenic needs of the patient will reduce the risk of side effects. Above the 50 ug estrogen level there is significantly higher risk of pulmonary embolism, venous thrombosis, and cerebral thrombosis. Hypertension, depression and hepatic disorders are other potential side effects. Less serious complications are breakthrough bleeding, likely caused by low level estrogen dosage and amenorrhea. Progestogenic effects include sustained noncyclic weight gain and amenorrhea. Prescribing these agents necessitates adequate follow-up and willingness to alter the prescription.

  14. Recent innovations in oral contraception.

    PubMed

    Cremer, Miriam; Phan-Weston, Scarlett; Jacobs, Adam

    2010-03-01

    Traditional forms of oral contraception contain 21 days of hormone-containing pills and 7 days of placebo during the hormone-free interval (HFI). Since 2003, the Food and Drug Administration has approved 24/4, 84/7, and 365-day regimens. These regimens shorten the HFI in an attempt to decrease bleeding and menstrual-associated side effects. Safety and efficacy of these regimens is comparable with traditional 21/7 dosing. Extended regimens are associated with high patient satisfaction. Bleeding patterns are similar or shorter in women using extended regimens, along with improvement in menstrual symptoms. One of the new formulations contains the new progestin drospirenone, which has antimineralocorticoid and antiandrogenic properties. This review summarizes the data about new formulations of oral contraception available in the United Sates and also provides a summary of the current literature on drospirenone.

  15. Oral contraceptive compliance during adolescence.

    PubMed

    Serfaty, D

    1997-06-17

    A review of the available literature suggests that adolescent lack of compliance with oral contraceptives (OCs) is a multifactorial problem that requires a multifactorial solution. Because of their lack of experience with contraception, higher frequency of intercourse, higher intrinsic fertility, and pattern of frequent stopping or switching of methods, adolescents experience higher OC failure rates than do adult women. Adolescents also are more likely to forget to take the pill or to discontinue due to side effects, without consulting their physician. A survey of European young women identified contraceptive protection without weight gain as the most necessary change in OCs. Adolescents must be counseled not to miss a single pill, observe the pill-free interval, take phasic formulations in the right order, and use a back-up method in case of diarrhea and vomiting or when certain medications (e.g., antibiotics and anti-epileptics) are used concurrently, and be informed of steps to take in the event of side effects and unprotected intercourse. The quality of the counseling appears to be more important to compliance than the quantity of information provided. Pharmacists should complete the counseling initiated by the physician and explain prescription use. The most significant predictor of consistent OC use is the adolescent's motivation.

  16. In-depth survey report: control technology assessment of unit operations employed in oral-contraceptive tablet-making operations at Ortho Pharmaceutical Corporation, Raritan, New Jersey, June 13-17, 1983

    SciTech Connect

    Anastas, M.Y.; Caplan, P.E.; Froehlich, P.A.

    1983-11-01

    An on-site visit was made to the Ortho Pharmaceutical Corporation (OPC), Raritan, New Jersey to evaluate methods of controlling exposure to hazardous materials during the manufacturing of medications. OPC produced oral-contraceptive tablets containing norethindrone (NOR), mestranol, and ethynylestradiol (EE). Ventilation was an important engineering control at this site. Other engineering controls included the isolation of work procedures and automation of work practices for weighing ingredients, granulation of substances, tableting, and packaging. Area samples were taken for air monitoring of steroid concentration levels in each manufacturing area. Access to the work areas was only through the locker rooms. Samples taken in the locker rooms revealed no detectable contaminant levels. Workers performing high risk activities wore air supplied vinyl suits and disposable rubber gloves. The vinyl suits had overshoes attached. For moderate risk activities the workers wore a disposable suit, rubber gloves and shoe covers. Appropriate respirators were provided. Workers in low risk activities wore disposable rubber gloves and appropriate respirators. Sampling indicated that processing workers experienced breathing-zone levels outside their vinyl suits of 16.40 and 0.36 micrograms/cubic meter of NOR and EE, respectively.

  17. A clinical trial of Neo Sampoon vaginal contraceptive tablets.

    PubMed

    Begum, S F; Liao, W C; McCann, M F; Ahmad, N

    1980-12-01

    Results are reported of a clinical trial of Neo Sampoon vaginal contraceptive tablets, conducted by the International Fertility Research Program (IFRP) in collaboration with the Dacca Medical College Hospital, Bangladesh. Of the 150 women enrolled, 115 remained in the study at the end of 12 months. The 12-month cumulative gross life-table rates per 100 women were 6.5 for pregnancy and 24.8 for discontinuation due to other reasons. Discomfort associated with the heart generated by the tablets' effervescence was the primary side effect of Neo Sampoon use, and was one of the major causes of discontinuation. Regularity of use and acceptability of this foaming tablet appeared to be high compared to other barrier methods. Further research is needed on Neo Sampoon and other vaginal contraceptives to develop and promote methods that can help meet the worldwide demand for fertility control.

  18. Oral contraceptive marketing in Ibadan, Nigeria.

    PubMed

    Bamgboye, E A; Ladipo, O A

    1992-10-01

    The demographic transition in Nigeria is gradually moving towards the second stage. There is clear evidence of a declining mortality but the fertility rate remains exceptionally high. A realistic approach towards reducing fertility rate is the use of oral contraceptive. This study assesses the distribution system of oral contraceptive in Ibadan, the second largest city in Nigeria. The findings revealed that the people are aware of modern oral contraceptives as they purchase them freely at chemist shops. But effective distribution is hampered by existing channels and high costs. A local source recommended is the proprietary medicine stores, often at convenient locations to the potential users of contraceptives. The current cost which is between $1.3 and $19.5 per couple-years of protection is exorbitant, consuming 0.5-7.8% of the gross annual income of the average individual. Therefore, the government should subsidize the prices of oral contraceptives, to facilitate freedom from the tyranny of excessive fertility.

  19. Serum Vitamin B12 and Folate Levels in Women Taking Oral Contraceptives

    PubMed Central

    Mountifield, J. A.

    1986-01-01

    Serum vitamin B12 and erythrocyte folate levels were determined in a group of healthy women eating a balanced diet. Approximately 50% were using oral contraceptives. Vitamin B12 levels were lower in the oral contraceptive users. However, their folate levels were no different from those of non-users. Age had no effect on either vitamin B12 or folate levels. Oral contraceptive users taking multiple vitamin tablets containing vitamin B12 and folate had slightly higher folate levels, but their vitamin B12 levels were no different from those of OC users who were not taking vitamin tablets. Hemoglobin and hematocrit levels were not affected by oral contraceptive steroids. No case of megaloblastosis was found. Regular folate supplementation is not required for OC users. In fact, such supplementation may be dangerous. PMID:21267137

  20. Headache, migraine and oral contraceptives.

    PubMed

    1998-01-01

    Many physicians will not provide oral contraceptives (OCs) to women with a history of migraine due to concerns about increasing the risk of a cerebrovascular accident. The World Health Organization's revised medical eligibility criteria indicate that only women with serious migraine that includes focal neurologic symptoms should be cautioned against OC use. This article reviews the research evidence on headache, migraine, and OCs. The recent literature suggests that healthy, nonsmoking women using low-dose OCs (35 mcg of estrogen or less) have no increased risk of stroke. Although the presence of diabetes, hypertension, and/or migraine appears to be associated with an increased risk of cerebral thromboembolism, the use of OCs does not synergistically add to the risk. It is important, however, for physicians to differentiate between tension headaches, migraines with aura (classic migraine), and migraines without aura (common migraine). Women with classic migraine should avoid OCs if an alternative method of contraception can be used. Common migraine is not a contraindication to OC use, although the frequency and severity of headaches during OC use should be monitored. OC discontinuation should be discontinued, at least temporarily, if previously existing migraine suddenly worsens, headaches that are qualitatively different than the type usually experienced by the patient occur, headaches wake a patient from sleep, or double vision or loss of vision occur.

  1. Non-Contraceptive Benefits of Oral Hormonal Contraceptives

    PubMed Central

    Schindler, Adolf E

    2012-01-01

    Abstract It is becoming evident that oral hormonal contraceptives-besides being well established contraceptives-seem to become important medications for many functional or organic disturbances. So far, clinical effectiveness has been shown for treatment as well as prevention of menstrual bleeding disorders and menstrual-related pain symptoms. Also this is true for premenstrual syndrome (PMS) and premenstrual disphoric disorder (PMDD). Particular oral contraceptives (OCs) containing anti-androgenic progestogens were shown to be effective medications for treatment of androgenisation symptoms (seborrhea, acne, hirsutism, alopecia). Through perfect suppression of the hypothalamic-pituitary-ovarian axis OCs have proven to be effective in elimination of persistent follicular cysts. Endometriosis/adenomyosis related pain symptoms are well handled similar to other drugs like Gonadotropine Releasing Hormone agonists but are less expensive, with less side effects, and possibility to be used for longer periods of time. This is also true for myoma. Pelvic inflammatory disease, rheumatoid arthritis, menstrual migraine, and onset of multiple sclerosis are prevented or delayed. Bone density is preserved and asthma symptoms improved. Endometrial hyperplasia and benign breast disease can be controlled. There is definitely a significant impact on risk reduction regarding endometrial, ovarian, and colon cancers. In conclusion, it needs to be recognized that oral combined hormonal contraceptives (estrogen/ progestogen combination) are - besides being reliable forms of contraception - are cost-effective medications for many medical disorders in women. Therefore, these contraceptives drugs are important for female and global health and should be used in clinical practice. PMID:23853619

  2. Should oral contraceptives be available without prescription?

    PubMed

    Trussell, J; Stewart, F; Potts, M; Guest, F; Ellertson, C

    1993-08-01

    In this paper, it is argued that oral contraceptives should be available without prescription. Prescription status entails heavy costs, including the dollar, time, and psychological costs of visiting a physician to obtain a prescription, the financial and human costs of unintended pregnancies that result from the obstacle to access caused by medicalization of oral contraceptives, and administrative costs to the health care system. After a review and evaluation of the reasons for strict medical control of oral contraceptives in the United States, safety concerns anticipated in response to the proposal discussed here are addressed. Also, concerns that prescription status is necessary for efficacious use are evaluated. It is concluded that neither safety nor efficacy considerations justify prescription status for oral contraceptives. Revised package design and patient labeling could allow women to screen themselves for contraindications, to educate themselves about danger signs, and to use oral contraceptives safely and successfully. Several alternatives to providing oral contraceptives by prescription with current package design and labeling and selling them over the counter are suggested; the proposals discussed would make these safe and effective contraceptives easier to obtain and to use.

  3. Should oral contraceptives be available without prescription?

    PubMed Central

    Trussell, J; Stewart, F; Potts, M; Guest, F; Ellertson, C

    1993-01-01

    In this paper, it is argued that oral contraceptives should be available without prescription. Prescription status entails heavy costs, including the dollar, time, and psychological costs of visiting a physician to obtain a prescription, the financial and human costs of unintended pregnancies that result from the obstacle to access caused by medicalization of oral contraceptives, and administrative costs to the health care system. After a review and evaluation of the reasons for strict medical control of oral contraceptives in the United States, safety concerns anticipated in response to the proposal discussed here are addressed. Also, concerns that prescription status is necessary for efficacious use are evaluated. It is concluded that neither safety nor efficacy considerations justify prescription status for oral contraceptives. Revised package design and patient labeling could allow women to screen themselves for contraindications, to educate themselves about danger signs, and to use oral contraceptives safely and successfully. Several alternatives to providing oral contraceptives by prescription with current package design and labeling and selling them over the counter are suggested; the proposals discussed would make these safe and effective contraceptives easier to obtain and to use. PMID:8342715

  4. [Evolution of the Hungarian oral contraceptives].

    PubMed

    Seregély, G

    1992-11-01

    Author gives a review of the development of Hungarian oral contraceptives from the beginning to the present status. He describes the three main historical phases that means the high-dose combined pills, the low-dose compositions and the most modern two- and three-phasic preparations. Besides, he mentions the monohormonal mini-pills and the so-called postcoital pill, too. He refers to the fact that the Hungarian pharmaceutical research followed truly the international development in oral contraception, too.

  5. Oral Contraceptive Estrogen Content and Adverse Effects

    PubMed Central

    Russell, Margaret; Ramcharan, Savitri

    1987-01-01

    The 1985 Health and Welfare Canada Report on Oral Contraceptives recommended oral contraceptives (OCs) containing 30-35 mcg of estrogen rather than 50 mcg as the preferred dosage for contraception. Many family physicians may regard these guidelines as mandatory when prescribing OCs, because of a presumption that pills of 50-mcg estrogen content carry a higher risk of disease. In this article, the epidemiologic evidence pertaining to a dose-response relationship between the estrogen dose of oral contraceptives and disease is critically reviewed. The review indicates that there is no incontrovertible evidence to support such a relationship. Implications of the recommendations in the Report for physicians and patients are discussed. PMID:21263837

  6. Oral contraceptives and liver cancer.

    PubMed

    1997-11-01

    To date, nine case-control studies conducted in developed countries have identified an association between oral contraceptives (OCs) and liver cancer. The most recent population-based data from both developed and developing countries failed to confirm such an association, however. A study conducted by the World Health Organization in eight developing countries (Chile, China, Colombia, Israel, Kenya, Nigeria, Philippines, and Thailand), in which 122 women with liver cancer were matched with 802 controls, found no elevated risk for OC users compared with never-users (relative risk, 0.7; 95% confidence interval, 0.4-1.2). This study is particularly significant since it was conducted in countries where hepatitis B virus infection, an important risk factor for primary liver cancer, is widespread. In addition, population mortality data from the US, UK, Japan, and Sweden have failed to document increases in liver cancer cases coincident with increases in OC use. Given that population statistics can detect changes on the magnitude of a 40-50% decrease in the risk of ovarian and endometrial cancer related to OC use, they should be able to detect increases of two to 20 times the risk of liver cancer. The increased risk of liver cancer found in the case-control studies may reflect bias resulting from the small size of these studies.

  7. Pharmacologic considerations for patients taking oral contraceptives.

    PubMed

    Hassan, T

    1987-03-01

    This is a brief review of the theoretical and known drug reactions with oral contraceptives. There are at least 6 possible types of drug reactions that may affect the action of oral contraceptives, not including malabsorption related to changes in intestinal motility or flora. Ampicillin is an example of an antibiotic that may cause diarrhea, thereby reducing absorption of pill steroids. The steroids in orals are subject to enterohepatic circulation, which is in turn affected by the gut flora. Antibiotics known to suppress gut flora include: penicillins, cephalosporins, tetracyclines, sulfas, neomycin and erythromycin. Although controlled clinical trials of antibiotic intake with oral contraception have not shown significant interactions, anecdotal reports of pill failures have been published. The other important drug interaction affecting contraception by orals is enhanced hepatic degradation, as seen with rifampicin. Other drugs such as cimetidine, MAO-inhibitor antidepressants, chloramphenicol, influenza or BCG vaccine, isoniazid, warfarin, metronidazole and disulfiram may delay steroid metabolism and possibly increase side effects. When prescribing drugs it is important to realize that certain drugs decrease oral contraceptive concentrations: antibiotics anticonvulsants, griseofulvin, purgatives and rifampicin.

  8. Effect of antibiotics on oral contraceptive efficacy.

    PubMed

    Zachariasen, R D

    1991-09-01

    It is estimated that there are currently 10 million women in the United States who are taking oral contraceptives on a daily basis. Although the actual number is not known, it is also estimated that a large number of these same women are on concomitant drug therapy. In recent years, there has been a number of published reports linking a loss of contraceptive efficacy with the concurrent administration of other drugs, including antibiotics. Because of the common practice of prescribing antibiotics in dentistry, oral healthcare providers should be aware of the possibility of oral contraceptive failure with antibiotic treatment. Since it is often the dental hygienist who interviews patients and assists them in completing their health questionnaire, she or he can play an important role in educating and counseling these patients in possible drug interactions. This article reviews the published incidence of oral contraceptive/antibiotic interaction, along with a discussion of the possible mechanisms by which this interaction occurs. Recommendations are also presented for the oral health management of women taking oral contraceptives and other prescribed drugs.

  9. 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.

  10. Oral contraceptives and breast cancer.

    PubMed

    Johnson, K H; Millard, P S

    1996-10-01

    The Collaborative Group on Hormonal Factors in Breast Cancer conducted a meta-analysis of data from 10 cohort and 44 case-control studies of the association between combined oral contraceptive (OC) use and breast cancer. 53,297 women with breast cancer and 100,239 women with no breast cancer from 25 countries worldwide were studied. Current OC users faced a 24% increased risk of developing breast cancer (confidence interval = 1.15-1.33). This risk fell steadily after cessation and reached 0 at 10 years and thereafter. Use of OCs with higher doses were associated with a greater risk of breast cancer than medium or low-dose OCs. The number of excess cancers in women while using OCs and up to 10 years after OC cessation stood at 0.5/10,000 women 16-19 years old, 1.5/10,000 women 20-24 years old, and 4.7/10,000 women 25-29 years old. The elevated risk of developing breast cancer did not differ by country of origin, ethnic background, reproductive history, or family history of breast cancer. OC users had less clinically advanced breast cancer than never-users who had breast cancer. This finding plus the moderate reduced risk of breast cancer more than 10 years after OC cessation suggest that OCs may effect earlier diagnosis of existing breast cancer instead of causing new breast cancers. The findings of this meta-analysis along with a plausible biologic mechanism (estrogen stimulates breast cancer cells) suggest a causal relationship between OC use and breast cancer. They also indicate that the risk is small, decreases with time, and is lower among low-dose OC users. It is reassuring that the breast cancers found among OC users is less clinically advanced than those found in never-users.

  11. Choosing a combined oral contraceptive pill

    PubMed Central

    Stewart, Mary; Black, Kirsten

    2015-01-01

    Summary The combined oral contraceptive pill is an effective contraceptive method which can also offer other benefits. However, other contraceptive options should be discussed. If the pill is the chosen method, prescribe a pill with the lowest effective dose of oestrogen and progestogen. Pills containing levonorgestrel or norethisterone in combination with ethinyloestradiol 35 microgram or less are considered first-line. They are effective if taken correctly, have a relatively low risk of venous thromboembolism, and are listed on the Pharmaceutical Benefits Scheme. The pill is usually taken in a monthly cycle. Some women may prefer an extended pill regimen with fewer or no inactive pills. PMID:26648603

  12. The risks of oral contraceptive pills.

    PubMed

    Pymar, H C; Creinin, M D

    2001-12-01

    Oral contraceptive pills have been associated with increased risk for myocardial infarction, stroke, and venous thromboembolism. Studies have been published recently that suggest that these risks are minimal in appropriately chosen low-risk women. Stroke is a very uncommon event in childbearing women, occurring in approximately 11 per 100,000 women over 1 year. Thus, even a doubling of this risk with oral contraceptive pills would have minimal effect on attributable risk. The estimated risk of myocardial infarction associated with oral contraceptive pill use in nonsmokers is 3 per million women over 1 year. The estimated risk of venous thromboembolism attributable to oral contraceptive pills is less than 3 per 10,000 women per year. Additionally, the literature suggests that there may be an increased risk of breast cancer associated with long-term oral contraceptive pill use in women under the age of 35. However, because the incidence of breast cancer is so low in this population, the attributable risk of breast cancer from birth control pill use is small.

  13. The Emotional Responses of Married Women Receiving Oral Contraceptives

    PubMed Central

    Ringrose, C. A. Douglas

    1965-01-01

    One hundred women taking oral contraceptives were questioned concerning their opinions about personal and sociological effects of this method of conception control. Fifty-three per cent reported improved coital satisfaction while 4% noted the opposite effect. Libido was increased in 22% and decreased in 13%. One woman in five believed that an increase in premarital and extramarital sexual activity would take place in the general population as a result of tablet-induced infertility. The problem of population control is discussed. It is paradoxical that the incidence of unplanned pregnancies continues to increase despite the availability of completely reliable conception control. This reflects present inability to communicate contraceptive knowledge to the appropriate people. PMID:14292887

  14. Procedures to improve prescribing and dispensing of oral contraceptives at an academic medical center.

    PubMed

    Rafie, Sally; Choy, Karla A

    2012-02-01

    An initiative to improve procedures and safeguards for inpatient oral contraceptive use at an academic medical center is described. A retrospective chart review was conducted to determine patterns of oral contraceptive use and potential areas for quality improvement. During the six-month period covered by the chart review, a total of 95 oral contraceptive orders were placed for 55 patients, mainly for continuation of home contraception (24% of cases) and other indications unrelated to the patients' primary diagnoses, such as menorrhagia (23% of cases); more than 1 in 5 (22%) of those orders were for non-formulary products, and about 35% of the prescribed regimens called for multiple daily dosages. The evaluation also focused on pharmacy procedures for stocking and dispensing oral contraceptives, as well as procedures for processing oral contraceptive orders through the computerized prescriber-order-entry (CPOE) system. In addition to discrepancies in the numbers and types of oral contraceptive products on the formulary and in pharmacy inventories, the review identified suboptimal CPOE controls and dispensing practices that posed an undue risk of nurse confusion and administration errors. Pursuant to the evaluation, a number of system and procedural changes were recommended, approved by the medical center's pharmacy and therapeutics committee, and implemented. A review of existing processes for the use of oral contraceptives led to the identification of several strategies to improve prescribing and dispensing practices. Strategies to improve medication safety included reducing the number of oral contraceptive products on the formulary, modifying the CPOE system to restrict ordering to formulary products, dispensing only tablets that contain active drug, and repackaging oral contraceptives in unit dose form.

  15. [Health risks of oral contraceptives].

    PubMed

    Meier, Christoph R

    2011-06-01

    Oral contraceptives (OC) are either composed of a combination of an estrogen derivative (usually ethinly estradiol) and a progestogen, or they contain a progestogen only. OC are characterized by a high effectiveness and have a low failure rate if taken correctly. Most women tolerate OC relatively well, but adverse effects do occur which are driven by the estrogen dose as well as by the type of progestogen. The most frequently reported adverse effects are nausea or vomiting, breast tenderness, headache or inbalanced mood, but these unwanted side effects are often transient. The fear of weight gain of many OC users is not necessarily supported by data from studies which report relatively little differences in body mass index on average during OC use. Nevertheless, substantial weight gain can occur in individual women. The widely discussed fear of breast cancer is also not justified, and the risk of developing ovarian or endometrial cancer is reduced for women who use OC on a regular basis. Venous thromboembolism (VTE) is the adverse effect with the greatest potential for serious harm if pulmonary embolism develops. This rare, but potentially dangerous adverse effect of OC has been discussed emotionally for many years and keeps attracting a lot of public interest. VTE is rare in young women, but the VTE risk is increased two- to sixfold for OC users as compared to non-users. The VTE risk increases with increasing estrogen dose, is highest in the first year of use, and is higher for OC from the third generation (containing desogestrel, gestodene or norgestimate) than for OC from the second generation (containing levonorgestrel) or than for the progestogen-only pill. According to most studies, OC containing the progestogens drospirenone or cyproterone acetate are similar with regard to VTE risks than OC from the third generation. Individual genetic susceptibility affecting the clotting system plays a major role in the risk of developing VTE in combination with OC, and

  16. Use of combined oral contraceptives and headaches.

    PubMed

    Simonienė, Diana; Vanagienė, Virginija; Zilaitienė, Birutė; Vanagas, Tadas

    2011-01-01

    The study was designed to examine the certain patterns of combined oral contraceptive use in women of childbearing potential and evaluate the relationship between the use of combined oral contraceptives and headaches, bad habits, type of work, and concomitant diseases. In total, 194 randomly selected women aged 18 to 40 years who visited a gynecologist for preventive gynecological examination were surveyed. Respondents were categorized as combined oral contraceptive users (n=116; study group) and nonusers (n=78; control group). An anonymous questionnaire developed by the authors of this study and a standardized scale called the Migraine Disability Assessment Scale (MIDAS) were used for the survey. A multivariate logistic regression analysis demonstrated a significantly higher prevalence of combined oral contraceptive use in women older than 20 years (odds ratio, 6.0; 95% CI, 2.6-14), better educated women (odds ratio, 5.7; 95% CI, 2.1-15.2), and women reporting a steady sexual partner (odds ratio, 4.0; 95% CI, 1.5-11.0). Relationship between headaches and use of combined oral contraceptives as well as other factors were analyzed in a group of 178 respondents; the rest 16 respondents reported not having headaches at all. The prevalence of reported minimal-to-mild and moderate-to-severe impact of headaches on daily activities did not differ significantly between the study and control groups, women with and without bad habits, and white-collar and blue-collar groups (P>0.05). However, women with concomitant diseases significantly more often reported moderate-to-severe impact on daily activities due to headaches (P<0.01). Differences in impact of headaches on daily activities between women using combined oral contraceptives containing 20 or less μg of ethinylestradiol and 30 or more μg of ethinylestradiol did not differ significantly. The prevalence of combined oral contraceptive use was higher in women older than 20 years, better educated women, and women reporting

  17. Residual ovarian activity during oral steroid contraception.

    PubMed

    van Heusden, A M; Fauser, B C J M

    2002-01-01

    Steroid drugs with contraceptive properties have been available in the clinical setting for over four decades and are still subject to improvement. Estrogens, progestins and anti-progestins have been used alone or in various combinations, regimens and routes of administration to favour the balance between efficacy and undesirable effects. One of the most important changes in this respect is the gradual lowering of steroid dosage in commercially available contraceptives. Current steroid contraceptive pills still achieve the goal of suppression of pituitary-ovarian activity, but the margins for error are minimal. In this review the available data on modes of action and the effects on suppressing pituitary-ovarian activity by different forms of oral contraception are reassessed. Although pregnancy rates provide a crude measure of contraceptive efficacy, no benchmark for pituitary-ovarian inhibition is available to test the suppressive potential of contraceptive drugs. Consequently, many studies provide incomplete and/or incomparable results. For the further study of those forms of steroid contraception that rely predominantly on suppression of ovarian activity, prevention of dominant follicles selection should be the objective.

  18. Oral contraceptives in the treatment of acne.

    PubMed

    Tan, J K; Degreef, H

    2001-02-01

    Oral contraceptives (OCs) can reduce acne by lowering the production of adrenal and ovarian androgens, by inhibiting 5-alpha-reductase, which in turn, reduces the levels of dihydrotestosterone, and by stimulating sex hormone binding globulin (SHBG), thus reducing the levels of free testosterone. In newer OCs, such as Tricyclen and Diane-35, the progestin component is minimally androgenic and anti-androgenic respectively, thereby enhancing the favorable profile of these products in the treatment of hyperandrogenic disorders, including acne. The efficacy of these agents and their long-term safety profile supports their use in various grades of acne in females: * As adjunctive therapy to topical agents for women with mild non-scarring acne desiring oral contraception * As primary therapy for patients with moderate non-scarring acne in combination with topical therapy and systemic antibiotics * As one of two preferred methods of contraception in patients with scarring and severe inflammatory acne being treated with systemic isotretinoin.

  19. [Oral contraception and circulatory risks].

    PubMed

    Wingrave, S J

    1984-10-01

    The longterm prospective study of health effects of oral contraceptives (OCs) conducted by the Royal College of General Practitioners compared 23,000 OC users with 23,000 controls matched for age and marital status. As of 1981, 55 deaths attributable to circulatory problems had occurred in ever-users of OCs, ciompared to 10 in controls, giving a relative risk of 4.2 for OC users. No relation was found between duration of use and mortality risk among users, although mortality risks were greater at all durations of use than for nonusers. Parity was related to mortality risk among users but not among controls. The most significant factors affecting the relation between pill use and circulatory risk were age and smoking. Among users who smoked, the risk ratios were 3.4 for those aged 25-34, 4.2 for those aged 35-44, 7.4 for those aged 45 and over, and 5.1 for the entire group. Among nonsmoking pill users, the ratios were 1.6 for those aged 25-34, 3.3 for those aged 35-44, 4.6 for those 45 and over, and 3.2 for the total sample. Among smokers, the rates of excess deaths were 1 in 10,000 for users aged 15-34, 1 in 2000 for those aged 35-44, and 1 in550 for those aged 45 and over. Among nonsmokers, the rates were 1 in 50,000 users for those aged 25-34, 1 in 6700 for those aged 35-44, and 1 in 2500 for those aged 45 and over. The majority of deaths were attributed to ischemic cardiac problems and to sub-arachnoid hemorrhages, and risks appeared to be elevated in former as well as current users. The total incidence of circulatory effects in former users appears to be elevated only for cerebrovascular disorders, but the suggestion of residual effects requires further study before conclusions can be drawn. Smokers who developed cardiovascular or cerebrovascular problems were at 2-3 times greater risk of dying than were other women. The percentages of fatal cases of ischemic heart and cerebrovascular diseases were 22.8% among ever-users who smoked, 10.9% among controls who

  20. 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…

  1. 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…

  2. Oral contraceptives and vitamins: a review.

    PubMed

    Larsson-Cohn, U

    1975-01-01

    The literature concerning the influence of estrogen-containing oral contraceptives on vitamins is reviewed. The appearance of an elevated plasma concentration of vitamin A is probably without clinical importance, while there seems to be a clear connection between disturbances of vitamin B6 metabolism and mental symptoms. Low levels of folic acid and vitamin B12 have also been noted. Despite this, it is very rare that hematologic abnormalities develop during hormonal contraception. A reduced concentration of vitamin C in plasma and blood corpuscles has been reported. The clinical significance of these alterations is unknown.

  3. Do oral contraceptives increase epileptic seizures?

    PubMed

    Reddy, Doodipala Samba

    2017-02-01

    Hormonal contraceptives are used by over 100 million people worldwide. Recently, there has been an emerging interest in studying the potential impact of oral contraceptives (OCs) on certain neurological conditions. It has been suspected for some time that hormonal birth control increases seizure activity in women with epilepsy, but there is little supportive data. Areas covered: Literature from PubMed and online sources was analyzed with respect to hormonal contraception and epilepsy or seizures. New evidence indicates that OCs can cause an increase in seizures in women with epilepsy. The epilepsy birth control registry, which surveyed women with epilepsy, found that those using hormonal contraceptives self-reported 4.5 times more seizures than those that did not use such contraceptives. A preclinical study confirmed these outcomes wherein epileptic animals given ethinyl estradiol, the primary component of OCs, had more frequent seizures that are more likely to be resistant. Expert commentary: OC pills may increase seizures in women with epilepsy and such refractory seizures are more likely to cause neuronal damage in the brain. Thus, women of child bearing age with epilepsy should consider using non-hormonal forms of birth control to avoid risks from OC pills. Additional research into the mechanisms and prospective clinical investigation are needed.

  4. [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.

  5. 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.

  6. Vitamins and oral contraceptive use.

    PubMed

    Wynn, V

    1975-03-08

    Reports concerning the interaction between steroidal contraceptives (the combined pill) and vitamins indicate that in users the mean serum-vitamin-A level is raised and the mean serum-vitamin-B2 (riboflavine), vitamin-B6 (pyridoxine), vitamine-C, folic-acid, and vitamin-B12 levels are reduced. Other vitamins have been insufficiently studied for comment. Biochemical evidence of co-enzyme deficiency has been reported for vitamin B2, vitamin B6, and folic acid. Clinical effects due to vitamin deficiency have been described for vitamin B6--namely, depression and impaired glucose tolerance. Folic-acid deficiency with megaloblastic anaemia has been reported in only 21 cases.

  7. [Emotional changes under oral contraceptives].

    PubMed

    Prill, H J; Heister, R

    1971-02-05

    278 women on the pill were investigated by means of a questionnaire concerning emotional instability associated with the therapy. The majority reported emotional changes, although 90% did not consider these changes to interfere significantly in their lives. The chief complaints were emotional instability (40.3%), increased need for sleep (39.5%), diminished personal drive (22%), moodiness (26.5%), increased appetite (33.2%), and decreased libido (34.7%). Emotional instability and lack of drive were found to increase with prolonged treatment, in contrast to the general assumption that side effects of the pill decrease or disappear after the 1st few cycles of treatment. The reported emotional symptoms could be due to increased activity of monoamino-oxidase; changes in the enzyme and steroid metabolism system may also play a role. For these patients preparations with low progesterone dosages, sequential treatments, or other contraceptive methods are recommended.

  8. Pancreatitis, multiple infarcts and oral contraception

    PubMed Central

    Foster, M. E.; Powell, D. E. B.

    1975-01-01

    The fact that oral contraceptives may predispose to thrombosis is not disputed, although its frequency is still debated. Any reliable assessment of the prevalence of this complication must in the main depend on careful statistical studies of well controlled groups, because the isolated case may well be coincidental when conditions such as coronary thrombosis, cerebral thrombosis, and pulmonary embolism are not extreme rarities in adult women. However, occasionally the clinical and pathological findings are so striking that they afford compelling evidence. The patient to be described presented with clinical features of pancreatitis that did not initially suggest an association with oral contraception. A hitherto undescribed state of multiple infarcts was found at post-mortem. This also illustrates the way in which the official figures for thrombotic complications can be underestimated. ImagesFig. 1 PMID:1197171

  9. Loss of oral contraceptive efficacy by concurrent antibiotic administration.

    PubMed

    Zachariasen, R D

    1994-01-01

    There are approximately 10 million women in the United States who are currently taking oral contraceptives on a daily basis. Although the actual number is not known, it is also estimated that a large number of these same women are on concomitant drug therapy. In recent years there have been a number of published reports linking a loss of contraceptive efficacy with the concurrent administration of other drugs, including antibiotics. Whereas the actual risk of drug interaction between antibiotics and oral contraceptives is yet unknown, it is important that women who are on oral contraceptive therapy be aware of possible contraceptive failure. This article reviews the published incidence of oral contraceptive/antibiotic interaction, along with a discussion of the possible mechanisms by which this interaction occurs. Recommendations are also presented for the health management of women taking oral contraceptives and other prescribed drugs.

  10. Erythema nodosum and oral contraceptive therapy.

    PubMed

    Winkelman, R K

    1978-04-03

    A generalized erythema nodosum developed in a 17 year old girl receiving oral contraceptive therapy, which was immediately discontinued. The erythema failed to respond to tetracycline, potassium iodide or prednisone therapy (partially successful), and recurred 6 times, usually just before menstruation. The recommended therapy is bed rest, salicylates and 10 cm roller elastic bandages. No medication can help in the face of unrestricted physical activity.

  11. 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…

  12. 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…

  13. [Headache and oral contraceptives (author's transl)].

    PubMed

    Farias Da Silva, W; Benicio, G

    1978-01-01

    175 patients using oral contraceptives (OCs) for periods from 2 months-6 years were studied. A survey was made of the secondary effects of the treatment. Among the total group, 101 of them had not presented headache before the use of contraceptives, and the remaining 75 patients had previously complained of chronic headaches which were considered due to different etiologies. 50 patients from the group without previous headache claimed that OC treatment marked the initiation of the headaches. 25 had vascular headaches and 25 had tension headaches. Among the 75 patients included in the other group as complainers of chronic headache prior to treatment, 30 had a worsening of the symptoms after use of the OCs. The authors compare their results with those referred to in the literature. (author's)

  14. Taste masking microspheres for orally disintegrating tablets.

    PubMed

    Xu, Jianchen; Bovet, Li Li; Zhao, Kang

    2008-07-09

    The purpose of this study was to evaluate the potential of microspheres for taste masking when incorporated into orally disintegrating tablets. The microspheres were produced by spray drying a mixture of the model compound (famotidine) with taste masking material. The spray process was optimized using a central composite design for two variables to obtain microspheres with desirable characteristics. Then the microspheres were mixed with other excipients to form orally disintegrating tablets. The optimal spray-drying process parameters were 34mg/ml for solid concentration and 7ml/min for feed rate. The drug encapsulation efficiency of the spray-dried microspheres ranges from of 37.59 to 61.56%, with a mean diameter of less than 10microm size and low moisture content (less than 4%). Results from an evaluation by a panel of six human volunteers demonstrated that the orally disintegrating tablets with taste masking microspheres improved the taste significantly. Furthermore, an in vivo study in rats showed that the microspheres neither decrease the bioavailability nor retard the release of famotidine significantly. In conclusion, spray-dried microspheres can effectively mask the bitter taste of the active pharmaceutical ingredients in combination with the orally disintegrating tablets.

  15. 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

  16. Long term effects of oral contraception.

    PubMed

    Koetsawang, S; Chiemprasert, T; Premyodhin, M

    1972-01-01

    This study attempts to assess the long-term effects of oral contraceptives on Asian women. At the Family Planning Clinic, Siniray Hospital, Thailand, 181 of the more than 800 women who had used oral contraceptives for more than 4 years prior to May 31, 1971, were studied. All had completed premedical examinations before beginning the drugs. In addition to being studied for changes in body weight, blood pressure, hematocrit, liver function, thyroid function, oral glucose tolerance, and blood urea nitrogen, they were interviewed on their experience with oral contraception. Most were between ages 25-29 years, had only primary education, were housewives, and more than half were in the lower income group. Living children ranged from 1 to 10 with 52.5% having 4 or more. They had been started on a variety or oral contraceptives but in the last 2 years all were given Ovral (norgestrel .5 mg with ethinyl estradiol .05 mg). A total of 10,830 cycles were recorded. Only 9 requested anotehr method. Culdoscopic tubal sterilization was done on 6 and 3 discontinued because they wanted to get pregnant. All had heard rumors of adverse effects but few believed them because 89.3% had no adverse effects. 81.2% said they were in better physical and mental condition because of absence of pregnancy and a majority reported better socioeconomic status. Neurotic complaints were noted in 6.1%. Libido was unchanged in a majority, decreased in a few, but rarely increased. Weight gain of 2.5 kg or more was present in 68%. Slight increase in blood pressure was noted in 17.1%, mostly in those starting with increased pressure. Hematocrit values changed only slightly may have been due to other causes. Liver function tests showed prolonged bromsulphthalein retention in a considerable number. Thyroid function tests were normal except for increased TBG level in 17.8%. Carbohydrate metabolism remained normal in all but a few. Pretreatment glucose tolerance tests not been recorded. Normal findings were

  17. [Venous thromboembolic disease and oral contraceptives].

    PubMed

    Overgaard, K; Hauch, O; Lidegaard, O

    1986-09-08

    Ever since 1961, there has been discussion on possible thromboembolic effects from the use of oral contraceptives. The purpose of this Danish study was to determine if birth-control pill users did have an increased risk of venous thromboembolic disease (VTD), including deep venous thrombosis and pulmonary embolism. In previous research, morbidity from VTD has been found to show a great variance, as high as 1/330 woman years in 1 study to as low as 1/5,000 woman years in another. In these studies no significant difference was found between users and non-users of oral contraceptives. Only in 1 study was there found to be increased morbidity from VTD among pill users: 1/5,200 woman years, compared with 1/35,000 woman years for non-pill users. As a possible explanation of the pill's effect, several studies have demonstrated a rise in certain coagulation factors, increased fibrinogen and lowered antithrombin III. In the present study, medical records of all women aged 34 or under who had been referred to a Copenhagen hospital between 1981 and 1983 for treatment of phlebographic-or lungescintographic-confirmed VTD were investigated. After controlling for exclusion factors, there remained 35 test subjects between the ages of 16 and 34 (median age 22). Of the 22 cases of known etiology, 16 suffered from iatrogenic VTD. Of 13 women who suffered from VTD of unknown etiology, 69% were pill users, compared with only 29% (a significant difference) in a background-population interview study conducted in Denmark during 1983. With a known disposition to VTD, oral-contraceptive usage meant a relative risk of 0.9 for developing the disease, which figure conforms well with other cited research (in which the risk factor varied from 0.4 to 3.8).

  18. Patient counseling women using oral contraceptives.

    PubMed

    Dominguez, Celia E

    2007-06-01

    Oral contraceptives (OCs) are the most widely used form of reversible birth control in the United States. However, incorrect and/or inconsistent use may result in increased failure rates and unintended pregnancies, which present a significant cost burden to the health care system and HMOs. One of the best mechanisms to improve outcomes is through high-quality clinician-patient communication. Managed care organizations may benefit from encouraging their providers to counsel and educate patients on the proper use of OCs, as this may reduce unnecessary follow-up visits, lower the number of unintended pregnancies, and increase patient satisfaction with their health care.

  19. Evaluation of smartphone oral contraceptive reminder applications.

    PubMed

    Gal, Noga; Zite, Nikki B; Wallace, Lorraine S

    2015-01-01

    Oral contraceptives (OCs) are the most widely used contraceptive method among women of reproductive age in the United States (US). Routine download and use of health-related smartphone applications (apps) continues to increase. The purpose of this study was to evaluate the utility of English-language, smartphone-platform OC reminder apps currently available for download in the US. During June-July 2013, official Internet-based, mobile app platforms for the two major smartphone operating systems in the US-Android (Google Play Store) and iPhone (iTunes)-were searched. "Birth control," "the pill," and "contraception" were entered into the search-bar of each Smartphone store. Apps were assessed for the following: cost, health care professionals' involvement in app development, reminder mechanisms, and functionality. Of the 39 unique OC reminder apps meeting inclusion criteria, 7 (18%) did not operate as intended when downloaded. Most apps functioned without an Internet connection (97%) and included pop-up notifications (84%). Certain app features overcome common causes of missing an alarm, and hypothetically, may minimize likelihood of an OC user missing a daily pill. Health care providers should inform users of potential pitfalls and advise them that an OC reminder app should be not be used as a sole reminder method. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. Striae distensae of augmented breasts after oral contraceptive therapy.

    PubMed

    Har-Shai, Y; Barak, A; Taran, A; Weissman, A

    1999-02-01

    A case of striae distensae (SD) of bilateral augmented breasts following oral contraceptive therapy is presented. Striae maturation and the prevention of additional skin marks was achieved with immediate cessation of oral contraceptive pill therapy and long-term daily topical application of tretinoin cream. It is suggested that patients who are candidates for breast augmentation surgery should be informed of the possible risk of developing SD if they are taking or planning to take the contraceptive pill.

  1. 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…

  2. 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…

  3. Estrogen potency of oral contraceptive pills.

    PubMed

    Chihal, H J; Peppler, R D; Dickey, R P

    1975-01-01

    The estrogen potencies of 9 oral contraceptive pills, Enovid-E, Enovid-5, Ovulen, Demulen, Norinyl+80, Norinyl+50, Ovral, Norlestrin 1 mg. and Norlestrin 2.5 mg., were determined by bioassay. Relative estrogen potency was determined by analysis of variance. Enovid-5, the most estrogenic compound, had a potency of 4.88 compared to ethinyl estradiol, 50 mcg. equal 1.00; Ovral, the least estrogenic compound, had a potency of 0.81, a sixfold difference. Estrogen potencies at a fractional dose of 0.00155 correlate with reports of the incidence of minor side effects and thromboembolic disease. The effect of progestins on estrogen potency was purely additive (norgestrel and norethynodrel), purely antagonistic, or additive at low concentrations and antagonistic at high concentrations (norethindrone, norethindrone acetate, and ethynodiol diacetate). These results suggest that pills with a greater margin of safety might be developed by utilizing greater ratios of progestin to estrogen. In addition, differences in relative estrogen potency of oral contraceptive pills may be used as a basis for better clinical selection.

  4. Oral contraceptive labeling disclosure of possible benefits.

    PubMed

    1982-02-17

    Oral contraceptive (OC) labeling disclosure of possible benefits from use of the products, was recommended by the U.S. Food and Drug Administration's (FDA) Fertility and Maternal Health Drugs Advisory Committee at its February 11 meeting. Committee member Howard Orr, Centers for Disease Control, noting the emphasis on cautionary and warning statements contained in current OC labeling maintained: "Women should make informed decisions and this is the other half. The package insert must include the benefits information." The recommendation by the committee represents a shift in the approach to what constitutes proper labeling for OC products. Since first approved, the drugs have never carried a discussion of benefits on their labels. "A number of additional benefits from OCs--other than contraception--have emerged from the large number of studies recorded in the literature on OC use," Ron Nelson, White Memorial Medical Center, stated. "Studies cited a more regular and lighter menstrual flow, resulting in less blood loss and lower iron deficiency and anemia in contraceptive pill users, and dysmenorrhea and premenstrual tension have been sifnificantly reduced." "Ovarian cysts and pelvic inflammatory disease occurred less frequently in pill users than in controls," Nelson continued, "and the incidence of fibrocystic disease of the breast were less. There are some instances where OCs may incur protection against the development of ovarian cancer, endometrial cancer, and rheumatoid arthritis." Orr added: "I think there are 2 good studies that show almost a total elimination of ectopic pregnancy with women who took the pill. Given that now there's an epidemic of the disease going around, I think it's worth adding." The committee was asked by FDA last November to recommend changes in the current physician and patient OC labeling. FDA's Solomon Sobel, MD, Endocrine and Metabolic Drugs Division, told the committee that an agency subcommittee would review the recommendations

  5. Oral contraception for women of middle age.

    PubMed

    Ruan, Xiangyan; Mueck, Alfred O

    2015-11-01

    Women at middle age have decreased fertility and their pregnancies are higher risk. Combined oral contraceptives (COC) are effective but confer increased risk of age-related diseases, especially cardiovascular diseases. These risks are lower, however, with progestogen-only pills (POP). Therefore, other than the levonorgestrel intrauterine device (LNG-IUD), POP are usually the first choice, even though they do often lead to bleeding problems, which are already frequent in the perimenopause. However, the main risk of COC, venous thromboembolism, seems not to be relevant in (non-hospitalized) Chinese women and perhaps also other Asian women. COC may therefore be in fact a better choice than POP for these groups. In contrast to POP and IUDs, they have a variety of benefits especially important for middle-aged women, including a large decrease of the risk of ovarian, endometrial and colorectal cancer, an improvement in bleeding irregularities, a reduction of climacteric symptoms and some protection against bone loss. Further research is needed into individualized and safe contraception that takes into account ethnicity, as well as other factors.

  6. The combined oral contraceptive pill -- recent developments, risks and benefits.

    PubMed

    Dragoman, Monica V

    2014-08-01

    The introduction of the birth control pill as an effective, coitally-independent method of contraception was a public health milestone of the last century. Over time, combined oral contraception (COC) formulations and pill-taking regimens have evolved with improved safety and tolerability while maintaining contraceptive efficacy. In addition to protection against pregnancy, use of combined oral contraception confers a number of significant non-contraceptive benefits to users. COC use is also associated with well-studied risks. Common side effects are generally self-limiting and improve with increasing duration of use while serious adverse events, including venous thromboembolism, are rare among healthy COC users. Contraceptive decision-making should include consideration of both the risks and benefits of a given method versus the real consequences of unintended pregnancy.

  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. Compliance and oral contraceptives: a review.

    PubMed

    Rosenberg, M J; Burnhill, M S; Waugh, M S; Grimes, D A; Hillard, P J

    1995-09-01

    Compliance difficulties are more common among oral contraceptive (OC) users than generally appreciated by clinicians, in part because unintended pregnancy is a relatively infrequent consequence and in part because more common manifestations such as spotting and bleeding may not be recognized as resulting from poor compliance. While improving compliance is a shared responsibility of patients, clinicians, and manufacturers, the clinician is the focal point for these efforts. Counseling must be individualized, which requires knowledge of factors that predict compliance and an understanding of the patient's decision-making process as it relates to medications. Most OC compliance research has focused on adolescents, where predictors of poor compliance include multiple sex partners, low evaluation of personal health, degree of concern about pregnancy, and previous abortion. Good compliance has been linked with patient satisfaction with the clinician, the absence of certain side effects, establishing a regular daily routine to take OCs, and reading information distributed with OC packaging.

  9. Oral contraceptive pills and clinical otosclerosis.

    PubMed

    Podoshin, L; Gertner, R; Fradis, M; Feiglin, H; Eibschitz, I; Sharf, M; Reiter, A

    1978-01-01

    Clinical otosclerosis is a familial disease which is more frequent among women in their reproductive years. The condition usuallly is aggravated by pregnancy. Endocrinologic variables may influence the time of onset and the course of the disease. It is suspected that oral contraceptives (OCs) might stimulate the onset of the disease. Six hundred nulliparous women between the ages of 16 and 30, who used a variety of OCs for 12-36 months, were examined. The hearing of these women was thoroughly investigated. The first audiometric examination of the 600 women revealed three cases (0.5%) of clinical otosclerosis. This incidence is equal to that of the population as a whole, but lower than the incidence found in previously parous women. Audiometric examinations were normal in the remaining 597 women, and repeated examinations revealed no new cases of clinical otosclerosis, despite continuous OC use.

  10. Oral contraceptives and the prothrombin time.

    PubMed

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

    1980-02-02

    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.

  11. Oral contraceptives and the risk of thrombosis and atherosclerosis.

    PubMed

    Barton, Matthias; Dubey, Raghvendra K; Traupe, Tobias

    2002-03-01

    Oral contraceptives containing synthetic oestrogens have been used successfully as birth control for > 40 years and are currently prescribed to > 100 million women worldwide. Several new progestins have been introduced and the third generation of progestins has now been available for two decades. Oral contraceptives are prescribed over a prolonged period of time and therefore substantially impact on hormonal, metabolic and plasmatic functions. Oral contraceptives increase the risk for venous thrombosis and pulmonary embolism, particularly if associated with confounding factors, such as genetic predisposition, smoking, hypertension or obesity. The risk of developing coronary artery disease is also increased in users with cardiovascular risk factors. This article discusses mechanistic and clinical issues and reviews the need for novel approaches targeting the considerable side effects in order to reduce cardiovascular morbidity in women using oral contraceptives.

  12. Oral Contraception: A Survey of College Women's Concerns and Experience.

    ERIC Educational Resources Information Center

    Sawyer, Robin G.; Beck, Kenneth H.

    1989-01-01

    Results are reported from a study which examined attitudes, experiences, and concerns of college women (N=237) regarding oral contraception. Implications of the findings for health educators are discussed. (IAH)

  13. Megaloblastic anemia in a vegetarian taking oral contraceptives.

    PubMed

    Green, J D

    1975-02-01

    A case is reported of megaloblastic anemia resulting from folate deficiency in a vegetarian who had been taking oral contraceptives for eight years. A brief report of the pertinent literature is included,

  14. [Oral contraceptives: recent safety studies (author's transl)].

    PubMed

    Edgren, R A

    1983-09-01

    Considerable research evidence now exists to suggest that the risks of oral contraceptive (OC) use were seriously overestimated in earlier work. Because experimentation in medicine is never possible in the rigorous sense in which it is employed in basic sciences, other sources of information must be substituted. Information on the dangers of OC use has come from anecdotal reports, retrospective case control studies, prospective cohort studies, and statistical analyses of deaths, each source being associated with specific problems of interpretation. Recent findings of the Royal College of General Practitioners, the Walnut Creek Study, and the Oxford Study have suggested a lowered incidence of malignant neoplasms in OC than in IUD or diaphragm users; a reduced incidence of breast cancer although the relationship did not consistently achieve statistical significance, and a reduced incidence of ovarian and endometrial cancer. The risks of cervical cancer among OC users appeared slightly higher but disappeared when sexual behavior was controlled. Despite much concern with the possibility of postpill amenorrhea and perhaps sterility among women discontinuing OC use, it now appears that after 2 years there is no difference in the fertility of women who have discontinued use of OCs, IUDs, or diaphragms. Use of OCs as a contraceptive before pregnancy does not appear to be associated with fetal malformations, spontaneous abortion, or perinatal mortality, and the inadvertent use of OCs in early pregnancy is apparently associated with only a very slight risk of anomalies. Recent studies of cardiovascular disease risks indicate that the relative risks of cardiovascular disease among OC users have been greatly exaggerated, especially when smoking is taken into account. Various studies of mortality data have failed to establish a link between OC use and excess mortality from cardiovascular disease.

  15. Menstrual nirvana: amenorrhea through the use of continuous oral contraceptives.

    PubMed

    Edelman, Alison

    2002-12-01

    Medically induced amenorrhea has been used successfully in women who have medical conditions that worsen during menstruation. Menstrual suppression through the use of continuous oral contraceptives has been proven to be safe, effective, and extremely acceptable to women. Women without medical indications for menstrual suppression may find medically induced amenorrhea to be a significant improvement in their quality of life. Greater satisfaction with use of oral contraception may encourage compliance and increase the prevalence of pill-related health benefits.

  16. Physician attitudes toward over the counter availability for oral contraceptives.

    PubMed

    Howard, David L; Wall, Jeffrey; Strickland, Julie L

    2013-12-01

    To assess physician attitude towards making oral contraceptives available over the counter in the United States (US). We assessed physician attitudes towards a transition from prescription only to over-the-counter availability (rx-OTC) for oral contraceptive pills by disseminating an electronic survey directed primarily to residents training in Obstetrics and Gynecology (OBGYN) and Family Practice in the US. An overwhelming majority of 638 respondents (71 %) were against an rx-OTC switch for combined oral contraceptives and among this subset of respondents the primary concern was safety (92.3 %). Overall, respondents were evenly divided on the issue of an rx-OTC switch for progestin-only-pills but of those who opposed, 73.2 % cited safety as their primary concern. For progestin-only-pills female respondents were more likely to support OTC availability. Most OBGYN and Family Practice residents opposed to OTC availability for oral contraceptives cite safety as their primary concern. Considering the abundant evidence as to the overall safety of oral contraceptives, especially progestin-only-pills, there appears to be a knowledge deficit among OBGYN and Family Practice residents regarding the safety of oral contraceptives.

  17. Oral contraceptives and antibiotics: important considerations for dental practice.

    PubMed

    Gibson, J; McGowan, D A

    This paper considers the possible interactions between oral contraceptive pills and antibiotics, in the context of modern dental practice. A review of the literature on such interactions leads to the conclusion that current national guidelines on the use of alternative contraceptive measures during a course of broad spectrum antibiotics in women also using the oral contraceptive pill should be emphasised and encouraged as part of good clinical practice. A patient information leaflet may be considered as a useful way of presenting such advice to female patients.

  18. The identification, selection and use of oral contraceptives.

    PubMed

    Flowers, C E; Griffith, S F

    1975-01-01

    Facts about oral contraceptives and their use are provided for the practcing generalist and specialist. Identification of oral contraceptives is given in chart form including company, name, contents, pill color, number in pack and special markings. Section 2 entitled "facts that may be helpful in prescribing or changing the prescription of oral contraceptives" includes potency of progestins and estrogens and symptoms indicating excessive or deficient progestin and estrogen activity. Contraindications such as migraine headaches, epilepsy, hepatic disease, renal disease and hypertension are among the reasons for obtaining a complete family history prior to prescription of oral contraceptives. This information provides the basis for choice of contraception tailored to the individual. A 100 pound 17 year old with a normal menstrual history and with adequate estrogen production would be safest with a medication low in estrogen and progestin. An older heavier woman with prolonged menstruation and cramps would require a pill which is potent in progestins since these are excellent for causing endometrium regression and vascular reduction. Length of time on oral c ontraceptives depends upon the patient's general health. If responding well to contraceptives the patient should continue to use them because 1) the body is programmed for lengthy periods of ovulation suppression; 2) the patient becomes accustomed to infertility and 3) too many unplanned pregnancies occur during rest intervals. Complaints of nausea, migraine headaches, change in libido, chloasma or thrombophlebitis determine the termination of the drug.

  19. [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.

  20. 21 CFR 310.501 - Patient package inserts for oral contraceptives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... comparing the effectiveness of oral contraceptives to other methods of contraception. (4) A boxed warning... indications in addition to contraception that are identified in the professional labeling for the drug...

  1. 21 CFR 310.501 - Patient package inserts for oral contraceptives.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... comparing the effectiveness of oral contraceptives to other methods of contraception. (4) A boxed warning... indications in addition to contraception that are identified in the professional labeling for the drug...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... comparing the effectiveness of oral contraceptives to other methods of contraception. (4) A boxed warning... indications in addition to contraception that are identified in the professional labeling for the drug...

  3. 21 CFR 310.501 - Patient package inserts for oral contraceptives.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... comparing the effectiveness of oral contraceptives to other methods of contraception. (4) A boxed warning... indications in addition to contraception that are identified in the professional labeling for the drug...

  4. 21 CFR 310.501 - Patient package inserts for oral contraceptives.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... comparing the effectiveness of oral contraceptives to other methods of contraception. (4) A boxed warning... indications in addition to contraception that are identified in the professional labeling for the drug...

  5. Oral Health and Oral Contraceptive - Is it a Shadow behind Broad Day Light? A Systematic Review

    PubMed Central

    Patthi, Basavaraj; Singla, Ashish; Gupta, Ritu; Dhama, Kuldeep; Niraj, Lav Kumar; Kumar, Jishnu Krishna; Prasad, Monika

    2016-01-01

    Introduction Oral contraceptives are one of the risk factors for gingival disease. Oral contraceptives can affect the proliferation of cell, growth and differentiation of tissues in the periodontium. Nowadays recent research has suggested that the newer generation oral contraceptives have less influence on gingival diseases. Aim The purpose of this study was to systematically review the effect of oral contraceptives on periodontium. Materials and Methods A literature review was performed; PubMed, PubMed Central and Cochrane Library, Embase, Google Scholar were searched from 1970 up to December 2015 to identify appropriate studies. Results Out of the total 94 titles appeared 13 articles fulfilled the criteria and were selected for the review. Two articles which were hand searched and one article which was through e-mail was also included. The hormones progesterone and estrogen have direct impact on immune system of the body and thus, affect the pattern and rate of collagen production in the gingiva. Furthermore, the review also shows that longer duration usage of oral contraceptive could lead to poorer oral hygiene status, gingival inflammation and increased susceptibility to periodontal disease. Conclusion There are relatively few studies evaluating the effect of oral contraceptives on periodontium. It was found that oral contraceptives have a marked effect on periodontium. The gingival changes after use of oral contraceptives are pronounced in the first few months and with the passage of time these changes get enhanced. PMID:28050520

  6. Contraception

    PubMed Central

    McMahon, Sharon; Hansen, Lisa; Mann, Janice; Sevigny, Cathy; Wong, Thomas; Roache, Marlene

    2004-01-01

    Health Issue Contraception choices affect the long-term sexual health and fertility of women and men. Data from the 1998 Canadian Contraception Study and the 2000/2001 Canadian Community Health Survey were assessed for measures of contraceptive use and familiarity with various methods among Canadian women. Key Findings The oral contraceptive (OC) pill is the dominant method of contraception for Canadian women. Canadian women demonstrate high awareness of the benefits of condom use, but 75% are unaware of the female condom. Among youth, condom use drops as OC use increases. Contraception use in sexually active females aged 15–17 is fairly high, but use is inconsistent. Sexually active adolescent females report high awareness of emergency contraception but poor knowledge of the time frame within which it is most effective. Women aged 35–44 are more familiar with and likely to choose sterilization than younger women. There has also been a shift away from tubal ligation in favour of vasectomies. Data Gaps and Recommendations National data to guide policy and program development are limited. More data are needed on contraception use among males, and factors affecting accessibility, adherence and negotiation of choice. The importance of dual protection, and correct and consistent use of the chosen contraceptive method must be communicated to younger Canadians, as well as health care providers and educators. All women of reproductive age should be made aware of emergency contraception methods and increased efforts on sexual health promotion and education are required. Further research is essential to develop expanded contraceptive choices. PMID:15345088

  7. Factors affecting the enterohepatic circulation of oral contraceptive steroids.

    PubMed

    Orme, M L; Back, D J

    1990-12-01

    Oral contraceptive steroids may undergo enterohepatic circulation, but it is relevant for only estrogens, because these compounds can be directly conjugated in the liver. Animal studies show convincing evidence of the importance of the enterohepatic circulation, but studies in humans are much less convincing. The importance of the route and the rate of metabolism of ethinyl estradiol are reviewed. Some antibiotics have been reported anecdotally to reduce the efficacy of oral contraceptive steroids, but controlled studies have not confirmed this observation. Although gut flora are altered by oral antibiotics, the blood levels of ethinyl estradiol are not reduced, and one antibiotic at least (cotrimoxazole) enhances the activity of ethinyl estradiol.

  8. 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

  9. Chlamydia trachomatis and oral contraceptive use: a quantitative review.

    PubMed Central

    Cottingham, J; Hunter, D

    1992-01-01

    OBJECTIVES--Chlamydia trachomatis is now recognised as a major sexually transmitted disease; oral contraceptive use is rapidly increasing particularly in developing countries. There are thus important public health implications of the many reports that isolation of C trachomatis is more frequent among users of oral contraceptives. The aim of this analysis was to assess the strength and consistency of this association by summarising published studies between 1972 and 1990. DESIGN--Studies identified were grouped according to whether they were prospective or case-control studies. Data were extracted and pooled estimates of the unadjusted odds ratios were made for all studies, as well as for sub-groups defined by an index of study quality, background prevalence of C trachomatis, and the contraceptive comparison being made. LOCATION--Studies in the analysis were mainly conducted in Europe and North America; the meta-analysis was done at the Harvard School of Public Health, Boston, MA, USA. RESULTS--The pooled estimated unadjusted odds ratio for 29 case-control studies examined was 1.93 (95% CI, 1.77-2.11), indicating an almost twofold increased risk of chlamydial infection for oral contraceptive users. Neither study quality nor prevalence of C trachomatis modified this risk. When compared to the use of barrier contraceptives, however, the risk of infection for women using oral contraceptives increased to 2.91 (95% CI, 1.86-4.55). The pooled estimated protective effect of barrier methods in these studies was 0.34 (95% CI, 0.22-0.54). CONCLUSIONS--Cross-study comparisons of the relationship between oral contraceptive use and chlamydial infection are limited by the design and analysis of many component studies which did not control for confounding factors such as sexual behaviour and age. The almost twofold risk of increased chlamydial infection for oral contraceptive users, supported by the findings of two prospective studies, however, points to the importance of

  10. Female sexual dysfunction with combined oral contraceptive use.

    PubMed

    Lee, Jean Jasmin M L; Tan, Thiam Chye; Ang, Seng Bin

    2017-06-01

    Combined oral contraceptive pills (COCs) remain one of the most popular forms of contraception to prevent unwanted pregnancy in women. While it is known that COCs can cause sexual dysfunction in women, there is currently no recommendation to screen for sexual function before and after initiation of COCs. We propose that, based on the evidence available, assessment of sexual function should be done at initiation of COCs, as well as at regular intervals thereafter. This would allow COC-related sexual dysfunction to be managed early, such as by switching the patient to newer-generation COCs or other forms of contraception. Copyright: © Singapore Medical Association.

  11. Colonic Crohn's disease and use of oral contraception.

    PubMed Central

    Rhodes, J M; Cockel, R; Allan, R N; Hawker, P C; Dawson, J; Elias, E

    1984-01-01

    The prevalence of use of oral contraception before the onset of disease was established in 100 consecutive women attending follow up clinics for inflammatory bowel disease. A significant excess of women with Crohn's disease confined to the colon had taken oral contraceptives in the year before developing symptoms (10/16 (63%] compared with women with small-intestinal Crohn's disease (12/49 (24%); p less than 0.02) and women with ulcerative colitis (3/35 (9%); p less than 0.0005). When the patient groups were matched for age and year of onset of disease usage of oral contraception before the onset of disease was still more common among women with isolated colonic Crohn's disease (9/12, 75%) than among those with ulcerative colitis (2/12 (17%); p less than 0.02) and was also more common than would be expected from reported figures for oral contraception in England and Wales (31.4% of women aged under 41; p less than 0.005). A survey of current patient records showed that isolated colonic disease was at least twice as common among women with Crohn's disease (63/218, 29%) compared with men (25/181, 14%; p less than 0.001). These data support the suggestion made previously that oral contraceptives may predispose to a colitis that resembles colonic Crohn's disease. PMID:6421392

  12. Factors affecting the association of oral contraceptives and ovarian cancer.

    PubMed

    Cramer, D W; Hutchison, G B; Welch, W R; Scully, R E; Knapp, R C

    1982-10-21

    We investigated the relation between epithelial ovarian cancer and the use of oral contraceptives in a case-control study of 144 white women under the age of 60 who had ovarian cancer and 139 white women under 60 who were selected from the general population. We observed a decreased risk for ovarian cancer associated with the use of oral contraceptives in subjects 40 through 59 years of age at the time of the study. The relative risk, adjusted for parity, was 0.11, with 95 per cent confidence limits of 0.04 to 0.33. In contrast to the findings in older women, a decreased risk for ovarian cancer associated with oral-contraceptive use was not found in women under 40. In this group, the adjusted relative risk associated with any use of oral contraceptives was 1.98, with 95 per cent confidence limits of 0.74 to 5.27. The lowest risk for ovarian cancer associated with the use of oral contraceptives was observed in older parous subjects and in women who had discontinued use more than 10 years previously.

  13. Reversed-phase high-performance liquid chromatography for the determination of steroid hormones in oral contraceptives.

    PubMed

    Bond, A M; Heritage, I D; Briggs, M H

    1984-12-19

    Reversed-phase high-performance liquid chromatography with UV detection is studied for the determination of both progestogenic and oestrogenic components of oral contraceptive formulations. The applicability of the assay is demonstrated for a number of different progestogen-oestrogen combinations in both conventional tablet and novel "paper" formulations. The results show that the method developed is a versatile technique for the routine assay of these pharmaceutical formulations.

  14. [Lipids, lipoproteins, arterial accidents and oral contraceptives].

    PubMed

    Bakir, R; Hilliquin, P

    1986-01-01

    This work reviews lipoprotein metabolism and relationships to atherosclerosis, examines the nature of arterial accidents and lipid modifications that occur with oral contraceptive (OC) use, and assesses the practical consequences for OC prescription. Cholesterol, triglycerides, and phospholipids are not soluble in aqueous milieus, and their transport in plasma is provided by macromolecules comprising a protein part and a lipid part. 5 types of these lipoproteins are distinguished by their relative richness in lipids and protein and by the nature of their proteins. The chylomicrons carry exogenous triglycerides to the peripheral tissues and cholesterol of dietary origin to the liver. Very low density lipoprotein (VLDL) cholesterol is secreted by the liver and transports triglycerides and cholesterol of endogenous origin. Low denisty lipoprotein (LDL) cholesterol originates in the degradation of VLDL cholesterol and transports cholesterol to the cells. High density lipoprotein (HDL) cholesterol is secreted by the liver and intestines or formed in the course of degradation of chylomicrons and VLDL cholesterol. Its role is to carry excess cholesterol in the peripheral tissues to the liver for elimination in the bile. Cholesterol thus follows 2 different pathways in the body: a path from the liver to the peripheral cells, whose markers are LDL and VLDL cholesterol and the plasma apoprotein B, and a path of return of excess cholesterol from the tissues and especially the arteries to the liver, marked by HDL cholesterol and the plasma apoprotein A. Only a proper balance between the 2 flows can prevent an excess of cholesterol in the arteries and the consequent constitution of atherosclerotic lesions. LDL and to a lesser extent VLDL cholesterol are strongly and positively correlated to atherogenic risk, while HDL cholesterol is negatively correlated to risk, independently of other risk factors. Arterial accidents occurring with OC use do not seem to be atheromatous in

  15. Effect of oral contraceptives on sebum excretion rate.

    PubMed Central

    Pye, R J; Meyrick, G; Pye, M J; Burton, J L

    1977-01-01

    Oral contraceptives containing a high dose of oestrogen reduce the sebum excretion rate (SER) and improve acne vulgaris, but more progestogenic preparations may exacerbate acne. The effect on the SER of several oral contraceptives with varying progestogenic potencies was studied in 81 women. The predominantly progestogenic pills (Eugynon 30, Gynovlar) produced no significant change in SER, whereas the rate in women taking a more oestrogenic pill (Minovlar) was significantly reduced compared with the rate in controls. Progestogens therefore do not exacerbate acne by inducing seborrhoea, but in the doses we studied they nullified the inhibitory effect of oestrogens on the sebaceous glands. Acne-prone women who require an oral contraceptive should be given a predominantly oestrogenic preparation. PMID:145268

  16. Lifetime cancer risk and combined oral contraceptives: the Royal College of General Practitioners' Oral Contraception Study.

    PubMed

    Iversen, Lisa; Sivasubramaniam, Selvaraj; Lee, Amanda J; Fielding, Shona; Hannaford, Philip C

    2017-06-01

    Oral contraceptives have been used by hundreds of millions of women around the world. Important questions remain regarding the very long-term cancer risks that are associated with oral contraception. Despite previous research, important questions remain about the safety of these contraceptives: (1) How long do endometrial, ovarian, and colorectal cancer benefits persist? (2) Does combined oral contraceptive use during the reproductive years produce new cancer risks later in life? (3) What is the overall balance of cancer among past users as they enter the later stages of their lives? The purpose of this study was to examine the very long-term cancer risks or benefits associated with the use of combined oral contraceptives, including the estimated overall life-time balance. The 46,022 women who were recruited to the UK Royal College of General Practitioners' Oral Contraception Study in 1968 and 1969 were observed for up to 44 years. Directly standardized rates of specific and any cancer were calculated for "ever" and "never" users of combined oral contraceptives; data were standardized for age, parity, social class, and smoking. Attributable risk and preventive fraction percentages were calculated. Poisson regression that adjusted for the same variables was used to estimate incidence rate ratios between ever and never users and to examine effects by time since last oral contraceptive use. There were 4661 ever users with at least 1 cancer during 884,895 woman-years of observation and 2341 never users with at least 1 cancer during 388,505 woman-years of observation. Ever use of oral contraceptives was associated with reduced colorectal (incidence rate ratio, 0.81; 99% confidence interval, 0.66-0.99), endometrial (incidence rate ratio, 0.66; 99% confidence interval, 0.48-0.89), ovarian (incidence rate ratio, 0.67; 99% confidence interval, 0.50-0.89), and lymphatic and hematopoietic cancer (incidence rate ratio, 0.74; 99% confidence interval, 0.58-0.94). An increased

  17. [Fast-disintegration oral tablets having sustained release property].

    PubMed

    Jin, Yi; Ohkuma, Hideki; Wang, Hua; Natsume, Hideshi; Sugibayashi, Kenji; Morimoto, Yasunori

    2002-11-01

    Fast-disintegrating (FD) tablets containing nicorandil-loaded dry emulsions were prepared and their controlled-release properties were examined and compared with the plain FD tablets (FD tablets without dry emulsions) and commercial tablets. The dry emulsions were prepared with myristyl alcohol and stearyl alcohol and their property was modified by mixing the ratio of the two alcohols. Disintegration time of the prepared FD tablets was sufficiently fast (i.e., 12 to 23 s). In vitro release of nicorandil from the FD tablets containing the dry emulsions was sustained over 6 h, while that from plain FD and commercial tablets was complete within 5 min. In vivo absorption of nicorandil from the tablets was evaluated by oral administration in beagle dogs. FD tablets containing dry emulsions showed a similar AUC, lower Cmax, and delayed Tmax compared to the plain FD and commercial tablets. These results suggest that the dry emulsion-loaded FD tablets can be utilized to improve the sustained-release property of active drugs.

  18. [Oral contraception in 1983 (author's transl)].

    PubMed

    Castadot, R G

    1982-11-01

    Recent studies have demonstrated new benefits of pill use, reduced risks associated with the minipill, and the possibility of screening out high risk women. The minipill is as effective as other formulations except in cases of chronic malnutrition or concomitant use of antibiotics or anticonvulsives. Oral contraceptives (OCs) frequently lessen menstrual problems. They prevent functional cysts in the ovaries, and reduce the incidence of benign breast tumors and the relative risk of developing ovarian cancer after 3 years of use. Combined OCs reduce the risk of endometrial cancer although sequentials increase it. OCs offer protection against salpingitis and other pelvic infections, against tubal pregnancies, and against chronic rheumatoid arthritis. Minipills appear to be less frequently associated with bothersome side effects than other OCs. The most significant risk of OCs is of death due to thrombo emboli of venous origin, myocardial ischemia, cerebrovascular accidents, and hypertension in women over 35, particularly those who smoke heavily. In 1981 the 2 British studies reported a reduced risk from these causes compared to results published in 1977. Estrogens are clearly responsible for some of the complications, apparently due to a weakening of the fibrinolytic systems, but progestagens or estrogen-progestagen combinations are also implicated. Arterial hypertension and cerebral and cardiac accidents appear to be due to the effect of progestagens on arterial tension, glucose metabolism, and the level of high density lipoprotein cholesterol. Risks of some liver diseases are elevated in pill users, but the question of tumors of the pituitary is not yet resolved. The incidence of uterine cancer appears to be elevated in pill users although the association is obscured by other factors. Some evidence exists of an association between estrogen-progestagen formulations and melanoma. No increase in abortion or fetal malformations except possibly an increase in twin

  19. Newer oral contraceptives and the risk of venous thromboembolism.

    PubMed

    Walker, A M

    1998-03-01

    Research on the relationship between venous thromboembolism and the progestagen content of combined oral contraceptives has pointed to an increase in risk associated with products containing desogestrel and gestodene. Although many biases must have been at play in these nonexperimental studies, the errors that have been suggested and examined are not of a sufficient magnitude to account for the observed results. The most plausible explanation of the available data is that combined oral contraceptives containing desogestrel and gestodene carry a very small risk of venous thromboembolism, which exceeds the even smaller risk carried by products containing levonorgestrel. The position of norgestimate is uncertain.

  20. Oral Contraceptives and Increased Formation of Soluble Fibrin

    PubMed Central

    Pilgeram, L. O.; Ellison, J.; Bussche, G. Von Dem

    1974-01-01

    Soluble fibrin was measured weekly for two months in 12 normal women and in 12 women on combined oestrogen-progestogen therapy (Ortho-Novin, Norinyl, Enavid, Ovral, Ovulen, Demulen). Plasma soluble fibrin concentration in women on oral contraceptives showed an increase of 97·2% (P <0·001) above that of normal women. In three cases, where each woman on the oral contraceptive served as her own control, stopping medication led to a return to normal of the plasma content of soluble fibrin. PMID:4414937

  1. 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

  2. Myocardial infarction and stroke in young women: what is the impact of oral contraceptives?

    PubMed

    Lewis, M A

    1998-09-01

    Recent discussions have centered on the small apparent risk increase for venous thromboembolism found with newer oral contraceptives (third-generation oral contraceptives containing the progestins desogestrel and gestodene) compared with older oral contraceptives (second-generation). This article reviews the studies addressing the association between oral contraceptive use and thromboembolic conditions affecting the arterial system, ischemic stroke, and myocardial infarction. Differences are found between a US database study, which showed no risk of ischemic stroke or myocardial infarction associated with low-dose oral contraceptive use, and the European studies, which showed oral contraceptive use in general to be associated with increased risks of ischemic stroke and myocardial infarction. The European studies showed no difference between oral contraceptive generations with respect to the occurrence of ischemic stroke; however, the risk of myocardial infarction associated with oral contraceptive use was consistently lower for third- than for second-generation oral contraceptives. Although there seems to be no differential risk of ischemic stroke associated with oral contraceptive generations, third-generation oral contraceptives appear to be consistently associated with no excess risk of myocardial infarction. In all instances, however, cardiovascular risk factors other than oral contraceptive use play the predominant role in the occurrence of ischemic stroke and myocardial infarction.

  3. Ziprasidone and the pharmacokinetics of a combined oral contraceptive

    PubMed Central

    Muirhead, G J; Harness, J; Holt, P R; Oliver, S; Anziano, R J

    2000-01-01

    Aims To determine whether multiple doses of ziprasidone alter the steady-state pharmacokinetics of the component steroids, ethinyloestradiol and levonorgestrel, of an oral contraceptive; to evaluate the tolerability of a co-administered combined oral contraceptive and ziprasidone; and to compare plasma concentrations of prolactin in subjects taking a combined oral contraceptive with placebo or ziprasidone. Methods Nineteen women taking a combined oral contraceptive (ethinyloestradiol 30 µg day−1 and levonorgestrel 150 µg day−1) were enrolled into a double-blind, placebo-controlled, two-way crossover study. They received ziprasidone 40 mg day−1 in two divided daily doses or placebo for 8 days (days 8–15) in one of two 21 day treatment periods separated by a 7 day washout period. Venous blood samples were collected immediately before and up to 24 h after the morning dose of oral contraceptive and ziprasidone or placebo on day 15 of each 21 day treatment period. These were assayed for ethinyloestradiol and levonorgestrel and the resulting data used to derive pharmacokinetic data for these steroids. Additional samples were collected immediately before and 4 h after the morning dose of oral contraceptive and ziprasidone or placebo on day 15 of each 21 day treatment period for prolactin assay. All observed and volunteered adverse events were recorded throughout the study. Results The mean AUC(0,24 h), Cmax and tmax for ethinyloestradiol and the mean AUC(0,24 h) and Cmax for levonorgestrel during ziprasidone co-administration were not statistically significantly different from corresponding values occurring during placebo co-administration. The tmax for levonorgestrel was approximately 0.5 h longer. Concomitant therapy with a combined oral contraceptive and ziprasidone did not result in adverse events not previously seen with either preparation alone. Conclusions The findings of this study suggest that, based on pharmacokinetic and tolerability data, ziprasidone

  4. Combined oral contraceptives: a comprehensive review.

    PubMed

    Kiley, Jessica; Hammond, Cassing

    2007-12-01

    Millions of women use birth control pills for contraceptive and noncontraceptive reasons. Although there have been reports of rare adverse events, birth control pills do offer well-documented health benefits, including a decrease in the risk of ovarian and endometrial carcinoma. In addition, manufacturers continue to modify birth control pills to reduce side effects and medical risks.

  5. [Place of persistence trouble during oral contraception and subsequent use of emergency contraception].

    PubMed

    Jamin, C; Lachowsky, M

    2015-10-01

    In order to improve the understanding of hormonal contraceptive failures, this study evaluates the persistence of oral contraception and the use of emergency contraception (EC) during persistence incidents. We made the hypothesis of the existence of a strong link between the risk of unplanned pregnancies and these two parameters. In this study, we also evaluated women's perception of EC in order to elucidate the reasons of EC insufficient use. One survey was carried out on Internet on a representative sample of women, aged 16-45. In this survey, 3775 French women were interviewed (source-population). We defined a target population of 2415 fertile women who had heterosexual intercourse during the last 12 months, and a population of 760 women at risk of unintended pregnancy who had unprotected sexual intercourse during the last 12 months(risk-population). A little more than 30% of the target population, meaning 20% of the source-population (n=745) stopped their contraceptive method temporarily for an average time of two months. Almost 60% of women had a risk of unwanted pregnancy during this period without contraception, which is 59% of the risk-population. Only 20% of women among the population at risk used EC. The main reasons given for EC insufficient use were the misperception of the risk of pregnancy, the lack of knowledge about EC and its way of use. For the first time, this survey shows that 13% of women (of the source population) decide to stop temporarily their contraceptive method for an average time of two months per year. Fifty-nine percent of unplanned pregnancy situations are due to this poor contraception persistence. Although there is a need to reduce the risk of women being at risk, it seems also highly desirable to overcome the consequences of this poor persistence. Giving information about EC and a systematic prescription during contraception consultations would lead to an increased use of EC. Copyright © 2014 Elsevier Masson SAS. All rights

  6. Oral contraceptive risks: a realistic appraisal.

    PubMed

    Bressler, R; Durand, J L

    1979-10-01

    Reports regarding the question of whether oral contraceptive (OC) use enhances the risk of cancer or one of several serious cardiovascular disorders, i.e., thromboembolic disease, stroke, and myocardial infarction are reviewed. In 1974 the Royal College of General Practitioners (RCGP) issued an interim report of a large prospective study involving 46,000 women. The study found a 5-fold increase in the risk of deep venous thrombosis among women taking OCs. Laboratory studies have tried to establish a direct causal relationship between OC use and altered hemostatis. In review of these studies, Bingel and Benoit reported an increased incidence of thromboembolism in OC users with blood group A. Other hemostatic alterations in OC users were also noted. Other investigators have examined the effect of OCs on antithrombin 3. In 1 study, the inhibitory activity of antithrombin 3 on factor X was significantly reduced among 57 women using the combined OCs, but there was no substantial difference in the quantity of antithrombin 3 in these women as compared with 48 women in the control group. In 1 retrospective case control study of 60 surgical patients with complications of pulmonary embolism or venous thrombosis, the risk of postoperative thromboembolism was 6.7 times greater in OC users than in 97 well matched surgical controls. The RCGP study showed that the risk of cerebrovascular disease in women using OCs was 4 times greater than in nonusers. This finding was substantiated by the Boston-based Collaborative Group for the Study of Stroke in Young Women, which observed a 2-fold increase in risk for all types of stroke among OC users. Several studies have demonstrated that serum lipids are higher in women who use OCs than in those who do not, with estrogen being implicated as the cause of the elevation. Other studies have attempted to link serum lipid elevations to myocardial infarction, but the association is unclear. Both epidemiological and laboratory studies have

  7. Phototoxic reaction to a combined oral contraceptive (levonorgestrel/ethinylestradiol).

    PubMed

    Richarz, N A; Aguilera, J; Castillo, G; Fuente, M J; Ferrándiz, C; Carrascosa, J M

    2017-09-13

    We present the case of a phototoxic skin reaction due to the regular intake of a combined oral contraceptive (levonorgestrel/ethinylestradiol). Upon spectrophotometer testing, we demonstrated high absorption in the UV-B region of the solar spectrum of the combined product (Ovoplex®), especially for the estrogen compound (ethinylestradiol).

  8. 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…

  9. 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…

  10. Oral Contraceptives and Bone Health in Female Runners

    DTIC Science & Technology

    2006-10-01

    that a history of stress fractures, lower bone mass, lower dietary calcium intake, younger chronological age, younger age at menarche, and possibly a... history of irregular menstrual periods were associated with an increased risk. 15. SUBJECT TERMS bone mass, oral contraceptives, physical activity...year decrease). Although not statistically significant, a history of irregular menstrual periods was also associated with increased rate of stress

  11. Oral contraceptives and gynecologic cancer: an update for the 1990s.

    PubMed

    Kaunitz, A M

    1992-10-01

    The most recent statistical evidence confirms a protective effect of oral contraceptive use against ovarian and endometrial cancers. Studies of the association between oral contraceptive use and cervical cancer continue to be hampered by confounding factors; however, results suggest that the overall risk of invasive cervical neoplasia is not increased. Although the association between oral contraceptive use and breast cancer remains controversial, existing data strongly suggest that overall risk of breast cancer is not increased by the use of oral contraceptives. In most candidates for oral contraceptive use, the benefits greatly outweigh the risks.

  12. Association of oral contraceptive use, other contraceptive methods, and infertility with ovarian cancer risk.

    PubMed

    Tworoger, Shelley S; Fairfield, Kathleen M; Colditz, Graham A; Rosner, Bernard A; Hankinson, Susan E

    2007-10-15

    Although oral contraceptives are protective for ovarian cancer, it is unclear how long this protection persists. The authors prospectively assessed this question as well as associations of other, less studied contraceptive methods (tubal ligation, rhythm method, diaphragm, condoms, intrauterine device, foam, spousal vasectomy) and infertility with ovarian cancer risk among 107,900 participants in the US Nurses' Health Study. During 28 years of follow-up (1976-2004), 612 cases of invasive epithelial ovarian cancer were confirmed. Duration of oral contraceptive use was inversely associated with risk (p-trend = 0.02), but no clear trend was observed for years since last use. However, for women using oral contraceptives for >5 years, the rate ratio for ovarian cancer for 20 years since last use (rate ratio (RR) = 0.92, 95% CI: 0.61, 1.39). Tubal ligation (RR = 0.66, 95% CI: 0.50, 0.87) was associated with decreased ovarian cancer risk, whereas intrauterine device use (RR = 1.76, 95% CI: 1.08, 2.85) and infertility (RR = 1.36, 95% CI: 1.07, 1.75) were associated with an increased risk. Results suggest that the beneficial effect of oral contraceptives on ovarian cancer risk attenuates after 20 years since last use. Furthermore, tubal ligation, intrauterine device use, and infertility were associated with ovarian cancer risk.

  13. Speech Articulation of Low-Dose Oral Contraceptive Users.

    PubMed

    Meurer, Eliséa Maria; Fontoura, Giana Valeria Fagundez; Corleta, Helena von Eye; Capp, Edison

    2015-11-01

    In the female life cycle, hormonal fluctuations may result in impaired verbal efficiency and vocal worsening during the premenstrual phase. Oral contraceptives may interfere with vocal range. Voice, resonance, and articulation variations clarify speech content. To investigate the phonoarticulatory sounds produced by oral contraceptive users aged between 20 and 30 years. This is a cross-sectional study. Our study included four groups of women (n = 66): two groups used low-dose oral contraceptives and two groups did not use any oral contraceptives. Questionnaires and sound records were used. Acoustic analysis was performed using the Computerized Speech Laboratory program, Model 4341 (Kay Elemetrics Corp, Lincoln Park, New Jersey). The statistical analysis of the SPPS database, version 13.0, was performed by means of generalized estimating equation. In the groups that did not use oral contraceptives, sustained vowel tones were more acute in the two phases and cycles of women older than 25 years (w/oOC1, 175 ± 74 to 190 ± 55 Hz; w/oOC2, 194 ± 56 to 210 ± 32 Hz). At the midfollicular phase (Fph) and midluteal phase (Lph) of the two cycles, the speed of the speech was slower in this group (w/oOC1: Fph, 5.3 ± 1.6/s and Lph, 5.4 ± 1.4/s; w/oOC2: Fph, 4.5 ± 1.7/s and Lph, 4.8 ± 1.1/s). In both groups that used oral contraceptives, there was a higher modulation frequency in the sentences when compared with nonusers (OC1, 33 ± 10 Hz; w/oOC1, 28 ± 10 Hz; OC2, 34 ± 10 Hz; w/oOC2, 27 ± 10 Hz). Vocal intensity was closer between the OC1 (62 ± 4 dB), w/oOC1 (61 ± 3 dB), and OC2 (63 ± 4 dB) groups when compared with the w/oOC2 (67 ± 6 dB) group. We demonstrated hormonal influences on speech articulation of contraceptive users and nonusers. Copyright © 2015 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

  14. Cryptogenic Cerebral Embolism in Women Taking Oral Contraceptives

    PubMed Central

    Enzell, Karin; Lindemalm, Gunnar

    1973-01-01

    Fourteen women taking oral contraceptives were admitted during a five-year period because of acute cerebrovascular lesions. A diagnosis of major cerebral embolism was established in four of them. No source of embolism was found, and thorough investigation failed to reveal any predisposing illness. Cerebral embolism was a probable diagnosis in several of the remaining 10 patients. A comparison was made with the strokes occurring in women not taking contraceptive pills in corresponding age groups. ImagesFIG. 1FIG. 2FIG. 3 PMID:4758486

  15. Low dosage progestagen as an oral contraceptive: a clinical study

    PubMed Central

    Whyte, J. C.; Pooransingh, C. S.

    1973-01-01

    A low dose of an oral progestagen (norethindrone 0.35 mg. daily) was used as a contraceptive agent in a group of 70 women. The average period of use was 16.7 months; it was over two years in 21 subjects. Eight patients withdrew from the trial because of excessive or irregular bleeding. The incidence of side effects was lower than with the combined type of contraceptive preparations. Of the six pregnancies that occurred, only two could be attributed to failure of the method. PMID:4730201

  16. Oral contraceptive pills: considerations for the adolescent patient.

    PubMed

    Cromwell, P F; Daley, A M

    2000-01-01

    Combined oral contraceptive pills (OCPs) are the most commonly prescribed method of birth control for adolescents. This article presents an overview of OCP pharmacology and summarizes the different types of OCPs. The initial patient evaluation and subsequent care are described, with a focus on management plans specific to adolescents. Emergency contraception, an alternative use of OCPs, is described as well. A thorough knowledge of OCPs and an appreciation of adolescent-specific management plans will enhance nurse practitioners' skills in preventing pregnancy in their adolescent patients.

  17. 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.

  18. Erythema multiforme limited to the oral mucosa in a teenager on oral contraceptive therapy.

    PubMed

    Jawetz, Robert E; Elkin, Avigayil; Michael, Lisa; Jawetz, Sheryl A; Shin, Helen T

    2007-10-01

    Erythema multiforme has been linked to numerous drugs and infectious agents. A link to oral contraceptive use has been reported in the past in the adult population but thus far has not been reported in children or adolescents. We report the case of an 18-yr-old female who developed oral erosions consistent with erythema multiforme two and a half weeks after initiating therapy with an oral contraceptive agent. A thorough examination for other inciting factors was negative, and the lesions slowly resolved over the course of 3 weeks. This case illustrates that erythema multiforme should be considered in the differential diagnosis of adolescents with oral erosions who have been prescribed oral contraceptives.

  19. 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.

  20. 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

  1. [Preparation and quality control of pyridostigmine bromide orally disintegrating tablet].

    PubMed

    Zhang, Li; Tan, Qun-you; Cheng, Xun-guan; Wang, Hong; Hu, Ni-ni; Zhang, Jing-qing

    2012-05-01

    To prepare orally disintegrating tablets containing pyridostigmine bromide and optimize formulations. Solid dispersion was prepared using solvent evaporation-deposition method. The formulation was optimized by central composite design-response surface methodology (RSM plus CCD) with disintegration time as a reference parameter. The orally disintegrating tablets showed integrity and were smooth with desirable taste and feel in mouth. The disintegration time was less than 30 s. The cumulative drug dissolution was around 8.5% (around 2.5 mg which was less than bitterness threshold of pyridostigmine bromide of 3 mg) within 5 min in water while the cumulative drug dissolution was higher than 95% within 2 min in 0.1 N HCl. The orally disintegrating tablets are reasonable in formulation, feasible in technology and patient-friendly.

  2. Combined oral contraceptives and body weight: do oral contraceptives cause weight gain? A primate model.

    PubMed

    Edelman, A; Jensen, J T; Bulechowsky, M; Cameron, J

    2011-02-01

    The aim of this study was to determine if oral contraceptive (OC) use affects body weight, body composition and metabolism in primates. Reproductive-age female rhesus monkeys of normal and obese BMI were studied to document baseline weight stability, then treated continuously with an OC (dosed to achieve equivalent human serum levels for a 30 µg ethinyl estradiol/150 µg levonorgestrel preparation) for 237 days. Monkeys were monitored for changes in body weight, levels of physical activity (measured by a triaxial Actical accelerometer), food/caloric intake, percent body fat (dual energy X-ray absorptiometry, DEXA) and metabolism (24 h metabolic rate and serum metabolic substrate and hormone concentrations). All 10 monkeys completed the study protocol with no adverse events. While body weight (-0.73% change) and percent body fat (-1.78% change) of the normal BMI group did not significantly decrease from baseline, obese monkeys showed a significant decrease in body weight (-8.58% change, P < 0.01) and percent body fat (-12.13% change P = 0.02) with OC treatment. In both the obese (P = 0.03) and the normal BMI (P = 0.01) groups, there was a significant increase in basal metabolic rate with OC use. No changes were seen in food intake, activity level or % lean muscle mass with OC use for either BMI-based group. Overall, OC use appears to cause a slight increase in basal metabolic rate in female monkeys, leading to a decrease in body weight and percent body fat in obese individuals.

  3. Pharmacists' counseling on oral contraceptives: A theory informed analysis.

    PubMed

    Amin, Mohamed E K; Chewning, Betty

    2016-01-01

    Providing correct and complete counseling on the use of oral contraceptives (OCs) is central to securing the autonomy of women in child-bearing age and is a powerful, proven tool of social change. Pharmacists in many developing countries such as Egypt are involved in dispensing and at times prescribing pharmaceuticals, including oral contraceptives that are readily available without a prescription. To predict Egyptian community pharmacists' counseling on oral contraceptives while utilizing a theoretical framework guided by the Theory of Planned Behavior (TPB). A cross-sectional, self-administered survey was completed by a random sample of community pharmacists in Alexandria, Egypt to determine their attitudes and behaviors regarding counseling on OCs. Multiple regression was used to predict self-reported counseling on oral contraceptives as a function of the TPB-related constructs and six other factors - "perceived importance of profit from dispensing OCs on pharmacy revenue," "number of hours worked," "age," "gender," "pharmacy practice degree" and "marital status" of the pharmacist. Of the 181 pharmacists invited to complete the survey, 168 (93%) participated. Pharmacists indicated they talked to a slightly higher proportion of women about the importance of taking OCs at the same time daily than about topics such as which day to start taking OCs, side effects and what to do when a dose of OCs was missed. Pharmacists' reported counseling on oral contraceptives was positively associated with their perception that women welcomed pharmacist initiated OC counseling (β = 0.315, P < 0.001), perceived adequacy of time available to counsel women on OCs (β = 0.290, P = 0.003) and the perceived number of women who asked for their help in selecting an OC without providing a prescription in the past week (β = 0.160, P = 0.018). Pharmacists reported that women's welcoming pharmacists initiating OC counseling was associated with the pharmacists' reported percent

  4. Stress, serotonergic function, and mood in users of oral contraceptives.

    PubMed

    Tuiten, A; Panhuysen, G; Koppeschaar, H; Fekkes, D; Pijl, H; Frölich, M; Krabbe, P; Everaerd, W

    1995-01-01

    The relationship between stress and changes in insulin levels, plasma ratio of tryptophan to other large neutral amino acids (LNAAs), mood, and food intake was investigated in women taking monophasic oral contraceptives containing progestagens. Subjects experiencing high levels of stress displayed significant decreases of insulin and tryptophan to other LNAAs ratios, before and after the consumption of a standard meal during the pill-free period as compared with the period of pill use. The decline of the tryptophan to other LNAAs ratio was accompanied by worsening of mood. In a control group of subjects experiencing low levels of stress there was no relationship between insulin and tryptophan to other LNAAs ratio, nor between tryptophan to other LNAAs ratio and mood. These results suggest that the combination of stress and alterations in sex hormones may be responsible for mood changes during the pill-free period in women taking oral contraceptives.

  5. Selection of steroid combinations for oral contraceptives of maximum benefit.

    PubMed

    Stubblefield, P G

    1986-09-01

    Low-dose oral contraceptives differ in the specific progestin component. Our review of available animal and human data revealed differences between the progestins as to their potencies for estrogenic, anti-estrogenic, androgenic and progesterone effects. Ideally, oral contraceptive formulations should have the minimal effective dose, sufficient to prevent pregnancy but with the fewest metabolic changes. The risk of cardiovascular disease may be predicted by changes in the composition and amount of circulating lipoproteins. Progestins with significant androgenic potency can lower high-density lipoprotein2; that is a possible adverse effect. Randomized, blind, comparative trials of the new multiphasic preparations are needed to determine which ones truly cause the fewest metabolic changes that might be of clinical significance.

  6. 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

  7. A New and Practical Oral Contraceptive Agent: Norethindrone with Mestranol

    PubMed Central

    Dickinson, J. H.; Smith, G. G.

    1963-01-01

    The usefulness of a new oral contraceptive compound containing norethindrone 5 mg. and mestranol 0.075 mg. (Ortho-Novum) was studied. One hundred and seventeen private patients used this preparation for a total of 998 menstrual cycles. There were no pregnancies. Side effects were minimal and caused few (11 patients) to discontinue use. The most significant of these was weight gain and a premenstrual tension syndrome including nausea, breakthrough bleeding and skin effects. Other symptoms were minor and easily controlled. Instruction in use of the preparation is easy. Patient acceptance is excellent. Possible masculinizing effects, liver damage, or harmful effects on the uterus were checked specifically by laboratory evaluation; no significant abnormal findings were noted. This appears to be an effective oral contraceptive which is well accepted by the patient and which produced no serious side effects as used in this study. PMID:14027723

  8. Evaluation of emotional reactions to oral contraceptive use.

    PubMed

    Kane, F J

    1976-12-15

    A review of available clinical studies indicates that 10 to 40 per cent of oral contraceptive users may suffer mild to moderate depression syndromes. Clinical and animal data indicate that a variety of mechanisms may be involved, including alterations in folate, pyridoxine, and vitamine B12 metabolism, as well as related effects on biogenic amine metabolism. Interactive effects may result, such as impairment of usual coping mechnisms and psychological defenses by altered central nervous system function.

  9. Discovering novel carriers for oral insulin tablets: a pharmacoinformatics approach.

    PubMed

    Seenivasagam, R; Hemavathi, K; Sivakumar, G; Niranjan, Vidya

    2013-01-01

    Insulin is used medically to treat Type 1 diabetes mellitus most commonly injected subcutaneously for human beings. The realisation that insulin injections have become a part of life can be extremely harrowing for many diabetic patients. Using insulin therapeutically is not a new practice, but still delivery methods to make the process more bearable have not gained widespread prominence as of yet. Oral delivery of insulin in tablet form has always been a significant challenge for pharmaceutical researchers. This study is a prospect of oral insulin tablet through pharmacoinformatics approach.

  10. [Oral contraceptive pill and thrombotic risk: epidemiological studies].

    PubMed

    Fruzzetti, F; Perini, D; Spirito, N; Manca, R

    2012-12-01

    The venous thromboembolism (VTE) is a rare event during childbearing age and during the assumption of combined oral contraceptive. The absolute risk of VTE in users of combined oral contraceptives is 20-30 per 100000 women years. A number of case-control studies published in recent years have shown an apparent increase in the risk of VTE among users of oral contraceptives (OCs) containing desogestrel, gestodene, drospirenone and cyproterone, relative to the use of levonorgestrel. The data derived from these recent studies is of borderline statistical significance because any important factors are not considered to evaluate the real correlation between the assumption of OCs and risk of venous thromboembolism. Among the factors that should be considered, there are: EE dose, duration of use, coexistance of other risk factors of venous thromboembolism (age, BMI, familiarity, surgical interventions) and other prescription bias. The lack of these factors is likely to contribute to the increased risk of venous thromboembolism observed in users of third-generation OCs when compared to that in users of second-generation OCs. To date, because of the inadequacy of epidemiological studies, the data about the correlation between OCs and TVE, are not conclusive and it will be necessary to carry out other studies to clarify this debating point, definitively.

  11. Laryngeal aerodynamics associated with oral contraceptive use: preliminary findings.

    PubMed

    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/repetitions were obtained using a circumferentially vented face mask and small translabial tube. All participants were recorded on or near days 7 and 14 of their menstrual cycle. Subglottal pressure (P(SG)) and average airflow rates were obtained to determine laryngeal airway resistance. Glottal airflow measures of peak flow, minimum flow, alternating flow, as well as relative sound level (RSL) were obtained. P(SG) was obtained from the pressure peak associated with/p/. All airflow parameters and RSL were obtained from the vowel portion. No significant differences were found related to day of recording or OC use, indicating that OC use does not significantly affect laryngeal airflow regulation. The reader will better understand the effects of hormones and oral contraceptives on the female voice, as well as the specific changes in vocal function that may occur in conjunction with the use of oral contraceptives.

  12. Fibrin formation and dissolution in women receiving oral contraceptive drugs.

    PubMed

    Ball, A P; McKee, P A

    1977-04-01

    Factors affecting fibrin formation and dissolution were compared for 15 women taking combined oral contraceptives and 15 women using nonpharmacological methods of birth control. The two groups were matched for age, body weight, time of blood collection, and day in menstrual cycle; none of the women was receiving other drugs known to affect the blood coagulation or fibrinolytic parameters measured in this study. Fibrinogen concentrations tended to be higher in the experimental group; the degree of fibrinogen degradation, number of fibrin cross-links, and levels of factor XIII and plasminogen were the same for both group. There were significant reductions in antithrombin activity, the euglobulin lysis time, and fibrinolytic inhibitor level in women using oral contraceptives. An estrogen dose effect was suggested for fibrinogen concentration and the degree of antithrombin activity. The increased fibrinolytic activity and decreased fibrinolytic inhibitor levels are consistent with in vitro observations that antithrombin also inhibits plasmin activity. Thus while oral contraceptive-induced depression of antithrombin III could possibly predispose to thrombosis by diminishing the inhibition of the serine protease clotting factors, the concomitant decreased level of plasmin inhibition might balance the system by favoring thrombolysis as well as the digestion and inactivation of certain clotting factors by plasmin.

  13. Mothers' attitude to the use of a combined oral contraceptive pill by their daughters for menstrual disorders or contraception.

    PubMed

    Yiu, K W; Chan, S Sc; Chung, T Kh

    2017-04-01

    Mothers' attitude may affect use of combined oral contraceptive pills by their daughters. We explored Chinese mothers' knowledge of and attitudes towards the use of combined oral contraceptive pills by their daughters for menstrual disorders or contraception, and evaluate the factors affecting their attitude. This survey was conducted from October 2012 to March 2013, and recruited Chinese women who attended a gynaecology clinic or accompanied their daughter to a gynaecology clinic, and who had one or more daughters aged 10 to 18 years. They completed a 41-item questionnaire to assess their knowledge of and attitude towards use of the combined oral contraceptive pills by their daughters. The demographic data of the mothers and their personal experience in using the pills were also collected. A total of 300 women with a mean age of 45.2 (standard deviation, 5.0) years completed the questionnaire. Only 58.3% of women reported that they had knowledge about the combined oral contraceptive pills; among them, a majority (63.3%) reported that their source of knowledge came from medical professionals. Of a total possible score of 22, their mean knowledge score for risk, side-effects, benefits, and contra-indications to use of combined oral contraceptive pills was only 5.0 (standard deviation, 4.7). If the medical recommendation to use an oral contraceptive was to manage their daughter's dysmenorrhoea, menorrhagia, acne, or contraception needs, 32.0%, 39.3%, 21.0% and 29.7%, respectively would accept this advice. Women who were an ever-user of combined oral contraceptive pills or who were more knowledgeable about combined oral contraceptives had a higher acceptance rate. Chinese women had a low acceptance level of using combined oral contraceptive pills as a legitimate treatment for their daughters. This was associated with lack of knowledge or a high degree of uncertainty about their risks and benefits. It is important that health caregivers provide up-to-date information

  14. 77 FR 1695 - Determination That AVALIDE (Hydrochlorothiazide and Irbesartan), Oral Tablets, 25 Milligrams/300...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-11

    ... Irbesartan), Oral Tablets, 25 Milligrams/300 Milligrams and 12.5 Milligrams/75 Milligrams, Were Not Withdrawn... and irbesartan), oral tablets, 25 milligrams (mg)/300 mg and 12.5 mg/75 mg, were not withdrawn from... new drug applications (ANDAs) for hydrochlorothiazide and irbesartan, oral tablets, 25 mg/300 mg and...

  15. Women's satisfaction with Norplant as compared with oral contraceptives.

    PubMed

    Eilers, G M; Swanson, T K

    1994-06-01

    In Wisconsin, 115 Norplant users and 148 oral contraceptive (OC) users, all of whom attended the university-administered family medicine residency training clinic in Eau Claire between May, 1991, and February, 1993, returned questionnaires as part of a study to examine satisfaction with their chosen contraceptive and its benefits and side effects. Most women were satisfied with their contraceptive method (60% for Norplant users and 72% for OC users). OC users were more likely to use their method again than were Norplant users (88% vs. 63%; p .001). Even though most women would recommend their method to a friend, OC users were more likely to do so than Norplant users (97% vs. 74%; p .001). Irregular bleeding was more common among Norplant users than among OC users (73% vs. 34%; p .001). OC users were more likely to feel that OCs caused less bleeding and less cramping than did Norplant users (72% vs. 30% and 60% vs. 30%, respectively; p .001). They were less likely to complain of acne (7% vs. 29%; p .001), weight gain (33% vs. 49%; p .04), and bleeding irregularities (8% vs. 60%; p .001) than Norplant users. Overall, both Norplant and OC users were satisfied with their current contraceptive method, but satisfaction was lower and side effects were more common among Norplant users.

  16. 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.

  17. An update on new orally administered contraceptives for women.

    PubMed

    Nelson, Anita L

    2015-01-01

    The focus in contraception is shifting from oral contraceptives to more effective methods, such as implants and intrauterine devices. Generics are favored by third-party payors. As a result, potentially exciting developments in branded pills to increase safety or to reduce side effects may have gone unnoticed. This article reviews the features of each of the four new oral contraceptives that have been introduced in the United States and/or Europe in the last few years. The motivation for the development of each product is outlined as is its efficacy, safety, tolerability and the noncontraceptive applications that have been explored are described. The hypothesis that using estradiol in place of ethinyl estradiol would reduce the risk of venous thromboembolism is still to be proven. However, the stronger progestogens used in these formulations may offer other tangible benefits for selected women. The new products for extended cycle pill use may have less impact. The flexible regimen can be adopted using any pill, but the approved product does provide convenience to patients. Cost will continue to be the determining factor in the acceptance of these new products, unless substantial health benefits can be conclusively proven.

  18. It's all about money: oral contraception alters neural reward processing.

    PubMed

    Bonenberger, Martina; Groschwitz, Rebecca C; Kumpfmueller, Daniela; Groen, Georg; Plener, Paul L; Abler, Birgit

    2013-12-04

    Mating preferences in phases of the natural menstrual cycle with a low probability to conceive have been associated with lower interest in characteristics promising genetic benefits but increased search for safety and future security. We hypothesized that this effect would also be evident under oral contraception and may therefore alter neural processing of monetary rewards as a proxy for potential safety. Our aim was to assess the activation of reward-related brain areas using a monetary incentive task in women with functional MRI (fMRI). We compared fMRI activation of 12 young women taking oral contraceptives with 12 women with a natural hormonal cycle in their follicular phase during the expectation of monetary rewards. Women under hormonal contraception who have already shown decreased anterior insula activation upon erotic stimulation in a previous study of the same sample now showed enhanced activation during monetary reward expectation in the anterior insula/inferior lateral prefrontal cortex (t=2.84; P<0.05) relative to young normal cycling women in the follicular phase. Our finding supports the notion that the switch in mating preferences related to different hormonal states in women is mirrored by a switch in the stimulus-dependent excitability of reward-related brain regions. Beyond highlighting hormonal effects on reward processing, our data underline the importance of monitoring hormonal states in fMRI research in women.

  19. Venous and arterial thrombosis during oral contraceptive use: risks and risk factors.

    PubMed

    Tanis, Bea C; Rosendaal, Frits R

    2003-02-01

    Since the introduction of oral contraceptives, their use has been associated with an increased risk of both venous and arterial thrombosis. Pulmonary embolism, myocardial infarction, and stroke are serious disorders with a considerable risk of mortality. Because worldwide over 100 million women use oral contraceptives, issues of drug safety are of great importance. The risk of venous thrombosis during low-dose oral contraceptive use is three- to sixfold increased compared with that of nonusers. The association is not only attributed to the estrogen component of the pill: the risk is twice as high for desogestrel and gestodene (third generation) containing oral contraceptives as for levonorgestrel (second generation) containing oral contraceptives. The risk of venous thrombosis is highest in the first year of use and in women with genetic or acquired risk factors for thrombosis. Both venous or arterial thrombosis are unrelated to duration of use or past use of combined oral contraceptives. The risk of myocardial infarction and stroke during low-dose oral contraceptive use is two- to fivefold increased relative to that of nonusers. The risk of arterial thrombosis induced by oral contraceptive use is more pronounced in smokers and women with hypertension, diabetes, and hypercholesterolemia. All types of thrombosis have strongly age-dependent incidences, and therefore in absolute figures the risks and effects of risk factors increase with age. The lowering of the estrogen dose in combined oral contraceptives from 50 microg to 20-30 microg in the last decade did not clearly reduce the risk of venous thrombosis, myocardial infarction, stroke, or peripheral arterial disease. For stroke and peripheral arterial disease no difference in risk was found between second and third generation oral contraceptives. For myocardial infarction study results are conflicting, and a small benefit of third- over second-generation oral contraceptives cannot be ruled out. However, this is

  20. Effects on hemostatic variables of desogestrel- and gestodene-containing oral contraceptives in comparison with levonorgestrel-containing oral contraceptives: a review.

    PubMed

    Winkler, U H

    1998-09-01

    In some studies third-generation oral contraceptives have been reported to be associated with a higher risk of venous thromboembolism than are second-generation oral contraceptives, whereas recent, more refined studies have not confirmed this. The reasons for the alleged differences are under discussion, and differential effects on hemostasis have been proposed. Eighteen studies comparing second- and third-generation oral contraceptives with respect to their effects on hemostasis were analyzed. Significant changes from baseline were reported for many variables with both second- and third-generation oral contraceptives without significant between-group differences. Also, in a combined analysis of nonsignificant changes, no consistent pattern of change emerged for any marker, with the exception of higher factor VII levels associated with third-generation oral contraceptives. However, factor VII is not related to venous thromboembolism risk. In addition, 1 cross-sectional study with an unvalidated assay reported a higher ratio of activated protein C sensitivity with third-generation oral contraceptives. Only 2 components of the hemostatic system (factor VII and activated protein C sensitivity ratio) emerged as potentially differentially affected by second- and third-generation oral contraceptives; the association with venous thromboembolism risk is questionable in the former case and unknown in the latter.

  1. Seizure facilitating activity of the oral contraceptive ethinyl estradiol.

    PubMed

    Younus, Iyan; Reddy, Doodipala Samba

    2016-03-01

    Contraceptive management is critical in women with epilepsy. Although oral contraceptives (OCs) are widely used by many women with epilepsy, little is known about their impact on epileptic seizures and epileptogenesis. Ethinyl estradiol (EE) is the primary component of OC pills. In this study, we investigated the pharmacological effect of EE on epileptogenesis and kindled seizures in female mice using the hippocampus kindling model. Animals were stimulated daily with or without EE until generalized stage 5 seizures were elicited. EE treatment significantly accelerated the rate of epileptogenesis. In acute studies, EE caused a significant decrease in the afterdischarge threshold and increased the incidence and severity of seizures in fully-kindled mice. In chronic studies, EE treatment caused a greater susceptibility to kindled seizures. Collectively, these results are consistent with moderate proconvulsant-like activity of EE. Such excitatory effects may affect seizure risk in women with epilepsy taking OC pills.

  2. A new estradiol-dienogest oral contraceptive marks "The Pill's" 50th anniversary.

    PubMed

    Keder, Lisa M

    2011-01-01

    Oral contraceptive pills were first approved by the Food and Drug Administration 50 years ago. Discovery of the physiology of reproduction and demonstration of the ability to inhibit ovulation with ovarian extracts laid the early groundwork for the development of contraceptives. Later, characterization of the hormones controlling ovulation and synthesis of progestins allowed production of oral contraceptives. Modern estrogen and progestin pills have undergone significant changes since their initial introduction. New formulations have been developed, doses have been lowered, and extended use introduced. The Food and Drug Administration has recently approved a new oral contraceptive containing estradiol valerate and dienogest. This pill contains an orally active estradiol in combination with a progestin with strong endometrial activity. The decreasing estrogen dose combined with an increasing progestin dose decreases the risk of break through bleeding when compared to previous estradiol valerate formulations. The contraceptive efficacy and a tolerability of this new pill are similar to currently marketed low dose combined estrogen-progestin oral contraceptives.

  3. Fexofenadine in pediatrics: oral tablet and suspension formulations.

    PubMed

    Mansfield, Lyndon E

    2008-02-01

    Allergic rhinitis is a common chronic condition in children. Oral antihistamines are a first-line treatment option in allergic rhinitis and different formulations are available to aid administration to children. The tablet formulation of the second-generation antihistamine fexofenadine has established efficacy and safety in both adults and children. To aid administration in young children, a new oral suspension formulation of fexofenadine has been developed, indicated for the relief of seasonal allergic rhinitis symptoms in children aged 2-11 years and for uncomplicated skin manifestations of chronic idiopathic urticaria in children aged 6 months-11 years. Clinical studies have shown the oral suspension to have both bioequivalence with the 30 mg tablet formulation and a favorable safety and tolerability profile.

  4. Patterns of Oral Contraceptive Pill-taking and Condom Use among Adolescent Contraceptive Pill Users

    PubMed Central

    Woods, Jennifer L.; Shew, Marcia L.; Tu, Wanzhu; Ofner, Susan; Ott, Mary A.; Fortenberry, J. Dennis

    2008-01-01

    Purpose Imperfect oral contraceptive pill (OCP) regimen adherence may impair contraceptive effectiveness. The purpose of this study was to describe daily adherence patterns of OCP use, to analyze OCP protection on an event level basis, and to examine pill-taking and condom use during method transitions. Methods Women (n = 123, ages 14–17 years) completed quarterly interviews to classify OCP method choice into four categories: stable, initiated, stopped, and discordant use. Within each OCP category, daily diaries were used to assess occurrence of coitus, condom use, and patterns of day-to-day OCP use (i.e., consecutive days of OCP use reported with no more than two consecutive days of nonuse). A coital event was OCP protected if pills were used on both the day of the coitus and the day preceding. Results There were 123 participants who reported at least some OCP use in 210 diary periods (average diary length = 75.5 days). Fifty-three participants categorized as stable users reported 87 diary periods: the average interval of consecutive OCP use in this group was 32.5 days. Among stable users, only 45% of coital events were associated with both OCP and condom use. Over one-fifth of coital events in all groups were protected by no method of contraception. Conclusion Dual use of OCP and barrier contraception remains an elusive goal. The time during OCP adoption or discontinuation is often unprotected by condoms. However, concurrent missed pills and condom nonuse increase pregnancy and infection risk even among stable OCP users. Understanding motivation for method usage may improve education and prevention techniques. PMID:16919800

  5. Over-the-Counter Access to Oral Contraceptives.

    PubMed

    Grossman, Daniel

    2015-12-01

    Making oral contraceptives (OCs) available over the counter (OTC) could help to reduce the high rate of unintended pregnancy in the United States. Surveys show widespread support for OTC access to OCs among US women. Studies indicate that women can accurately use checklists to identify contraindications to OCs. Continuation is as good or better among OTC users compared with women using OCs obtained by prescription. Women and clinicians have expressed concerns related to making OCs available OTC. These concerns can be addressed by existing data or through research required by the Food and Drug Administration as part of the application to make OCs available OTC.

  6. [Serious adverse effect of combined oral contraceptive pills among teenagers].

    PubMed

    Nylander, Malin Chatarina; Clausen, Helle V

    2014-06-23

    PubMed-search found studies investigating adverse effects of combined oral contraceptive pills (COC) among teenagers. Four studies found a small negative impact of COC on acquisition of bone mineral density. COC is associated with elevated risk of venous thrombotic events (VTE), especially during the first year of usage. VTE risk increases with EE dose and progestin of 3rd and 4th generation. There are several difficulties in studying COC use in teenagers: high dropout rates, ethical considerations and many different COC formulas.

  7. No effect of oral contraceptives on the metabolism of levetiracetam.

    PubMed

    Sabers, Anne; Christensen, Jacob

    2011-08-01

    The effect on clearance of levetiracetam (LEV) was estimated in women with epilepsy of childbearing potential using oral contraceptives (OCs). The estimated clearance (plasma concentration/daily dose) was 39 nmol/L/mg (range 14-88 nmol/L/mg) among women who did not use OC (n=30) and 38 nmol/L/mg (range 18-103 nmol/L/mg) among OC users (n=23) (p=0.8). In conclusion, combing LEV and OCs seems safe from a pharmacokinetic perspective.

  8. [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. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

  9. Estimating systemic exposure to ethinyl estradiol from an oral contraceptive.

    PubMed

    Westhoff, Carolyn L; Pike, Malcolm C; Tang, Rosalind; DiNapoli, Marianne N; Sull, Monica; Cremers, Serge

    2015-05-01

    This study was conducted to compare single-dose pharmacokinetics of ethinyl estradiol in an oral contraceptive with steady-state values and to assess whether any simpler measures could provide an adequate proxy of the "gold standard" 24-hour steady-state area under the curve (AUC) value. Identification of a simple, less expensive measure of systemic ethinyl estradiol exposure would be useful for larger studies that are designed to assess the relationship between an individual's ethinyl estradiol exposure and side-effects. We collected 13 samples over 24 hours for pharmacokinetic analysis on days 1 and 21 of the first cycle of a monophasic oral contraceptive that contained 30 μg ethinyl estradiol and 150 μg levonorgestrel in 17 nonobese healthy white women. We also conducted an abbreviated single-dose 9-sample pharmacokinetic analysis after a month washout. Ethinyl estradiol was measured by liquid chromatography-tandem mass spectrometry. We compared results of a full 13-sample steady-state pharmacokinetic analysis with results that had been calculated with the use of fewer samples (9 or 5) and after the single doses. We calculated Pearson correlation coefficients to evaluate the relationships between these estimates of systemic ethinyl estradiol exposure. The AUC, maximum, and 24-hour values were similar after the 2 single oral contraceptive doses (AUC; r=0.92). The steady-state 13-sample 24-hour AUC value was correlated highly with the average 9-sample AUC value after the 2 single doses (r=0.81; P=.0002). This correlation remained the same if the number of single-dose samples was reduced to 4, taken at time 1, 2.5, 4, and 24 hours. The 24-hour value at steady-state was correlated highly with the 24-hour steady-state AUC value (r=0.92; P<.0001). The average of the 24-hour values after the 2 single doses was also correlated quite highly with the steady-state AUC value (r=0.72; P=.0026). Limited blood sampling, including results from 2 single doses, gave highly

  10. ESTIMATING SYSTEMIC EXPOSURE TO ETHINYL ESTRADIOL FROM AN ORAL CONTRACEPTIVE

    PubMed Central

    WESTHOFF, Carolyn L.; PIKE, Malcolm C.; TANG, Rosalind; DINAPOLI, Marianne N.; SULL, Monica; CREMERS, Serge

    2015-01-01

    Objectives This study was conducted to compare single-dose pharmacokinetics of ethinyl estradiol in an oral contraceptive to steady-state values, and to assess whether any simpler measures could provide an adequate proxy of the ‘gold standard’ 24-hour steady-state area-under-the-curve. Identifying a simple, less expensive, measure of systemic ethinyl estradiol exposure would be useful for larger studies designed to assess the relationship between an individual’s ethinyl estradiol exposure and her side effects. Study Design We conducted a 13 samples over 24 hours pharmacokinetic analysis on day 1 and day 21 of the first cycle of a monophasic oral contraceptive containing 30 mcg ethinyl estradiol and 150 mcg levonorgestrel in 17 non-obese healthy white women. We also conducted an abbreviated single dose 9-sample pharmacokinetic analysis after a month washout. Ethinyl estradiol was measured by liquid chromatography-tandem mass spectrometry. We compared results of full 13-sample steady-state pharmacokinetic analysis with results calculated using fewer samples (9 or 5) and following the single doses. We calculated Pearson correlation coefficients to evaluate the relationships between these estimates of systemic ethinyl estradiol exposure. Results The area-under-the-curve, maximum (Cmax), and 24-hour (C24) values were similar following the two single oral contraceptive doses (area-under-the-curve, r = 0.92). The steady-state 13-sample 24-hour area-under-the-curve was highly correlated with the average 9-sample area-under-the-curve after the two single doses (r = 0.81, p = 0.0002). This correlation remained the same if the number of samples was reduced to 4, taken at time 1, 2.5, 4 and 24 hours. The C24 at steady-state was highly correlated with the 24-hour steady-state area-under-the-curve (r = 0.92, p < 0.0001). The average of the C24 values following the two single doses was also quite highly correlated with the steady-state area-under-the-curve (r = 0.72, p = 0

  11. Oral contraceptives can cause falsely low vitamin B(12) levels.

    PubMed

    Gardyn, J; Mittelman, M; Zlotnik, J; Sela, B A; Cohen, A M

    2000-01-01

    Serum vitamin B(12) radioimmunoassays may give falsely low results in patients with folate deficiency, multiple myeloma, megadose of vitamin C and following radioisotope organ scan. We evaluated 10 consecutive healthy women on oral contraceptives (OC) who had falsely low vitamin B(12) levels, as reflected by normal urine methylmalonic acid and plasma homocysteine. After 1-month cessation of OCs, vitamin B(12) returned to the normal range in all women. Transcobalamin I (TCI) blood level was decreased in 60% of patients. OCs may cause temporary low vitamin B(12) blood levels of no clinical significance that can be associated with low TCI levels

  12. Active E-rosette formation in women taking oral contraceptives.

    PubMed

    Satoh, P S; Fleming, W E; Johnston, K A; Ozmun, J M

    1977-01-06

    On the assumption that the number of E-rosettable lymphocytes (active T lymphocytes) is an index of cell-mediated immunity, rosette assays were performed at early cycle and at midcycle for 6 women taking oral contraceptives (OCs) for 1-4 years. OC subjects at midcycle had 21.4% active rosette-forming lymphocytes as compared with 14.1% in controls (p less than .05). The 2 youngest subjects had higher values during the early cycle. These results imply the possibility of hormonal regulation of human T-cell activity.

  13. A history of oral contraception: from evolution to revolution.

    PubMed

    1995-09-01

    Women throughout the world and throughout time have ingested substances such as mercury, diluted copper ore, and various noxious solutions in the mistaken belief that these substances would prevent pregnancy. The era of modern contraception began in 1937 with the discovery that the administration of progesterone could halt ovulation in rabbits. During the next decade, work proceeded on finding an easy and less expensive way to synthesize progesterone and to develop the synthetic estrogens mestranol and ethinyl estradiol. Initial trials in humans proved that these hormones could prevent ovulation. In 1950, with support from Margaret Sanger and Katharine Dexter McCormick, Gregory Goodwin Pincus developed the first oral contraceptive (OC), which consisted of supplemental progestin and 0.5 mg norethindrone. In the early 1990s, the Ortho Pharmaceutical Corporation introduced an OC that combined the synthetic progesterone norgestimate and 35 mcg of ethinyl estradiol. By 1988, several noncontracepting health benefits of the OC were recognized, including decreased rates of ovarian cancer, endometrial cancer, pelvic inflammatory disease, ovarian cysts, benign breast disease, iron deficiency anemia, and dysmenorrhea. These health benefits outweigh risks even in nonsmoking women over 40. In the US, 80% of women have used the OC at one time, and they are using this most popular form of reversible contraception longer than ever.

  14. Misconceptions about oral contraception pills among adolescents and physicians.

    PubMed

    Hamani, Y; Sciaki-Tamir, Y; Deri-Hasid, R; Miller-Pogrund, T; Milwidsky, A; Haimov-Kochman, R

    2007-12-01

    Limited access to contraception and poor compliance are the major reasons for unintended pregnancy in adolescence. This study was designed to compare knowledge of the combined oral contraceptive pill (COCP) in teenage users and non-users. We speculated that consultations between COCP users and their physicians would dispel misconceptions. A cross-sectional survey was undertaken in public clinics affiliated with an academic center. High school-educated female adolescents aged 14-20 years opting for contraception (n = 254) and Israeli physicians (n = 114) specializing in Obstetrics, Gynecology and Reproductive Endocrinology participated in the study. Information about past or present COCP use and views of the COCP were recorded by employing a ten-question YES/NO self-completion questionnaire, designed by the researchers. The prevalence of incorrect beliefs was exceedingly high in the whole adolescent study group and relatively high among the physicians. The prevalence of incorrect beliefs was comparable between COCP users and non-users, regarding the 10 misconceptions investigated. The duration of COCP use did not influence the prevalence of misconceptions about the pill. Age did not serve as a confounding factor for all misconceptions. Lack of informative communication between COCP-prescribing physicians and users and mistaken knowledge of the caring physicians may contribute to adolescent ignorance of the COCP. Focusing on adolescent-specific disbeliefs could lead to construction of better educational programs in schools and clinics.

  15. [Myocardial infarction associated with oral contraceptive use, smoking and elevated cholesterol level in a young patient].

    PubMed

    Krasznai, Zsuzsa; Tóth, Péter

    2011-09-04

    Oral hormonal contraceptives are the safest methods for young patients to avoid unwanted pregnancy. They are well accepted and have certain beneficial effects; however, physicians should pay attention to risk factors even when applied in young age. Obesity, dyslipidemia, smoking and oral contraceptive pills alone or in combination may lead to serious adverse events. Authors present a young woman who developed acute myocardial infarction in association with several unconsidered risk factors including the use of contraceptive pills.

  16. Design and study of lamivudine oral controlled release tablets.

    PubMed

    Ravi, Punna Rao; Ganga, Sindhura; Saha, Ranendra Narayan

    2007-12-07

    The objective of this study was to design oral controlled release matrix tablets of lamivudine using hydroxypropyl methylcellulose (HPMC) as the retardant polymer and to study the effect of various formulation factors such as polymer proportion, polymer viscosity, and compression force on the in vitro release of drug. In vitro release studies were performed using US Pharmacopeia type 1 apparatus (basket method) in 900 mL of pH 6.8 phosphate buffer at 100 rpm. The release kinetics were analyzed using the zero-order model equation, Higuchi's square-root equation, and the Ritger-Peppas empirical equation. Compatibility of the drug with various excipients was studied. In vitro release studies revealed that the release rate decreased with increase in polymer proportion and viscosity grade. Increase in compression force was found to decrease the rate of drug release. Matrix tablets containing 60% HPMC 4000 cps were found to show good initial release (26% in first hour) and extended the release up to 16 hours. Matrix tablets containing 80% HPMC 4000 cps and 60% HPMC 15,000 cps showed a first-hour release of 22% but extended the release up to 20 hours. Mathematical analysis of the release kinetics indicated that the nature of drug release from the matrix tablets was dependent on drug diffusion and polymer relaxation and therefore followed non-Fickian or anomalous release. No incompatibility was observed between the drug and excipients used in the formulation of matrix tablets. The developed controlled release matrix tablets of lamivudine, with good initial release (20%-25% in first hour) and extension of release up to 16 to 20 hours, can overcome the disadvantages of conventional tablets of lamivudine.

  17. A comparative clinical trial of the contraceptive sponge and Neo Sampoon tablets.

    PubMed

    Borko, E; McIntyre, S L; Feldblum, P J

    1985-04-01

    Neo Sampoon, a foaming vaginal tablet containing 60 mg of the spermicide menfegol, and the Collatex sponge (now marketed in the United States as the Today sponge), a dome-shaped polyurethane device that contains 1 g of nonoxynol-9, were compared in terms of effectiveness, safety, and acceptability. Both methods were new to the Maribor General Hospital, Yugoslavia, where the trial was conducted among 450 volunteers randomly assigned to one of the two methods. At 12 months, the life-table pregnancy rate per 100 women for the Neo Sampoon group was 12.8, compared with a rate of 10.4 among the sponge users (P greater than .10). After pregnancy, the second most frequent reason for termination was discomfort, with a 12-month termination rate due to this cause of 6.9 per 100 women in the Neo Sampoon group and 6.2 in the sponge group. Although fewer than a quarter of the volunteers had any experience with barrier methods before this trial, the life-table continuation rate was high in both groups, with more than 70% using their assigned method for the full 12 months. Also, upon conclusion of the study, 41% of the volunteers chose another barrier contraceptive method. Although the effectiveness of the sponge and Neo Sampoon is not comparable to that of the pill or IUD, both vaginal methods appear to be safe and acceptable additions to the range of contraceptive choices.

  18. Oral Contraceptive Use and Psychiatric Disorders in a Nationally Representative Sample of Women

    PubMed Central

    Cheslack-Postava, Keely; Keyes, Katherine M.; Lowe, Sarah R.; Koenen, Karestan C.

    2014-01-01

    Purpose Examine the association between oral contraceptive use (any current use, duration and type) and major depression disorder (MDD), generalized anxiety disorder (GAD), and panic disorder (PD) in a nationally representative sample of women in the United States. Methods Data were drawn from 1,105 women aged 20–39 in the National Health and Nutrition Examination Surveys from 1999 to 2004. The associations between self-reported use of oral contraceptives in the past year and DSM-IV diagnosed and sub-threshold MDD, GAD, and PD in the past year were assessed comparing oral contraceptive users to all non-users, former users and former long-term users. Results Women using oral contraceptives had a lower past-year prevalence of all disorders assessed, other than sub-threshold MDD. When adjusted for confounders, women using oral contraceptives in the past year had significantly lower odds of sub-threshold PD, compared to former users (OR=0.34, 95% C.I. 0.14–0.84). Effects estimates were strongest for monophasic (versus multiphasic) oral contraceptive users. Conclusions Hormonal contraceptive use was associated with reduced risk of subthreshold PD. A potential mental health benefit of hormonal contraceptives has substantial public health implications; prospective longitudinal studies are needed to confirm whether hormonal contraceptive use improves mental health. PMID:25113319

  19. Bioequivalence of two oral ciprofloxacin tablets formulations.

    PubMed

    Cuadrado, A; Gascón, A R; Solinís, M A; Ramírez, E; Hernández, R M; Knie, U; Pedraz, J L

    2004-06-01

    The relative bioavailability of a new 750 mg tablet formulation of ciprofloxacin (test formulation supplied by Dr. August Wolff GmbH and Co., Germany) was compared with that of Ciprobay tablets 750 mg (reference formulation from Bayer Vital GmbH and Co., Germany). Twenty-four healthy volunteers (12 male and 12 female) were included in this single-dose, 2-sequence, crossover randomized study. Blood samples were obtained prior to dosing and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24 and 30 hours after drug administration. Plasma concentrations of ciprofloxacin were determined by HPLC. No differences were found when the in vitro dissolution profiles of both formulations were compared. The pharmacokinetic parameters AUC(0-t), AUC(0-infinity), Cmax and Cmax/AUC(0-infinity) were tested for bioequivalence after log-transformation of data, and ratios of tmax were evaluated nonparametrically. The parametric analysis revealed the following mean values for the test/reference ratios (90% standard confidence intervals in parenthesis (ln-transformed data): 1.01 (0.95-1.07) for AUC(0-t), 0.99 (0.93-1.05) for AUC(0-infinity), 1.05 (0.97-1.14) for Cmax and 1.06 (0.97-1.15) for Cmax/AUC(0-infinity). The nonparametric confidence interval for tmax was 0.77-1.15. All parameters showed bioequivalence between both formulations as their confidence intervals were within the bioequivalence acceptable range of 0.80-1.25 limits; the 90% confidence interval for tmax slightly exceeded limits of bioequivalence. We conclude that both formulations show bioequivalence for both the rate and the extent of absorption.

  20. [The risk of breast cervical, endometrial and ovarian cancer in oral contraceptive users].

    PubMed

    Veljković, Milena; Veljković, Slavimir

    2010-01-01

    Oral contraceptives, mainly combined monophasic pills, are widely used by young women who expect their physicians to prescribe them safe drugs which will not harm their health and which will simplify their life. Numerous epidemiologic studies have been performed to determine the relation between oral contraceptive use and the development of neoplasms. An increased incidence of breast cancer has occurred simultaneously with the growing use of oral contraceptives. The possibility of a link between the oral contraceptive use and breast cancer has led to intensive research, but studies have provided inconsistent results causing confusion among clinicians. It was noticed that the risk of breast cancer was slightly elevated in current and recent young oral contraceptives users. That finding could be influenced by a detection bias or could be due to the biologic effect of the pills. The absolute number of additional breast cancer cases will be very small because of low baseline incidence of the disease in young women. Oral contraceptives probably promote growth of the already existing cancer, they are probably promoters not initiators of breast cancer. The available data do not provide a conclusive answer that is needed. Numerous factors may influence the development of cervical cancer. The evidence suggests that current and recent oral contraceptive users have an increased risk of cervical cancer which decline after discontinuation of the application of medication. Oral contraceptives might increase the biological vulnerability of the cervix. Cervical cancer develops slowly over a long time period and can be effectivelv prevented by periodic cervical screening. Fortunately, oral contraceptives do not mask abnormal cervical citology. Conclusions regarding invasive cervical cancer and oral contraceptive use are not definitive but if there is any increased risk, it is low. In oral contraceptive users the endometrium is almost under the influence of progestin component which

  1. Oral contraceptives cause evolutionarily novel increases in hormone exposure

    PubMed Central

    Lovett, Jennie L.; Chima, Margo A.; Wexler, Juliana K.; Arslanian, Kendall J.; Friedman, Andrea B.; Yousif, Chantal B.

    2017-01-01

    Abstract Background and objectives: In the evolutionary past, women spent most of their reproductive lives either pregnant or in lactational amenorrhea, and rarely menstruated. The current pattern of frequent menses, and the associated increase in endogenous hormonal exposure, has been implicated in the current breast cancer epidemic. It is not known, however, whether oral contraceptives further increase, or actually decrease, hormonal exposure over one menstrual cycle. Here, we examined variation in hormonal exposure across seven oral contraceptive (OC) formulations, and produced the first quantitative comparison of exogenous versus endogenous hormone exposure. Methodology: Data from 12 studies of serum estradiol (E2) and progesterone (P4) were aggregated to create a composite graph of endogenous hormone levels over one menstrual cycle in European or American women (age 19–40 years). Pharmacokinetic package insert data, also from Western women, were used to calculate exposures for hormones in seven different OC formulations. Endogenous and exogenous hormone levels were compared after adjusting for the relative binding affinity (RBA) of progestin to the progesterone receptor and ethinyl estradiol (EE) to the estrogen receptor. Results: After adjusting for RBA, median ethinyl estradiol exposure across 28 days in the OCs was 11.4 nmol/l, similar to median E2 exposure. One formulation, however, was 40% higher in ethinyl estradiol exposure relative to median endogenous estradiol. Median exposure from progestins in OCs (1496 nmol/l) was 4-fold higher than the median endogenous exposure from P4 (364 nmol/l). Exposure from OC progestins ranged from one sixtieth to 8-fold median endogenous P4 over 28 days. Conclusions and implications: Given that breast cancer risk increases with hormonal exposure, our finding that four widely prescribed formulations more than quadruple progestin exposure relative to endogenous progesterone exposure is cause for concern. As not all

  2. [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).

  3. Lipid profile of women using oral contraceptive pills.

    PubMed

    Naz, F; Jyoti, S; Akhtar, N; Afzal, M; Siddique, Y H

    2012-10-01

    Oral contraceptives (OCs) are the most popular type of birth control pills. The study was designed to examine the biochemical changes which occur due to the use of oral contraceptive pills (OCs). The study was based on the questionnaire for having the information of any reproductive history fasting, age, health, nature of menstrual cycle, bleeding, disease etc and blood profiling for biochemical analysis of the women includes high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and triglycerides (TG). Lipid profiling was carried out by using a commercially available diagnostic test kits. SPSS was used to analyze the data. The results showed statistically significant differences among users of OCs compared to non-users. Total cholesterol (242.92 +/- 2.842 mg dL(-1)), HDL-C (58.65 +/- 1.098 mg dL(-1)), LDL-C (115.84 +/- 1.266 mg dL(-1)) and triglycerides (105.56 +/- 2.341 mg dL(-1)) were significantly higher compared to the non-users (Total cholesterol 218.49 +/- 1.762, HDL-C 48.17 +/- 0.543, LDL-C 100.321 +/- 0.951 and triglycerides 83.77 +/- 2.299 mg dL(-1)). The result suggests that OCs increase the level of high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and triglycerides (TG).

  4. Effect of oral and vaginal hormonal contraceptives on inflammatory blood biomarkers.

    PubMed

    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.

  5. 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

  6. Intrauterine devices: an effective alternative to oral hormonal contraception.

    PubMed

    2009-06-01

    (1) Intrauterine devices (IUDs) are placed in the uterine cavity with the objective of providing long-term contraception, mainly by preventing fertilisation. The best-known IUDs contain copper, but there is also an IUD delivering levonorgestrel, a progestin; (2) How effective are these devices, and what are their adverse effects? To answer these questions, we analysed the literature using the standard Prescrire methodology; (3) T-shaped copper IUDs, with a copper surface area of 380 mm2 on 3 arms, and the levonorgestrel-releasing device, have similar contraceptive efficacy as combined oral contraceptives that are used correctly. In contrast, IUDs are more effective than oral contraception used incorrectly; (4) Among IUD users, there are on average about 6 pregnancies per 1000 woman-years. There is less experience with the levonorgestrel IUD which seems to be at least as effective as copper IUDs; (5) The rare intrauterine pregnancies that occur in women using an IUD generally end in miscarriage. About 25% of these pregnancies end in a live birth if the device is left in place, compared to about 90% if the device is removed; (6) Ectopic pregnancies are rarer in IUD users than in women who do not use contraception. However, about one in 20 pregnancies that occur in women using an IUD is ectopic; (7) The IUD is expelled in about 5% to 10% of cases within 5 years, and expulsion recurs in about 30% of these women; (8) Problems such as difficult insertion, pain, bleeding and syncope are reported in less than 1.5% of cases overall; (9) Uterine perforation during insertion is rare, occurring in 0.6 to 16 cases per 1000 insertions, regardless of the type of IUD. The risk of perforation is higher when the IUD is inserted less than 4 to 6 weeks after delivery or elective abortion; (10) During the first 3 months after insertion, the risk of pelvic infection is slightly higher than in the general population, especially in women with pre-existing asymptomatic Chlamydia

  7. 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

  8. Effects of Oral Contraceptive Use on Anterior Cruciate Ligament Injury Epidemiology.

    PubMed

    Gray, Aaron M; Gugala, Zbigniew; Baillargeon, Jacques G

    2016-04-01

    Anterior cruciate ligament injuries often incur major consequences for athletes. Elevated estrogen levels are likely increase the risk for injury. This risk may be partially or fully mitigated by the use of oral contraceptives. The purpose of this study was to determine if women undergoing anterior cruciate ligament surgical reconstruction were less likely to use oral contraceptives than matched noninjured population. This is a case-control study utilizing national insurance claims data from 2002 TO 2012. Participants included women age 15-39 yr. Cases were defined as those receiving surgical reconstruction of the anterior cruciate ligament between 2002 and 2012. Controls were matched 3/1 to cases. Exposure to oral contraceptives was defined as the presence of any prescription fill for oral contraceptives during the previous 12 months to index date. Conditional multivariate logistic regression was used to estimate adjusted odds ratios for the use of oral contraceptives. Women age 15-19 yr undergoing surgical repair of the anterior cruciate ligament were 18% less likely to use oral contraceptives than matched controls (adjusted odds ratio, 0.82; 95% CI, 0.75-0.91; P < 0.0001). Cases among two older age groups, 25-29 and 30-34 yr, were more likely to use oral contraceptives than controls with adjusted odds ratios of 1.15 (95% CI, 1.02-1.30; P < 0.05) and 1.16 (95% CI, 1.04-1.31; P < 0.05), respectively. The use of oral contraceptives potentially modifies anterior cruciate ligament injury risk in young women. Despite reports that athletes, who are more prone to anterior cruciate ligament injury, use oral contraceptives at about twice the rate of nonathletes, these data suggest that women ages 15-19 yr undergoing anterior cruciate ligament reconstruction used oral contraceptives at a lower rate than the general population.

  9. Ingestibility and Formulation Quality of Lansoprazole Orally Disintegrating Tablets

    PubMed Central

    Matsui, Megumi; Nakamura, Katsuki; Kasai, Ryoya

    2016-01-01

    Objectives. We evaluated the ingestibility and formulation quality of one branded (formulation A) and five generic (formulations B, C, D, E, and F) lansoprazole orally disintegrating (OD) tablets. Methods. Ingestibility, including the oral disintegrating time, taste, mouth feeling, and palatability, was examined by sensory testing in healthy subjects. Formulation qualities, including salivary stability, gastric acid resistance, and intestinal dissolution behavior, were examined. Results and Discussion. The oral disintegration time of formulation F (52 s) was significantly longer than that of other formulations (32–37 s). More than 90% of subjects did not experience bitterness with formulations A, E, and F, whereas 50% of subjects felt rough and powdery sensations with formulations B, C, and D. More than 80% of subjects suggested that formulations A, E, and F had good palatability. Ingestibility was different between formulations. OD tablets consist of enteric granules containing lansoprazole, which is unstable in gastric acid. Enteric granules of each formulation were stable in artificial saliva and gastric juice. No differences were observed in dissolution behaviors among the formulations, indicating that the formulation quality of the formulations was almost equivalent. Conclusions. This study provides useful information for selecting branded or generic lansoprazole OD tablets for individualized treatments. PMID:28044122

  10. Design, Formulation, and Physicochemical Evaluation of Montelukast Orally Disintegrating Tablet

    PubMed Central

    Aslani, Abolfazl; Beigi, Maryam

    2016-01-01

    Background: Orally disintegrating tablets (ODTs) are a modern form of tablets that when placed in the oral cavity, disperses rapidly. These tablets have advantages, particularly good applications for children and old patients who have a complication in chewing or swallowing solid dosage forms. The aim of this study was to design, formulate, and evaluate the physicochemical properties of 5 mg montelukast ODTs for the prevention of asthma and seasonal allergies. Methods: Formulations were prepared with different amounts of super disintegrating agents and effervescent bases as disintegrant agents. Flowability and compressibility of mixed powders were evaluated. The prepared formulations were tested for hardness, thickness, friability, weight variation, drug content, wetting time, disintegration time, dissolution study, and moisture uptake studies. Results: The compressibility index and angle of repose were in the range of 15.87%–23.43% and 32.93–34.65, respectively. Hardness, thickness, friability, wetting time, and content uniformity of formulations were in the range of 33.7–37.1 N, 3.00–3.81 mm, 0.27%–0.43%, 31–50 s and 96.28%–99.90%, respectively. Disintegration time of the tablets prepared with super disintegrating agents, effervescent bases, and combination of two were in the range of 30–50, more than 60 and 20–36 s, respectively. Conclusions: Mixture of powders and tablets passed all the specified tests. The results showed formulations prepared by super disintegrating agents and super disintegrating agents with effervescent bases had shorter disintegration time compared to formulations with effervescent bases alone. PMID:27857833

  11. Pharmacists' knowledge and interest in developing counseling skills relating to oral contraceptives.

    PubMed

    Amin, Mohamed E K

    2016-04-01

    Possessing correct therapeutic information on oral contraceptives is an important prerequisite for the provision of sound advice to women who are using these products. This study examines Egyptian pharmacists' knowledge of pharmacotherapeutic aspects of oral contraceptives as well as interest in developing skills in providing counseling on oral contraceptive pills. Community pharmacies throughout Alexandria, Egypt. A cross-sectional survey was self-administered by a random sample of community pharmacists in Alexandria, Egypt. Five multiple choice questions likely to arise when counseling women on oral contraceptives were constructed. Questions covered compatibility with breastfeeding, precautions, health risks and managing missed pills of oral contraceptives. Using ordered logistic regression, a model was estimated to predict pharmacists' interest in developing skills in providing counseling on oral contraceptives. Pharmacists' aggregate scores for knowledge questions and pharmacists' interest in developing skills in providing counseling on oral contraceptive pills. Of the 181 approached pharmacists, 92 % participated. Twenty one pharmacists (13 %) did not know the correct answer to any question, 122 (73 %) answered one-two correctly, 23 (14 %) answered three-four correctly. No pharmacist answered all five questions correctly. For pharmacists' interest in developing skills in providing counseling on oral contraceptives, the percentage values for answers were: not interested at all (10.2 %), slightly interested (27.0 %), somewhat interested (23.4 %), interested (30.0 %) and extremely interested (9.6 %). Pharmacists' interest in developing skills in providing counseling on oral contraceptives was significantly associated with the number of women who requested advice from the pharmacists on oral contraceptives (OR 1.54, CI 1.24-1.91). In terms of the learning method of preference, percentage values for answers were: attending a workshop (4 %), online course (18

  12. Development of oral acetaminophen chewable tablets with inhibited bitter taste.

    PubMed

    Suzuki, Hiroyuki; Onishi, Hiraku; Takahashi, Yuri; Iwata, Masanori; Machida, Yoshiharu

    2003-01-30

    Various formulations with some matrix bases and corrigents were examined for development of oral chewable tablets which suppressed the bitter taste of acetaminophen, often used as an antipyretic for infants. Corn starch/lactose, cacao butter and hard fat (Witepsol H-15) were used for matrix bases, and sucrose, cocoa powder and commercial bitter-masking powder mixture made from lecithin (Benecoat BMI-40) were used for corrigents against bitter taste. The bitter taste intensity was evaluated using volunteers by comparison of test samples with standard solutions containing quinine at various concentrations. For the tablets made of matrix base and drug, Witepsol H-15 best inhibited the bitter taste of the drug, and the bitter strength tended to be suppressed with increase in the Witepsol H-15 amount. When the inhibitory effect on the bitter taste of acetaminophen solution was compared among the corrigents, each tended to suppress the bitter taste; especially, Benecoat BMI-40 exhibited a more inhibitory effect. Further, chewable tablets were made of one matrix base and one corrigent, and of one matrix base and two kinds of corrigents, their bitter taste intensities after chewing were compared. As a result, the tablets made of Witepsol H-15/Benecoat BMI-40/sucrose, of Witepsol H-15/cocoa powder/sucrose and of Witepsol H-15/sucrose best masked the bitter taste so that they were tolerable enough to chew and swallow. The dosage forms best masking bitter taste showed good release of the drug, indicating little change in bioavailability by masking.

  13. [Oral contraceptives and the internal ecology of women].

    PubMed

    Lefebvre, Y

    1974-11-01

    This review of the general effects of oral contraceptives includes mode of action, criteria for severity of side effects, discussion of the most important side effects, and possible drug interactions; each topic is outlined in tables. Pills work by inhibiting ovulation, altering cervical mucus, and suppressing the endometrium. Criteria for severity of side effects are 1) increased incidence in the population, 2) change in the woman's current or future life bearing on her health or 3) that of her offspring, and 4) irreversible changes. Accordingly, the most important probelms are amenorrhea or "oversuppression syndrome," more common in nulliparas and those taking depot contraceptives; abortion due to severe malformation of the embryo within 6 months of stopping the pill; hyperplasia of the cervix or breast fibrosis; and thromboembolism, particularly postoperative. Tables for choosing the type of pill to suit the patient, brands available in Canada, and doses, are provided. Drug interations may involve modification of absorption, augmentation of hormone-protein linkage, and changes in liver metabolism.

  14. Misconceptions about the side effects of combined oral contraceptive pills.

    PubMed

    Küçük, Mert; Aksu, Hilmiye; Sezer, Selda Demircan

    2012-04-01

    Although combined oral contraceptive pills (COCPs) are one of the most commonly used methods of contraception in western countries, they are taken by only a minority of sexually active women in Turkey. The purpose of this research has been to define women's specific misconceptions with regard to the side effects of COCPs. This descriptive and cross-sectional research was conducted on 418 reproductive aged women who agreed to participate. Data were collected through face-to-face interviews with a questionnaire which assessed socio-demographic characteristics and women's beliefs about the side effects of COCPs. It is observed that 45.2% believed that the pills cause weight gain. Another 7.9% of the cases held the belief that COCPs cause cancer. A group of 13.4% of the subjects thought that COCPs lead to infertility, 28.7% believed that they cause headache, 41.1% believed that they cause acne and/or an increase in body hair, and 11.7% were afraid that they cause a decrease in libido. The present study has shown that misconceptions about the side effects of COCPs were considerably prevalent among this cohort group of Turkish women. Healthcare professionals have the potential of playing an important role in dispersing these misconceptions.

  15. Oral contraceptives and venous thromboembolism: pill scares and public health.

    PubMed

    Reid, Robert L

    2011-11-01

    Post-marketing surveillance of combined oral contraceptives (COCs) for rare complications such as venous thromboembolism (VTE) presents unique challenges. Prospective studies, which are costly and time consuming, have to date been undertaken by only a few contraceptive manufacturers willing to commit to full evaluation of product safety. Often such studies are conducted with the approval of regulatory authorities as a precondition for marketing. Alternatively, independent investigators with access to large databases have conducted retrospective studies to compare the incidence of VTE between new and older products. Such studies, however, run the risk of erroneous conclusions if they cannot ensure comparable risk profiles for users of these different products. Often database studies are unable to access information on important confounders, and medical records may not be available to validate the actual diagnosis of VTE. "Pill scares" generated following publication and media dissemination of worrisome findings, when the conclusions are in doubt and not corroborated by stronger prospective study designs, are frequently damaging to public health. From a review of recent publications on the VTE risk with drospirenone-containing COCs, it can be concluded that the best quality evidence does not support a difference in risk between users of COCs containing drospirenone and those of COCs containing levonorgestrel.

  16. Oral contraceptives and colorectal cancer risk: a meta-analysis

    PubMed Central

    Fernandez, E; Vecchia, C La; Balducci, A; Chatenoud, L; Franceschi, S; Negri, E

    2001-01-01

    Several studies have suggested an inverse association between use of combined oral contraceptives (OC) and the risk of colorectal cancer and here we present a meta-analysis of published studies. Articles considered were epidemiological studies published as full papers in English up to June 2000 that included quantitative information on OC use. The pooled relative risks (RR) of colorectal cancer for ever OC use from the 8 case-control studies was 0.81 (95% confidence interval (CI): 0.69–0.94), and the pooled estimate from the 4 cohort studies was 0.84 (95% CI: 0.72–0.97). The pooled estimate from all studies combined was 0.82 (95% CI: 0.74–0.92), without apparent heterogeneity. Duration of use was not associated with a decrease in risk, but there was some indication that the apparent protection was stronger for women who had used OCs more recently (RR = 0.46; 95% CI: 0.30–0.71). A better understanding of this potential relation may help informed choice of contraception. © 2001 Cancer Research Campaign http://www.bjcancer.com PMID:11237397

  17. Use of and access to oral and injectable contraceptives in Brazil

    PubMed Central

    Farias, Mareni Rocha; Leite, Silvana Nair; Tavares, Noemia Urruth Leão; Oliveira, Maria Auxiliadora; Arrais, Paulo Sergio Dourado; Bertoldi, Andréa Dâmaso; Pizzol, Tatiane da Silva Dal; Luiza, Vera Lucia; Ramos, Luiz Roberto; Mengue, Sotero Serrate

    2016-01-01

    ABSTRACT OBJECTIVE To analyze the prevalence of current use of oral and injectable contraceptives by Brazilian women, according to demographic and socioeconomic variables and issues related to access to those medicines. METHODS A cross-sectional, population-based analytical study with probability sampling based on data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines), carried out between September 2013 and February 2014 in 20,404 Brazilian urban households. Prevalence was calculated based on reports from non-pregnant women aged 15-49 on the use of oral or injectable contraceptives. The independent variables were gender, age, level of education, socioeconomic class, Brazilian region and marital status. Also analyzed were access, means of payment, sources, and reported medicines. Statistical analyses considered 95% confidence intervals (95%CI) and Pearson Chi-square test to evaluate the statistical significance of differences between groups, considering a 5% significance level. RESULTS Prevalence of use was 28.2% for oral contraceptives (OC) and 4.5% for injectable contraceptives (IC). The highest prevalence of oral contraceptives was in the South region (37.5%) and the lowest in the North region (15.7%). For injectable contraceptives there was no difference between regions. Access was higher for oral contraceptive users (90.7%) than injectable contraceptives users (81.2%), as was direct payment (OC 78.1%, IC 58.0%). Users who paid for contraceptives acquired them at retail pharmacies (OC 95.0% and IC 86.6%) and at Farmácia Popular (Popular Pharmacy Program) (OC 4.8% and IC 12.7%). Free of charge contraceptives were mostly obtained from the Brazilian Unified Health System – SUS (OC 86.7%; IC 96.0%). Free samples were reported by 10.4% of users who did not pay for oral contraceptives. Most of paying users did not try to obtain

  18. Risk of fatal pulmonary embolism with oral contraceptives.

    PubMed

    Poulter, N R

    2000-06-17

    This commentary addresses the New Zealand study (case report) of a fatal pulmonary embolism (PE) associated with oral contraceptive (OC) use by L. Parkin and colleagues. The study significantly adds to the knowledge on the relationship between fatal PE and OC use, because most of the evidence up to now has related to nonfatal venous thromboembolic events (VTE). Several areas of the study, however, are criticized. These include the method used, definition, and the adjustment of data. However, these criticisms have been offered explanations in this commentary. It is noted that data from the study indicated that OCs containing desogestrel or gestodene are associated with higher risks of fatal PE than are those containing levonorgestrel. This is consistent with most previous studies comparing the effects of second-generation progestogens on VTE. Overall, data support previous pragmatic recommendations that second-generation pills, which contain levonorgestrel, are the combined OCs of choice.

  19. Bone mineral density and history of oral contraceptive use.

    PubMed

    Fortney, J A; Feldblum, P J; Talmage, R V; Zhang, J; Godwin, S E

    1994-02-01

    To examine the relationship between oral contraceptive (OC) use and bone mineral density (BMD), we conducted a cross-sectional study on 352 white, nonsmoking, perimenopausal women aged 40-54 years. We measured bone mineral density of lumbar vertebrae 2-4 with dual photon absorptiometry and mid-radius and distal radius with single photon absorptiometry. After controlling for age, body mass, current physical activity, current calcium intake and history of breastfeeding, our analysis did not find substantial differences in BMD at any site between OC ever users and never users. However, OC ever users had slightly higher lumbar BMD among premenopausal women. No significant association was identified between recency of OC use and BMD. The results of our study suggest that when other factors are accounted for, OC use is not strongly associated with BMD among perimenopausal women, although we cannot exclude a slight beneficial effect.

  20. Lansoprazole does not affect the bioavailability of oral contraceptives.

    PubMed Central

    Fuchs, W; Sennewald, R; Klotz, U

    1994-01-01

    The effects of the proton pump inhibitor lansoprazole on the bioavailability of a low-dose oral contraceptive (OC), containing 0.03 mg ethinyloestradiol (EE) and 0.15 mg levonorgestrel (LNG), were investigated. Twenty-four healthy females (aged 19-35 years; weight 60.6 +/- 7.1 kg) participated in a multiple-dose, placebo-controlled, randomized two-way cross-over study. All subjects received the OC over 2 full menstrual cycles from day 1 to day 21 separated by a drug-free interval of 7 days. Lansoprazole (60 mg day-1) or placebo was coadministered for 3 weeks each. Plasma concentrations of EE and LNG were determined by GC-MS. The 90% confidence intervals for ratios of Cmax and AUC after log transformation of both EE and LNG ranged between 91 and 111%, indicating that lansoprazole did not affect the bioavailability of EE and LNG. PMID:7833230

  1. Lansoprazole does not affect the bioavailability of oral contraceptives.

    PubMed

    Fuchs, W; Sennewald, R; Klotz, U

    1994-10-01

    The effects of the proton pump inhibitor lansoprazole on the bioavailability of a low-dose oral contraceptive (OC), containing 0.03 mg ethinyloestradiol (EE) and 0.15 mg levonorgestrel (LNG), were investigated. Twenty-four healthy females (aged 19-35 years; weight 60.6 +/- 7.1 kg) participated in a multiple-dose, placebo-controlled, randomized two-way cross-over study. All subjects received the OC over 2 full menstrual cycles from day 1 to day 21 separated by a drug-free interval of 7 days. Lansoprazole (60 mg day-1) or placebo was coadministered for 3 weeks each. Plasma concentrations of EE and LNG were determined by GC-MS. The 90% confidence intervals for ratios of Cmax and AUC after log transformation of both EE and LNG ranged between 91 and 111%, indicating that lansoprazole did not affect the bioavailability of EE and LNG.

  2. [Clinical experiences with a gestodene containing oral contraceptive (femoden)].

    PubMed

    Gimes, G; Valent, S

    1998-09-01

    In order to reduce the side-effects (blood-lipid alterations, androgen effects etc.) new gestogens were introduced, while the ethinyl-estradiol component of the pill was unchanged. Authors report about clinical trial on monophasic oral contraceptive containing 0.030 mg ethinyl-estradiol and 0.075 mg gestodene. In a follow up of 92 women, in 1740 cycles no pregnancy and no cardivascular or thromboembolic complication was observed. The frequency of bleeding disorders was below 10% already in the first cycle. The quantity of withdrawal bleeding, as well the frequency of breakthrough bleeding and spotting decreased during the treatment. Significant alteration in body weight or blood pressure did not occur. Femoden containing third generation gestogen has an excellent cycle control and good patient compliance.

  3. Treatment of acne with oral contraceptives: criteria for pill selection.

    PubMed

    Koulianos, G T

    2000-10-01

    Combination oral contraceptives (OCs) (those that contain estrogen and progestin) are widely used in the treatment of acne because they modify an excessively androgenic hormonal environment and can decrease lesions. Dermatologists' knowledge of the most appropriate OC may be hampered by an incomplete understanding of these agents, misleading promotion, and confusion surrounding the new generation of OCs. Despite reports attributing significance to the degree of androgenicity of the progestin components of OCs, in vitro and animal bioassays of androgenicity have little clinical relevance. Because all of today's low-dose combination OCs are estrogen dominant, they are equally beneficial in women with androgenic conditions such as acne. Use of the OC containing the lowest dose of each hormone, consistent with the patient's needs, can enhance compliance by preventing or limiting common early-cycle side effects (e.g., nausea/vomiting, breast tenderness, weight gain, headache), while providing acne improvement.

  4. Stroke in women - oral contraception, pregnancy, and hormone replacement therapy.

    PubMed

    Rantanen, Kirsi; Tatlisumak, Turgut

    2013-01-01

    Stroke is a devastating disease affecting millions of people worldwide every year. Female stroke victims have higher mortality rates and they do not re-cover as well as men. Women's longevity and different vascular risk factor burden like a larger prevalence of atrial fibrillation play a role. Women also have unique risk factors such as oral contraception, pregnancy, estrogen decrease after the menopause and hormone replacement therapy, which should all be evaluated and taken into consideration in treatment decisions both in the acute phase of stroke and in secondary prevention. In this review, the evidence regarding these hormonal aspects and the risk of stroke in women are evaluated. The relevant guidelines are studied and research gaps identified. Future topics for research are recommended and current treatment possibilities and their risks discussed.

  5. Acceptability of the combined oral contraceptive pill among Hong Kong women.

    PubMed

    Lo, S St; Fan, S Ys

    2016-06-01

    To evaluate the motivators and barriers to the use of the combined oral contraceptive pill among Hong Kong women. The Family Planning Association of Hong Kong commissioned the ESDlife to launch an online survey and invited its female members aged 18 to 45 years who had used contraceptives in the past 12 months to participate in this survey. The online survey was posted on the ESDlife website between April 2015 and May 2015. Measurements included contraceptive choice, and motivators and barriers to the use of a combined oral contraceptive pill. A total of 1295 eligible women with a median age of 32 years participated in this survey. In the past 12 months, 76.1% of them used a male condom, 20.9% practised coitus interruptus, 16.2% avoided coitus during the unsafe period, and 12.6% took a combined oral contraceptive pill. These women chose a combined oral contraceptive for convenience, effectiveness, and menstrual regulation, though 60.9% had stopped the pills because they were worried about side-effects, experienced side-effects, or consistently forgot to take the pills. Some women had never tried a combined oral contraceptive pill because they feared side-effects, they were satisfied with their current contraceptive method, or pill-taking was inconvenient. The combined oral contraceptive pill is underutilised by Hong Kong women compared with those in many western countries. A considerable proportion of respondents expressed concern about actual or anticipated side-effects. This suggests that there remains a great need for doctors to dispel the underlying myths and misconceptions about the combined oral contraceptive pill.

  6. Factors predicting mood changes in oral contraceptive pill users

    PubMed Central

    2013-01-01

    Background Over 100 million women worldwide are using oral contraceptives pills (OCP) and mood changes were being as the primary reason for OCP discontinuation. The purpose of this study was to determine the prevalence and predicting factors of mood changes in oral contraceptive pills users. Methods This was a cross-sectional study of 500 women aged 15–49 years old using low dose (LD) pills attending family planning centers in Ahwaz, Iran. Data were collected via face-to-face interviews using a structured questionnaire including items on demographic, self-efficacy and mood change. Both univarate and multiple logistic regression analyses were performed to assess the relationship between reported mood change and the independent variables. Results In all 406 women reported that they did experience OCP side effects. Of these, 37.7% of women (n =153) reported mood changes due to OCP use. The results of multiple logistic regression revealed that place of living (OR =2.57, 95% CI = 1.06-6.20, p =0.03), not receiving information on OCP side effects (OR =1.80, 95% CI = 1.15-2.80, p =0.009), and lower self-efficacy (OR = 0.87, 95% CI = 0.80-0.94, p =0.001) were significant predictors of mood changes. Conclusion The findings from this study indicated that the prevalence of reported mood changes due to OCP use among Iranian women appeared to be consistent with other studies. In addition the findings showed that receiving information on OCP side effects from health care workers and self-efficacy were important predicting factors for mood changes. Indeed implementing educational programs and improving self-efficacy among women are recommended. PMID:24015872

  7. 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

  8. 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

  9. Efficacy and safety of the new antiandrogenic oral contraceptive Belara.

    PubMed

    Zahradnik, H P; Goldberg, J; Andreas, J O

    1998-02-01

    The aim of this open, noncontrolled phase III study was the assessment of the contraceptive efficacy and the evaluation of the safety of long-term use of Belara (30 micrograms ethinyl estradiol plus 2 mg chlormadinone acetate). Furthermore, cycle stability during administration of Belara and the influence of Belara on acne and seborrhea as clinical signs of androgenization were observed. Belara was taken by 1655 women for a total of 22,337 cycles. For the theoretical Pearl index, a value of 0.269 (95% CI [0.109, 0.600]) was calculated. In 1655 of 22,337 cycles (7.4%), no withdrawal bleeding was documented, whereas in 2565 of 22,308 cycles (11.5%), spottings and, in 786 of 22,308 cycles (3.5%), breakthrough bleeding occurred. After the intake of Belara for 12 cycles, acne on the face/neck improved in 64.1% of the women (209 of 326). In 53.4% of the women (175 of 326), acne disappeared completely. Seborrhea improved after 12 cycles in 89 of 131 women (67.9%), of whom 76 women (58.0%) were completely cured. Sixty-two serious adverse events (SAE) occurred in 59 of 1655 women. Accidents and injuries of the musculoskeletal system were the SAE with the highest incidence (0.66%). Two cases of deep venous thrombosis, one pulmonary embolism, and two cases of visual disturbances were observed. Only for the two cases of deep venous thrombosis could a relation to Belara be assumed. Of the adverse events commonly reported for oral contraceptives, headache was observed for the first time under study medication in 37.4%, nausea in 23.1%, breast tenderness in 21.7%, and vaginal discharge in 19.4% of the women. The frequency of adverse events decreased with longer duration of a drug consisting of intake of Belara. In conclusion, Belara can be described as an effective and safe oral contraceptive with marked antiandrogenic properties.

  10. Oral contraceptive use alters the balance of platelet prostaglandin and thromboxane synthesis.

    PubMed

    Schorer, A E; Gerrard, J M; White, J G; Krivit, W

    1978-07-01

    The ability of platelet microsomes to generate platelet aggregating activity on addition of arachidonic acid was evaluated in women taking oral contraceptives and in controls taking no medication but matched for age, sex, and family history. Oral contraceptive users generated significantly more platelet aggregating activity per 100 ug of platelet microsomal protein than controls. Variation in generation of platelet aggregating activity during the menstrual cycle was also observed with highest activity during the third week. These studies show an altered balance of platelet prostaglandin and thromboxane synthesis in oral contraceptive users which may contribute to their increased incidence of thromboembolic phenomena.

  11. Factors associated with the contraindicated use of oral contraceptives in Brazil

    PubMed Central

    Corrêa, Daniele Aparecida Silva; Felisbino-Mendes, Mariana Santos; Mendes, Mayara Santos; Malta, Deborah Carvalho; Velasquez-Melendez, Gustavo

    2016-01-01

    ABSTRACT OBJECTIVE To estimate the prevalence of the contraindicated use of oral contraceptives and the associated factors in Brazilian women. METHODS 20,454 women who answered the VIGITEL survey in 2008 also participated in this study, of which 3,985 reported using oral contraceptives. We defined the following conditions for the contraindicated use of contraceptives: hypertension; cardiovascular diseases such as heart attack, stroke/cerebrovascular accident; diabetes mellitus; being smoker and 35 years old or older. We estimated the prevalence and 95% confidence intervals of contraindicated use in users of oral contraceptives and the factors associated with contraindication by prevalence ratio and 95% confidence intervals. RESULTS In the total population, 21% (95%CI 19.7–21.9) of women showed some contraindication to the use of oral contraceptives, of which 11.7% (95%CI 10.6–13.7) belonged to the group of users of oral contraceptives. The most frequent contraindication in users of oral contraceptives was hypertension (9.1%). The largest proportion of women with at least one contraindication was aged between 45 and 49 years (45.8%) and with education level between zero and eight years (23.8%). The prevalence of contraindication to oral contraceptives was higher in women less educated (zero to eight years of study) (PR = 2.46; 95%CI 1.57–3.86; p < 0.05) and with age between 35-44 years (PR = 4.00; 95%CI 2.34–6.83) and 45-49 years (PR = 5.59; 95%CI 2.90–10.75). CONCLUSIONS Age greater than or equal to 35 and low education level were demographic and iniquity factors, respectively, in the contraindicated use of oral contraceptives. PMID:28099550

  12. Oral contraceptive use and cancer: final report from the Oxford-Family Planning Association contraceptive study.

    PubMed

    Vessey, Martin; Yeates, David

    2013-12-01

    This analysis provides the final results on cancer incidence in relation to oral contraceptive (OC) use from the Oxford-Family Planning Association (Oxford-FPA) contraceptive study, which closed at the end of 2010. An additional 6 years of observation have been added since our last report and there has been an increase in the numbers of cancers of over 50% at seven of the sites considered. The Oxford-FPA study includes 17032 women aged 25-39 years recruited from 1968 to 1974 at contraceptive clinics in England and Scotland. These women were using OCs, a diaphragm or an intrauterine device. Information about cancer incidence among them has been collected from recruitment until closure of the study. OC use was not related to nonreproductive cancer. Breast cancer findings (1087 cases) were entirely negative; the rate ratio (RR) comparing ever users of OCs with never users was 1.0 [95% confidence interval (CI): 0.9-1.1]. Only two cases of cervical cancer have been added since our last report (total: 61 cases); the RR comparing ever use with never use is now 3.4 (95% CI: 1.6-8.9). The risk of this disease increases sharply with duration of OC use and declines steadily with interval since last OC use. OC use protects against both uterine body cancer (124 cases) and ovarian cancer (143 cases). The RRs comparing ever use with never use were 0.5 (95% CI: 0.3-0.7) and 0.5 (95% CI: 0.4-0.7), respectively. Protection against both these cancers increased with duration of OC use and waned with interval since last use, but an effect was still present 28 or more years after discontinuation. In our study, OC use had no effect on nonreproductive cancers or on breast cancer. The risk of cervical cancer was increased and that of uterine body cancer and ovarian cancer was decreased by OC use. All these effects increased with duration of use and declined with interval since last use. The beneficial effects of OC use on cancer outweighed the adverse effects. These findings should

  13. Hormonal contraception decreases bacterial vaginosis but oral contraception may increase candidiasis: implications for HIV transmission.

    PubMed

    van de Wijgert, Janneke H H M; Verwijs, Marijn C; Turner, Abigail Norris; Morrison, Charles S

    2013-08-24

    A 2012 WHO consultation concluded that combined oral contraception (COC) does not increase HIV acquisition in women, but the evidence for depot medroxyprogesterone acetate (DMPA) is conflicting. We evaluated the effect of COC and DMPA use on the vaginal microbiome because current evidence suggests that any deviation from a 'healthy' vaginal microbiome increases women's susceptibility to HIV. We conducted a systematic review and reanalysed the Hormonal Contraception and HIV Acquisition (HC-HIV) study. Vaginal microbiome outcomes included bacterial vaginosis by Nugent scoring, vaginal candidiasis by culture or KOH wet mount and microbiome compositions as characterized by molecular techniques. Our review of 36 eligible studies found that COC and DMPA use reduce bacterial vaginosis by 10-20 and 18-30%, respectively. The HC-HIV data showed that COC and DMPA use also reduce intermediate microbiota (Nugent score of 4-6) by 11% each. In contrast, COC use (but not DMPA use) may increase vaginal candidiasis. Molecular vaginal microbiome studies (n=4) confirm that high oestrogen levels favour a vaginal microbiome composition dominated by 'healthy' Lactobacillus species; the effects of progesterone are less clear and not well studied. DMPA use does not increase HIV risk by increasing bacterial vaginosis or vaginal candidiasis. COC use may predispose for vaginal candidiasis, but is not believed to be associated with increased HIV acquisition. However, the potential role of Candida species, and vaginal microbiome imbalances other than bacterial vaginosis or Candida species, in HIV transmission cannot yet be ruled out. Further in-depth molecular studies are needed.

  14. 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

  15. Emergency contraception.

    PubMed

    Ellertson, C; Trussell, J; Stewart, F; Koenig, J; Raymond, E G; Shochet, T

    2001-12-01

    Emergency contraceptives are methods that prevent pregnancy when used shortly after unprotected sex. Three different emergency contraceptive methods are safe, simple, and widely available in the United States. These are: (1) ordinary combined oral contraceptives containing ethinyl estradiol and levonorgestrel taken in a higher dose for a short period of time and started within a few days after unprotected intercourse; (2) levonorgestrel-only tablets used similarly; and (3) copper-bearing intrauterine devices inserted within approximately 1 week after unprotected intercourse. Emergency contraceptive use is best known for women who have been raped, but the methods are also appropriate for women who have experienced condom breaks, women who did not use any method because they were not planning on having sex, or women who had unprotected intercourse for any other reason. Unfortunately, few women know about emergency contraceptives, and few clinicians think to inform their patients routinely about the option. A nationwide toll-free hotline (1-888-NOT-2-LATE) and a website (http://not-2-late.com) can help women learn about these options. Sharing "family planning's best-kept secret" widely with women could prevent as many as a million unwanted pregnancies annually in the United States.

  16. Evaluation of the Effect of Tofacitinib on the Pharmacokinetics of Oral Contraceptive Steroids in Healthy Female Volunteers

    PubMed Central

    Menon, Sujatha; Riese, Richard; Wang, Ronnie; Alvey, Christine W.; Shi, Haihong; Petit, Wendy

    2016-01-01

    Abstract Tofacitinib is an oral Janus kinase inhibitor. Tofacitinib metabolism is primarily mediated by cytochrome P450 3A4. This phase 1 randomized, open‐label, 2‐way crossover study (NCT01137708) evaluated the effect of tofacitinib 30 mg twice daily on the single‐dose pharmacokinetics of combination oral contraceptives ethinylestradiol (EE) and levonorgestrel (LN). EE and LN were administered as a single Microgynon 30® tablet (30 μg EE and 150 μg LN) to 19 healthy women. In the presence of tofacitinib, the area under the curve from time zero to infinity (AUC∞) increased by 6.6% and 0.9% for EE and LN, respectively. Maximal plasma concentrations decreased by 10.4% for EE and increased by 12.2% for LN when coadministered with tofacitinib. The 90% confidence intervals for the adjusted geometric mean ratios for AUC∞ fell within the 80%–125% region for both EE and LN. Mean half‐life was similar in the presence and absence of tofacitinib: 13.8 and 13.3 hours, respectively, for EE; 25.9 and 25.4 hours, respectively, for LN. Tofacitinib had no clinically relevant net inhibitory or inductive effect on the pharmacokinetics of EE and LN. Therefore, there is no evidence to suggest dose adjustments of oral contraceptive drugs containing EE or LN when coadministered with tofacitinib. PMID:27138968

  17. A Comparison of Second and Third Generations Combined Oral Contraceptive Pills’ Effect on Mood

    PubMed Central

    Shahnazi, Mahnaz; Farshbaf Khalili, Azizeh; Ranjbar Kochaksaraei, Fatemeh; Asghari Jafarabadi, Mohammad; Gaza Banoi, Kamal; Nahaee, Jila; Bayati Payan, Somayeh

    2014-01-01

    Background: Most women taking combined oral contraceptives (COCs) are satisfied with their contraceptive method. However, one of the most common reasons reported for discontinuation of combined oral contraceptives (COCs) is mood deterioration. Objectives: This study aimed to compare effects of the second and third generation oral contraceptive pills on the mood of reproductive women. Materials and Methods: This randomized, double-blind, controlled clinical trial was conducted in reproductive women at health centers in Tehran, Iran. Participants were randomized into the second and third generation oral contraceptive groups. Positive and negative moods were recorded using positive affect, negative affect scale (PANAS) tools at the end the second and fourth months of the study. Data analysis was carried out using ANOVA and P Values < 0.05 was considered significant. Results: Statistically significant difference was seen in positive and negative mood changes in women receiving contraceptive pills. The second generation oral contraceptive pills resulted in a decrease in positive mood (95% CI: 43.39 to 38.32 in second month and 43.39 to 26.05 in four month) and increase in negative mood (95% CI: 14.23 to 22.04 in second month and 14.23 to 32.26 in four month - P < 0.001), but the third generation led to an increase in positive mood (95% CI: 22.42 to 25.60 in second month and 22.42 to 33.87 in four month) and decrease in negative mood (95% CI: 36.78 to 31.97 in second month and 36.78 to 22.65 in four month - P < 0.001). Conclusions: Third generation combined oral contraceptive pills have a better effect on mood in women in reproductive ages than the second generation pills. It can be recommended as a proper combined oral contraceptive in Iran. PMID:25389478

  18. Formulation of multiparticulate systems as lyophilised orally disintegrating tablets.

    PubMed

    Alhusban, Farhan; Perrie, Yvonne; Mohammed, Afzal R

    2011-11-01

    The current study aimed to exploit the electrostatic associative interaction between carrageenan and gelatin to optimise a formulation of lyophilised orally disintegrating tablets (ODTs) suitable for multiparticulate delivery. A central composite face centred (CCF) design was applied to study the influence of formulation variables (gelatin, carrageenan and alanine concentrations) on the crucial responses of the formulation (disintegration time, hardness, viscosity and pH). The disintegration time and viscosity were controlled by the associative interaction between gelatin and carrageenan upon hydration which forms a strong complex that increases the viscosity of the stock solution and forms tablet with higher resistant to disintegration in aqueous medium. Therefore, the levels of carrageenan, gelatin and their interaction in the formulation were the significant factors. In terms of hardness, increasing gelatin and alanine concentration was the most effective way to improve tablet hardness. Accordingly, optimum concentrations of these excipients were needed to find the best balance that fulfilled all formulation requirements. The revised model showed high degree of predictability and optimisation reliability and therefore was successful in developing an ODT formulation with optimised properties that were able deliver enteric coated multiparticulates of omeprazole without compromising their functionality.

  19. Effects of oral contraceptives on tryptophan metabolism and vitamin B6 requirements in women.

    PubMed

    Brown, R R; Rose, D P; Leklem, J E; Linkswiler, H M

    1975-01-01

    To evaluate the effect of oral contraceptive usage on the nutritional requirement for vitamin B6, control women and oral contraceptive users were depleted of vitamin B6 for 1 month followed by a month of repletion with 0.8, 2.0, or 20.0 mg of pyridoxine hydrochloride per day. At weekly intervals a number of indices of vitamin B6 nutrition were measured. Marked elevation in excretion of tryptophan metabolites occurred in oral contraceptive users after tryptophan loads. However, other indices of vitamin B6 nutritional state, including urinary 4-pyridoxic acid excretion, urinary cystathionine excretion, plasma pyridoxal phosphate concentrations, and erythrocyte aspartate and alanine aminotransferases were not different between controls and oral contraceptive users. The excretion of metabolites after oral loading doses of L-kynurenine (which bypasses tryptophan oxygenase) was elevated in oral contraceptive users indicating that abnormal metabolism of tryptophan was not due only to induced tryptophan oxygenase. The data indicate that use of oral contraceptives does not generally change the requirement for vitamin B6 but rather produces a specific change in activity of enzymes beyond kynurenine in the pathway of tryptophan metabolism.

  20. Oral contraceptives alter sleep and raise body temperature in young women.

    PubMed

    Baker, F C; Mitchell, D; Driver, H S

    2001-08-01

    Female reproductive steroids, oestrogen and progesterone, not only affect reproductive function, but also thermoregulation and sleep. Chronic administration of synthetic steroids, as occurs in women taking oral contraceptives, may affect these regulatory systems differently from endogenous oestrogen and progesterone. We therefore investigated body temperature and sleep in ten young women taking oral contraceptives, in the active and placebo phases of the contraceptive pack, and compared them to a group of nine women with ovulatory cycles, in the mid-follicular and mid-luteal phases. Body temperature was raised throughout 24 h in the women taking oral contraceptives in the active phase, and in the naturally cycling women in the luteal phase, compared to the follicular phase. The women taking oral contraceptives in the placebo phase, however, continued to have raised body temperatures, similar to those in the active phase, indicating a prolonged action of synthetic reproductive steroids on body temperature. Sleep also was influenced by the endogenous and synthetic reproductive steroids, but independently of body temperature. The women taking oral contraceptives had more stage-2 non-rapid eye movement sleep in the active phase, both compared to their placebo phase and the naturally cycling women. The naturally cycling women, however, had more slow wave sleep in the luteal phase compared to the contraceptive group of women. Exogenous reproductive steroids therefore influence body temperature and sleep differently from endogenous progesterone and oestrogen.

  1. Combined Oral Contraceptive Pills: Profile of Acceptors in a Tertiary Hospital in South-South Nigeria.

    PubMed

    Abasiattai, A M; Utuk, M N; Ojeh, S O; Eyo, U E

    2011-01-01

    BACKGROUND: Combined oral contraceptive pills were the first contraceptive method to provide sexual freedom of choice for women through reliable, personal and private control of fertility. They are the most widely used hormonal contraceptives and also the most popular non-surgical method of contraception. OBJECTIVE: To review the profile of acceptors of combined oral contraceptive pills at the University of Uyo Teaching Hospital, Uyo. METHODOLOGY: An 8 year review of all clients that accepted combined oral contraceptive pills in the family planning clinic. RESULTS: There were 1,146 new contraceptive acceptors during the period of study out of which 309 (27.9%) accepted the pills. Majority of the clients were between 20 and 29 years of age (54.0%), were multiparous (72.8%), Christians (99.7%) and 61.2% had tertiary level education. Two hundred and fifty-five women (82.5%) desired to use combined oral contraceptive pills to space births while 7.8% wanted to limit child bearing. There was a high discontinuation rate among the women (45.0%) and out of these 87.9% of the clients changed to other contraceptive methods. All the clients commenced their pills within seven days of menstruation and only the low dose monophasic preparations were available in the family planning unit and thus were given to the clients. CONCLUSION: Women who accept to initiate combined oral contraceptive pills in our center are young, well educated, multiparous women who want to space their pregnancies. However, due to the high discontinuation rate among the clients, there is need for further studies evaluating reasons for the high discontinuation rate, exploring interactions between clients and providers' and also providers' attitude towards combined pills in our environment.

  2. Oral contraceptives and cardiovascular risk. Taking a safe course of action.

    PubMed

    Derman, R J

    1990-09-15

    Although a prospective, longitudinal study on the long-term cardiovascular effects of oral contraceptives has yet to be performed, available data are useful in determining a safe course of action while physicians await definitive answers. Exogenous sex steroids produce important effects on lipid metabolism. Early intervention against cholesterol is important in reducing cardiovascular risk. Current users of high-dose formulations, particularly older women who smoke, are at greatest risk for cardiovascular complications, especially myocardial infarction. Low-dose oral contraceptives have more modest effects on lipid metabolism, but important differences in the potency of progestins remain. Fortunately, recent studies among users of lower-dose oral contraceptive formulations fail to show an increase in cardiovascular morbidity and mortality. Nonetheless, prudent physicians will avoid oral contraceptives that may adversely affect lipoprotein metabolism, such as those containing progestins with high androgenic and antiestrogenic potency.

  3. Side and site of deep vein thrombosis in women using oral contraceptives.

    PubMed

    Kierkegaard, A

    1985-01-01

    The anatomy of the thrombus in acute deep vein thrombosis (DVT) in women using oral contraceptives was studied in 277 reports on DVT received by the Swedish Adverse Drug Reaction Advisory Committee (SADRAC). The study revealed a similarity between the anatomy of DVT in women on oral contraceptives and that of DVT in pregnant women, suggesting a pharmacologic influence of the hormones in the pill on the pathogenesis of DVT in women on oral contraceptives. The anatomy of DVT in women on low-estrogen pills was identical with that of DVT in women on high-estrogen pills, suggesting an identical pharmacologic influence of the two types of pill on the pathogenesis of DVT in women on oral contraceptives.

  4. [Oral combined contraception: is there any difference between ethinyl-estradiol and estradiol?].

    PubMed

    Trémollieres, F

    2012-02-01

    Estradiol 17-β, which is the natural estrogen in women, offers an alternative to ethinyl-estradiol to be used in combined oral contraceptives. Thanks to its biochemical structure, estradiol has a far lesser impact on the synthesis of hepatic proteins than ethinyl-estradiol, which is likely to result in a better metabolic and vascular profile. However and until lately, the different clinical trials that had investigated estradiol-containing oral contraceptives were limited by bleeding disturbances, with breakthrough and irregular bleeding and higher rates of discontinuation. Development of anti-gonadotropic progestins with a potent endometrial activity is likely to make possible their combination with estradiol in oral contraceptives. The objective of this current review is to provide an overview of the development of combined oral contraceptives containing natural estrogen from the respective biochemical and pharmacological characteristics of ethinyl-estradiol and estradiol.

  5. Effects of oral contraceptive agents and sex steroids on carbohydrate metabolism.

    PubMed

    Kalkhoff, R K

    1972-01-01

    The article offers a general interpretation of the influence of oral contraceptive agents on glucose tolerance, emphasizing comparisons of synthetic sex hormones. Although there are conflicting reports on steroid-induced diabetes in normal women, their glucose curves are often higher when under oral contraceptive treatment, suggesting that oral contraceptives may induce a form of subclinical diabetes melitus that is reversible. Evidence from diabetic women suggests definite deliterious effects from contraceptive administration. Estradiol, estriol, and estrone may improve glucose tolerance in nondiabetic women and reduce insulin requirements in diabetics. Progesterone has little effect on carbohydrate tolerance, as did synthetic progestin. Conjugated equine estrogens (equilenine or Premarin) may provoke mild to moderate deterioration of carbohydrate tolerance. Parenterally administered natural estrogens and orally administered synthetic derivatives appear to differ sharply in their effects. Sex hormones' effects on carbohydrate metabolism likely involve interactions with insulin and endogenous glucocorticoids.

  6. Amygdala reactivity to negative stimuli is influenced by oral contraceptive use

    PubMed Central

    Cahill, Larry

    2015-01-01

    The amygdala is a highly interconnected region of the brain that is critically important to emotional processing and affective networks. Previous studies have shown that the response of the amygdala to emotionally arousing stimuli can be modulated by sex hormones. Because oral contraceptive pills dramatically lower circulating sex hormone levels with potent analogs of those hormones, we performed a functional magnetic resonance imaging experiment to measure amygdala reactivity in response to emotional stimuli in women using oral contraceptives, and compared their amygdala reactivity with that of naturally cycling women. Here, we show that women who use oral contraceptive pills have significantly decreased bilateral amygdala reactivity in response to negatively valenced, emotionally arousing stimuli compared with naturally cycling women. We suggest that by modulating amygdala reactivity, oral contraceptive pills may influence behaviors that have previously been shown to be amygdala dependent—in particular, emotional memory. PMID:25688096

  7. The oral contraceptive pill: a revolution for sportswomen?

    PubMed Central

    Bennell, K.; White, S.; Crossley, K.

    1999-01-01

    OBJECTIVES: To determine the effects of the oral contraceptive pill (OCP) on skeletal health, soft tissue injury, and performance in female athletes. METHODS: A literature review was performed using literature retrieval methods to locate relevant studies. RESULTS: Most female athletes primarily choose to use the OCP for contraceptive purposes, but cycle manipulation and control of premenstrual symptoms are secondary advantages of its use. The effect of the OCP on bone density in normally menstruating women is unclear, with some studies reporting no effect, others a positive effect, and some even a negative effect. The OCP is often prescribed for the treatment of menstrual disturbances in female athletes, and improvements in bone density may result. Whether the OCP influences the risk of stress fracture and soft tissue injuries is not clear from research to date. Effects of the OCP on performance are particularly relevant for elite sportswomen. Although a reduction in Vo2MAX has been reported in some studies, this may not necessarily translate to impaired performance in the field. Moreover, some studies claim that the OCP may well enhance performance by reducing premenstrual symptoms and menstrual blood loss. A fear of weight gain with the use of the OCP is not well founded, as population studies report no effect on weight, particularly with the lower dose pills currently available. CONCLUSIONS: Overall, the advantages of the pill for sportswomen would appear to outweigh any potential disadvantages. Nevertheless, there is individual variation in response to the OCP and these should be taken into account and monitored in the clinical situation. Women should be counselled as to the range of potential benefits and disadvantages in order to make an informed decision based on individual circumstances. 


 PMID:10450476

  8. [Fertility and characteristics of ovulation after discontinuing oral contraception].

    PubMed

    Gaspard, U; Lambotte, R

    1984-09-01

    A brief review of the literature is the basis for this discussion of residual effects of oral contraceptives (OCs) on fertility and the quality of ovulation after pill use is terminated. A 1982 study of the delay to conception attempted to avoid methological difficulties of earlier studies by comparing previous contraceptive usage among 7000 women hospitalized for childbirth. The analysis showed that the monthly percentage of pregnancies after OC use was significantly decreased for the 1st 3 months compared to levels in former IUD and diaphragm users. 13 months after OCs, 24.8% of OC users still had not conceived, compared to 12.4% if IUD and 8.5% of diaphragm users. Post-pill amenorrhea of longer than 6 months occurs in about 1% of cases. It is now agreed that post-pill amenorrhea is rare, nonspecific, and of multifactorial etiology. The previous existence of menstrual irregularity, stress, psychological troubles, malnutrition, and anorexia are particularly significant. OC use seems to mask the natural occurrence of secondary amenorrhea rather than to cause it. The most careful of available studies document that, although OC use may because of its estrogen content reveal an unsuspected prolactinemia, there is no increase in prolactinemia among OC users. A consensus exists that, excluding patients developing amenorrhea due to ovarian insufficiency, post-pill amenorrhea responds to ovulation inducing treatment exactly as do amenorrheas with no history of pill use. In cases of conception after failure of OCs and continued treatment with OCs, the aging of sperm or hypermaturation of ova at the time of fertilization is accompanied by a very slight increase in the proportion of male fetuses. The teratogenic risk appears to be negligable among former OC users and perhaps slightly greater if OCs, hormonal tests, or supplementary hormonal therapy are continued during pregnancy. The increased risk is not even seen in many studies and does not appear to indicate pregnancy

  9. Cardiovascular risk and the use of oral contraceptives.

    PubMed

    Kaminski, Pawel; Szpotanska-Sikorska, Monika; Wielgos, Miroslaw

    2013-01-01

    The use of combined oral contraceptives (COCs) is associated with approximately 2-fold and over 4-fold increased relative risks of arterial and venous thromboembolic events, respectively. The highest risk of venous thromboembolism occurs in the first year of use (OR: 4.17) and is reduced to 2.76 over baseline risk after 4 years of therapy. The risk of myocardial infarction does not correlate to the length of therapy and disappears after treatment termination. Most of women, using COCs, have low absolute cardiovascular risks and benefits outweigh the risk associated with this method of birth control. However, in some cases, COCs may be contraindicated due to excessively increased cardiovascular risks. Current users of COCs, older than 35 years, appear to show an estimated 2.5-fold and 10-fold increased risk of venous thromboembolism in comparison to younger than 35 years COCs non-users and users, respectively. COCs users, who are current smokers, have 10-fold increased risk of myocardial infarction, whereas the risk of stroke increases nearly 3-fold. The presence of poorly controlled hypertension is associated with approximately 3-fold increased risks of myocardial infarction and ischemic stroke, while the risk of haemorrhagic stroke rises 15-fold. In women suffering from hypertension, discontinuation of COCs may improve blood pressure control. Women, who had their blood pressure measured before COCs use, have 2-2.5-fold decreased risk of myocardial infarction and ischaemic stroke. In women with multiple cardiovascular risk factors the use of progestogen-only contraceptives (POCs) should be considered. POC therapy is associated with substantially less risk of cardiovascular events than COCs.

  10. Development of sildenafil-loaded orally disintegrating tablet with new lactate salt.

    PubMed

    Jung, Si-Young; Kim, Dong-Wuk; Seo, Youn Gee; Woo, Jong Soo; Yong, Chul Soon; Choi, Han-Gon

    2012-05-01

    To develop a sildenafil lactate-loaded orally disintegrating tablet with a faster drug effect onset and immediate action of erection, the orally disintegrating tablets were prepared with various amounts of menthol and colloidal silica using the direct compression technique followed by vacuum drying. Their tablet properties such as friability, hardness, wetting time and disintegration time were investigated. The oral bioavailability of sildenafil in the orally disintegrating tablet was then compared with the sildenafil citrate-loaded commercial tablet (Viagra(®)) in rabbits. Sildenafil lactate was a new salt form with more improved solubility and alleviated bitterness compared with commercial salt, sildenafil citrate. As the amount of menthol in the orally disintegrating tablet increased, the friability increased and hardness decreased, resulting in a shorter wetting time and disintegration time. Colloidal silica did the opposite. The sildenafil lactate-loaded orally disintegrating tablet prepared with 45 mg/tab of menthol and 1.5 mg/tab of colloidal silica gave a hardness of 3-4 KP, friability less than 0.5% and disintegration time less than 30 s, suggesting that it was a practical and commercial product with good tablet property and excellent efficacy. Furthermore, it gave higher AUC and C(max), and shorter T(max) values than did the commercial tablet, indicating that it improved the oral bioavailability of sildenafil in rabbits compared with the commercial tablet. Thus, the sildenafil lactate-loaded orally disintegrating tablet might induce a fast onset of action and immediate erection compared with the sildenafil citrate-loaded commercial tablet.

  11. Formulation study for orally disintegrating tablet using partly pregelatinized starch binder.

    PubMed

    Mimura, Kazuki; Kanada, Ken; Uchida, Shinya; Yamada, Masaki; Namiki, Noriyuki

    2011-01-01

    In this study, we aimed to design orally disintegrating tablets by employing a formulation design approach that enables the production of such tablets in the same facilities used for the production of solid dosage forms on an industrial scale. First, we examined the relationships between the types of binders used in the tablets and the properties of orally disintegrating tablets prepared by the wet granulation method. Results revealed that partly pregelatinized starch is a relatively suitable binder for orally disintegrating tablets as it also serves as a disintegrant. Next, we employed a central composite design for 2 factors, namely, corn starch and partly pregelatinized starch, in order to design granules suited for orally disintegrating tablets composed of D-mannitol, corn starch or partly pregelatinized starch. The effects of these 2 factors on 3 types of responses, namely, 50% granule size, compressing index and disintegrating index, were analyzed with a software package, and responses to changes in the factors were predicted. This study investigated the effects of binder type and binder content in orally disintegrating tablets, and provided evidence that the binder exerts a strong influence on tablet properties, and is therefore an important component of orally disintegrating tablets.

  12. Effect of low dose oral contraceptives on exercise performance.

    PubMed Central

    Bryner, R W; Toffle, R C; Ullrich, I H; Yeater, R A

    1996-01-01

    OBJECTIVE--to examine the effect of cycle phase or a low dose oral contraceptive on exercise performance in young women. METHODS--As controls, 15 men were tested twice by a maximal treadmill test (Vo2 max) and by an endurance run 14 d apart to determine performance variability from causes other than hormonal fluctuations. Ten women ages 18-30 were then tested for Vo2 max and endurance in the same way in both the follicular and the luteal phase (random order, ovulation assessed by sonography). They were then randomly assigned to placebo (n = 3) or oral contraceptive (1 mg norethindrone and 35 micrograms ethinyl oestradiol) (n = 7) for 21 days. Tests were repeated during the first and third weeks of treatment. Vo2 max and endurance tests were compared in the men and control cycle of the women by using independent t tests on percent change. The data for both cycles in the women were analysed by repeated measures ANOVA. RESULTS--There was no difference in per cent change in total test time, Vo2 max, or breathing frequency between the men and women in either test. Data obtained during the Vo2 max test revealed no difference between the follicular and luteal phases of the menstrual cycle for total test time [11.8 (SD 2.3) v 12.6 (2.3) min], Vo2 [41.6 (12.1) v 39.7 (11.4) ml.kg-1.min-1], or breathing frequency [26.8 (3.5) v 27.3 (9.9) breaths.min-1] respectively, or during the first and third weeks of treatment [total test time 12.0 (2.5) v 12.8 (2.4) min; Vo2 37.3 (7.4) v 41.0 (12.4) ml.kg-1.min-1; breathing frequency 27.8 (4.2) v 27.7 (3.4) breaths.min-1, respectively]. Data obtained during the endurance test revealed no difference between the follicular and luteal phase of the menstrual cycle for total test time [20.5 (15.7) v 16.2 (8.5) min], Vo2 [37.5 (9.4) v 32.9 (8.1) ml.kg-1.min-1], or breathing frequency [32.0 (6.0) v 33.2 (5.1) breaths.min-1, respectively], or during the first and third weeks of treatment [total test time 32.3 (34.9) v 30.6 (30.1) min; Vo2 33

  13. Development of a new disintegration method for orally disintegrating tablets.

    PubMed

    Kakutani, Ryo; Muro, Hiroyuki; Makino, Tadashi

    2010-07-01

    Recently, the focus has been on the importance of assessing the oral disintegrative properties of orally disintegrating tablets (ODTs). In particular, in the development stages and the quality control field of ODT products, a physical assessment method which easily measures oral disintegrative properties is desired. For this reason, we developed a new disintegration test method (Kyoto-model disintegration method or KYO method), which is useful to predict the oral disintegrative properties of an ODT easily, and examined the availability of the method. In the KYO method, ODT samples were classified in terms of their water permeability, and a moderate water volume was decided. Subsequently, the disintegrative properties were assessed with the newly proposed method. For 25 commercial prescription ODTs used as samples, a good correlation was shown between the results of a human sensory test by five healthy male volunteers and the results using the KYO method. Furthermore, the KYO method could evaluate time-dependent changes in ODT samples. On the other hand, no correlation was observed between the Japanese Pharmacopeia disintegration test and the human sensory test. These results suggested that the KYO method reflected the disintegration nature of the ODTs in the oral cavity, and could easily be applied to development stages and the quality control field of ODT products.

  14. Cancer of the breast and reproductive tract in relation to use of oral contraceptives.

    PubMed

    Schlesselman, J J

    1989-07-01

    Effects of oral contraception on cancers of the female breast and reproductive tract are critically reviewed from human studies reported since 1980. The cumulative risk of breast cancer through 59 years of age appears to bear no relationship to oral contraceptive (OC) use whatsoever. Studies restricted to women under age 45, however, raise concern about a possible adverse effect from OC use before a first-term pregnancy. A duration-related protective effect against endometrial cancer occurs from use of combined OCs. The risk is reduced by about 40% with 2 years of use, and by about 60% with 4 or more years of oral contraception. Oral contraception in excess of 3 years protects against ovarian cancer. Four years of use confers a 50% reduction in risk and 7 or more years of use confers a 60%-80% reduction in ovarian cancer risk. Studies of cervical dysplasia and carcinoma in situ suggest elevated risks with 2 or more years of OC use, although results are difficult to interpret in view of numerous factors that might distort the findings. The risk of invasive cervical cancer appear to be unaffected by up to 5 years of oral contraception. Beyond this, there is evidence suggesting an elevated risk which approaches a 2-fold increase at 10 years of use. Cancers of the vagina and fallopian tube are extremely rare. Their risks have yet to be characterized in relation to oral contraception.

  15. A Survey of Teenagers' Attitudes Toward Moving Oral Contraceptives Over the Counter.

    PubMed

    Manski, Ruth; Kottke, Melissa

    2015-09-01

    Evidence suggests that over-the-counter access to oral contraceptives may help expand use among adult women. Teenagers may particularly benefit from this approach, as they experience disproportionately high rates of unintended pregnancy and face unique challenges accessing contraceptives. However, limited research has explored teenagers' attitudes toward over-the-counter access. In 2014, a sample of 348 females aged 14-17, recruited via Facebook advertisements, participated in an online survey assessing teenagers' attitudes toward over-the-counter access and their understanding of how to use oral contraceptives after reading a prototype over-the-counter product label. Differences by participants' characteristics were assessed in bivariate analyses (Pearson chi-square and Fisher's exact tests for categorical measures, and independent t tests and one-way analyses of variance for continuous measures). Seventy-three percent of participants supported over-the-counter access, and 61% reported that they would likely use oral contraceptives available through this approach. Few subgroup differences were found. Notably, sexually experienced participants were significantly more likely than others both to support this approach (85% vs. 63%) and to be interested in obtaining oral contraceptives this way (77% vs. 48%). Participants understood an average of 7.1 of eight key concepts that the prototype product label was intended to convey; no significant differences were found among subgroups. Over-the-counter access may be a promising approach for providing oral contraceptives to teenagers. Additional research is needed to evaluate whether teenagers can screen themselves for contraindications to oral contraceptive use and correctly use oral contraceptives obtained over the counter. Copyright © 2015 by the Guttmacher Institute.

  16. Disintegration of chemotherapy tablets for oral administration in patients with swallowing difficulties.

    PubMed

    Siden, Rivka; Wolf, Matthew

    2013-06-01

    The administration of oral chemotherapeutic drugs can be problematic in patients with swallowing difficulties. Inability to swallow solid dosage forms can compromise compliance and may lead to poor clinical outcome. The current technique of tablet crushing to aid in administration is considered an unsafe practice. By developing a technique to disintegrate tablets in an oral syringe, the risk associated with tablet crushing can be avoided. The purpose of this study was to determine the feasibility of using disintegration in an oral syringe for the administration of oral chemotherapeutic tablets. Eight commonly used oral chemotherapeutic drugs were tested. Tablets were placed in an oral syringe and allowed to disintegrate in tap water. Various volumes and temperatures were tested to identify which combination allows for complete disintegration of the tablet in the shortest amount of time. The oral syringe disintegration method was considered feasible if disintegration occurred in ≤15 min and in ≤20 mL of water and the dispersion passed through an oral syringe tip. The following tablets were shown to disintegrate within 15 min and in <20 mL of water: busulfan, cyclophosphamide 50 mg, dasatinib, imatinib, methotrexate, and thioguanine. For these drugs, drug-specific information pamphlets can be prepared for patient or caregiver use. Mercaptopurine, cyclophosphamide 25 mg, and mitotane tablets did not pass the disintegration test. Disintegrating oral chemotherapeutic tablets in a syringe provides a closed system to administer hazardous drugs and allows for the safe administration of oral chemotherapeutic drugs in a tablet form to patients with swallowing difficulties.

  17. Frequency of Candidiasis and Colonization of Candida albicans in Relation to Oral Contraceptive Pills

    PubMed Central

    Aminzadeh, Atousa; Sabeti Sanat, Ali; Nik Akhtar, Saeed

    2016-01-01

    Background Candidiasis, the infection caused by Candida albicans, is one of the most common infections of the oral cavity in humans. Candidiasis causes irritation and is known for its carcinogenic effects. Thus, it is important to recognize the predisposing factors for this opportunistic infection. Several previous studies have demonstrated an increased frequency of vaginal candidiasis in relation to oral contraceptive consumption. Objectives Only a few studies on the relation between oral contraceptives and oral candidiasis have been previously conducted. This study aims to evaluate the possible relation between oral contraceptive pills and oral candidiasis. Methods This analytic, case-control study included 40 non-pregnant women divided into two groups: 20 who used oral contraceptive pills and 20 who did not. The groups were matched according to age, oral health, and past and present medical history. Samples were collected from the tongue’s dorsum using a cotton swab and inoculated on CHROMagar culture plates. The frequency of positive cultures and the number of Candida colonies were compared between the two groups using independent t-tests and Mann-Whitney statistical tests with SPSS18 software. Results The frequency of positive cultures of Candida albicans was higher (P value = 0.03) for the case group. Also, the number of C. albicans and C. krusei was significantly higher for the case group compared to the control group (P value = 0.04, P value = 0.03). Conclusions The results of the present study demonstrate that oral contraceptives containing estradiol can lead to Candida colonization in the oral cavity. It is recommended that further studies comparing the influence of oral contraceptives on Candida’s adherence to the epithelium is highly recommended. PMID:28184328

  18. Effect of oral contraceptive progestins on serum copper concentration.

    PubMed

    Berg, G; Kohlmeier, L; Brenner, H

    1998-10-01

    High serum copper concentration--a well-known effect of oral contraceptive (OC) use--has been linked to increased mortality from cardiovascular disease. The influence of OCs containing newer progestins has not been investigated, however. This concern was addressed in a 1987-88 cross-sectional epidemiologic study of 610 nonpregnant, nonlactating West German women 18-44 years of age. 195 women (32.1%) were current OC users, but only 152 of these women were able to cite the name of the formulation they were taking. In 70% of cases, the OC contained less than 45 mcg of ethylestradiol (median dose, 32.4 mcg). The most common progestin components were desogestrel (41%) and levonorgestrel (30%). Mean serum copper concentration was higher among users of all types of OCs than among non-users, but this concentration varied more strongly according to the OC's progestin compound than its estrogen content. The greatest increase in serum copper (55% compared with non-users) was recorded in users of OCs containing anti-androgen progestins, followed by desogestrel (46%), norethisterone/lynestrenol (42%), and levonorgestrel (34%). The increase in serum copper was more pronounced in women taking OCs containing 45 mcg or less of ethylestradiol than in users of OCs with a high estrogen dose. In the regression models, the different progestin compounds alone explained 28% of the total variance in serum copper concentration. Further investigation of OC-induced increases in serum copper concentration and their impact on cardiovascular risk are warranted.

  19. [Effect of oral contraceptives on the psyche and on sexuality].

    PubMed

    Nahrendorf, G; Carol, W; Klinger, G

    1978-01-01

    The problem of whether or not oral contraceptives affect the psychic function of the female is still controversal. The purpose of the present investigation was to study the occurrence of psychic and sexual effects in women taking either Ovosiston (mestranol 0,08 mg + chlormadinone acetate 2, 0 mg) or Non-Ovlon (ethinylestradiol 0,05 mg + norethisterone acetate 1,0 mg). 186 somatically healthy women were subject to two interviews, immediately before the start of therapy and six months after it. Most of the patients recorded distinctly alterations of their mood, their initiative, their elemental desires such as appetite, sleep, need of warmth, and their sexual behaviour. 73 of them noted a change in their emotional pattern, which was positive in 34 and negative in 39 cases. 99 women reported changes in their elemental desires. 136 patients exhibited alterations of their sexual behaviour, which were assessed as an improvement or impairment in 108 and 28 cases, respectively. There is a statistically significant correlation between the impairment of sexual function and the incidence of other untoward side effects. On the other hand, negative suggestion by poor experience of other women on by the influence of mass media seems to play a minor role in producing changes of sexual behaviour. There is, however, a clearcut relationship between negative suggestion and the incidence of unfavourable emotional alterations. The findings are discussed with reference to their clinical significance.

  20. Oral contraceptives in women with migraine: balancing risks and benefits.

    PubMed

    Allais, G; De Lorenzo, C; Mana, O; Benedetto, C

    2004-10-01

    Oral contraceptives (OCs) are a safe and highly effective method of birth control, but can also be associated with some risks, mainly a potential thrombotic risk. OCs may condition the course of headache and sometimes start it, but their influence on the clinical evolution of migraine is not easily assessable. The last Classification of Headache Disorders of the International Headache Society clearly identifies an "exogenous hormone-induced headache" that could be triggered by intake of OCs. Old high-dose OCs could effectively worsen headache in a significant proportion of patients, but the newest formulations influence headache course to a lesser extent. In any case, while an increase in migraine frequency or intensity do not oblige the cessation of OCs, experiencing a migraine aura for the first time, or even a clear worsening of a preexistent aura suggest discontinuation of OCs. Even if both migraine and OCs intake are associated with an increased risk of ischaemic stroke, migraine per se is not a contraindication for OCs use; however, patients suffering from migraine with aura generally show a greater thrombotic risk than women with migraine without aura. Other risk factors (patient's age, tobacco use, hypertension, hyperlipidaemia, obesity and diabetes) must be carefully considered when prescribing OCs in migraine patients. Furthermore, all OCs, even those with low oestrogen content, are a major risk for venous thrombosis, particularly in women with hereditary thrombophilia. A thorough laboratory control of the genetics of prothrombotic factors and coagulative parameters should precede any decision of OCs prescription in migraine patients.

  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. Effect of oral contraceptives on the ultrastructure of the endometrium.

    PubMed

    Mitra, P K; Roychadhuri, J

    1987-01-01

    A low dose oral contraceptive (OC) containing 0.3 mg norgestrel and 0.03 mg ethinyl estradiol was given for conception control in 10 cases, for dysfunction and uterine bleeding (DUB) in 10 cases, for dysmenorrhea in 5 cases, and for endometriosis in 5 cases. Prior to treatment and subsequently the endometrium was studied by transmission electron microscopy (TEM) and scanning electron microscopy (SEM). Post therapeutic TEM indicated marked shrinkage of mitochondria, subnuclear lipid deposition, and loss of nuclear nests in the conception control and dysmenorrhea groups. In the DUB group the epithelial cells and mitochondria became stunted, Golgi-complexes developed, lysosomes appeared, and lipid deposition took place. Significant epithelial and stromal changes also occurred in the endometriosis group with increased of intracellular lipid and hugh enlargement of cell size without abnormal structural alteration. SEM showed stunted isolated cilia, small openings at cell apices, and clear-cut gland openings in the conception control and dysmenorrhea groups. In the DUB group rounded shrunken epithelium with scanty ciliation and prominent microvilli, whereas in the endometriosis group after 6 months total epithelial regression and atrophy was evident. OC therapy may help prevent endometrial carcinoma by inducing regression of subcellular organelles.

  3. Process, cost, and clinical quality: the initial oral contraceptive visit.

    PubMed

    McMullen, Michael J; Woolford, Samuel W; Moore, Charles L; Berger, Barry M

    2013-01-01

    To demonstrate how the analysis of clinical process, cost, and outcomes can identify healthcare improvements that reduce cost without sacrificing quality, using the example of the initial visit associated with oral contraceptive pill use. Cross-sectional study using data collected by HealthMETRICS between 1996 and 2009. Using data collected from 106 sites in 24 states, the unintended pregnancy (UIP) rate, effectiveness of patient education, and unit visit cost were calculated. Staff type providing education and placement of education were recorded. Two-way analysis of variance models were created and tested for significance to identify differences between groups. Sites using nonclinical staff to provide education outside the exam were associated with lower cost, higher education scores, and a UIP rate no different from that of sites using clinical staff. Sites also providing patient education during the physical examination were associated with higher cost, lower education scores, and a UIP rate no lower than that of sites providing education outside of the exam. Through analyzing process, cost, and quality, lower-cost processes that did not reduce clinical quality were identified. This methodology is applicable to other clinical services for identifying low-cost processes that do not result in lower clinical quality. By using nonclinical staff educators to provide education outside of the physical examination, sites could save an average of 32% of the total cost of the visit.

  4. 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

  5. Oral contraceptives and the cobalamin (vitamin B12) metabolism.

    PubMed

    Hjelt, K; Brynskov, J; Hippe, E; Lundström, P; Munck, O

    1985-01-01

    The mean concentrations of serum (S)-cobalamin (vitamin B12) and S-unsaturated B12 binding capacity (UBBC) were significantly decreased in 101 women (mean age: 30.4 years) taking oral contraceptives (OC) of the combination type, compared to 113 controls. OC users more frequently showed decreased concentrations of S-cobalamin (less than 200 pmol/l) than did their controls. However, the incidence of particularly low concentrations (less than 150 pmol/l) in OC users was not increased. To study a possible dose-dependent effect, 27 women (mean age: 50.5 years) given high-dose estrogen preparations (1-4 mg estrogen) were compared with 31 controls. The two groups showed no difference with regard to S-cobalamin, but the mean S- and plasma-UBBC levels were significantly decreased in the high-dose estrogen group. 12 OC users with decreased S-cobalamin (less than 200 pmol/l), 9 OC users with normal S-cobalamin and 10 controls were studied more intensively. The mean hemoglobin concentration was significantly decreased in those OC users having decreased S-cobalamin. On the contrary, the absorption and excretion of radiolabeled cobalamin and the concentrations of erythrocyte-folate, S-iron and -transferrin did not show any difference between the groups, and all results were normal, by and large. No characteristic changes in plasma volume were found. It is concluded that routine measurement of S-cobalamin in women taking OC is not justified.

  6. Combined oral contraceptives in polycystic ovary syndrome - indications and cautions.

    PubMed

    Bozdag, Gurkan; Yildiz, Bulent Okan

    2013-01-01

    Combined oral contraceptive pills (OCPs) have been used in women with polycystic ovary syndrome (PCOS) for the treatment of menstrual disorders, acne and hirsutism. Despite years of their use and broad clinical experience, there are still ongoing doubts concerning their implications for the cardiovascular system and carbohydrate metabolism both in the general population and women with PCOS. In the general population, the risk of venous thromboembolism is reported to be increased. However, arterial thrombotic events seem to require concomitant risk factors to appear during administration of OCPs. In terms of carbohydrate metabolism, available data do not consistently suggest an increased risk of impaired glucose tolerance (IGT) or conversion of IGT to type 2 diabetes mellitus, in spite of some subtle fluctuations in glucose and insulin levels. In subgroup analyses of epidemiological studies in the general population, there is no finding indicating an increased risk of cardiovascular disease and related mortality in premenopausal women with PCOS. There is no significant alteration in carbohydrate and lipid metabolism after use of OCP in PCOS either. The absence of further cardiometabolic risk with OCP use in PCOS might suggest some unproven preventive alterations in this patient population.

  7. Menstrual suppression for combat operations: advantages of oral contraceptive pills.

    PubMed

    Powell-Dunford, Nicole C; Cuda, Amanda S; Moore, Jeffrey L; Crago, Mark S; Kelly, Amanda M; Deuster, Patricia A

    2011-01-01

    increasing numbers of women are deployed to austere settings in which menstruation may impose logistical challenges. Minimal data exists about the use of oral contraceptive pills (OCPs) for menstrual suppression in this population. Post-deployment survey was undertaken to establish prevalence of continuous OCP use, perceived barriers, and associations with menstrual burden in a military population within the austere environment. voluntary and anonymous 44-item questionnaire. of 500 women, 78% (n = 390) had personal experience using OCPs and 66% (n = 330) desired menstrual suppression. However, only 40% (n = 192) reported any OCP use and only 21% (n = 99) reported continuous use during deployment. Sixty-seven percent of women reported some difficulty in daily pill compliance and nearly half (45%) missed ≥ 1 pill per week in the austere setting. Continuous users were nearly twice as compliant as conventional users (p = .019) and compliant OCP users reported significantly less menstrual burden than noncompliant users (p = .017). Almost all women (85%) desired mandatory education about menstrual suppression through OCPs. despite OCP experience and desire for amenorrhea, prevalence of extended cycle OCP use in this population is low. Extended OCPs users in the austere setting report improved compliance and reduced menstrual burden compared with conventional users. Education about OCPs is highly desirable for most military women and may benefit those in austere settings. 2011 Jacobs Institute of Women's Health. Published by Elsevier Inc.

  8. Hypertriglyceridemic Pancreatitis Caused by the Oral Contraceptive Agent Estrostep.

    PubMed

    Abraham, Mary; Mitchell, Jennifer; Simsovits, Debra; Gasperino, James

    2015-07-01

    Norethindrone acetate/ethinyl estradiol (Estrostep; Warner Chilcott, Rockaway, New Jersey) is an "estrophasic" type of oral contraceptive, which combines a continuous low progestin dose with a gradually increasing estrogen dose. In clinical trials, this medication failed to produce clinically significant changes in serum lipid levels. We report a case of severe hypertriglyceridemia-induced acute pancreatitis in a 24-year-old woman caused by Estrostep, occurring nearly 10 years after she began using the drug. The patient was admitted to the medical intensive care unit (ICU) for aggressive volume resuscitation and management of severe electrolyte abnormalities. Laboratory studies obtained on admission indicated severe hypertriglyceridemia (2,200 mg/dL), hyponatremia (120 mEq/L), and hypocalcemia (0.78 mmol/L). Amylase and lipase levels were also elevated (193 and 200 U/L, respectively). Ranson score calculated after 48 hours of admission was 4, and her Acute Physiology and Chronic Health Evaluation (APACHE) IV score was 35. Treatment included an insulin infusion, ω-3 fatty acid esters, and gemfibrozil. The insulin infusion reduced serum triglyceride levels by 50% after 1 day of treatment and to 355 mg/dL by day 7 of her ICU course. We believe that this is the first reported case of severe, acute hypertriglyceridemia-induced pancreatitis caused by this medication. © The Author(s) 2014.

  9. Factors affecting riboflavin requirements of oral contraceptive users and nonusers.

    PubMed

    Roe, D A; Bogusz, S; Sheu, J; McCormick, D B

    1982-03-01

    Riboflavin depletion has been identified in women on oral contraceptives (OC) but change in riboflavin nutriture has not been consistently demonstrated in all OC user groups studied. Discrepant findings in reports have been attributed to differences of pill formulation or riboflavin intake. Aims of this study were to compare the riboflavin requirements of healthy OC users and nonusers on diets prepared in a metabolic unit. A single daily menu and meal pattern was used. The basic diet providing riboflavin at a level of 0.6 mg/1000 kcal was used in the period of acclimation and period 1. In periods 2 and 3, the riboflavin content of the diet was increased to 0.8 and 1.0 mg/1000 kcal, respectively. The riboflavin status of subjects was monitored by erythrocyte glutathione reductase assay and urinary riboflavin excretion. Eight women on OC and 10 nonusers participated. Erythrocyte glutathione reductase assay values and urinary riboflavin excretion showed intersubject and interperiod differences but no significant group differences (OC versus non-OC) in erythrocyte glutathione reductase values or in urinary riboflavin per g creatinine. It was concluded that when dietary intake is controlled, OC do not significantly influence riboflavin status. Riboflavin needs were related to energy requirements of the subjects.

  10. Safety implications of transferring the oral contraceptive from prescription-only to over-the-counter status.

    PubMed

    Potts, M; Denny, C

    1995-12-01

    The idea of making oral contraceptives available without prescription has a long history, and has been recently revived in the US and the UK. High dose oral contraceptives have generally been replaced by low dose formulations and, subsequently, most cardiovascular risks have been reduced and a protection against ovarian and uterine cancers has been consistently demonstrated. Oral contraceptive compliance, however, continues to be a problem, but there is no reason to assume that wise practice would be any more or less if oral contraceptives were available over-the-counter (OTC). Some countries have introduced alternatives to prescription-only oral contraceptives, whereby nurses, midwives, social workers and/or pharmacists are incorporated into the distribution process. This article concludes that the balance of risks and benefits is in favour of OTC access for oral contraceptives.

  11. Effects of oral contraceptives on glucoregulatory responses to exercise.

    PubMed

    Jankowski, Catherine M; Ben-Ezra, Vic; Gozansky, Wendolyn S; Scheaffer, Suzanne E

    2004-03-01

    Some of the effects of oral contraceptives (OCs) to alter glucoregulation may be ameliorated by exercise. To test this premise, the effects of acute aerobic exercise on postprandial glucose, insulin, and C-peptide responses (area under the curve [AUC]) were measured in 8 users of low-dose estrogen and progestin OCs (OC(+)) and 10 women not using OCs (OC(-)). They completed 2 randomly ordered intervention trials: (1) aerobic exercise on 3 consecutive days with a 2.5-hour, 75-g oral glucose tolerance test (OGTT) on day 4, and (2) no exercise for 3 days prior to the OGTT (control trial). The exercise was 50 minutes of treadmill walking at 70% (.-)VO(2max). The groups were similar in age (27 +/- 3 years), waist-to-hip ratio (0.74 +/- 0.01), and cardiorespiratory fitness (32.5 +/- 1.6 mL x kg body mass(-1) x min(-1)). Fasting plasma glucose, C-peptide, and insulin levels were similar (P >.05) between groups in the control trial. In both trials, glucose(AUC) was significantly greater (13%, P <.05) in OC(+). Exercise resulted in a significant (P <.05) decrease in fasting plasma glucose and insulin, insulin(AUC), glucose(AUC) x insulin(AUC), and C-peptide(AUC) in both groups, suggesting enhanced insulin action and/or reduced pancreatic insulin secretion. Hepatic insulin extraction ([C-peptide(AUC) - insulin(AUC)())]/C-peptide(AUC)) was increased following exercise only in OC(+). Thus, insulin action was enhanced in response to exercise in young sedentary women independent of OC use. The mechanisms for the acute exercise effect on insulin action may be different in OC users compared with normally menstruating women.

  12. The effect of elevated ovarian hormones on periodontal health: oral contraceptives and pregnancy.

    PubMed

    Zachariasen, R D

    1993-01-01

    The most common oral manifestation of elevated levels of ovarian hormones, as seen in pregnancy or oral contraceptive usage, is an increase in gingival inflammation with an accompanying increase in gingival exudate. This gingivitis can be avoided or at least minimized by establishing low plaque levels at the beginning of pregnancy or the beginning of oral contraceptive therapy. It would appear that bacteria are not solely responsible for the gingivitis seen during these times, nor are the ovarian hormones solely responsible for the condition. Data from numerous studies suggest that the ovarian hormones alter the microenvironment of the oral bacteria so as to promote their growth and shifts in their populations. The present article reviews the current state of knowledge concerning the relationship of gingivitis to elevated levels of ovarian hormones, and describes the role that these hormones may play in the gingivitis associated with pregnancy or oral contraceptive usage.

  13. Doxylamine and diphenhydramine pharmacokinetics in women on low-dose estrogen oral contraceptives.

    PubMed

    Luna, B G; Scavone, J M; Greenblatt, D J

    1989-03-01

    Thirteen women chronically using low-dose estrogen-containing oral contraceptives (50 micrograms or less of ethinyl estradiol or its equivalent for a minimum of 3 months) and 12 age-matched drug-free control women received a single 25 mg oral dose of doxylamine succinate in the fasting state. Ten women taking oral contraceptives and ten controls received a single 50 mg oral dose of diphenhydramine hydrochloride. Multiple plasma samples drawn during 30 hours following the dose of doxylamine, and 12 hours after diphenhydramine dosage, were analyzed by gas chromatography using nitrogen-phosphorus detection. Mean pharmacokinetic variables for doxylamine in control and oral contraceptive groups were: peak plasma concentration, 103 vs 100 ng/ml; time of peak, 2.40 vs 1.87 hours after dosage, elimination half-life, 10.1 vs 10.2 hours; and total clearance, 3.70 vs 3.88 ml/min/kg. Mean pharmacokinetic variables for diphenhydramine in control and oral contraceptive groups were: peak plasma concentration, 63.7 vs 73.8 ng/ml; time of peak, 2.7 vs 2.2 hours after dosage; elimination half-life, 6.0 vs 5.1 hours; and total clearance, 21.8 vs 25.5 ml/min/kg. None of these differences were statistically significant. Thus, low-dose estrogen-containing oral contraceptives do not significantly influence the pharmacokinetics of the antihistamines doxylamine or diphenhydramine.

  14. SOGC clinical practice guideline. No. 252, December 2010. Oral contraceptives and the risk of venous thromboembolism: an update.

    PubMed

    Reid, Robert

    2010-12-01

    To provide current and emerging evidence on oral contraceptives and the risk of venous thromboembolism. Articles published in English from 2005 were retrieved through searches of PubMed and Medline, using the following terms: venous thromboembolism, VTE, contraception, oral contraceptives, hormonal contraception. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. Searches were updated on a regular basis and incorporated in the guideline to May 2010. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of evidence was rated using the criteria described by the Canadian Task Force on Preventive Health Care (Table). SUMMARY STATEMENTS: 1. Modern oral contraceptives offer highly effective contraception and a range of non-contraceptive benefits. (I) 2. Venous thromboembolism, although rare, remains one of the serious adverse consequences of hormonal contraception. Best evidence indicates that venous thromboembolism rates in non-users of reproductive age approximate 4-5/10 000 women per year; rates in oral contraceptive users are in the range of 9-10/10 000 women per year. For comparison, venous thromboembolism rates in pregnancy approach 29/10 000 overall and may reach 300-400/10 000 in the immediate postpartum period. (II-1) 3. Research demonstrates that oral contraceptives with ≤ 35 µg of ethinyl estradiol carry a lower risk of venous thromboembolism than oral contraceptives with 50 µg. (II-2) Although preliminary data suggest a possible further reduction in venous thromboembolism with oral contraceptives with < 35 µg ethinyl estradiol, robust data to support this conclusion are presently lacking. 4. Recent contradictory evidence and the ensuing

  15. 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

  16. 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

  17. 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

  18. Dose finding in a low-dose 21-day combined oral contraceptive containing gestodene.

    PubMed

    Lüdicke, F; Sullivan, H; Spona, J; Elstein, M

    2001-10-01

    An open label, non-comparative study was carried out in 22 women over a total of five cycles. After an untreated cycle, oral administration of 20 microg ethinyl estradiol (EE) with 50 microg gestodene (GST) (tablets taken daily for 21 days with a break of 7 days) was commenced, and three treatment cycles were followed by an untreated follow-up control cycle. The ability of this formulation to inhibit ovulation and suppress ovarian activity was assessed by using hormonal parameters and ultrasound. One ovulation occurred during treatment. Luteinized unruptured follicles were observed in three cases in the second treatment cycle and in one case during the third treatment cycle. Follicle-like structures larger than 13 mm associated with a serum estradiol level of more than 30 pg/mL were noted in 19% of the women in the first treatment cycle. The rate of active follicle-like structures was 43% in the second treatment cycle and 28% in the third treatment cycle. The results were compared with previously reported findings of a preparation containing 20 microg EE and 75 microg GST. With regard to ovarian grading and endogenous hormone secretion, considerably more residual ovarian activity, with all parameters examined, was found in the 20 microg EE and 50 microg GST preparation compared to the 20 microg EE and 75 microg GST preparation. It was concluded that the 20 microg EE and 50 microg GST preparation administered for 21 days does not meet the requirements of a combined oral contraceptive with respect to ovulation inhibition.

  19. Side effects and discontinuation of oral contraceptive use in southern Brazil.

    PubMed

    Janowitz, B; Kane, T T; Arruda, J M; Covington, D L; Morris, L

    1986-07-01

    Oral contraceptives have many advantages, but sometimes also have side effects which can cause users to switch appropriately or inappropriately to less effective methods or abandon contraception. In Brazil, 2/3 of married women of childbearing age were using contraception in 1981, and 1/2 of these were using orals. Contraceptive behavior following reported side effects in users of oral contraceptives in Southern Brazil is examined in this study, in relation to diverse factors. Among 2904 currently-married women, aged 15-44, almost 75% reported that they had used the pill at some time, and of these, 45.6% were still doing so. Data on perceived side effects were gathered for all women. There was no independent medical evaluation of the effects, so the data did not necessarily represent actual prevalence of pill related problems. Women who reported problems with the pill were less likely to be current users (25%) than women who did not (65%). However, overall contraceptive prevalence was about the same in both groups (66.2% and 67.0% respectively), indicating that women who stop using oral contraceptives usually switch to another method. However, they are more likely to be using traditional methods than women in the general population, especially if they want more children. Termination of pill use varies little according to the type of problem reported. Women with problems who sought medical attention were more likely to stop using the pill, and 82.4% of women advised to stop by their physician did so, but the major factor affecting discontinuation was the reported experience of a problem. The most frequently reported problems were headaches (38.1%), nausea (34.1%), nervousness (27.9%), and vertigo (18.3%). Physician intervention should help to avoid women's abandoning oral contraceptives unnecessarily.

  20. Barrier versus oral contraceptive use: a study of female college students.

    PubMed

    Radius, S M; Joffe, A; Gall, M J

    1991-09-01

    Although they provide birth control and are easier to use, oral contraceptives (OCPs) are not the preferred approach to preventing sexually transmitted disease (STD). Do the knowledge, attitudes, and experiences of oral contraceptive users place them at greater risk for STDs than those who employ barrier methods? This study examined differences between sexually active female college students (ie, those who reported ever having had vaginal intercourse) who used OCPs and those who employed barrier methods of contraception at the time of their most recent intercourse. The authors analyzed HIV- and other STD-related knowledge, attitudes, and behaviors from three consecutive annual health surveys of young women about to begin their first year of college. Findings showed barrier and OCP users to be comparable in knowledge about the effectiveness of various contraceptive methods in protecting them against STDs, perceived personal susceptibility to HIV, and experiences with alcohol before sexual intercourse. Oral contraceptive users, compared with those in the group who used barrier methods, reported a greater number of recent partners (p less than .03) and greater perceived vulnerability to STDs (p less than .03). Student healthcare providers must develop creative educational strategies to encourage simultaneous use of both oral contraceptives and barrier methods to protect students against STDs and pregnancy.

  1. The technologies used for developing orally disintegrating tablets: a review.

    PubMed

    Badgujar, Bhatu P; Mundada, Atish S

    2011-06-01

    Orally disintegrating tablets (ODTs), also known as fast melts, quick melts, fast disintegrating and orodispersible systems, have the unique property of disintegrating in the mouth in seconds without chewing and the need of water and are thus assumed to improve patient compliance. Conventional methods like direct compression, wet granulation, moulding, spray-drying, freeze-drying and sublimation were used to prepare ODTs. New advanced technologies like Orasolv®, Durasolv®, Wowtab®, Flashtab®, Zydis®, Flashdose®, Oraquick®, Lyoc®, Advatab®, Frosta®, Quick-Disc® and Nanomelt® have been introduced by some pharmaceutical companies for the production of ODTs. The main objective of this review is to give a comprehensive insight into conventional and recent technologies used for the preparation of ODTs.

  2. Case-control study of oral contraceptives and risk of thromboembolic stroke: results from International Study on Oral Contraceptives and Health of Young Women.

    PubMed

    Heinemann, L A; Lewis, M A; Thorogood, M; Spitzer, W O; Guggenmoos-Holzmann, I; Bruppacher, R

    1997-12-06

    To determine the influence of oral contraceptives (particularly those containing modern progestins) on the risk for ischaemic stroke in women aged 16-44 years. Matched case-control study. 16 Centres in the United Kingdom, Germany, France, Switzerland, and Austria. Cases were 220 women aged 16-44 who had an incident ischaemic stroke. Controls were 775 women (at least one hospital and one community control per case) unaffected by stroke who were matched with the corresponding case for 5 year age band and for hospital or community setting. Information on exposure and confounding variables were collected in a face to face interview. Odds ratios derived with stratified analysis and unconditional logistic regression to adjust for potential confounding. Adjusted odds ratios (95% confidence intervals) for ischaemic stroke (unmatched analysis) were 4.4 (2.0 to 9.9), 3.4 (2.1 to 5.5), and 3.9 (2.3 to 6.6) for current use of first, second, and third generation oral contraceptives, respectively. The risk ratio for third versus second generation was 1.1 (0.7 to 2.0) and was similar in the United Kingdom and other European countries. The risk estimates were lower if blood pressure was checked before prescription. Although there is a small relative risk of occlusive stroke for women of reproductive age who currently use oral contraceptives, the attributable risk is very small because the incidence in this age range is very low. There is no difference between the risk of oral contraceptives of the third and second generation; only first generation oral contraceptives seem to be associated with a higher risk. This small increase in risk may be further reduced by efforts to control cardiovascular risk factors, particularly high blood pressure.

  3. Enhancement of oral moisture using tablets containing extract of Capparis masaikai Levl.

    PubMed

    Kitada, Katsuhiro; Shibuya, Koji; Ishikawa, Masao; Nakasugi, Toru; Oho, Takahiko

    2009-03-18

    This study was performed to examine the effects of tablets containing an extract of Capparis masaikai Levl. (M-tablets) on enhancing oral moisture. The moistening effect of M-tablets was examined in 21 healthy subjects aged 25.1+/-2.4 (mean+/-S.D.) years in comparison with control tablets. After sucking tablets, the oral moisture was measured using a saliva wetness tester and a moisture checker. To evaluate the effects of the M-tablets on oral conditions, additional 50 subjects aged 30.6+/-7.5 years were examined. The subjects recorded changes in refreshment, oral moisture, ease in speaking, and taste of water using a visual analog scale (VAS). The L-SALIVO value of the M-tablet increased significantly from 1.83+/-0.17 (mean+/-S.E.M.) at baseline to 3.02+/-0.21 at 15 min (P<0.01). The Mucus((R)) value of the M-tablet also increased from 37.50+/-0.22 at baseline to 38.30+/-0.26 at 15 min (P<0.01). The VAS value for oral moisture increased significantly from 47.4+/-2.0 to 69.6+/-2.2 after taking the M-tablet (P<0.01). The VAS value for taste of water also increased from 50.0+/-1.1 to 66.7+/-3.2 (P<0.01). These results suggest that M-tablets are useful for enhancing oral moisture, which leads to improvement of oral conditions.

  4. 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.

  5. Risk of venous thromboembolism among users of third generation oral contraceptives compared with users of oral contraceptives with levonorgestrel before and after 1995: cohort and case-control analysis

    PubMed Central

    Jick, Hershel; Kaye, James A; Vasilakis-Scaramozza, Catherine; Jick, Susan S

    2000-01-01

    Objective To compare the risk of idiopathic venous thromboembolism among women taking third generation oral contraceptives (with gestodene or desogestrel) with that among women taking oral contraceptives with levonorgestrel. Design Cohort and case-control analyses derived from the General Practice Research Database. Setting UK general practices, January 1993 to December 1999. Participants Women aged 15-39 taking third generation oral contraceptives or oral contraceptives with levonorgestrel. Main outcome measures Relative incidence (cohort study) and odds ratios (case-control study) as measures of the relative risk of venous thromboembolism. Results The adjusted estimates of relative risk for venous thromboembolism associated with third generation oral contraceptives compared with oral contraceptives with levonorgestrel was 1.9 (95% confidence interval 1.3 to 2.8) in the cohort analysis and 2.3 (1.3 to 3.9) in the case-control study. The estimates for the two types of oral contraceptives were similar before and after the warning issued by the Committee on Safety of Medicines in October 1995. A shift away from the use of third generation oral contraceptives after the scare was more pronounced among younger women (who have a lower risk of venous thromboembolism) than among older women. Fewer cases of venous thromboembolism occurred in 1996 and later than would have been expected if the use of oral contraceptives had remained unchanged. Conclusions These findings are consistent with previously reported studies, which found that compared with oral contraceptives with levonorgestrel, third generation oral contraceptives are associated with around twice the risk of venous thromboembolism. PMID:11073511

  6. Oral contraceptives and venous thromboembolism: a quantitative discussion of the uncertainties.

    PubMed

    Koster, T; Small, R A; Rosendaal, F R; Helmerhorst, F M

    1995-07-01

    A meta-analysis of controlled studies between 1966 and 1993 was conducted by means of a Medline computer search. A total of 588 articles were reviewed for controlled studies. 1 randomized trial, 6 follow-up studies, and 8 case-control studies were included. Summary thrombosis risk for oral contraceptive users, number needed to discontinue oral contraceptives to prevent one (recurrent) thrombosis, comparison of additional unwanted pregnancies, and postpartum thrombosis between alternative birth-control methods were the main outcome measures. The studies proved highly heterogeneous with regard to size and direction of the risk estimate. The summary relative risk of first thrombosis during oral contraceptive use was 2.9 (95% CI 0.5-17). The reported risks were higher in case control (RR 4.2) than in follow-up studies (RR 2.1). Various hypothetical assumptions were advanced wherein women would continue to take oral contraceptives after a first episode of thrombosis, or switch to use of an IUD, condom, or the progestogen-only pill. The cost-benefit ratio of advising against the use of oral contraceptives after a first thrombosis varied tremendously. The outcome with regard to pregnancies and thrombosis in 5 hypothetical cohorts of 100,000 post-thrombotic women monitored for 1 year indicated that under all but the highest assumption for recurrence risk, among typical couples the number of unexpected pregnancies as well as thrombotic episodes would be highest among condom users. IUDs would result in a reduction of at least 30% in the number of venous thrombotic episodes and accidental pregnancies. The lowest expected failures rates would lead to a decrease in thrombosis for both IUD and condom use. These findings indicate that there is a lack of necessary data for recurrence risk of venous thrombosis during continuing use of oral contraceptives, or after switching to other modes of contraception.

  7. Oral contraceptives and cognition: A role for ethinyl estradiol.

    PubMed

    Beltz, Adriene M; Hampson, Elizabeth; Berenbaum, Sheri A

    2015-08-01

    This article is part of a Special Issue "Estradiol and cognition". Estrogens have been seen to play a role in human cognitive abilities, but questions remain about the cognitive impact of ethinyl estradiol, which is contained in many oral contraceptives (OCs). Inconsistencies in past studies likely reflect small samples and heterogeneous groups of OC users. The aims of the present work were to examine OC effects on sex-typed spatial and verbal abilities by (a) comparing mental rotations and expressional fluency in normally-cycling (NC) women and men to OC users considered as a heterogeneous group and then to homogeneous groups of OC users created by classifying pills according to their active constituents, and (b) determining the relation between synthetic hormone doses in OCs and mental rotations and expressional fluency. Participants were 136 men, 93 NC women, and 148 OC users, including homogeneous monophasic (n = 55) and triphasic (n = 43) OC groups, aged 18 to 30 years. Significant effects of OC use were seen in homogeneous group comparisons but not when OC users were considered as a heterogeneous group. On mental rotations, men outperformed women, and monophasic OC users outperformed NC women. The latter difference may be attributable to estradiol, as ethinyl estradiol was inversely related to spatial ability among OC users and was lower in monophasic than in triphasic users. On expressional fluency, NC women and monophasic OC users outperformed men, and monophasic users outperformed triphasic users. Thus, results show the importance of ethinyl estradiol and of considering pill constituents when studying the cognitive effects of OCs.

  8. Oral contraceptives combined with interferon β in multiple sclerosis

    PubMed Central

    De Giglio, Laura; Barletta, Valeria T.; Marinelli, Fabiana; Angelis, Floriana De; Gallo, Valentina; Pagano, Veronica A.; Marini, Stefano; Piattella, Maria C.; Tomassini, Valentina; Pantano, Patrizia

    2015-01-01

    Objective: To test the effect of oral contraceptives (OCs) in combination with interferon β (IFN-β) on disease activity in patients with relapsing-remitting multiple sclerosis (RRMS). Methods: One hundred fifty women with RRMS were randomized in a 1:1:1 ratio to receive IFN-β-1a subcutaneously (SC) only (group 1), IFN-β-1a SC plus ethinylstradiol 20 μg and desogestrel 150 μg (group 2), or IFN-β-1a SC plus ethinylestradiol 40 μg and desogestrel 125 μg (group 3). The primary endpoint was the cumulative number of combined unique active (CUA) lesions on brain MRI at week 96. Secondary endpoints included MRI and clinical and safety measures. Results: The estimated number of cumulative CUA lesions at week 96 was 0.98 (95% confidence interval [CI] 0.81–1.14) in group 1, 0.84 (95% CI 0.66–1.02) in group 2, and 0.72 (95% CI 0.53–0.91) in group 3, with a decrease of 14.1% (p = 0.24) and 26.5% (p = 0.04) when comparing group 1 with groups 2 and 3, respectively. The number of patients with no gadolinium-enhancing lesions was greater in group 3 than in group 1 (p = 0.03). No significant differences were detected in other secondary endpoints. IFN-β or OC discontinuations were equally distributed across groups. Conclusions: Our results translate the observations derived from experimental models to patients, supporting the anti-inflammatory effects of OCs with high-dose estrogens, and suggest possible directions for future research. Classification of evidence: This study provides Class II evidence that in women with RRMS, IFN-β plus ethinylstradiol and desogestrel decreases the cumulative number of active brain MRI lesions compared with IFN-β alone. PMID:26140279

  9. The influence of humidity, temperature, and oral contraceptive in tear

    NASA Astrophysics Data System (ADS)

    Sousa, Raul A. R. C.; Ribeiro, Tânia L. C.; Moreira, Sandra M. B.; Baptista, António M. G.

    2013-11-01

    The aim of this study is to ascertain whether the quantity and quality of tear and eye subjective comfort are influenced by the temperature, humidity and oral Contraceptives Taking or Non-taking (CTNT). Forty-one students, females, from the University of Minho, Braga, Portugal, aged (mean+/-1standard deviation) of 21.51+/-1.85 years, ranging from 20 to 30 years, participated in this study. The McMonnies Questionnaire (MMQ), Break Up Time (BUT) and Phenol Red Test (PRT) were accessed between 14-17 hours in four sets of visits throughout the year: Visit 1, Visit 2, Visit 3 and Visit 4. The PRT and BUT values (mean+/-1standard deviation) for Visit 1, Visit 2, Visit 3 and Visit 4 were respectively 23.88+/-6.50mm, 22.29+/-8.00mm, 23.61+/-6.75mm, 22.88+/-7.00mm and 6.02+/-1.58s, 5.62+/-1.22s, 5.23+/-0.88s, 5.53+/-1. 42s. The MMQ scores for Visit 1, Visit 2, Visit 3 and Visit 4 ranged from 2-13, 2-15, 1-14 and 2-14 with medians of 6, 7, 6 and 6, respectively. The influence of temperature, humidity and CTNT on PRT, BUT and MMQ were evaluated using generalized linear mixed model. For BUT and MMQ statistical significant effects were found regarding temperature and humidity. The temperature and humidity influenced the tear quality and subjective comfort but did not influence the tear quantity. The CTNT did not influence tear quantity, quality or subjective eye comfort.

  10. [Oral contraceptives and cardiovascular disease--aspects of lipid metabolism].

    PubMed

    Crona, N; Silfverstolpe, G

    1984-02-08

    A review of the research data concerning cardiovascular disease induced by oral contraceptives (OC) relies on the findings of 3 US and British prospective studies involving 80,000 women. Pill users under 35 who were nonsmokers had 1/4 of the risk of dying as a result of this use than of pregnancy complications (in smokers, the risk is the same). Acute pathogenetical effects include blood coagulation homeostasis leading to thromboembolism and long-term disorders of lipid and carbohydrate metabolism. The estrogen component of OCs, ethinyl estradiol (EE), tends to increase Very Low Density Lipoprotein (VLDL) and High Density Lipoprotein (HDL) levels while decreasing Low Density Lipoprotein (LDL) levels. The gestagen component, a nortestosterone derivative, acts in the opposite way. The estrogen component also increases the level of triglycerides in the VLDL fraction and in serum. There seems to be an inverse ratio between VLDL and HDL levels (gestagen-dominant OCs lower the HDL cholesterol level). The thromboembolitic side effects of estrogen led to the introduction of low-dose pills in the 1970s (acute pancreatitis, a severe side effect, has been all but eliminated). The cardiovascular complications and cerebral insult induced by the gestagen component, a 19-nortestosterone derivative, have also resulted in decreased doses of gestagens in OCs. Non-alkylated estrogens ("natural" estrogens) have been favored recently because they do not increase VLDL levels, while still increasing HDL. A 17-alpha-hydroxprogesterone derivative as the gestagen component of pills has been used in recent years, since it is inert in lipid metabolism, unlike 19-nortestosterone. The effect of exogenous sexual steriods on prostaglandin synethis and on the balance of thromboxanes and prostacyclines will require futher study.

  11. 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

  12. Effects of oral contraceptives on body fluid regulation.

    PubMed

    Stachenfeld, N S; Silva, C; Keefe, D L; Kokoszka, C A; Nadel, E R

    1999-09-01

    To test the hypothesis that estrogen reduces the operating point for osmoregulation of arginine vasopressin (AVP), thirst, and body water balance, we studied nine women (25 +/- 1 yr) during 150 min of dehydrating exercise followed by 180 min of ad libitum rehydration. Subjects were tested six different times, during the early-follicular (twice) and midluteal (twice) menstrual phases and after 4 wk of combined [estradiol-norethindrone (progestin), OC E + P] and 4 wk of norethindrone (progestin only, OC P) oral contraceptive administration, in a randomized crossover design. Basal plasma osmolality (P(osm)) was lower in the luteal phase (281 +/- 1 mosmol/kgH(2)O, combined means, P < 0.05), OC E + P (281 +/- 1 mosmol/kgH(2)O, P < 0.05), and OC P (282 +/- 1 mosmol/kgH(2)O, P < 0. 05) than in the follicular phase (286 +/- 1 mosmol/kgH(2)O, combined means). High plasma estradiol concentration lowered the P(osm) threshold for AVP release during the luteal phase and during OC E + P [x-intercepts, 282 +/- 2, 278 +/- 2, 276 +/- 2, and 280 +/- 2 mosmol/kgH(2)O, for follicular, luteal (combined means), OC E + P, and OC P, respectively; P < 0.05, luteal phase and OC E + P vs. follicular phase] during exercise dehydration, and 17beta-estradiol administration lowered the P(osm) threshold for thirst stimulation [x-intercepts, 280 +/- 2, 279 +/- 2, 276 +/- 2, and 280 +/- 2 mosmol/kgH(2)O for follicular, luteal, OC E + P, and OC P, respectively; P < 0.05, OC E + P vs. follicular phase], without affecting body fluid balance. When plasma 17beta-estradiol concentration was high, P(osm) was low throughout rest, exercise, and rehydration, but plasma arginine vasopressin concentration, thirst, and body fluid retention were unchanged, indicating a lowering of the osmotic operating point for body fluid regulation.

  13. History of oral contraceptive use and risk of spontaneous abortion

    PubMed Central

    Hahn, Kristen A.; Hatch, Elizabeth E.; Rothman, Kenneth J.; Mikkelsen, Ellen M.; Brogly, Susan B.; Sørensen, Henrik T.; Riis, Anders H.; Wise, Lauren A.

    2015-01-01

    Purpose To examine the association between pregravid oral contraceptive (OC) use and spontaneous abortion (SAB). Methods In an Internet-based preconception cohort study of 4,862 Danish pregnancy planners, we used Cox proportional hazards models to estimate adjusted hazard ratios (HR) and 95% confidence intervals (CI) for the association between OC use and SAB. We controlled for maternal age, physical activity, parity, education, alcohol and caffeine consumption, body mass index, and smoking. Results Compared with women who discontinued OCs >1 year before conception, HRs were 0.95 (95% CI: 0.77, 1.17), 0.99 (95% CI: 0.82, 1.19), and 0.80 (95% CI: 0.60, 1.06) for women who discontinued OCs 7-12, 2-6, and 0-1 months before conception, respectively. Compared with <4 years of OC use, HRs for 4-7, 8-11, and ≥12 years of OC use were 1.05 (95% CI: 0.80, 1.37), 0.92 (95% CI: 0.71, 1.19), and 0.88 (95% CI: 0.65, 1.19), respectively. Dose of estrogen and generation of progestin were not materially associated with SAB risk. Conclusions We found no evidence that pregravid OC use is associated with an increase in SAB. Use within one month of conception was associated with a slightly lower risk of SAB, but this may be due to increased reproductive fitness in women who conceive quickly after discontinuation of OCs. PMID:26452607

  14. 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.

  15. Long-term experience with a low-dose oral contraceptive.

    PubMed

    Brill, K; Schnitker, J; Albring, M

    1990-12-01

    Oral contraception has proved to be the most efficient reversible method of fertility control for over 25 years. During this period, various investigations and epidemiological studies have suggested that some risks may be involved, but, on the other hand, a number of non-contraceptive benefits have become obvious. The results of these investigations were taken into account when new formulations had to be developed, with an aim to improving hormonal fertility control with regard to its tolerance, cycle control, and impact on metabolism. Since then, the objective of research has been to contrive new hormonal contraceptives which ensure safety to the largest possible extent, from a medical point of view, for the sake of the patient, without affecting contraceptive effectiveness. The aim to reduce side-effects connected with the use of oral contraception, as well as to lower the risks possibly involved, has obviously been achieved by extensive research. Both by devising a new substance and reducing doses, the criteria of modern low-dose oral contraception have been met, as has become evident in the course of the clinical experience gathered with Femovan.

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

    PubMed

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

    2015-01-01

    The aim of this study was to compare the effects of the second- and third-generation oral contraceptives on women's reproductive sexual function. 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. 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. 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.

  17. 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

  18. 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.

  19. Investigation on the effect of polymer and starch on the tablet properties of lyophilized orally disintegrating tablet.

    PubMed

    Liew, Kai Bin; Peh, Kok Khiang

    2015-01-13

    Orally disintegrating tablet (ODT) is a user friendly and convenient dosage form. The study aimed to investigate the effect of polymers and wheat starch on the tablet properties of lyophilized ODT, with dapoxetine as model drug. Three polymers (hydroxypropylmethyl cellulose, carbopol 934P and Eudragit(®) EPO) and wheat starch were used as matrix forming materials in preparation of lyophilized ODT. The polymeric dispersion was casted into a mould and kept in a freezer at -20 °C for 4 h before freeze dried for 12 h. It was found that increasing in HPMC and Carbopol 934P concentrations produced tablets with higher hardness and longer disintegration time. In contrast, Eudragit(®) EPO was unable to form tablet with sufficient hardness at various concentrations. Moreover, HPMC seems to have a stronger effect on tablet hardness compared to Carbopol 934P at the same concentration level. ODT of less friable was obtained. Wheat starch acted as binder which strengthen the hardness of ODTs and prolonged the disintegration time. ODT comprising of HPMC and wheat starch at ratio of 2:1 was found to be optimum based upon the tablet properties. The optimum formulation was palatable and 80 % of the drug was released within 30 min in the dissolution study.

  20. Estimate of Venous Thromboembolism and Related-Deaths Attributable to the Use of Combined Oral Contraceptives in France

    PubMed Central

    Tricotel, Aurore; Raguideau, Fanny; Collin, Cédric; Zureik, Mahmoud

    2014-01-01

    Purpose To estimate the number of venous thromboembolic events and related-premature mortality (including immediate in-hospital lethality) attributable to the use of combined oral contraceptives in women aged 15 to 49 years-old between 2000 and 2011 in France. Methods French data on sales of combined oral contraceptives and on contraception behaviours from two national surveys conducted in 2000 and 2010 were combined to estimate the number of exposed women according to contraceptives generation and age. Absolute risk of first time venous thromboembolism in non-users of hormonal contraception and increased risk of thromboembolism in users vs. non-users of hormonal contraception were estimated on the basis of literature data. Finally, immediate in-hospital lethality due to pulmonary embolism and premature mortality due to recurrent venous thromboembolism were estimated from the French national database of hospitalisation and literature data. Results In France, more than four million women are daily exposed to combined oral contraceptives. The mean annual number of venous thromboembolic events attributable to their use was 2,529 (778 associated to the use of first- and second-generation contraceptives and 1,751 to the use of third- and fourth-generation contraceptives), corresponding to 20 premature deaths (six with first- and second-generation contraceptives and fourteen with third- and fourth-generation contraceptives), of which there were eight to nine immediate in-hospital deaths. As compared to the use of first- and second-generation contraceptives, exposure to third- and fourth-generation contraceptives led to a mean annual excess of 1,167 venous thromboembolic events and nine premature deaths (including three immediate in-hospital deaths). Conclusions Corrective actions should be considered to limit exposure to third- and fourth-generation contraceptives, and thus optimise the benefit-risk ratio of combined oral contraception. PMID:24751717

  1. Formulation and Taste Masking of Ranitidine Orally Disintegrating Tablet.

    PubMed

    Hesari, Zahra; Shafiee, Akram; Hooshfar, Shirin; Mobarra, Naser; Mortazavi, Seyed Alireza

    2016-01-01

    Orally Disintegrating Tablets (ODT) have the advantages of both solid dosage form specially the stability and ease of handling and liquid dosage forms including ease of swallowing and pre-gastric absorption. We focused on taste masking and formulation of ranitidine ODT which disintegrates rapidly in the mouth within 60 sec using super-disintegrants, special polymers, water soluble and even insoluble excipients, sweeteners and essence. Various formulations were designed and made in four series. The amount of ranitidine in each formulation was 150 mg, and the final weight of tablets was around 500 mg. Prepared formulations were evaluated in terms of several physicochemical tests including powder/granule flowability, appearance, thickness, uniformity of weight, hardness, friability and disintegration time. Several taste masking techniques were investigated in each series of formulation, in order to cover the bitter taste of wranitidine. These included the addition of sweetener, granulation, solid dispersion with soluble and insoluble agents and complex formation with cellulose derivatives. The best formulation(s) in each group was/were chosen for taste evaluations with the help of 10 volunteers. Finally, formulation F14 was selected as the ultimate formulation, based on its better taste and shorter disintegration time (around 5 seconds). Formulation F14 contained Na CMC, avicel, Na starch glycolate, xylitol, saccharin, Na benzoate and menthol. The chosen formulation successfully passed the complementary evaluations such as assay of active ingredient and dissolution time. Na CMC was found to be acceptable in terms of decreasing disintegration time and enhanced taste masking potential and can be used in further ODT formulations.

  2. Formulation and Taste Masking of Ranitidine Orally Disintegrating Tablet

    PubMed Central

    Hesari, Zahra; Shafiee, Akram; Hooshfar, Shirin; Mobarra, Naser; Mortazavi, Seyed Alireza

    2016-01-01

    Orally Disintegrating Tablets (ODT) have the advantages of both solid dosage form specially the stability and ease of handling and liquid dosage forms including ease of swallowing and pre-gastric absorption. We focused on taste masking and formulation of ranitidine ODT which disintegrates rapidly in the mouth within 60 sec using super-disintegrants, special polymers, water soluble and even insoluble excipients, sweeteners and essence. Various formulations were designed and made in four series. The amount of ranitidine in each formulation was 150 mg, and the final weight of tablets was around 500 mg. Prepared formulations were evaluated in terms of several physicochemical tests including powder/granule flowability, appearance, thickness, uniformity of weight, hardness, friability and disintegration time. Several taste masking techniques were investigated in each series of formulation, in order to cover the bitter taste of wranitidine. These included the addition of sweetener, granulation, solid dispersion with soluble and insoluble agents and complex formation with cellulose derivatives. The best formulation(s) in each group was/were chosen for taste evaluations with the help of 10 volunteers. Finally, formulation F14 was selected as the ultimate formulation, based on its better taste and shorter disintegration time (around 5 seconds). Formulation F14 contained Na CMC, avicel, Na starch glycolate, xylitol, saccharin, Na benzoate and menthol. The chosen formulation successfully passed the complementary evaluations such as assay of active ingredient and dissolution time. Na CMC was found to be acceptable in terms of decreasing disintegration time and enhanced taste masking potential and can be used in further ODT formulations. PMID:28243264

  3. A study of the influence of a gestodene-containing triphasic oral contraceptive on endometrial morphology.

    PubMed

    Rabe, T; Leppien, G; Fossman, W G; Hessing, C; Vladescú, E; Runnebaum, B

    1997-09-01

    The objective of the study was to investigate histological changes in the endometrium in 20 volunteers treated with a low-dose, gestodene-containing triphasic oral contraceptive. Endometrial biopsy specimens were taken before, during a 6-month period of oral contraceptive use and in a post-treatment period. These specimens were evaluated using light microscopy, scanning and transmission electron microscopy. In addition, ultrasound examinations of the uterus, endometrial thickness and ovaries were performed. The low-dose, gestodene-containing triphasic oral contraceptive had no adverse effects on the endometrium (e.g. no proliferation, no polyps, no inflammatory processes), was well tolerated and showed a low side-effect profile. The inhibition of endometrial transformation was demonstrated both by endometrial morphology as well as by endometrial thickness, as measured by transvaginal ultrasound examination.

  4. [Effect of combined hormonal oral contraception on the somatic and psychic status of women of reproductive age].

    PubMed

    Vertkin, A L; Nosova, A V

    2012-01-01

    The paper is devoted to the topical problem of maintaining somatic and psychic health of the women of reproductive age by rational pregnancy planning and prevention of abortions by modern methods of contraception including combined oral hormonal contraception. Unfortunately, this approach is rarely employed in this country (5-6%). Results of retrospective analysis of medical documentation, clinical efficacy and safety of modern combined oral hormonal contraception are presented.

  5. Sequential gonadotrophin-releasing hormone agonist/low-dose oral contraceptive treatment for leiomyomata uteri.

    PubMed

    Balasch, J; Manau, D; Mimó, J; Durán, M; Puerto, B; Vanrell, J A

    1995-03-01

    On the basis that gonadotrophin-releasing hormone agonists (GnRHa) induce a significant but transient shrinkage of leiomyomas and that oral contraceptive use may be associated with a decreased risk of fibroids, we tested the hypothesis that sequential GnRHa/low-dose oral contraceptive treatment could be a therapeutic alternative in perimenopausal women with uterine fibroids. Six premenopausal women with leiomyomata uteri were treated with D-tryptophan-6-luteinizing hormone-releasing hormone (D-Trp-6-LHRH) depot (Decapeptyl 3.75) for 6 months and demonstrated a significant reduction in mean uterine volume. A low-dose oral contraceptive containing 30 micrograms of ethinyl oestradiol plus 150 micrograms of desogestrel was given during the ensuing 12 months. When GnRHa therapy was discontinued, there was a rapid regrowth of the uterine fibroids and the uterine volume had reached, or even exceeded, pretreatment values by the eighth to 12th month of contraceptive therapy. Sequential GnRHa/low-dose oral contraceptive treatment is not a useful tool for leiomyomata uteri.

  6. Reduced serum cholecystokinin and increase in body fat during oral contraception.

    PubMed

    Hirschberg, A L; Byström, B; Carlström, K; von Schoultz, B

    1996-02-01

    This investigation was undertaken to explore a possible role of the "satiety peptide" cholecystokinin and some other gastrointestinal hormones for changes in appetite and weight during oral contraception. Ten young healthy women attending a youth health care center for contraceptive counseling volunteered for the study. A standardized meal test was used for recordings of appetite and gastrointestinal hormone response before and after 5 months of treatment with a monophasic combined oral contraceptive. Body fat was calculated from measurements of skin-fold thickness. Oral contraceptives caused a suppression of basal levels of serum cholecystokinin, which was correlated to an increase in body fat. Meal-related response of cholecystokinin and appetite were not affected. Serum levels of gastrin and insulin were also unchanged, whereas triglycerides and postprandial glucose levels were elevated. The results suggest a role of cholecystokinin in regulation of body composition. Cholecystokinin stimulates the release of insulin and stimulates lipolysis in adipose tissue. Reduced cholecystokinin levels may, therefore, be related to mild impairment of glucose tolerance and promote body fat storage during oral contraception.

  7. Oral Contraceptive Pill Alters Acute Dietary Protein-Induced Thermogenesis in Young Women.

    PubMed

    Duhita, Maharani Retna; Schutz, Yves; Montani, Jean-Pierre; Dulloo, Abdul G; Miles-Chan, Jennifer L

    2017-09-01

    There is much interest in the role of dietary protein for weight control. However, there remains a need to characterize individual determinants of the thermogenic effects of protein. This study aimed to investigate the influence of menstrual cycle phase and the combined, monophasic oral contraceptive pill on the thermogenic response to a standardized high-protein (HP) versus normal-protein (NP) meal. Following an overnight fast, resting energy expenditure (EE) was measured in 16 healthy young women (8 taking and 8 not taking the pill) and 8 men for 30 minutes pre ingestion and 3 hours post ingestion of a NP (11%) or HP (24%) meal. There was no effect of menstrual phase or contraceptive pill use on fasting EE or NP response. However, HP increased EE significantly more than NP in women not taking the oral contraceptive pill and in men, but not in women taking the pill. This study shows an absence of the greater thermic effect of HP versus NP in women taking the oral contraceptive pill and has important implications regarding the effectiveness of HP for body weight regulation in women. With current obesity treatment/prevention strategies remaining largely ineffective, understanding the relationship between oral contraceptive pill use and protein-induced thermogenesis may enable the successful recalibration of existing dietary recommendations. © 2017 The Obesity Society.

  8. 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.

  9. The role of combined oral contraceptives in the management of acne and seborrhea.

    PubMed

    del Marmol, V; Teichmann, A; Gertsen, K

    2004-06-01

    Acne and seborrhea (or facial oiliness) are related androgenic skin disorders which affect a high proportion of women after menarche. They can have a negative effect on psychological well-being and social life. Androgens play an important role in the pathogenesis of acne through the stimulation of sebum secretion, increasing sebaceous gland size and possibly through follicular hyperkeratinization. Conversely, estrogens decrease sebum production by suppressing gonadotropin release and androgen production and increasing sex hormone binding globulin production. One of the treatment options for these conditions is hormonal therapy, especially for women who require contraception. The effect of combined oral contraceptives in androgenic skin disorders depends on their estrogen:progestogen balance and on the antiestrogenic activity of the progestogen component. Improved understanding of what women value about oral contraceptives suggests that the choice of product should be tailored as much as possible to the individual. Several combined oral contraceptives containing new-generation progestogens (e.g. desogestrel, gestodene) or progestational antiandrogens (e.g. cyproterone acetate, chlormadinone acetate) have demonstrated efficacy in the treatment of women with acne, although comparisons between trials are difficult because of differing endpoints. Seborrhea has been less well studied, but the few studies that are available show an improvement in women with this condition using combined oral contraceptives.

  10. Contraindications to combined oral contraceptives among over-the-counter compared with prescription users.

    PubMed

    Grossman, Daniel; White, Kari; Hopkins, Kristine; Amastae, Jon; Shedlin, Michele; Potter, Joseph E

    2011-03-01

    To compare the estimated proportion of contraindications to combined oral contraceptives between women who obtained combined oral contraceptives in U.S. public clinics compared with women who obtained combined oral contraceptives over the counter (OTC) in Mexican pharmacies. We recruited a cohort of 501 women who were residents of El Paso, Texas, who obtained OTC combined oral contraceptives in Mexico and 514 women who obtained combined oral contraceptives from family planning clinics in El Paso. Based on self-report of World Health Organization category 3 and 4 contraindications and interviewer-measured blood pressure, we estimated the proportion of contraindications and, using multivariable-adjusted logistic regression, identified possible predictors of contraindications. The estimated proportion of any category 3 or 4 contraindication was 18%. Relative contraindications (category 3) were more common among OTC users (13% compared with 9% among clinic users, P=.006). Absolute contraindications (category 4) were not different between the groups (5% for clinic users compared with 7% for OTC users, P=.162). Hypertension was the most prevalent contraindication (5.6% of clinic users and 9.8% of OTC users). After multivariable adjustment, OTC users had higher odds of having contraindications compared with clinic users (odds ratio [OR] 1.59, 95% confidence interval [CI] 1.11-2.29). Women aged 35 years or older (OR 5.30, 95% CI 3.59-7.81) and those with body mass index 30.0 or more (OR 2.24, 95% CI 1.40-3.56) also had higher odds of having contraindications. Relative combined oral contraceptive contraindications are more common among OTC users in this setting. Progestin-only pills might be a better candidate for the first OTC product given their fewer contraindications.

  11. Omitting the first oral contraceptive pills of the cycle does not automatically lead to ovulation.

    PubMed

    Elomaa, K; Rolland, R; Brosens, I; Moorrees, M; Deprest, J; Tuominen, J; Lähteenmäki, P

    1998-07-01

    The hypothesis that omission of the first three pills of the oral contraceptive (OC) cycle leads to ovulation by extending further the pill-free period was investigated in 107 healthy women 18-35 years of age recruited from family planning programs in Finland, the Netherlands, and Belgium. Study participants were randomly allocated to one of the following treatment groups: 1) monophasic gestodene--75 mcg of gestodene and 30 mcg of ethinyl estradiol; 2) triphasic gestodene--6 days of 50 mcg gestodene and 30 mcg ethinyl estradiol, 5 days of 70 mcg gestodene and 40 mcg ethinyl estradiol, and 10 days of 100 mcg gestodene and 30 mcg ethinyl estradiol; or 3) monophasic desogestrel--150 mcg desogestrel and 20 mcg ethinyl estradiol. Noncompliance with OC taking was simulated by extending the pill-free period from 7 to 10 days. During or after the extended pill-free interval, follicular growth exceeding 18 mm occurred in 24% of women in the monophasic gestodene group, 24% in the triphasic gestodene group, and 40% in the monophasic desogestrel group. Follicle-stimulating hormone reached a maximum serum concentration in most women during the first 7 pill-free days, indicating complete pituitary recovery. No normal ovulation was observed after either a 7- or 10-day pill-free period as evaluated by ultrasonography of follicles and serum progesterone assays. Since normal ovulation did not occur when pill omissions were limited to 3 days, OC users who forget to take these three tablets can be safely advised to start the pill cycle on day 11.

  12. Clotting Factor Changes during the First Cycle of Oral Contraceptive Use

    PubMed Central

    Westhoff, Carolyn L.; Eisenberger, Andrew; Tang, Rosalind; Cremers, Serge; Grossman, Lisa V.; Pike, Malcolm C.

    2016-01-01

    Objectives The risk of venous thromboembolism (VTE) is highest during the initial months of oral contraceptive (OC) use. We sought to evaluate the extent of hemostatic variable changes during the initial OC cycle and if such changes are related to systemic ethinyl estradiol (EE2) exposure. Study Design Participants provided multiple blood samples during a 21-day OC cycle (30 mcg EE2; 150 mcg levonorgestrel) and after a single dose following a wash-out period. Analytes included D-dimer, factor VIII activity, protein C total antigen and the hepatic proteins corticosteroid- and sex-hormone-binding globulins (CBG and SHBG). EE2 pharmacokinetic analyses related to the 24 hours after the first OC tablet (OC1) and at steady state (OC21). Results Seventeen women completed the study. D-dimer more than doubled by OC6 (p = 0.013) and remained elevated at OC21 (p=0.012). D-dimer levels within women varied widely from day-to-day. Factor VIII increased 27% by OC2 (p < 0.001), but declined to a 9% increase by OC21. Protein C increased only 6%. EE2 steady-state area-under-the-curve ranged from 488 to 1103 pg·h/mL; higher levels were not correlated with greater increases in clotting variables. CBG and SHBG increased significantly, but were not significantly correlated with levels of EE2 or with the hemostatic variables. Conclusions D-dimer increases during the first OC cycle were at least as great as increases seen with longer OC use. These results provide support for the increased VTE risk during initial OC use. The extreme variability in D-dimer levels may be an important component of this risk. PMID:26452328

  13. 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.

  14. Oxidative Stress in Female Athletes Using Combined Oral Contraceptives.

    PubMed

    Cauci, Sabina; Buligan, Cinzia; Marangone, Micaela; Francescato, Maria Pia

    2016-12-01

    Oxidative stress in female athletes is understudied. We investigated oxidative stress in sportswomen of different disciplines according to combined oral contraceptive (OC) use and lifestyle/alimentary habits. Italian sportswomen (n = 144; mean age 23.4 ± 4.2 years; body mass index 21.2 ± 2.2 kg m(-2); sport activity 9.2 ± 4.1 h week(-1)) were analyzed; 48 % were volleyball players, 12.5 % soccer players, 10.4 % track-and-field sports, and followed by other disciplines' athletes. Oxidative stress was evaluated by free oxygen radical test (FORT) assessing blood hydroperoxides and free oxygen radical defense (FORD) assay evaluating antioxidant capacity in OC users (n = 42) compared to non-OC users. Elevated oxidative stress levels (≥310 FORT units) were found in 92.9 % of OC users and in 23.5 % of non-OC users (crude OR = 42, 95 % CI 12-149, p < 0.001; adjusted OR = 60, 95 % CI 11-322, p < 0.001). Continuous values of hydroperoxides were twofold higher in OC users versus non-OC users (median 484 versus 270 FORT units, p < 0.001) and were inversely related to FORD units in OC users (p = 0.01). Hydroperoxides were not associated with weekly hours of exercise. In OC users, lifestyle/alimentary habits were not correlated to hydroperoxides. In non-OC users only, hydroperoxide values were positively correlated with weight and BMI and inversely correlated with chocolate and fish consumption. The markedly elevated oxidative stress we revealed in OC-user athletes could be detrimental to physical activity and elevate cardiovascular risk (as thromboembolism). Further research is needed to extend our results, to clarify the biochemical pathways leading to increased hydroperoxides (mainly lipid peroxides) and reduced antioxidant defense, and to elucidate the potential effects on athletic performance. OC use should be considered when developing gender-focused strategies against oxidative stress.

  15. Response from women to adverse publicity about oral contraceptives.

    PubMed

    Portnoy, A

    1984-06-01

    The response of the oral contraceptive (OC) clients of a general practice in Leicester, England to the publication of 2 1983 articles reporting on the adverse effects of OCs was assessed for the 6-week period following publication. During this period, 223 women representing 24% of the practice's OC patients, inquired about the risks associated with OCs. 43 of these patients made phone inquires. They were advised to make an appointment with their physicians when their currnt prescription expired. The remaining 180 patients inquired in person. 48 of the women came to the office for the sole purpose of inquiring about the risk, 91 inquired during the course of routinely scheduled OC checkups, and 34 inquired during consultations unrelated to OC usage. The other 7 women used OCs in the past and came to the clinic to inquire about the possible risks associated with previous use. The prescriptions of 67 of the 180 women were changed to low dose OCs. Only 1 patient decided to discontinue using OCs. Despite the emphasis in the articles on the risks associated with OC use for women 25 years of age or less, the proportion of inquiries (63%) from women 25 in this age group was similar to the proportion of women (62%) in that age category in the practice's OC user population. Among patients who inquired in person, 37% received blood pressure checks 32% received blood pressure and breast checks, and 31% were not examined. About 1/3 were advised to have a cervical smear examination. The response to the article was moderate in comparison to the response which followed the 1969 adverse report on OCs by the Committee on Safety of Medicines. As a result of that report, many women stopped taking OCs, and the abortion rate increased markedly the following year. The mild response observed in this study may have been due to the more effective handling of inquiries on the part of physicians, less sensational reporting of the findings, or, perphaps, users become immune to repeated

  16. Estimating systemic exposure to levonorgestrel from an oral contraceptive.

    PubMed

    Basaraba, Cale N; Westhoff, Carolyn L; Pike, Malcolm C; Nandakumar, Renu; Cremers, Serge

    2017-04-01

    The gold standard for measuring oral contraceptive (OC) pharmacokinetics is the 24-h steady-state area under the curve (AUC). We conducted this study to assess whether limited sampling at steady state or measurements following use of one or two OCs could provide an adequate proxy in epidemiological studies for the progestin 24-h steady-state AUC of a particular OC. We conducted a 13-sample, 24-h pharmacokinetic study on both day 1 and day 21 of the first cycle of a monophasic OC containing 30-mcg ethinyl estradiol and 150-mcg levonorgestrel (LNG) in 17 normal-weight healthy White women and a single-dose 9-sample study of the same OC after a 1-month washout. We compared the 13-sample steady-state results with several steady-state and single-dose results calculated using parsimonious sampling schemes. The 13-sample steady-state 24-h LNG AUC was highly correlated with the steady-state 24-h trough value [r=0.95; 95% confidence interval (0.85, 0.98)] and with the steady-state 6-, 8-, 12- and 16-h values (0.92≤r≤0.95). The trough values after one or two doses were moderately correlated with the steady-state 24-h AUC value [r=0.70; 95% CI (0.27, 0.90) and 0.77; 95% CI (0.40, 0.92), respectively]. Single time-point concentrations at steady state and after administration of one or two OCs gave highly to moderately correlated estimates of steady-state LNG AUC. Using such measures could facilitate prospective pharmaco-epidemiologic studies of the OC and its side effects. A single time-point LNG concentration at steady state is an excellent proxy for complete and resource-intensive steady-state AUC measurement. The trough level after two single doses is a fair proxy for steady-state AUC. These results provide practical tools to facilitate large studies to investigate the relationship between systemic LNG exposure and side effects in a real-life setting. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. Oral contraceptives and MI: how strong is the link?

    PubMed

    Jick, H

    1982-05-15

    Most of the evidence for an association between oral contraceptives (OCs) and myocardial infarction (MI) comes from case control studies and must consequently be interpreted with care. Among other things, the following must be considered: the selection of patients studied; the method of determining drug exposure; and the comparability of women identified as cases with women used as controls. The doses of estrogen and progesterone in marketed OCs have changed over the years, and this fact must be remembered. To interpret the literature on this subject it is necessary to understand the meaning of certain epidemiologic terms. The term "relative risk" (or risk ratio) refers to a comparison of risks for women exposed to OCs and those not exposed. Relative risk estimates themselves provide no information on the actual risks, only on the ratio of risks. Most of the available data on this subject relate to the risks of current OC use. The 1st formal body of data of substantial size on OCs and nonfatal MI was published by Mann and colleagues. In comparing the OC use of 72 women below age 45 who were hospitalized for nonfatal MI with OC use in controls, they estimated that current users had a 4-fold higher risk for acute MI than did nonusers. There was no positive association between past OC use and MI. A report on the relationship of OC to fatal MI also found a positive modest association. The data published before 1979 are quite consistent and provide reasonable estimates of risk for nonfatal MI among healthy OC users and nonusers. There are striking differences in absolute risk related to age and smoking status. For nonsmoking women younger than 38 the risk of MI is negligible; for women over 40 who smoke and use OCs the risk is estimated to be as high as 1.7/1000 woman-years. The results of a case-control study published last year purport to show a modest elevation of risk for nonfatal MI in women who used OCs for at least 5 years but had discontinued using them. These

  18. Oral contraceptive use: interview data versus pharmacy records.

    PubMed

    Norell, S E; Boethius, G; Persson, I

    1998-12-01

    In studies where women are interviewed about oral contraceptive (OC) use only after the emergence of disease (e.g., breast cancer), the experience of disease may enhance recall and reporting of OC use, resulting in overestimation of relative risks. This community-based study compared two sources of information on ever-use of OCs--structured interviews and pharmacy prescription records--in 427 women 20-34 years of age who were long-term residents of Sweden's Jamtland County where registration of prescriptions has been virtually complete since 1970. A life-events calendar and photographs of OCs in use since 1970 were used in the interviews to facilitate recall. 153 women reported current OC use; the pharmacy register failed to document a current prescription for 37 (24%). Only 4 (1.5%) of the 274 women who denied current OC use had an active prescription on file. Of the 37 women identified as never-users by interview, 2 (5%) had records of OC prescriptions (for under 2 years of use). Of the 36 women identified as never-users by pharmacy records, only 1 reported ever-use. Compared to the pharmacy registry, 13% reported a shorter and 28% a longer duration of OC use. Of women who reported OC use within 5 years of interview, 5-10 years earlier, and more than 10 years ago, 2.6% (8/312), 4.6% (14/307), and 12.8% (26/203), respectively, had no prescriptions on file for that time period. Discrepancies between the two data sources in time since first OC use were usually less than 2 years; the tendency was for women to overestimate rather than understate the actual duration of OC use. These findings suggest that interview data on OC use introduce minimal--if any--bias. Agreement between interviews and records in terms of the specific brands of OCs taken was less satisfactory. 19% of users of high-dose OCs, for example, did not recall the type of pill dispensed by the pharmacy. Thus, use of pharmacy records is recommended over interview data in studies where the specific OC

  19. Heparanase procoagulant activity is elevated in women using oral contraceptives.

    PubMed

    Matan, Moshe; Axelman, Elena; Brenner, Benjamin; Nadir, Yona

    2013-09-01

    What is the effect of estrogen on heparanase procogulant activity? Estrogen increases heparanase procoagulant activity. Estrogen therapy increases the risk of thrombosis and was previously found to up-regulate heparanase expression. Heparanase is involved in angiogenesis and metastasis, and has been shown to form a complex with tissue factor (TF) and also shown to enhance the generation of factor Xa. A case-control study. Thirty-four healthy women using oral contraceptives (OC) and 41 women not using hormonal therapy and not pregnant per history were enrolled, over a 5-month period, at the Rambam Medical Center, Haifa, Israel. In vitro, estrogen receptor-positive (MCF-7) and -negative (MDA-231) cell lines were incubated with estrogen, tamoxifen and ICI-182.780 a pure estrogen receptor antagonist. The cell medium was evaluated for TF/heparanase complex activity, TF activity and heparanase procoagulant activity by chromogenic substrate. Exclusion criteria included age <18 years, post-menopausal women, concomitant medications other than supplement minerals and vitamins, acute or chronic illness. The study demonstrates increased risk of high heparanase procoagulant activity in OC users. When a cutoff level of 0.25 (absorbance 405-490 nm) was set, the odds ratio was 131 (P < 0.0001). When all results were studied by quartiles, in quartiles 3 and 4 the results were almost exclusively of the OC users (P < 0.0001). In cell cultures, estrogen and tamoxifen increased heparanase procoagulant activity in the medium of estrogen receptor-positive (MCF-7) cells. The main limitation of the current study is that the two estrogens given to the women and cell cultures, ethinyl estradiol (EE) and 17-β-estradiol (E2), respectively, may have different effects on the coagulation system, although an increase in heparanase procoagulant activity was demonstrated in both of them. Although the sample size of the study group was limited, significant differences in the activation of the

  20. The influence of formulation and manufacturing process parameters on the characteristics of lyophilized orally disintegrating tablets.

    PubMed

    Jones, Rhys J; Rajabi-Siahboomi, Ali; Levina, Marina; Perrie, Yvonne; Mohammed, Afzal R

    2011-07-20

    Gelatin is a principal excipient used as a binder in the formulation of lyophilized orally disintegrating tablets. The current study focuses on exploiting the physicochemical properties of gelatin by varying formulation parameters to determine their influence on orally disintegrating tablet (ODT) characteristics. Process parameters, namely pH and ionic strength of the formulations, and ball milling were investigated to observe their effects on excipient characteristics and tablet formation. The properties and characteristics of the formulations and tablets which were investigated included: glass transition temperature, wettability, porosity, mechanical properties, disintegration time, morphology of the internal structure of the freeze-dried tablets, and drug dissolution. The results from the pH study revealed that adjusting the pH of the formulation away from the isoelectric point of gelatin, resulted in an improvement in tablet disintegration time possibly due to increase in gelatin swelling resulting in greater tablet porosity. The results from the ionic strength study revealed that the inclusion of sodium chloride influenced tablet porosity, tablet morphology and the glass transition temperature of the formulations. Data from the milling study showed that milling the excipients influenced formulation characteristics, namely wettability and powder porosity. The study concludes that alterations of simple parameters such as pH and salt concentration have a significant influence on formulation of ODT.

  1. Oral Delivery of Probiotics in Poultry Using pH-Sensitive Tablets.

    PubMed

    Jiang, Tao; Li, Hui-Shan; Han, Geon Goo; Singh, Bijay; Kang, Sang-Kee; Bok, Jin-Duck; Kim, Dae-Duk; Hong, Zhong-Shan; Choi, Yun-Jaie; Cho, Chong-Su

    2017-04-28

    As alternatives to antibiotics in livestocks, probiotics have been used, although most of them in the form of liquid or semisolid formulations, which show low cell viability after oral administration. Therefore, suitable dry dosage forms should be developed for livestocks to protect probiotics against the low pH in the stomach such that the products have higher probiotics survivability. Here, in order to develop a dry dosage forms of probiotics for poultry, we used hydroxypropyl methylcellulose phthalate 55 (HPMCP 55) as a tablet-forming matrix to develop probiotics in a tablet form for poultry. Here, we made three different kinds of probiotics-loaded tablet under different compression forces and investigated their characteristics based on their survivability, morphology, disintegration time, and kinetics in simulated gastrointestinal fluid. The results indicated that the probiotics formulated in the tablets displayed higher survival rates in acidic gastric conditions than probiotics in solution. Rapid release of the probiotics from the tablets occurred in simulated intestinal fluid because of fast swelling of the tablets in neutral pH. As a matrix of tablet, HPMCP 55 provided good viability of probiotics after 6 months under refrigeration. Moreover, after oral administration of probiotics-loaded tablets to chicken, more viable probiotics were observed, than with solution type, through several digestive areas of chicken by the tablets.

  2. The Influence of Formulation and Manufacturing Process Parameters on the Characteristics of Lyophilized Orally Disintegrating Tablets

    PubMed Central

    Jones, Rhys J.; Rajabi-Siahboomi, Ali; Levina, Marina; Perrie, Yvonne; Mohammed, Afzal R.

    2011-01-01

    Gelatin is a principal excipient used as a binder in the formulation of lyophilized orally disintegrating tablets. The current study focuses on exploiting the physicochemical properties of gelatin by varying formulation parameters to determine their influence on orally disintegrating tablet (ODT) characteristics. Process parameters, namely pH and ionic strength of the formulations, and ball milling were investigated to observe their effects on excipient characteristics and tablet formation. The properties and characteristics of the formulations and tablets which were investigated included: glass transition temperature, wettability, porosity, mechanical properties, disintegration time, morphology of the internal structure of the freeze-dried tablets, and drug dissolution. The results from the pH study revealed that adjusting the pH of the formulation away from the isoelectric point of gelatin, resulted in an improvement in tablet disintegration time possibly due to increase in gelatin swelling resulting in greater tablet porosity. The results from the ionic strength study revealed that the inclusion of sodium chloride influenced tablet porosity, tablet morphology and the glass transition temperature of the formulations. Data from the milling study showed that milling the excipients influenced formulation characteristics, namely wettability and powder porosity. The study concludes that alterations of simple parameters such as pH and salt concentration have a significant influence on formulation of ODT. PMID:24310589

  3. Cluster headache in women: relation with menstruation, use of oral contraceptives, pregnancy, and menopause

    PubMed Central

    van Vliet, J A; Favier, I; Helmerhorst, F M; Haan, J; Ferrari, M D

    2006-01-01

    In contrast with migraine, little is known about the relation between cluster headache and menstrual cycle, oral contraceptives, pregnancy, and menopause. A population based questionnaire study was performed among 224 female cluster headache patients, and the possible effect of hormonal influences on cluster headache attacks studied. For control data, a similar but adjusted questionnaire was sent to healthy volunteers and migraine patients. It was found that menstruation, use of oral contraceptives, pregnancy, and menopause had a much smaller influence on cluster headache attacks than in migraine. Cluster headache can, however, have a large impact on individual women, for example to refrain from having children. PMID:16407458

  4. Interaction of St John's wort with low-dose oral contraceptive therapy: a randomized controlled trial

    PubMed Central

    Pfrunder, Arabelle; Schiesser, Monika; Gerber, Simone; Haschke, Manuel; Bitzer, Johannes; Drewe, Juergen

    2003-01-01

    Aims Breakthrough bleeding or even unwanted pregnancies have been reported in women during concomitant therapy with oral contraceptives and St John's wort extract. The aim of the present study was to investigate the effects of St John's wort extract on oral contraceptive therapy with respect to ovarian activity, breakthrough bleeding episodes and the pharmacokinetics of ethinyloestradiol and 3-ketodesogestrel. Methods Eighteen healthy females were treated with a low-dose oral contraceptive (0.02 mg ethinyloestradiol, 0.150 mg desogestrel) alone (control cycle) or combined with 300 mg St John's wort extract given twice daily (cycle A) or three times daily (cycle B). Ovarian activity was assessed by measuring follicle maturation and serum oestradiol and progesterone concentrations. The number of breakthrough bleeding episodes and the pharmacokinetics of ethinyloestradiol and 3-ketodesogestrel were assessed under steady-state conditions. Results During concomitant administration of low-dose oral contraceptive and St John's wort, there was no significant change in follicle maturation, serum oestradiol or progesterone concentrations when compared with oral contraceptive treatment alone. However, significantly more subjects reported intracyclic bleeding during cycles A (13/17 (77%), P < 0.015) and cycle B (15/17 (88%), P < 0.001) than with oral contraceptives alone (6/17 (35%)). The AUC(0,24 h) and Cmax of ethinyloestradiol remained unchanged during all study cycles, whereas the AUC(0,24 h) and Cmax of 3-ketodesogestrel decreased significantly from 31.2 ng ml−1 h to 17.7 ng ml−1 h (43.9%; 95% confidence interval (CI) −49.3, −38.5, P = 0.001) and from 3.6 ng ml −1 to 3.0 ng ml −1(17.8%; CI −29.9, −5.7, P = 0.005), respectively, during cycle A and by 41.7% (CI −47.9, −35.6; P = 0.001) and by 22.8% (CI −31.2, −13.3; P < 0.001) during cycle B respectively, compared with the control cycle. Conclusions There was no evidence of ovulation during low

  5. Timing of oral contraceptive use and the risk of breast cancer in BRCA1 mutation carriers.

    PubMed

    Kotsopoulos, Joanne; Lubinski, Jan; Moller, Pal; Lynch, Henry T; Singer, Christian F; Eng, Charis; Neuhausen, Susan L; Karlan, Beth; Kim-Sing, Charmaine; Huzarski, Tomasz; Gronwald, Jacek; McCuaig, Jeanna; Senter, Leigha; Tung, Nadine; Ghadirian, Parviz; Eisen, Andrea; Gilchrist, Dawna; Blum, Joanne L; Zakalik, Dana; Pal, Tuya; Sun, Ping; Narod, Steven A

    2014-02-01

    It is not clear if early oral contraceptive use increases the risk of breast cancer among young women with a breast cancer susceptibility gene 1 (BRCA1) mutation. Given the benefit of oral contraceptives for the prevention of ovarian cancer, estimating age-specific risk ratios for oral contraceptive use and breast cancer is important. We conducted a case-control study of 2,492 matched pairs of women with a deleterious BRCA1 mutation. Breast cancer cases and unaffected controls were matched on year of birth and country of residence. Detailed information about oral contraceptive use was collected from a routinely administered questionnaire. Conditional logistic regression was used to estimate the odds ratios (OR) and 95 % confidence intervals (CI) for the association between oral contraceptive and breast cancer, by age at first use and by age at diagnosis. Among BRCA1 mutation carriers, oral contraceptive use was significantly associated with an increased risk of breast cancer for women who started the pill prior to age 20 (OR 1.45; 95 % CI 1.20-1.75; P = 0.0001) and possibly between ages 20 and 25 as well (OR 1.19; 95 % CI 0.99-1.42; P = 0.06). The effect was limited to breast cancers diagnosed before age 40 (OR 1.40; 95 % CI 1.14-1.70; P = 0.001); the risk of early-onset breast cancer increased by 11 % with each additional year of pill use when initiated prior to age 20 (OR 1.11; 95 % CI 1.03-1.20; P = 0.008). There was no observed increase for women diagnosed at or after the age of 40 (OR 0.97; 95 % CI 0.79-1.20; P = 0.81). Oral contraceptive use before age 25 increases the risk of early-onset breast cancer among women with a BRCA1 mutation and the risk increases with duration of use. Caution should be taken when advising women with a BRCA1 mutation to take an oral contraceptive prior to age 25.

  6. The care of oral contraceptive users by general practitioners in Oxfordshire

    PubMed Central

    Johnson, Bridget; Thorogood, Margaret

    1977-01-01

    A questionnaire was circulated to a sample of general practitioners in Oxfordshire enquiring about the supervision of women taking oral contraceptives. A high standard of care was being offered and the doctors believed that there was a wide range of conditions that should influence the prescription of oral contraceptives. We conclude that while suitably trained paramedical staff could provide the same standard of care as the general practitioners, this could not be achieved through the use of a package insert listing possible contraindications. PMID:894634

  7. Evaluation of coprocessed disintegrants produced from tapioca starch and mannitol in orally disintegrating paracetamol tablet.

    PubMed

    Adeoye, Oluwatomide; Alebiowu, Gbenga

    2014-01-01

    The study evaluated two novel coprocessed excipients (with two methods) as disintegrants in an orally disintegrating paracetamol tablet formulation. The tablets produced were assessed for mechanical properties with the use of friability and tensile strength while the release properties were assessed with wetting time, water absorption ratio, disintegration time and dissolution profile. The results obtained showed that the methods of coprocessing and disintegrant incorporation influenced the activities of the disintegrants. The novel disintegrant enhanced the mechanical properties of the tablets containing them as shown by lower friability and higher tensile strength of the tablets. The result further showed that the rate and amount of water absorbed, type of disintegrant and the method of disintegrant incorporation influenced the total amount of paracetamol released. The study concluded that the novel disintegrants will be effective in the formulation of orally disintegrating paracetamol tablets.

  8. A consumer intercept study of oral contraceptive users in the Dominican Republic.

    PubMed

    Green, E C

    1988-01-01

    Purchasers of a low-cost oral contraceptive were intercepted and interviewed in a sample of Santo Domingo pharmacies that represented the highest sales of the product, yet also reflected the socioeconomic profile of the city's entire population. Users of the contraceptive were later interviewed in greater depth in their homes. The survey of users showed that the Dominican Republic's social marketing program, implemented by PROFAMILIA, was reaching an appropriate target market--that is, younger, lower-middle-class women of low parity. The program was, in addition, successful in attracting first-time adopters, and it was also expanding the overall commercial market for all contraceptives. The marketing campaign was successful in part because a mass audience was reached, through brief television spots. Program impact on contraceptive prevalence can be assessed from sales data.

  9. Proniosomal oral tablets for controlled delivery and enhanced pharmacokinetic properties of acemetacin.

    PubMed

    Shehata, Tamer M; Abdallah, Marwa H; Ibrahim, Mahmoud Mokhtar

    2015-04-01

    Free-flowing proniosomal powders of acemetacin (AC) were prepared using the slurry method and maltodextrin as carrier. Positively charged proniosomes composed of 70:20:10 of Span 60/cholesterol (Chol)/stearylamine (SA), respectively, were successively compressed into tablets using direct compression method. The tablets were characterized for weight variability, friability, hardness, drug content uniformity, and dissolution properties. The in vivo evaluation of the prepared proniosomes (powder or tablet forms) after oral administration was investigated by the determination of AC and its active metabolite indomethacin (IND) in the blood of albino rabbits. Results indicated that the increase of Chol from 10% to 20% markedly reduced the efflux of the drug. Further Chol addition from 30% to 50% led to increased AC release rates. The proniosome tablets of AC showed greater hardness and disintegration time and less friability than AC plain tablets. The dissolution of proniosomal tablets indicated a lower drug release percentage compared to powdered proniosomes and AC plain tablets. The mean pharmacokinetic parameters of AC and IND from different formulations indicated increased t 1/2 and area under the curve (AUC) of both AC and IND for proniosomal tablets compared with both proniosomal powders and AC plain tablets. This study suggested the formulation of AC proniosomal powder into tablets to control and extend its pharmacologic effects.

  10. Combined oral contraceptive pills for treatment of acne.

    PubMed

    Arowojolu, Ayodele O; Gallo, Maria F; Lopez, Laureen M; Grimes, David A

    2012-06-13

    Acne is a common skin disorder among women. Although no uniform approach to the management of acne exists, combination oral contraceptives (COCs), which contain an estrogen and a progestin, often are prescribed for women. To determine the effectiveness of combined oral contraceptives (COCs) for the treatment of facial acne compared to placebo or other active therapies. In January 2012, we searched for randomized controlled trials of COCs and acne in the computerized databases of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, and LILACS. We also searched for clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP) (Aug 2011). For the initial review, we wrote to researchers to seek any unpublished or published trials that we might have missed. We considered randomized controlled trials reported in any language that compared the effectiveness of a COC containing an estrogen and a progestin to placebo or another active therapy for acne in women. We extracted data on facial lesion counts, both total and specific (i.e., open or closed comedones, papules, pustules and nodules); acne severity grades; global assessments by the clinician or the participant, and discontinuation due to adverse events. Data were entered and analyzed in RevMan. For continuous data, we calculated the mean difference (MD) and 95% confidence interval (CI). For dichotomous data, we calculated the Peto odds ratio (OR) and 95% CI. The review includes 31 trials with 12,579 participants. Of 24 comparisons made, 6 compared a COC to placebo, 17 different COCs, and 1 compared a COC to an antibiotic. Of nine placebo-controlled trials with data for analysis, all showed COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. A levonorgestrel-COC group had fewer total lesion counts (MD -9.98; 95% CI -16.51 to -3.45), inflammatory and non-inflammatory lesion counts, and were more likely to

  11. Combined oral contraceptive pills for treatment of acne.

    PubMed

    Arowojolu, Ayodele O; Gallo, Maria F; Lopez, Laureen M; Grimes, David A

    2012-07-11

    Acne is a common skin disorder among women. Although no uniform approach to the management of acne exists, combination oral contraceptives (COCs), which contain an estrogen and a progestin, often are prescribed for women. To determine the effectiveness of combined oral contraceptives (COCs) for the treatment of facial acne compared to placebo or other active therapies. In January 2012, we searched for randomized controlled trials of COCs and acne in the computerized databases of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, and LILACS. We also searched for clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP) (Aug 2011). For the initial review, we wrote to researchers to seek any unpublished or published trials that we might have missed. We considered randomized controlled trials reported in any language that compared the effectiveness of a COC containing an estrogen and a progestin to placebo or another active therapy for acne in women. We extracted data on facial lesion counts, both total and specific (i.e., open or closed comedones, papules, pustules and nodules); acne severity grades; global assessments by the clinician or the participant, and discontinuation due to adverse events. Data were entered and analyzed in RevMan. For continuous data, we calculated the mean difference (MD) and 95% confidence interval (CI). For dichotomous data, we calculated the Peto odds ratio (OR) and 95% CI. The review includes 31 trials with 12,579 participants. Of 24 comparisons made, 6 compared a COC to placebo, 17 different COCs, and 1 compared a COC to an antibiotic. Of nine placebo-controlled trials with data for analysis, all showed COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. A levonorgestrel-COC group had fewer total lesion counts (MD -9.98; 95% CI -16.51 to -3.45), inflammatory and non-inflammatory lesion counts, and were more likely to

  12. Reversible ischemic colitis in young women. Association with oral contraceptive use.

    PubMed

    Deana, D G; Dean, P J

    1995-04-01

    Ischemic colitis, a condition of middle-aged to elderly patients, occurs uncommonly in younger persons. In this study, we describe the clinical and pathological features of 18 young adults (mean age, 29 years; age range, 17-39 years) with spontaneous ischemic colitis, 17 of whom were women. All presented with abrupt onset of severe, cramping abdominal pain followed by hematochezia. Colonoscopic visualization of the mucosa showed segmental hyperemia, friability, and erosion affecting the distal transverse colon (three cases), splenic flexure (three cases), descending colon (five cases), and sigmoid (seven cases). Mucosal biopsy documented superficial ischemic necrosis in seven patients; 11 patients had full-thickness mucosal necrosis with regeneration. Colonic mucosa proximal and distal to the ischemic segment was endoscopically normal in all patients and histologically normal in the eight patients in whom biopsies were obtained. All patients recovered with supportive care. Median duration of illness was 2.1 days (range, 1-4 days). Ten women (59%) were using low-dose estrogenic oral contraceptive agents, compared with the 1988 national average of 18.5% oral contraceptive users among females aged 15 to 44 years. The calculated odds ratio yielded a greater than sixfold relative risk for the occurrence of ischemic colitis among oral contraceptive users. In addition, four women not currently on hormonal contraceptive therapy had a past history of oral contraceptive use; the three remaining women were taking estrogen as replacement therapy after oophorectomy. In one patient, documented reversible ischemic colitis recurred on resumption of oral contraceptive use; four women reported symptoms and signs of recurrent ischemia but did not seek further medical evaluation. Our data indicate that transient colonic ischemia represents a form of acute segmental colitis in young adults; before the 5th decade of life, spontaneous ischemic colitis is a disorder found almost

  13. Factors affecting pituitary gonadotropin function in users of oral contraceptive steroids.

    PubMed

    Scott, J A; Brenner, P F; Kletzky, O A; Mishell, D R

    1978-04-01

    In order to determine whether certain factors influence the direct pituitary suppressive effect of contraceptive steroid, 50 subjects who had used various formulations of oral contraceptive steroids for periods of time ranging from one to nine years were stimulated with 50 microgram of gonadotropin-releasing hormone (GnRH) during the last week of oral contraceptive ingestion. The response of lutinizing hormone (LH) and follicle-stimulating hormone (FSH) was compared to the results obtained in nine control subjects with regard to: (1) age of subject. (2) type of contraceptive formulation used, and (3) length of use. Prestimulation levels of LH and FSH, respectively, were significantly decreased in 37 (74 per cent) and 42 (84 per cent) of the subjects. Following GnRH stimulation, peak responses of serum LH and FSH, respectively, were also significantly lower than those in the control subjects in 40 (80 per cent) and 45 (90 per cent of the subjects. The degree of suppression of pituitary gonadotropins, both before and after GnRH administration was significantly correlated with the type of steroid formulation used, being greatest with a combination of d-norgestrel and ethinyl estradiol. No correlation was found with length of use of oral contraceptives or age of the subjects.

  14. A new formulation for orally disintegrating tablets using a suspension spray-coating method.

    PubMed

    Okuda, Y; Irisawa, Y; Okimoto, K; Osawa, T; Yamashita, S

    2009-12-01

    The aim of this study was to design a new orally disintegrating tablet (ODT) that has high tablet hardness and a fast oral disintegration rate using a new preparation method. To obtain rapid disintegration granules (RDGs), a saccharide, such as trehalose, mannitol, or lactose, was spray-coated with a suspension of corn starch using a fluidized-bed granulator (suspension method). As an additional disintegrant, crospovidone, light anhydrous silicic acid, or hydroxypropyl starch was also included in the suspension. The RDGs obtained possessed extremely large surface areas, narrow particle size distribution, and numerous micro-pores. When tabletting these RDGs, it was found that the RDGs increased tablet hardness by decreasing plastic deformation and increasing the contact frequency between granules. In all tablets, a linear relationship was observed between tablet hardness and oral disintegration time. From each linear correlation line, a slope (D/H value) and an intercept (D/H(0) value) were calculated. Tablets with small D/H and D/H(0) values could disintegrate immediately in the oral cavity regardless of the tablet hardness and were considered to be appropriate for ODTs. Therefore, these values were used as key parameters to select better ODTs. Of all the RDGs prepared in this study, mannitol spray-coated with a suspension of corn starch and crospovidone (2.5:1 w/w ratio) showed most appropriate properties for ODTs; fast in vivo oral disintegration time, and high tablet hardness. In conclusion, this simple method to prepare superior formulations for new ODTs was established by spray-coating mannitol with a suspension of appropriate disintegrants.

  15. 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.

  16. An Ethinyl Estradiol-Levonorgestrel Containing Oral Contraceptive Does Not Alter Cytochrome P4502C9 In Vivo Activity

    PubMed Central

    Pearson, Jacob; Maslen, Cheryl; Edelman, Alison

    2014-01-01

    Oral contraceptives have been in wide use for more than 50 years. Levonorgestrel, a commonly employed progestin component of combined oral contraceptives, was implicated in drug–drug interactions mediated via CYP2C9. Although in vitro studies refuted this interaction, there are no confirmatory in vivo studies. In the current study, we examined the phenotypic status of CYP2C9 using low-dose (125 mg) tolbutamide before and after oral contraceptive use in reproductive age women. Blood was collected 24 hours after the tolbutamide oral dose was administered, plasma was isolated, and tolbutamide concentration (C24) was measured using liquid chromatography–mass spectrometry. The natural logarithm of tolbutamide C24, a metric for CYP2C9 phenotype, was found to be equivalent (within 80%–125% equivalency boundaries) before and after oral contraceptive use. In conclusion, levonorgestrel-containing oral contraceptives, the most commonly used form of oral contraception, do not affect the status of the CYP2C9 enzyme. This suggests that it is safe to coadminister levonorgestrel-containing oral contraceptives and CYP2C9 substrates, which include a wide array of drugs. PMID:24368832

  17. An ethinyl estradiol-levonorgestrel containing oral contraceptive does not alter cytochrome P4502C9 in vivo activity.

    PubMed

    Cherala, Ganesh; Pearson, Jacob; Maslen, Cheryl; Edelman, Alison

    2014-03-01

    Oral contraceptives have been in wide use for more than 50 years. Levonorgestrel, a commonly employed progestin component of combined oral contraceptives, was implicated in drug-drug interactions mediated via CYP2C9. Although in vitro studies refuted this interaction, there are no confirmatory in vivo studies. In the current study, we examined the phenotypic status of CYP2C9 using low-dose (125 mg) tolbutamide before and after oral contraceptive use in reproductive age women. Blood was collected 24 hours after the tolbutamide oral dose was administered, plasma was isolated, and tolbutamide concentration (C24) was measured using liquid chromatography-mass spectrometry. The natural logarithm of tolbutamide C24, a metric for CYP2C9 phenotype, was found to be equivalent (within 80%-125% equivalency boundaries) before and after oral contraceptive use. In conclusion, levonorgestrel-containing oral contraceptives, the most commonly used form of oral contraception, do not affect the status of the CYP2C9 enzyme. This suggests that it is safe to co-administer levonorgestrel-containing oral contraceptives and CYP2C9 substrates, which include a wide array of drugs.

  18. Therapeutic, prophylactic, untoward, and contraceptive effects of combined oral contraceptives: catholic teaching, natural law, and the principle of double effect when deciding to prescribe and use.

    PubMed

    Casey, Murray Joseph; Salzman, Todd A

    2014-01-01

    Combined oral contraceptives (COC) have been demonstrated to have significant benefits for the treatment and prevention of disease. These medications also are associated with untoward health effects, and they may be directly contraceptive. Prescribers and users must compare and weigh the intended beneficial health effects against foreseeable but unintended possible adverse effects in their decisions to prescribe and use. Additionally, those who intend to abide by Catholic teachings must consider prohibitions against contraception. Ethical judgments concerning both health benefits and contraception are approached in this essay through an overview of the therapeutic, prophylactic, untoward, and contraceptive effects of COC and discussion of magisterial and traditional Catholic teachings from natural law. Discerning through the principle of double effect, proportionate reason, and evidence gathered from the sciences, medical and moral conclusions are drawn that we believe to be fully compliant with good medicine and Catholic teaching.

  19. Low-dose oral contraceptives: progestin potency, androgenicity, and atherogenic potential.

    PubMed

    Ellis, J

    1986-01-01

    The effects of oral contraceptives and estrogen replacement drugs on blood lipids that affect cardiovascular disease (atherogenic effects) are reviewed by comparing their androgenicity and progestin potency. Although early oral contraceptives with high doses of estrogen were indicted for increasing risk of thromboembolic disorders and heart attacks, today's pills low in estrogen still bear the same risk for cardiovascular events. A brief explanation of the lipoproteins is presented, emphasizing the importance of High Density Lipoprotein (HDL) in protecting against heart disease and stroke. Menstruating women have naturally high HDL. The estrogen in oral contraceptives and postmenopausal estrogen replacements increases HDL as much as 30%, while decreasing LDL, the component carrying most of the cholesterol. It seems that the progestin in oral contraceptives will lower HDL, and studies show that this action is related to androgenicity and dose of the progestin. Progestins such as levonorgestrel and norgestrel are more androgenic, while norethynodrel, ethynodiol diacetate and norethindrone are less so. When used in combination with estrogens, progestins are less androgenic, but when used alone, the androgenic and atherogenic effects dominate. The lower the estrogen dose in the combination, say around 20-35 mcg ethinyl estradiol, the more atherogenic the progestin. These actions are confirmed theoretically by measurements of sex hormone binding globulin, a blood protein that reflects estrogen activity, as well as by epidemiologic studies in Sweden and Great Britain, where rates of heart attack and stroke in pill users remain as high as they were when pills contained high doses of estrogen.

  20. Oral contraceptives, antithrombin- III activity, and postoperative deep-vein thrombosis.

    PubMed

    Sagar, S; Stamatakis, J D; Thomas, D P; Kakkar, V V

    1976-03-06

    Deep-vein thrombosis (D.V.T.) was detected by the fibrinogen-uptake test in six out of a total of thirty-one young women undergoing emergency abdominal surgery who gave a history of recent oral contraceptive intake. In contrast, no D.V.T. developed in nineteen similar patients who were not on oral contraceptives (P less than 0-01). Plasma-antithrombin-III activity was significantly lower preoperatively in patients taking oral contraceptives; postoperative D.V.T. subsequently developed in three out of five patients with preoperative antithrombin-III activity below 50%. In seventy-eight dental patients undergoing molar extraction, antithrombin-III activity was measured before, during, and after operation. Activity fell in all patients during operation, but the fall was significantly greater in women taking oral contraceptives (P less than 0-01). The intra-operative fall in antithrombin-III activity was prevented by a small preoperative dose of subcutaneous heparin.

  1. Cerebral arterial occlusion and intracranial venous thrombosis in a woman taking oral contraceptives.

    PubMed Central

    Montón, F.; Rebollo, M.; Quintana, F.; Berciano, J.

    1984-01-01

    Occlusion of the middle cerebral artery and thrombosis of the superior sagittal sinus are reported in a 30-year-old woman taking oral contraceptives (OC). The coexistence of arterial and venous cerebral pathology as a complication of OC use has only been previously reported in one case. The pathogenesis of this rare association is briefly discussed. Images Fig. 1 Fig. 2 PMID:6462985

  2. 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…

  3. 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

  4. 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…

  5. Impact of exercise on bone health and contraindication of oral contraceptive use in young women.

    PubMed

    Weaver, C M; Teegarden, D; Lyle, R M; McCabe, G P; McCabe, L D; Proulx, W; Kern, M; Sedlock, D; Anderson, D D; Hillberry, B M; Peacock, M; Johnston, C C

    2001-06-01

    The effect of quantified resistance and high impact exercise training on bone mass as modified by age and oral contraceptive (OCont) use in young women was studied. Women were categorized by age (18-23 vs 24-31 yr) and OCont use, and were then randomized into either three sessions of resistance exercise plus 60 min.wk-1 of jumping rope or a control group for 24 months. Total body, spine, femoral neck, greater trochanter, Ward's area, and radial bone mineral density (BMD) and/or content (BMC), biochemical markers of bone turnover, dietary intake of calcium, lean body mass, maximal oxygen uptake, and strength were determined at baseline and every 6 months. Total body (TB) BMC percent change from baseline was higher in exercisers compared with nonexercisers at 6 and 24 months. OCont users had lower bone turnover at baseline and a decrease in TBBMC from baseline compared with non-OCont users at 24 months. Spine BMC and BMD decreased in the exercise and OCont group at 6 months and remained significantly below nonexercisers who used oral contraceptives at 2 yr. Femoral neck BMD also decreased in the exercise and oral contraceptive group at 6 months. Exercise prevented a decline in TBBMC seen in the nonexercisers. On the other hand, exercise in oral contraceptive users prevented the increase observed in the spine of the nonexercise plus OCont group.

  6. Menstrual and oral contraceptive use patterns among deployed military women by race and ethnicity.

    PubMed

    Deuster, Patricia A; Powell-Dunford, Nicole; Crago, Mark S; Cuda, Amanda S

    2011-01-01

    Menstrual cycle patterns and concerns and oral contraceptive use in the combat environment were examined in Caucasian, Asian, Hispanic, and African American women to guide the development of educational resources for women soldiers. An anonymous, questionnaire was completed by 455 U.S. Army women-Caucasian (CA: n = 141); Asian (AS: n = 67); Hispanic (HIS: n = 67); and African American (AA: n = 184) to compare menstrual patterns and concerns, dysmenorrhea, and oral contraceptive patterns. Total menstrual concerns were significantly lower among African Americans relative to Caucasians, Asians, or Hispanics; Asians and Hispanics reported the greatest concern. Overall, secondary amenorrhea was noted by 14.9% of women. Severe dysmenorrhea rates were significantly lower in African American (6.1%) compared to Caucasian (11.6%), Asian (20.9%) and Hispanic (19.7%) women. Asian women reported missing less work-only 9.3% with moderate to severe dysmenorrhea missed work compared to 25.1% of all other women. Only 9.2% of women with mild, compared to 25.8% with moderate to severe (OR = 3.44; p ≤ 0.0001) dysmenorrhea sought health care. Less than 50% of women took oral contraceptive, and less than half of those women took oral contraceptive continuously. African Americans seemed to experience menstruation as less bothersome than others, despite no difference in the proportion with menstrual irregularities, mean duration of menses, and/or mean time between cycles.

  7. [Objective and perceived knowledge of oral contraceptive methods among adolescent mothers].

    PubMed

    Sousa, Michelle Chintia Rodrigues de; Gomes, Keila Rejane Oliveira

    2009-03-01

    The high rate of early pregnancy in Brazil and particularly in Teresina (21.5%), Piauí State, motivated the current study, the aim of which was to identify levels of objective and perceived knowledge on oral contraceptives, as well as predictive reproductive and socio-demographic variables for high knowledge. A cross-sectional study was performed including 278 teenage mothers (15-19 years), with their childbearing history, admitted to four maternity hospitals in Teresina in 2006. Logistic regression provided the basis for the statistical analysis. Nearly 98% of the adolescent mothers showed low objective and perceived knowledge of oral contraceptives. High parity was the only predictor of increased objective knowledge on oral contraceptives. The adolescents' low level of objective and perceived knowledge on use of oral contraceptives emphasized their susceptibility to risky sexual behavior. The findings emphasize the need for a more interactive approach with adolescents concerning their level of objective and perceived knowledge, to reduce the occurrence and repetition of unwanted teenage pregnancy and its negative consequences for the lives of these young mothers and their children.

  8. Maternal use of oral contraceptives and risk of birth defects in Denmark: prospective, nationwide cohort study.

    PubMed

    Charlton, Brittany M; Mølgaard-Nielsen, Ditte; Svanström, Henrik; Wohlfahrt, Jan; Pasternak, Björn; Melbye, Mads

    2016-01-06

    Is oral contraceptive use around the time of pregnancy onset associated with an increased risk of major birth defects? In a prospective observational cohort study, data on oral contraceptive use and major birth defects were collected among 880,694 live births from Danish registries between 1997 and 2011. We conservatively assumed that oral contraceptive exposure lasted up to the most recently filled prescription. The main outcome measure was the number of major birth defects throughout one year follow-up (defined according to the European Surveillance of Congenital Anomalies classification). Logistic regression estimated prevalence odds ratios of any major birth defect as well as categories of birth defect subgroups. Prevalence of major birth defects (per 1000 births) was consistent across each oral contraceptive exposure group (25.1, never users; 25.0, use >3 months before pregnancy onset (reference group); 24.9, use 0-3 months before pregnancy onset (that is, recent use); 24.8, use after pregnancy onset). No increase in prevalence of major birth defects was seen with oral contraceptive exposure among women with recent use before pregnancy (prevalence odds ratio 0.98 (95% confidence interval 0.93 to 1.03)) or use after pregnancy onset (0.95 (0.84 to 1.08)), compared with the reference group. There was also no increase in prevalence of any birth defect subgroup (for example, limb defects). It is unknown whether women took oral contraceptives up to the date of their most recently filled prescription. Also, the rarity of birth defects made disaggregation of the results difficult. Residual confounding was possible, and the analysis lacked information on folate, one of the proposed mechanisms. Oral contraceptive exposure just before or during pregnancy does not appear to be associated with an increased risk of major birth defects. BMC was funded by the Harvard T H Chan School of Public Health's Maternal Health Task Force and Department of Epidemiology Rose Traveling

  9. [Withdrawal of high estrogen containing oral contraceptives and the demand for medical service].

    PubMed

    Kamper-Jorgensen, F; Albertsen, J; Almind, G; Andersen, K; Braae, M; Dybkjaer, L; Frolund, F; Granlie, K; Hald, E; Hald, J; Hector, O; Jacobsen, K; Kaltoft, S; Kjaerulff, E; Mabeck, C D; Magnusson, B; Nielsen, A; Novella, P; Olsen, O M; Pedersen, P A; Rasmussen, I; Strunk, K; Traeden, J B; Veje, J O

    1975-03-24

    The results of a survey are presented conerning the effectiveness of mass media publicity with the public. After oral contraceptives containing high levels of estrogen were prohibited in Denmark, a telephone survey of 23 doctors was taken to determine the fluctuation in demand for medical information from patients, and the reason for the fluctuation. The reasons were divided into 3 groups: 1) resulting from mass media publicity, 2) resulting from the unavailability of a particular contraceptive, and 3) other. 3 surveys were conducted of the frequency of demand for information on the high estrogen contraceptives, 1 for each of the 2 weeks after the prohibition and withdrawal of the contraceptives took place, and 1 1 month after the prohibition. 2-3% of the inquiries received by the doctors concerned the prohibited contraceptives, and half of these could be attributed directly to the mass media publicity. The number of requests in categories 1 and 2 dropped sharply in the 2nd and 3rd surveys, indicating that the effect of the mass meida publicity and the withdrawal of the contraceptive from the market had only a very immediate effect. It is also shown that the telephone can be used successfully to ascertain the effects of a short-term social phenomenon on the public.

  10. Preparation and evaluation of swelling induced-orally disintegrating tablets by microwave irradiation.

    PubMed

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

    2011-09-15

    A major challenge in the development of orally disintegrating tablets (ODTs) is to achieve a good balance between tablet hardness and disintegration time. In this study, an advanced method was demonstrated to improve these opposing properties in a molded tablet using a one-step procedure that exploits the swelling induced by microwave treatment. Wet molded tablets consisting of the delta form of mannitol and silicon dioxide were prepared and microwave-heated to generate water vapor inside the tablets. This induced either swelling or shrinking of tablets, in the extent of each being dependent on tablet formulation and manufacturing conditions. A two-level full factorial design method was used to evaluate the effects of several variables in formulation and manufacturing conditions on the tablet properties, hardness, disintegration time and change in shape. The variables investigated in this study were: ratio of silicon dioxide in formulation, water volume added in granulation, ratio of water absorbed by silicon dioxide prior to granulation, and microwave irradiation time. Swelling of tablet by microwave irradiation was observed in the batches with high ratio of silicon dioxide and low levels of water volume. The disintegration time was clearly shortened by induction of the swelling, while tablet hardness increased. We demonstrated that the water vapor generated by microwave irradiation promoted a change in the crystalline form of mannitol from delta to beta, and that this may have contributed to an increase in tablet hardness. Additionally, it was found that new solid bridges were formed between the granules in the tablet via the pathway from dissolution of mannitol in water vapor to congelation, resulting in an increase in tablet hardness. Thus, both tablet hardness and disintegration properties of the molded tablets were improved by the proposed one-step method and the appropriate ranges for variables are indicated. In addition, multiple regression modeling was

  11. Effect of combined oral contraceptives on glycosylated haemoglobin.

    PubMed Central

    Oakley, N; Rostron, W

    1982-01-01

    Glycosylated haemoglobin (HbA), was measured in 164 Caucasian women aged 20-40 years who were using: (1) barrier contraceptive methods; (2) contraceptive pills with 30 micrograms ethinyloestradiol and 150 micrograms laevo-norgestrel; (3) contraceptive pills with 30-35 micrograms ethinyloestradiol and 0.5-1 mg norethisterone. Mean +/- 1 s.d. values for the three groups were 7.64 +/- 0.69, 7.56 +/- 0.56 and 7.27 +/- 0.74 respectively. Groups (1) and (2) did not differ significantly from one another but the mean value for group (3) was significantly lower than for the other groups (P less than 0.01). Age, percentage ideal body weight and smoking did not influence HbA, but the value was higher for parous than for nulliparous women (P = 0.02). These findings can be explained in terms of the known effects of oestrogens and progestogens on fasting blood glucose. PMID:7069693

  12. Combining oral contraceptives with a natural nuclear factor-kappa B inhibitor for the treatment of endometriosis-related pain

    PubMed Central

    Maia, Hugo; Haddad, Clarice; Casoy, Julio

    2014-01-01

    Endometriosis is a chronic disease in which a persistent state of heightened inflammation is maintained by nuclear factor-kappa B (NF-κB) activation. The progestins present in oral contraceptives are potent inhibitors of NF-κB translocation to cell nuclei, while Pycnogenol® (Pinus pinaster) acts by blocking post-translational events. In this study, the effects of Pycnogenol on pain scores were investigated in patients with endometriosis using oral contraceptives containing either gestodene or drospirenone in extended regimens. Pain scores were determined using a visual analog scale before and after 3 months of treatment. Oral contraceptives, used alone (groups 1 and 3) or in association with Pycnogenol (groups 2 and 4), resulted in significant decreases in pain scores after 3 months of treatment; however, this reduction was significantly greater in the groups using oral contraceptives + Pycnogenol (groups 2 and 4) compared with those using oral contraceptives alone (groups 1 and 3). In the groups using oral contraceptives alone, 50% of patients became pain-free by the end of the third month of treatment. These results suggest that Pycnogenol increases the efficacy of oral contraceptives for the treatment of endometriosis-related pain. PMID:24379702

  13. Examining the role of oral contraceptive users as an experimental and/or control group in athletic performance studies.

    PubMed

    Elliott-Sale, Kirsty Jayne; Smith, Stephanie; Bacon, James; Clayton, David; McPhilimey, Martin; Goutianos, Georgios; Hampson, Jennifer; Sale, Craig

    2013-09-01

    This study was conducted to examine the effect of oral contraceptives on endogenous reproductive hormone levels in order to assess the suitability of oral contraceptive users as experimental and/or control groups in human performance studies. Ninety-five females who were taking a variety of oral contraceptives (2 types and 11 brands) were recruited. A single blood sample was analysed for endogenous concentrations of oestradiol and progesterone. There were significant differences (p<.05) in circulating oestradiol and progesterone as a result of oral contraceptive type and brand. Overall, oral contraceptive use resulted in low levels of oestradiol and progesterone and large variation in hormone concentration when multiple brands were analysed together. This study indicates that future studies should employ a single pill type and brand when using oral contraceptive users as either a control or experimental group and that comparison between oral contraceptive users as a control group and the early follicular phase of the menstrual cycle as an experimental group should be reconsidered. Copyright © 2013 Elsevier Inc. All rights reserved.

  14. A case-control study of oral contraceptive use and invasive epithelial ovarian cancer.

    PubMed

    Rosenberg, L; Palmer, J R; Zauber, A G; Warshauer, M E; Lewis, J L; Strom, B L; Harlap, S; Shapiro, S

    1994-04-01

    The relation of oral contraceptive use to the risk of ovarian cancer was assessed with data collected during 1977-1991 from patients under 65 years of age in hospitals in Boston, New York, Philadelphia, and Baltimore. We compared 441 women with recently diagnosed invasive epithelial ovarian cancer to 2,065 control women. Logistic regression was used to control risk factors for ovarian cancer. The multivariate relative risk estimate decreased with the increasing duration of oral contraceptive use (p < 0.05): the estimate was close to 1.0 for duration categories of less than 3 years; it was reduced for the categories of 3-4 years of use and greater, but it did not decline further as the duration of use increased. For > or = 3 years of use, the estimate was 0.6 (95% confidence interval 0.4-0.8). The inverse association of risk with > or = 3 years of use was consistently present across categories of age, parity, interview year, and geographic area. It was apparent for as long as 15-19 years after cessation. Many different specific oral contraceptive formulations appeared related to a decreased risk; however, data were sparse for the newer types, particularly phasic preparations, and the ability to assess specific preparations in the context of use of multiple preparations was limited. The present data confirm previous reports of an inverse association of ovarian cancer risk with oral contraceptive use of several years in duration. They also suggest that the association may persist for as long as two decades and that it is not confined to any particular type of oral contraceptive formulation.

  15. The risks of venous thromboembolic disease among German women using oral contraceptives: a database study.

    PubMed

    Farmer, R D; Todd, J C; Lewis, M A; MacRae, K D; Williams, T J

    1998-02-01

    This study investigated the risk of venous thromboembolic disease (VTE) between second and third generation combined oral contraceptives, using the German MediPlus database of patient records. Women studied included 42 patients between the ages of 18 and 49 years, with a diagnosis of VTE treated with an anticoagulant, who were exposed to an oral contraceptive (OC). Four controls per patient (168), matched by year of birth and exposure to an OC on the even day, were identified. More women were users of second generation than third generation OC, and none were using progestogen-only pills. There was no significant difference between patients and control subjects with respect to the type of OC used on the event day (unadjusted odds ratio for third versus second generation users was 0.77; 95% confidence interval [CI] 0.38-1.57). There was no significant age difference between second and third generation users among patients or control subjects. Between January 1 and the event date, there was no significant difference between the patients and control subjects in terms of the number of oral contraceptive prescriptions, number of consultations for psychotherapeutic complaints, or mixed physical and psychotherapeutic consultations; however, patients did demonstrate significantly more consultations for purely physical complaints compared with control subjects (p < 0.0001). There were no significant consultation differences between patients with pulmonary emboli (n = 6) and other VTE patients (n = 36). No significant differences with respect to VTE risk between users of second and third generation oral contraceptives were found in this study. Consultations (physical) for patients were higher than for control subjects before the VTE event. If consultation rate relates to the general health status of a person, this might indicate that VTE risk is higher among women of poorer health, but that this is not related to the type of progestogen in the oral contraceptive that they use.

  16. Evaluating the practice of Iranian community pharmacists regarding oral contraceptive pills using simulated patients

    PubMed Central

    Foroutan, Nazanin; Dabaghzadeh, Fatemeh

    2016-01-01

    Background: As oral contraceptive pills are available over the counter in pharmacies, pharmacists are professionally responsible for checking and informing patients about every aspect of taking these drugs. Simulated patient method is a new and robust way to evaluate professional performance of pharmacists. Objective: The aim of the present study was to evaluate the pharmacy practice of Iranian pharmacists regarding over-the-counter use of oral contraceptive pills using simulated patient method. Methods: Simulated patients visited pharmacy with a prescription containing ciprofloxacin and asked for oral contraceptive pills. The pharmacist was expected to ask important questions for using these drugs and to inform the patient about them properly. Moreover, the Pharmacists should advise patients in regard to the possible interaction. Results: Ninety four pharmacists participated in this study. In 24 (25.3%) visits, the liable pharmacist was not present at the time of purchase. Furthermore, In 13 (18.57 %) visits by the simulated patients, the liable pharmacists did not pay any attention to the simulated patients even when they asked for consultation. Twenty nine (41.43%) pharmacists did not ask any question during dispensing. Nausea was the most frequent described side effect by pharmacists (27 (38.57%)). Yet important adverse effects of oral contraceptive pills were not mentioned by the pharmacists except for few ones. Only twelve (17.14%) pharmacists mentioned the possible interaction. There was a significant relation between the pharmacists’ gender and detection of possible interaction (p value= 0.048). Conclusion: The quality of the pharmacists’ consultations regarding the over the counter use of oral contraceptive pills was not satisfactory and required improvement. PMID:28042350

  17. 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.

  18. 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

  19. Pharmacokinetics of Oral Combination Contraceptive Drugs Containing Ethinyl Estradiol and Levonorgestrel in Healthy Female Chinese Volunteers.

    PubMed

    Xin, X; Wu, Y; Liu, X; Sun, C; Geng, T; Ding, L

    2016-02-01

    A new combination contraceptive tablet containing 0.02 mg ethinyl estradiol (EE) and 0.10 mg levonorgestrel (LNG) with potential advantages has been developed in China. This study was aimed to describe the pharmacokinetic characteristics of this new combination contraceptive tablet in female Chinese volunteers. This study was designed as phase I, open-label, and one-sequence clinical trial. 12 healthy nonpregnant female Chinese volunteers received a single dose (1 tablet) and multiple dose (1 tablet per day) administration for 21 consecutive days under fasting condition. Blood samples were analyzed with 2 validated LC-MS/MS methods for EE and LNG, respectively. After the single dose administration, the C max of EE and LNG were 44.76±18.64 pg/mL and 2.256±1.008 ng/mL, respectively. The steady-state condition of EE was achieved on the 6(th) day after the beginning of the multiple dose administration, while the steady-state condition of LNG was achieved on the 21(st) day. For EE, the mean MRT 0-72 and t 1/2 increased by 40.2 and 30.6%, meanwhile the mean Cl/F and Vd/F decreased by 18.5 and 29.1%, respectively from Day 1 to Day 24. For LNG, the mean MRT 0-72 increased by 27.1%, while the mean Cl/F and Vd/F decreased by 62.4 and 86.3%, respectively from Day 1 to Day 24. The t 1/2 remained unchanged for LNG. The exposure of LNG significantly increased with repeated dosing, but that of EE just slightly increased. © Georg Thieme Verlag KG Stuttgart · New York.

  20. Efficacy of oral powder compared with chewable tablets for lanthanum carbonate administration in hemodialysis patients.

    PubMed

    Sakurada, Tsutomu; Oishi, Daisuke; Shibagaki, Yugo; Yasuda, Takashi; Kimura, Kenjiro

    2013-10-01

    Lanthanum carbonate (LC) has been administered in a chewable tablet form for patients with hyperphosphatemia undergoing dialysis. However, some patients have difficulty chewing the tablets. LC oral powder has recently been released in Japan. The purpose of this study was to clarify the efficacy of LC oral powder form compared with that of chewable tablet form. The efficacy and safety of LC oral powder was retrospectively assessed in hemodialysis patients who switched from chewable tablet form to oral powder form without dose modification. Thirty-six patients (mean age, 66.8 ± 10.5 years; male, 64%; 39% with diabetes; mean duration of dialysis treatment, 99.2 ± 95.6 months) were enrolled in this study between June and July of 2012. Changes in clinical data and adverse events after the switch to oral powder form were investigated. The average dose of LC was 1180 ± 520 mg/day. Serum phosphorus levels were significantly decreased after the switch from chewable tablet form to oral powder form (5.3 ± 1.7 mg/dL at baseline vs. 4.9 ± 1.2 mg/dL at after 1 month after, P = 0.038). In contrast, no significant differences were observed in serum calcium and parathyroid hormone levels. Furthermore, no significant differences were evident in weight gain after the switch to oral powder form (2.5 ± 1.2 kg at baseline vs. 2.4 ± 1.1 kg at 1 month after the switch, P = 0.29). No serious adverse events were recorded. Our results suggest that LC is more effective in oral powder form than chewable tablet form for hemodialysis patients.

  1. Oral Disintegration Tablets of Stavudine for HIV Management: A New Technological Approach.

    PubMed

    Sankar, V; Ramakrishna, B; Devi, P Shalini; Karthik, S

    2012-11-01

    Stavudine oral disintegration tablets were formulated to minimize the bitter taste and to reduce the first-pass hepatic metabolism. The various precompression parameters like the angle of repose, bulk density, compressibility index and Hausner's ratio were determined for the powder blend. In this study, 14 formulations of stavudine oral disintegration tablet were prepared by direct compression method. The tablets were evaluated for weight variation, percentage friability, disintegration time, hardness, wetting time and water absorption ratio. The in vitro dissolution study results of the batch S1 (stavudine+crospovidone+sodium starch glycollate) are encouraging as highest dissolution rate (99.2% in 100 min) and lowest time of disintegration (56 s) was achieved. The in vivo drug release studies were carried out in rabbits and the relative bioavailability of formulation S1 was found to be 2.83 times greater than that of conventional tablets.

  2. Oral contraception in women with mild thrombophilia: what have we learned recently?

    PubMed

    Blanco-Molina, Ángeles

    2012-10-01

    Mild thrombophilias include heterozygous forms of Factor V Leiden and prothrombin G20210A mutation and high levels of factor VIII. These defects are responsible for only a moderate increase of venous thromboembolism (VTE) risk compared with strong thrombophilias (antithrombin III, protein C and protein S deficiencies and homozygous forms of factor V Leiden and G20210A prothrombin mutation). Combined oral contraceptives increase the VTE risk in women in a fertile age, and in a far more important way in thrombophilia carrier women. Universal screening of thrombophilia test before the use of combined oral contraceptives is not recommended. However, selective VTE-history based screening is associated with a better cost-effectiveness, especially in asymptomatic relatives of carriers of strong thrombophilia. Currently, combined oral contraceptives are discouraged in women with any thrombophilic defects. The VTE risk is higher during pregnancy and postpartum period compared to hormonal contraceptive use period in women with mil thrombophilia. For this reason, a careful election of an alternative birth control method is necessary in these women.

  3. Orally disintegrating films and mini-tablets-innovative dosage forms of choice for pediatric use.

    PubMed

    Preis, Maren

    2015-04-01

    Oral drug delivery is a non-invasive and therefore a very convenient route of administration. Orally disintegrating dosage forms, like soluble films and (mini-)tablets, appear promising for use in the pediatric population. New guidance for the development of pediatric medicines has been published, which provides considerations on how pediatric products should be designed. However, most of the considerations leave a lot of room for interpretations. Bearing in mind the different aspects discussed in the latest guideline, the use of orally disintegrating films and tablets, in particular, small-sized tablets, is discussed and reflected upon by providing evidence from the scientific literature. The available dosage forms for children are various and examples of currently licensed products for use in the pediatric population were compiled. Aspects such as the appropriateness for pediatrics, the choice of excipients, the opportunities for modified drug release preparations or fixed-dose combinations, the acceptability and palatability, and also limitations were discussed with respect to the new dosage forms of orally disintegrating films and mini-tablets. This paper points out that innovation in pediatric medicines are planned and should be encouraged; however, supported by the regulatory guidance, only general considerations are provided. Nevertheless, the guideline summarizes multiple points to consider during the development of medicines for pediatric use. Considering the scientific evidence and the regulatory guidance, orally disintegrating dosage forms, like soluble films and (mini-)tablets, offer an innovative solution for pediatric drug delivery.

  4. Evaluation of disintegration properties of orally rapidly disintegrating tablets using a novel disintegration tester.

    PubMed

    Kondo, Keita; Niwa, Toshiyuki; Danjo, Kazumi

    2012-01-01

    This report describes a new disintegration tester that can determine not only the disintegration time of orally rapidly disintegrating tablets (ODT), but also the disintegration behavior and mechanism. Using the tester, the disintegration properties of the tablets prepared in a previous study were examined. The purpose of this study is to confirm the utility of the tester as an instrument for evaluating the disintegration properties of ODT and determine relations among time, behavior and mechanism of the disintegration. Results demonstrated that in vitro disintegration time in the tester is similar to that in the commercial disintegration tester for ODT and is highly correlated with oral disintegration time. Observations of disintegration process revealed that a difference in disintegration behavior between tablets compressed at 50-75 MPa and 100 MPa; the disintegration behavior of the tablets were designated immediate disintegrating type and gradual disintegrating type, respectively. The dynamic swelling profile and water absorption profile indicated that the disintegration mechanism of the tablets involved wicking action induced by swelling of the disintegrant; the disintegration time was closely related to the initial rates of swelling and water absorption. Furthermore, the mechanism of water absorption of tablets compressed at 50-75 MPa and 100 MPa shows anomalous diffusion and case-II transport, respectively. The shift in this mechanism is consistent with differences in disintegration time and behavior between the tablets. These findings suggest that information on disintegration properties obtained by our tester is useful for understanding of disintegration phenomena of ODT.

  5. A single-arm study to evaluate the efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel.

    PubMed

    Taylor, Douglas J; Lendvay, Anja; Halpern, Vera; Bahamondes, Luis G; Fine, Paul M; Ginde, Savita Y; Wheeless, Angie; Raymond, Elizabeth G

    2014-03-01

    An oral dose of 0.75 mg levonorgestrel (LNG) taken shortly after sex was marketed as a routine, nonemergency contraceptive method until the 1990s. Because a hormonal method used only at the time of intercourse may be desirable for women who have infrequent sex, we conducted a study to reevaluate the potential of pericoital LNG as a primary means of contraception. We enrolled women aged 18-45 years in Brazil and the USA who expected to have sex 1-4 days per month for 6.5 months. Participants were instructed to take one tablet 0.75 mg LNG within 24 h before or after sex, with no more than one dose in any 24-h period. The primary efficacy measure was the Pearl Index among women aged 18-35 years. The study was stopped after 72 of the planned 300 participants were enrolled due to slow recruitment and related feasibility considerations. In the primary analysis, three pregnancies occurred during 13.4 woman-years of follow-up, resulting in a Pearl Index of 22.4 (95% confidence interval, 4.6-65.4). No serious adverse events were reported, and vaginal bleeding patterns were generally acceptable. Our estimated Pearl Index was noticeably higher than expected from previous research of LNG for pericoital contraception. Although the regimen was safe and generally acceptable, the study was challenged by slow enrollment and curtailed person-years of follow-up, resulting in poor precision for the estimated treatment effect. Future research may inform whether our results are symptomatic of the regimen, study design or characteristics of the populations from which we recruited. Our study failed to confirm prior data suggesting that 0.75 mg LNG for pericoital contraception could be more effective than typical use of barrier methods among women having infrequent sex. Characterizing populations most likely to adhere to, and benefit from, pericoital regimens is essential to future research on these methods. Copyright © 2014 Elsevier Inc. All rights reserved.

  6. Effect of powder characteristics on oral tablet disintegration.

    PubMed

    Yamamoto, Yoshihisa; Fujii, Makiko; Watanabe, Ken-ichi; Tsukamoto, Masashi; Shibata, Yusuke; Kondoh, Masuo; Watanabe, Yoshiteru

    2009-01-05

    This report describes an investigation of the factors affecting disintegration time in the mouth (DTM) of rapidly disintegrating tablets. The relation between DTM and stationary time of upper punch displacement (STP) was examined using a tableting process analyzer (TabAll). Results indicated that the bulk density of mixed excipient powder used for tablet preparation affects both DTM and STP. As the value of bulk density increased, STP became longer and DTM shorter. The results of a combination of granules and powder with or without a drug showed liner relation between apparent volume (reciprocal of bulk density) and DTM (r(2)=0.7332). For a DTM less than 60 s, a formulation with a bulk density greater 0.5 g/mL should be chosen with a compression force of 5 kN. The hardness of tablets could be greater than 3 kg if at least one high-compressibility excipient was used in the formulation.

  7. Cancer incidence attributable to the use of oral contraceptives and hormone therapy in Alberta in 2012

    PubMed Central

    Grevers, Xin; Grundy, Anne; Poirier, Abbey E.; Khandwala, Farah; Feldman, Matthew; Friedenreich, Christine M.; Brenner, Darren R.

    2016-01-01

    Background: Hormonal contraceptives and hormone replacement therapies are classified as carcinogenic to humans (group 1) by the International Agency for Research on Cancer. We sought to estimate the proportion and total number of cancers attributable to the use of oral contraceptives and hormone therapy in Alberta in 2012. Methods: Population attributable risks were used to estimate the proportion of attributable cases for each associated cancer site. Relative risk estimates were obtained from the most relevant and recent epidemiologic literature. Prevalences of the use of oral contraceptives and hormone therapy in Alberta were collected from Alberta's Tomorrow Project. Specific cancer incidence data were obtained from the Alberta Cancer Registry for the year 2012. Results: Overall, 6.3% of breast cancers (n = 135) diagnosed in Alberta in 2012 were estimated to be attributable to the use of oral contraceptives, and the exposure potentially prevented about 57.3% of endometrial cancers (n = 276) and 29.1% of ovarian cancers (n = 52). About 15.5% of breast cancers (n = 258) and 8.9% of ovarian cancers (n = 13) were estimated to be attributable to the use of hormone therapy, whereas 11.3% of endometrial cancers (n = 48) were possibly prevented by the exposure. Interpretation: Based on our estimates, oral contraceptive use resulted in a net protective effect among the cancer sites studied, thus reducing the cancer burden in Alberta in 2012. The use of hormone therapy was estimated to increase the cancer burden in the province, therefore the risk and benefit of hormone therapy should be carefully considered before use. PMID:28018891

  8. Danger signals and the combined oral contraceptive pill.

    PubMed

    Williams, H

    1999-12-01

    The COCP is a safe form of contraception for the majority of women. The challenge is to identify the women who have risk factors that make the use of COCP less safe. This approach is summarised by a recent consensus statement from an international conference on evidence based prescribing of COCPs. This states that 'current evidence suggests only two prerequisites for the safe provision of COCPs: a careful personal and family medical history with particular attention to cardiovascular risk factors, and an accurate blood pressure measurement'.

  9. Influence of Menstrual Cycle and Oral Contraceptive Phase on Spinal Excitability

    PubMed Central

    Casey, Ellen; Reese, Maria; Okafor, Ezi; Chun, Danielle; Gagnon, Christine; Nigl, Franz; Dhaher, Yasin Y.

    2016-01-01

    Background Rates of musculoskeletal injury differ substantially between the genders, with females more likely to experience conditions such as anterior cruciate ligament (ACL) injuries than males in the same sports. Emerging evidence suggests a significant hormonal contribution. Most research has focused solely on how hormonal fluctuations affect connective tissue, but a direct link between hormonal shifts, ligamentous laxity, and ACL injury has not been borne out. There is also evidence to suggest that sex hormones can modulate the central nervous system, but how this affects neuromuscular control is not well understood. Objective To determine whether changes in sex hormone concentrations would alter spinal excitability, measured across the menstrual and oral contraceptive pill cycle. We hypothesized that spinal excitability would fluctuate across the menstrual cycle (with increased excitability during the periovulatory phase due to peak estradiol concentration), but that there would be no fluctuation in oral contraceptive users. Design This was a prospective cohort study. Setting The study took place at a biomechanics laboratory at a rehabilitation hospital. Participants A total of 30 healthy women aged 18–35 who were similar in age, body composition, and exercise-training status were included. Fifteen of the women were eumenorrheic and nonusers of oral contraceptives (nonusers), and 15 of the women were taking oral contraceptives (users). Main Outcome Measures H-reflex (Hmax/Mmax ratio), serum estradiol, and progesterone concentrations were measured at 3 time points during the menstrual and contraceptive pill cycle. Results The H-reflex (Hmax/Mmax ratio) remained stable across the menstrual and contraceptive pill cycle. Spinal excitability was lower in the users compared with the nonusers across all testing sessions, but this was not statistically significant. Conclusions Our results suggest that acute fluctuations of endogenous estradiol and progesterone do

  10. Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data.

    PubMed

    Jick, Susan S; Hernandez, Rohini K

    2011-04-21

    To compare the risk of non-fatal venous thromboembolism in women receiving oral contraceptives containing drospirenone with that in women receiving oral contraceptives containing levonorgestrel. Nested case-control and cohort study. The study was based on information from PharMetrics, a United States based company that collects information on claims paid by managed care plans. The study encompassed all women aged 15 to 44 years who received an oral contraceptive containing either drospirenone or levonorgestrel after 1 January 2002. Cases were women with current use of a study oral contraceptive and a diagnosis of venous thromboembolism in the absence of identifiable clinical risk factors (idiopathic venous thromboembolism). Up to four controls were matched to each case by age and calendar time. Odds ratios comparing the risk of non-fatal venous thromboembolism in users of the two contraceptives; incidence rates and rate ratios of non-fatal venous thromboembolism for users of each of the study contraceptives. 186 newly diagnosed, idiopathic cases of venous thromboembolism were identified in the study population and matched with 681 controls. In the case-control analysis, the conditional odds ratio for venous thromboembolism comparing use of oral contraceptives containing drospirenone with use of those containing levonorgestrel was 2.3 (95% confidence interval 1.6 to 3.2). The incidence rates for venous thromboembolism in the study population were 30.8 (95% confidence interval 25.6 to 36.8) per 100,000 woman years among users of oral contraceptives containing drospirenone and 12.5 (9.61 to 15.9) per 100,000 woman years among users of oral contraceptives containing levonorgestrel. The age adjusted incidence rate ratio for venous thromboembolism for current use of oral contraceptives containing drospirenone compared with those containing levonorgestrel was 2.8 (2.1 to 3.8). The risk of non-fatal venous thromboembolism among users of oral contraceptives containing

  11. Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data

    PubMed Central

    Hernandez, Rohini K

    2011-01-01

    Objective To compare the risk of non-fatal venous thromboembolism in women receiving oral contraceptives containing drospirenone with that in women receiving oral contraceptives containing levonorgestrel. Design Nested case-control and cohort study. Setting The study was based on information from PharMetrics, a United States based company that collects information on claims paid by managed care plans. Participants The study encompassed all women aged 15 to 44 years who received an oral contraceptive containing either drospirenone or levonorgestrel after 1 January 2002. Cases were women with current use of a study oral contraceptive and a diagnosis of venous thromboembolism in the absence of identifiable clinical risk factors (idiopathic venous thromboembolism). Up to four controls were matched to each case by age and calendar time. Main outcome measures Odds ratios comparing the risk of non-fatal venous thromboembolism in users of the two contraceptives; incidence rates and rate ratios of non-fatal venous thromboembolism for users of each of the study contraceptives. Results 186 newly diagnosed, idiopathic cases of venous thromboembolism were identified in the study population and matched with 681 controls. In the case-control analysis, the conditional odds ratio for venous thromboembolism comparing use of oral contraceptives containing drospirenone with use of those containing levonorgestrel was 2.3 (95% confidence interval 1.6 to 3.2). The incidence rates for venous thromboembolism in the study population were 30.8 (95% confidence interval 25.6 to 36.8) per 100 000 woman years among users of oral contraceptives containing drospirenone and 12.5 (9.61 to 15.9) per 100 000 woman years among users of oral contraceptives containing levonorgestrel. The age adjusted incidence rate ratio for venous thromboembolism for current use of oral contraceptives containing drospirenone compared with those containing levonorgestrel was 2.8 (2.1 to 3.8). Conclusions The risk of

  12. The association between current low-dose oral contraceptive pills and periodontal health: a matched-case-control study.

    PubMed

    Haerian-Ardakani, Ahmad; Moeintaghavi, Amir; Talebi-Ardakani, Mahammadreza Reza; Sohrabi, Keyvan; Bahmani, Shahin; Dargahi, Maede

    2010-05-01

    This study assessed the influence of current oral contraceptive pills on periodontal health in young females. Seventy women ranging in age from 17 to 35 years (mean 24 years) had a comprehensive periodontal examination. Their current and previous oral contraceptive pill use was assessed by a questionnaire. A periodontal assessment was performed that included recording the following: plaque index, gingival index, probing depth, and attachment level at six sites per tooth. The periodontal health of women taking birth control pills for at least two years was compared to that of women not taking an oral contraceptive. The control and test groups were matched for socioeconomic status, age, oral habits, occupation, and educational levels. Although there was no difference in plaque index levels between the two groups, current oral contraceptive pill users had higher levels of gingival inflammation and bleeding on probing. However, no significant differences were found regarding mean probing depths and attachment loss between the two groups. As birth control policies are advocated by most countries, and because oral contraceptives are the most widely used method for birth control, a need exists to assess the effects of oral contraceptives on the periodontal health of young women. Although additional studies are needed to better understand the mechanism of OC-induced gingivitis, female patients should be informed of the oral and periodontal side effects of OCs and the need for meticulous home care and compliance with periodontal maintenance.

  13. Survey of knowledge and practice on oral contraceptive and emergency contraceptive pills of drugstore personnel in Hat Yai, Thailand.

    PubMed

    Ratanajamit, C; Chongsuvivatwong, V

    2001-01-01

    In Thailand, oral contraceptive (OC) and emergency contraceptive pill (ECP) are available as over-the-counter (OTC) drugs, and drugstores share 30% of services. While the rate of dispensing contraceptive pills has increased, the knowledge and awareness of ECP use is limited among users and providers. The objective of this study was to assess knowledge and practice of drugstore personnel on providing OC and ECP, in order to improve the quality of services. Drugstores located in Hat Yai District, Songkhla Province, Southern Thailand, were the accessible population. There were 109 drugstores, half of them owned by pharmacists. The population was stratified by owner (pharmacist or non-pharmacist) and randomly selected to obtain a sample size of 30 drugstores for each class. Two study methods, questionnaire interview and secret shopping, were used to measure knowledge, and practice, respectively. History-taking, drug-choosing, and advice-giving were the domains measured. The results demonstrated that knowledge on OC was fair, but that on ECP was poor. Pharmacists had better knowledge of proper history taking and ECP indication than non-pharmacists. OC and ECP provision were inappropriately practised in drugstores in the study area. A majority of drugstores were mainly owned by non-pharmacists. For OC practice, drug-choosing was good, but history-taking and advice-giving were poor in both groups. Although both groups dispensed ECP poorly, pharmacists dispensed significantly better than non-pharmacists. Among non-pharmacist staff, the average scores of OC advice-giving, and ECP dispensing, were statistically significantly better among those working in pharmacist-owned drugstores. Both knowledge and practice on OC and ECP should be improved in both types of drugstores in the study area.

  14. 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.

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

    PubMed Central

    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

  16. The evolution of combined oral contraception: improving the risk-to-benefit ratio.

    PubMed

    Burkman, Ronald; Bell, Carrie; Serfaty, David

    2011-07-01

    Since its introduction in 1960, the combined oral contraceptive (COC) pill has become one of the most widely and frequently used methods of contraception worldwide. Although highly effective, early COC formulations were associated with significant adverse effects and unacceptable cardiovascular risk. Improvements in tolerability and safety have been achieved, without compromises in effectiveness, primarily via hormone dosage reductions and the development of several new progestins. Multiphasic COCs and extended-/continuous-cycle COCs have also been introduced, although the clinical advantages of these formulations vs. traditional COCs have yet to be established. Inclusion of natural estrogens such as estradiol valerate and 17β-estradiol with selective progestins in new combinations that maintain good cycle control is the most recent evolutionary step designed to improve COC tolerability and safety. Vigorous research needs to continue to help guarantee that the unmet need for safe and effective contraception is satisfied in future generations.

  17. Pharmacokinetics of desmopressin administered as tablet and oral lyophilisate formulation in children with monosymptomatic nocturnal enuresis.

    PubMed

    De Bruyne, Pauline; De Guchtenaere, Ann; Van Herzeele, Charlotte; Raes, Ann; Dehoorne, Jo; Hoebeke, Piet; Van Laecke, Erik; Vande Walle, Johan

    2014-02-01

    Desmopressin 120 μg oral lyophilisate and 200 μg tablet are considered bioequivalent, based on extrapolation of studies in a limited number of adults and on one dose-finding study of desmopressin oral lyophilisate in children. However, no comparative pharmacokinetic study in children was executed confirming this statement. No data are available on the influence of food intake on the bioavailability of desmopressin tablet in a pediatric setting, although studies in adults have documented that food intake results in a significantly lower desmopressin plasma concentration. In this study, we analyzed plasma concentrations of desmopressin oral lyophilisate and tablet with concomitant food intake. Twenty-three children with monosymptomatic nocturnal enuresis (mean age, 12.7 years) were recruited. Two tests were performed on two separate days in identical conditions with a standardized food and fluid intake. Desmopressin was administered as desmopressin tablet or desmopressin oral lyophilisate immediately after a meal. Desmopressin plasma concentration was measured at 1 h, 2 h, and 6 h postdosing. No significant difference in plasma concentration of 120 μg desmopressin oral lyophilisate and 200 μg tablet was demonstrated, even with concomitant food intake. A significant difference in variability was found, identifying a smaller variance for desmopressin oral lyophilisate plasma concentrations at all time points. This study demonstrates comparable plasma levels for desmopressin oral lyophilisate, despite the lower dose. The dosage for desmopressin oral lyophilisate is more predictable due to the significantly smaller variance. Therefore, desmopressin oral lyophilisate seems more suitable, especially in the younger age group for which time interval between dinner and drug administration is limited.

  18. A survey of bonobo (Pan paniscus) oral contraceptive pill use in North American zoos.

    PubMed

    Agnew, Mary K; Asa, Cheryl S; Clyde, Victoria L; Keller, Dominique L; Meinelt, Audra

    2016-09-01

    Contraception is an essential tool in reproductive management of captive species. The Association of Zoos and Aquariums (AZA) Reproductive Management Center (RMC) gathers data on contraception use and provides recommendations. Although apes have been given oral contraceptive pills (OCPs) for at least 30 years, there have been no published reports with basic information on why the pill is administered, formulations and brands used, and effects on physiology and behavior. Here, we report survey results characterizing OCP use in bonobos (Pan paniscus) housed in North American zoos, as well as information accumulated in the RMC's Contraception Database. Of 26 females treated, there have been no failures and nine reversals. The most commonly administered OCP formulation in bonobos contained ethinyl estradiol (EE) 35 μg/norethindrone 1 mg. Few females on combined oral contraceptives (COCs) were given a continuous active pill regimen; a hormone-free interval of at least 5 days was allowed in most. Crushing the pill and mixing with juice or food was common. Females on COCs seldom experienced breakthrough estrus or bleeding, while these conditions were sometimes observed for females on continuous COCs. All females on COCs exhibited some degree of perineal swelling, with a mean score of 3 or 3+ most commonly reported. Behavioral changes included less sexual behavior, dominant females becoming subordinate, and a negative effect on mood. No appreciable change in weight was noted. Taken together, these results indicate that OCPs are an effective and reversible contraceptive option for bonobos that can be used by zoos and sanctuaries to limit reproduction. Zoo Biol. 35:444-453, 2016. © Wiley Periodicals, Inc.

  19. 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…

  20. 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…

  1. Bioequivalence assessment of ambroxol orally-disintegrating tablet after a single oral-dose administration to healthy volunteers.

    PubMed

    Ni, Yaojun; Hou, Lili; Chen, Liang; Fan, Jiang

    2016-05-01

    In this study, a modified LC-MS/MS method was used to determine plasma ambroxol concentration and thereby examine the bioequivalence of two ambroxol medications among healthy Chinese male volunteers. The study used a single-dose, randomized, open-label design principle and calculated pharmacokinetic parameters for the comparison of the two formulations. Administration of a single oral dose of either the test drug or reference drug was found to be safe in healthy subjects. No severe, serious, or life-threatening clinical or drug-related side effects were reported during the study. The majority of clinical laboratory test results were within the normal range or not clinically significant. The pharmacokinetic parameters for ambroxol oral tablets and ambroxol orally disintegrating tablets were comparable. For the comparison of the two formulations, the 90% confidence intervals for the log-transformed pharmacokinetic parameters (Cmax, AUC0-t, and AUC0-inf) fell within the bioequivalence< acceptance criteria (80-125%). The ambroxol oral tablets were bioequivalent to ambroxol orally-disintegrating tablets in healthy human adult male volunteers, under fasting conditions.

  2. Preparation and evaluation of orally rapidly disintegrating tablets containing taste-masked particles using one-step dry-coated tablets technology.

    PubMed

    Kondo, Keita; Niwa, Toshiyuki; Ozeki, Yuichi; Ando, Masaki; Danjo, Kazumi

    2011-01-01

    In this study, in order to address the problems with manufacturing orally rapidly disintegrating tablets (ODT) containing functional (taste masking or controlled release) coated particles, such as the low compactability of coated particles and the rupture of coated membrane during compression, a novel ODT containing taste-masked coated particles (TMP) in the center of the tablets were prepared using one-step dry-coated tablets (OSDrC) technology. As a reference, physical-mixture tablets (PM) were prepared by a conventional tableting method, and the properties of the tablets and the effect of compression on the characteristics of TMP were evaluated. OSDrC was found to have higher tensile strength and far lower friability than PM, but the oral disintegration time of OSDrC is slightly longer than that of PM following high compression pressure. Consequently, OSDrC approaches the target tablet properties of ODT, whereas PM does not. The deformation of TMP in OSDrC due to compression is slight, and the release rate of acetaminophen (AAP) from OSDrC is the same as from TMP. However, TMP on the surface of PM are considerably deformed, and the release rate of AAP from PM is faster than from TMP. These findings suggest that OSDrC technology is a useful approach for preparing ODT containing functional coated particles. Furthermore, we demonstrate that the elastic recovery of tablets can affect differences in the properties of OSDrC, PM and placebo tablets (PC).

  3. Beliefs related to the use of oral contraceptives by African American women, ages 18-35.

    PubMed

    Libbus, K; Arps, C A

    1997-01-01

    This study looked at modal, salient beliefs regarding intention to use and use of oral contraceptives (OC) in a group of African American women aged 18-35 in a midwest urban community. Data were collected in face-to-face audio taped interviews using a format devised by Ajzen and Fishbein. Questions related to the identified behavior of deliberate action to avoid unwanted pregnancy by instituting the use of a contraceptive method. Twenty-five women consented to participate. Of these, 20 women (80%) reported using oral contraceptives as their primary birth control method. The study reports on women's perceptions of the advantages and disadvantages of OC acquisition and use and important social referents approving or disapproving of OC acquisition and use. Perceived barriers and facilitators to OC acquisition and use are also reported. Identification of individual and group attitudes regarding contraceptive behavior may be valuable in enhancing the provision of successful family planning services to women wishing to avoid delay of childbearing.

  4. 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

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

    PubMed

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

    2008-12-07

    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.

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

    PubMed Central

    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

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

    PubMed

    Benagiano, Giuseppe; Carrara, Sabina; Filippi, Valentina

    2009-11-03

    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

  8. Age at onset of multiple sclerosis is correlated to use of combined oral contraceptives and childbirth before diagnosis.

    PubMed

    Holmqvist, Per; Hammar, Mats; Landtblom, Anne-Marie; Brynhildsen, Jan

    2010-12-01

    The aim of this study was to evaluate whether age of onset of multiple sclerosis is related to use of combined oral contraceptives and/or timing of childbirth. The results showed that use of combined oral contraceptives and childbirth before the first multiple sclerosis symptom was correlated to a higher mean age at the onset of the disease. Copyright © 2010. Published by Elsevier Inc.

  9. Estrogen-containing oral contraceptives are allowable in young women with factor V Leiden heterozygosity without a history of thrombosis.

    PubMed

    Budev, Marie M; Abu-Hajir, Majed; Deitcher, Steven R; Gomes, Marcelo P V

    2003-11-01

    An 18-year-old woman without significant past medical and surgical history presents to discuss the safety and efficacy of oral contraceptives. She is sexually active and currently relying on condoms alone for birth control. Her cousin had a deep venous thrombosis (DVT) following a pregnancy. As part of the family screening, this patient was identified as a factor V Leiden heterozygote. The risks and benefits of initiating oral contraceptives are discussed.

  10. Acceptability of emergency contraception in Brazil, Chile, and Mexico: 1 - Perceptions of emergency oral contraceptives.

    PubMed

    Díaz, Soledad; Hardy, Ellen; Alvarado, Gloria; Ezcurra, Enrique

    2003-01-01

    This article presents the results of a study on the acceptability of emergency contraception (EC) in Brazil, Chile, and Mexico. Opinions of potential users and possible providers were obtained through discussion groups and those of authorities and policy-makers through semi-structured interviews. Most participants had a positive opinion of EC, based on the view that it can help reduce unplanned pregnancy, adolescent pregnancy, and unsafe abortion. Several interviewees felt that all women should be informed about EC, while others viewed it as a method for special situations such as rape and unprotected first sexual intercourse. Concern was expressed that its introduction might be associated with a decrease in condom use, increase in sexually transmitted diseases, and irresponsible or promiscuous sexual behavior among adolescents. The need for EC was clearly perceived by most participants, leading to the conclusion that health authorities have the responsibility of implementing programs for its introduction. Training of health care personnel should include the discussion of reproductive health problems that could be prevented by EC.

  11. 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

  12. Clinical acceptability, use-patterns and use-effectiveness of the vaginal contraceptive sponge and Neo Sampoon tablets--an international multi-center randomized clinical trial.

    PubMed

    Chi, I C; Smith, S C; Borko, E; Sun, T H; Begum, S F; Hunt, W L; Wilkens, L R

    1987-11-01

    This paper describes the results from a randomized clinical trial comparing the Collatex vaginal contraceptive sponge (a predecessor of the Today sponge) and Neo Sampoon foaming vaginal contraceptive tablets; the trial was conducted from 1979 to 1983 in four centers located in three countries (two in Yugoslavia and one each in Taiwan and Bangladesh). The sponge was associated with more insertion and retention problems than the tablet, especially in the two Asian centers. More Neo Sampoon users complained of a burning or stinging sensation. This complaint, however, seemed to be well-tolerated and was not a frequent reason for irregular use and/or discontinuation of use of the tablets. Clinically significant medical complications were rarely reported for either method. Sponge users were more likely to report irregular use than tablet users, primarily due to inconvenience of use. Rates of discontinuation at six months of use were also consistently higher among sponge users than Neo Sampoon users in the four centers. Life-table pregnancy rates at 12 months of use ranged from 3.8 to 18.2 per 100 sponge users and 6.2 to 29.9 per 100 Neo Sampoon users, based on data from the two Yugoslavian centers and the Taiwan center (data from the Bangladesh center were excluded from analysis of pregnancy rates). Practical implications of these findings are discussed.

  13. A case-series study of cerebral venous thrombosis in women using short course oral contraceptive

    PubMed Central

    Khomand, Payam; Hassanzadeh, Kambiz

    2016-01-01

    Background: We report a case series of cerebral vein thrombosis (CVT) in women who used oral contraceptive pill (OCP) in the Muslims Ramadan and fasting month. Methods: This study was a retrospective case series of 9 patients with diagnosis of CVT, who admitted in the neurology ward of Tohid Hospital of Sanandaj, Iran, in July-August 2014-2015. Results: Patients had no history of thrombosis before. They were treated with oral contraceptive more than 1 month to be able to fast during Ramadan. They did not have other possible risk factors for CVT. A headache was the most common in 9/9 patients (100%) followed by vomiting and vertigo. Conclusion: We found that high rate of CVT in female population during Ramadan indicates that it needs be considered as a specific risk factor and should be considered by healthcare system. PMID:27326364

  14. Patient understanding and use of oral contraceptive pills in a southern public health family planning clinic.

    PubMed

    Davis, Terry C; Fredrickson, Doren D; Potter, Linda; Brouillette, Rose; Bocchini, Anna C; Williams, Mark V; Parker, Ruth M

    2006-07-01

    To assess patient understanding and use of oral contraceptive pills (OCPs) and determine if these are associated with literacy. Four hundred OCP users from a southern public health family planning clinic were orally tested post visit for literacy, demographics, contraceptive knowledge, OCP use, side effects, and adherence. Patients were predominately African American (86%); 78% had completed high school and 42% read below a 9th grade level. Most (94%) understood what to do when they missed one pill, yet few knew the correct action to take after missing two or three pills (19% and 3% respectively); 33% reported missing one or more pills in the past 2 weeks. Literacy was not associated with OCP use, knowledge, or adherence. Patients of all literacy levels had limited understanding of OCP side effects and what to do about multiple missed pills. This puts them at risk for misuse.

  15. Serum levels of relaxin during the menstrual cycle and oral contraceptive use.

    PubMed

    Wreje, U; Kristiansson, P; Aberg, H; Byström, B; von Schoultz, B

    1995-01-01

    Serum relaxin levels were analysed in 12 healthy women every other day during the menstrual cycle and during a second cycle on oral contraceptives. Relaxin levels in 7 women with posterior pelvic and lumbar pain were also measured. Relaxin was detected during both the follicular and luteal phases of the menstrual cycle in some of the healthy women. Serum levels were further increased during the use of oral contraceptives. Oestradiol levels in the untreated women correlated to the relaxin levels. Women with posterior pelvic and lumbar pain had higher relaxin levels than did healthy women, a finding that needs to be further explored. Our data indicate the existence of sources for relaxin production other than the corpus luteum in the non-pregnant woman. Endogenous and exogenous oestrogens may stimulate the production of relaxin.

  16. Oral Contraception for Younger Woman: The Benefits of the Low-Dose Pill

    PubMed Central

    Powell, Marion

    1986-01-01

    Oral contraceptives provide the woman under 35 with the most effective and safest reversible method of birth control. As the estrogen content of oral contraceptives has gradually been lowered during the past 20 years, there has been a lessening of the side-effects first reported by the Royal College of General Practice in 1967. The research of two decades has brought about changes in “the pill”. The most recent change has been the introduction of biphasic and triphasic pills with lower hormone dosages and fewer side-effects, but the same overall effectiveness and cycle control. Nevertheless, the percentage of women using OCs drops dramatically for those over the age of 25. Today's pills, with their lower hormone content, offer the physician a more flexible means of prescribing effectively for the individual patient. PMID:21267119

  17. Use of and access to oral and injectable contraceptives in Brazil.

    PubMed

    Farias, Mareni Rocha; Leite, Silvana Nair; Tavares, Noemia Urruth Leão; Oliveira, Maria Auxiliadora; Arrais, Paulo Sergio Dourado; Bertoldi, Andréa Dâmaso; Pizzol, Tatiane da Silva Dal; Luiza, Vera Lucia; Ramos, Luiz Roberto; Mengue, Sotero Serrate

    2016-12-01

    To analyze the prevalence of current use of oral and injectable contraceptives by Brazilian women, according to demographic and socioeconomic variables and issues related to access to those medicines. A cross-sectional, population-based analytical study with probability sampling based on data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines), carried out between September 2013 and February 2014 in 20,404 Brazilian urban households. Prevalence was calculated based on reports from non-pregnant women aged 15-49 on the use of oral or injectable contraceptives. The independent variables were gender, age, level of education, socioeconomic class, Brazilian region and marital status. Also analyzed were access, means of payment, sources, and reported medicines. Statistical analyses considered 95% confidence intervals (95%CI) and Pearson Chi-square test to evaluate the statistical significance of differences between groups, considering a 5% significance level. Prevalence of use was 28.2% for oral contraceptives (OC) and 4.5% for injectable contraceptives (IC). The highest prevalence of oral contraceptives was in the South region (37.5%) and the lowest in the North region (15.7%). For injectable contraceptives there was no difference between regions. Access was higher for oral contraceptive users (90.7%) than injectable contraceptives users (81.2%), as was direct payment (OC 78.1%, IC 58.0%). Users who paid for contraceptives acquired them at retail pharmacies (OC 95.0% and IC 86.6%) and at Farmácia Popular (Popular Pharmacy Program) (OC 4.8% and IC 12.7%). Free of charge contraceptives were mostly obtained from the Brazilian Unified Health System - SUS (OC 86.7%; IC 96.0%). Free samples were reported by 10.4% of users who did not pay for oral contraceptives. Most of paying users did not try to obtain contraceptives from SUS. Monophasic

  18. Stability of cilazapril in pediatric oral suspensions prepared from commercially available tablet dosage forms.

    PubMed

    Stanisz, Beata J; Paszun, Sylwia K; Zalewska, Anna

    2014-01-01

    Abstract: Cilazapril is a drug commonly used in management of heart failure in pediatric population. On pharmaceutical market it is available only in inconvenient for pediatric use tablet dosage forms. Until now, no oral liquid formulation containing cilazapril has been evaluated. Therefore, the aim of this study was to prepare easy to made and palatable 1 mg/mL oral liquid formulation with cilazapril (with consideration of original and generic cilazapril tablet and different packages) and subsequent investigation of physicochemical stability of these suspensions. Formulations were compounded using cilazapril obtained from original or generic cilazapril marketed tablet formulations and Ora-Blend" suspending agent. Stability of prepared suspensions stored in closed amber glass or amber plastic PET bottles in the temperature of 298 K was estimated throughout 28 day shelf-life period. Chemical stability was assessed by HPLC cilazapril stability indicating method. Physical stability was evaluated by appearance, taste, smell, pH and theological assessments. Cilazapril oral suspensions at concentration of 1 mg/mL demonstrated satisfactory stability over 28 day long storage at room temperature. Cilazapril concentrations remained within acceptable limit (+/- 10%) stored in closed amber bottles made of glass or PET material. Moreover, suspensions physical properties remained unaffected. Cilazapril - Ora-Blend* pediatric oral liquid is easy to made, palatable and stable when stored at room temperature for 28 days. Stability of cilazapril oral liquid remains unchanged while using cilazapril tablets produced by different manufacturers and bottles made of amber glass or PET material.

  19. Use of Oral Vitamin-D Glass ampoule and tablet: Experience of patients and physicians.

    PubMed

    Maroof, Syed Umair; Shaukat, Faizan; Aslam, Junaid; Jawaid, Masood

    2017-01-01

    To ascertain patients and physician views regarding hazard and compliance of oral liquid Vitamin D glass ampoule and tablets. This cross sectional survey was conducted from November 1(st) 2016 to 15(th) December 2016. Patients who were prescribed Vitamin D glass ampoule from oral route in last three months were included along with physicians who routinely prescribe vitamin D after taking informed consent. The participants were asked about injuries related to the use of glass ampoule, ease of using this from, after taste preference of tablet or injectable form as well as demography. Data was analysed with SPSS version 24.0. Total 182 patients were included in the study with mean ± SD age of 39.4 ± 12.4 years. Majority of patients, 80.2% (142) said they prefer oral tablet in preference to injectable ampule in oral form if given choice while prescribing Vitamin D. Moreover 66.7% (64) doctors prefer to prescribe tablet form of Vitamin D instead of injection as oral form for vitamin D deficiency among their patients. One third of patients, 33% (n=59) sustained injury while breaking the ampule which included minor self-controlled bleeding by glass particles in 50% (n=35). Less than half of doctors 46.9% (n=45) said they taught their patients about usage of injectable Vitamin D ampules. Majority of patients prefer Vitamin D tablet instead of Oral liquid in glass ampoule if they got the choice among two. The results of this study provide important implications for our doctors about patients concern of hazard, after taste and compliance with orally administered Vitamin D glass ampoules.

  20. Pharmacokinetic overview of ethinyl estradiol dose and bioavailability using two transdermal contraceptive systems and a standard combined oral contraceptive

    PubMed Central

    Hofmann, Birte; Reinecke, Isabel; Schuett, Barbara; Merz, Martin; Zurth, Christian

    2014-01-01

    Objective: To determine the relative bioavailability of ethinyl estradiol (EE) and gestodene (GSD) after application of a novel transdermal contraceptive patch vs. a standard combined oral contraceptive (COC) pill (study 1), and to evaluate the pharmacokinetics (PK) of EE after application of the EE/GSD patch compared with an EE/norelgestromin (NGMN) patch (study 2). Materials: Participants were healthy, non-obese women aged 18 – 45 years (study 1) or 18 – 35 years (study 2). Compositions of study treatments were as follows: 0.55 mg EE/2.1 mg GSD (EE/GSD patch); 0.02 mg EE/0.075 mg GSD (standard COC); 0.6 mg EE/6 mg NGMN (EE/NGMN patch). Methods: In study 1, which consisted of 3 treatment periods (each followed by 7 patch- or pill-free days), treatments were administered in one of two randomized orders: either P–M–E (EE/GSD patch (P) every 7 days for 28 days → COC (M) once-daily for 21 days → two 7-day patch-wearing periods followed by one 10-day patch-wearing phase (E)), or the same treatments administered in sequence M–P–E. For study 2, participants received either the EE/GSD patch or EE/NGMN patch for seven treatment cycles (one patch per week for 3 weeks followed by a 7-day patch-free interval). Results: In study 1, average daily exposure to EE was similar for treatments P and M; the mean daily area under the concentration-time curve (AUC) ratio of treatment P vs. treatment M for EE was 1.06 (90% confidence interval (CI): 0.964 – 1.16), indicating average daily delivery similar to oral administration of 0.019 – 0.023 mg EE. For unbound GSD, average daily exposure was lower for treatment P vs. treatment M. The mean AUC ratio of treatment P vs. treatment M for unbound GSD was 0.820 (90% CI: 0.760 – 0.885), indicating average daily delivery from the patch of 0.057 – 0.066 mg GSD. Prolonged patch wearing did not result in a distinct decline in GSD and EE serum concentrations. In study 2, AUC at steady state (AUC0–168,ss

  1. 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.

  2. Effect of Oral Contraceptives on Depressive Mood Changes and on Endometrial Monoamine Oxidase and Phosphatases

    PubMed Central

    Grant, Ellen C. G.; Pryse-Davies, John

    1968-01-01

    Significant variations in the incidence of depression and loss of libido were found with the various types of oral contraceptives. The highest incidence occurred with strongly progestogenic compounds (especially with those containing a small amount of oestrogen) which have high monoamine oxidase activity for most of the cycle. The lowest incidence was found with the strongly oestrogenic sequential regimens which have weak monoamine oxidase activity for most of the cycle. PMID:5676714

  3. Prenatal exposure to oral contraceptives and transposition of the great vessels in man.

    PubMed

    Yasuda, M; Miller, J R

    1975-12-01

    The hypothesis that female sex hormones in the first trimester of pregnancy are causally related to transposition of the great vessels (TGV) was tested by a retrospective study of 135 cases of TGV ascertained through the British Columbia Health Surveillance Registry. During 1962-1972 there was no increase in the annual incidence rates of TGV. Analysis of questionnaires completed on 58 cases revealed no definite association between inadvertent use of oral contraceptives or other sex hormones during early pregnancy and TGV.

  4. Massive intestinal infarction in young women: complication of use of oral contraceptives?

    PubMed Central

    Koh, K. S.; Danzinger, R. G.

    1977-01-01

    Massive intestinal infarction due to occlusion of the celiac, superior mesenteric and inferior mesenteric arteries occurred in two young women, one of who subsequently died. Both were smokers. They had ingested oral contraceptives for 5 and 8 years, respectively, but this therapy could not be proven to be a causative factor in their ischemic bowel disease; although such an association is uncommon, it should be considered in young women with abdominal pain. Images FIG. 1 PMID:837318

  5. [Problem of oral surgical interventions during pregnancy, menstruation and under the intake of hormonal contraceptives].

    PubMed

    Stech, E

    1979-04-01

    Pregnancy, menstruation and hormonal contraceptives are no contraindications for necessary oral surgical procedures. If the pregnancy takes a normal course, surgical interventions with absolute indication are possible at any time. Surgical interventions with relative indication should be performed during the second trimester of pregnancy. The dental treatment of pregnant women should be terminated, as far as possible, by the 7th or 8th month of pregnancy. Metabolic imbalances, static loading and gingival changes deserve special attention.

  6. Simultaneous determination of ethinylestradiol and levonorgestrel in oral contraceptives by derivative spectrophotometry.

    PubMed

    Berzas, J J; Rodríguez, J; Castañeda, G

    1997-01-01

    A method for determining ethinylestradiol (ETE) and levonorgestrel (LEV) in mixtures by first-derivative spectrophotometry is described. The procedure does not require any separation step. Measurements are made at the zero-crossing wavelengths and the calibration graphs are linear up to 26 and 33 micrograms ml-1 of ETE and LEV, respectively. The method was applied to the determination of both compounds in five different Spanish commercial low-dose oral contraceptives. Similar results were obtained by an HPLC method.

  7. Use of oral contraceptives by adolescents and its consequences in Finland 1981-91.

    PubMed Central

    Rimpelä, A. H.; Rimpelä, M. K.; Kosunen, E. A.

    1992-01-01

    OBJECTIVES--To study use of oral contraceptives among Finnish teenagers during 1981-91 and how abortions, childbirths, sexually transmitted diseases, and cardiovascular diseases changed during this period. DESIGN--Biannual cross sectional surveys with mailed questionnaires from 1981 onwards and analysis of national statistics. SETTING--Finland. SUBJECTS--A nationwide sample of 14, 16, and 18 year olds. Sample size varied from 1249 to 3887 and response rate from 85% to 94%. MAIN OUTCOME MEASURES--Proportion taking oral contraceptive, fertility and abortion rates, hospital discharge rates, rates of sexually transmitted diseases. RESULTS--The proportion of teenagers taking oral contraceptives increased steadily. In 1991 the percentages among 14, 16, and 18 year olds were 2%, 18%, and 41% compared with 0.2%, 7% and 22% in 1981. Most users had a steady partner (80% of 16 year olds and 85% of 18 year olds). By 1989 rates of abortion had fallen from 12/1000 to 9.3/1000 in 16 year olds and from 25/1000 to 19.2/1000 in 18 year olds; fertility rates had fallen from 4.5/1000 to 2.3/1000 and from 23.5/1000 to 15.3/1000 respectively. Rates in 14 year olds fell only slightly. Gonorrhoea infection fell and HIV infection remained rare. Rates of hospital discharge after thromboembolic venous disease rose slightly. CONCLUSIONS--The increased use of oral contraceptives is the most likely explanation for decreasing abortion and fertility rates among teenagers. Increased reliance on the condom because of the threat of AIDS may increase unwanted pregnancies. PMID:1467684

  8. Peculiar observations in measuring testosterone in women treated with oral contraceptives supplemented with dehydroepiandrosterone (DHEA).

    PubMed

    Heijboer, Annemieke C; Zimmerman, Yvette; de Boer, Theo; Coelingh Bennink, Herjan; Blankenstein, Marinus A

    2014-03-20

    Total testosterone is considered to be decreased during the use of combined oral contraceptives. There is, however, considerable concern about the quality of testosterone assays, especially at low levels. We aimed to confirm testosterone levels measured by direct radioimmunoassay in a recent clinical trial with a state-of-the-art LC-MSMS method. Surplus specimens with known testosterone levels collected during the study (Clinical Trial Registration number ISRCTN06414473) were reanalyzed with an LC-MSMS method. This method was compared to another LC-MSMS method that had shown to concur excellently to a reference method. Follow-up experiments were designed to explain the results. In contrast to our expectation, LC-MSMS measurements did not corroborate the data obtained by radioimmunoassay. Subsequent experiments showed that this could be attributed to a strong dependency of the radioimmunoassay on SHBG. Testosterone results (n = 198) obtained by direct radioimmunoassay showed a negative correlation to SHBG levels (r = -0.676; p<0.001). By contrast, testosterone results obtained by LC-MSMS were not related to SHBG (r = 0.100; NS). In conclusion, our results indicate that total testosterone measurements during oral contraceptive use are unreliable when performed with assays sensitive to the SHBG concentration. The discrepancy with the literature can most likely be explained by the sensitivity of the immunoassay used to SHBG. Given the sharp increase in SHBG during the use of many oral contraceptives, total testosterone may not decrease, whereas its bioavailability, estimated by free testosterone levels, will be diminished. Studies aiming at restoration of testosterone homeostasis during oral contraception need to take this into account. Copyright © 2014 Elsevier B.V. All rights reserved.

  9. Quantitative evaluation of the disintegration of orally rapid disintegrating tablets by X-ray computed tomography.

    PubMed

    Otsuka, Makoto; Yamanaka, Azusa; Uchino, Tomohiro; Otsuka, Kuniko; Sadamoto, Kiyomi; Ohshima, Hiroyuki

    2012-01-01

    To measure the rapid disintegration of Oral Disintegrating Tablets (ODT), a new test (XCT) was developed using X-ray computing tomography (X-ray CT). Placebo ODT, rapid disintegration candy (RDC) and Gaster®-D-Tablets (GAS) were used as model samples. All these ODTs were used to measure oral disintegration time (DT) in distilled water at 37±2°C by XCT. DTs were affected by the width of mesh screens, and degree to which the tablet holder vibrated from air bubbles. An in-vivo tablet disintegration test was performed for RDC using 11 volunteers. DT by the in-vivo method was significantly longer than that using the conventional tester. The experimental conditions for XCT such as the width of the mesh screen and degree of vibration were adjusted to be consistent with human DT values. Since DTs by the XCT method were almost the same as the human data, this method was able to quantitatively evaluate the rapid disintegration of ODT under the same conditions as inside the oral cavity. The DTs of four commercially available ODTs were comparatively evaluated by the XCT method, conventional tablet disintegration test and in-vivo method.

  10. Metoclopramide nasal spray is effective in symptoms of gastroparesis in diabetics compared to conventional oral tablet.

    PubMed

    Parkman, H P; Carlson, M R; Gonyer, D

    2014-04-01

    Delayed gastric emptying symptoms interfere with the absorption of oral medications. Intranasal metoclopramide is being developed as an alternative to oral metoclopramide for patients with diabetic gastroparesis. To compare the efficacy and safety of metoclopramide nasal spray to oral tablets in diabetic patients with symptoms of gastroparesis, this randomized, open-label, parallel design study randomized subjects to 10 or 20 mg nasal spray or 10 mg tablet four times a day for 6 weeks. Efficacy was evaluated using a total symptom score (TSS). Eighty-nine subjects were enrolled. For the intention to treat population, both nasal dose groups (10 and 20 mg) had lower TSS with treatment compared to the oral 10 mg group. The change from baseline in TSS for nasal 20 mg was greater than the oral 10 mg at Week 6 (p = 0.026). For the per-protocol population, there was a significant difference in the TSS between baseline and Week 6 for both the nasal 10 mg (p = 0.026) and the nasal 20 mg (p = 0.008) cohorts compared to the oral 10 mg group. Based on the definition of a responder, 88.9% of subjects who received oral 10 mg, 91.2% who received nasal 10 mg, and 97.1% who received nasal 20 metoclopramide were classified as responders. The side-effect profile of the metoclopramide nasal spray was favorable. More side effects, especially nausea, occurred with the oral tablets. Metoclopramide nasal spray offers better symptom control than metoclopramide oral tablet in diabetic patients with symptoms of gastroparesis. © 2013 John Wiley & Sons Ltd.

  11. Rheumatoid factor seropositivity is inversely associated with oral contraceptive use in women without rheumatoid arthritis

    PubMed Central

    Bhatia, Shailaja S; Majka, Darcy S; Kittelson, John M; Parrish, Lezlie A; Ferucci, Elizabeth D; Deane, Kevin D; Arend, William P; Rewers, Marian; Holers, V Michael; Norris, Jill M

    2007-01-01

    Objectives To examine whether oral contraceptive use is associated with the presence of serum rheumatoid factor in women of reproductive age without rheumatoid arthritis. Methods 304 women selected from parents of children who were at increased risk of developing type 1 diabetes were studied, because they were enriched with the human leucocyte antigen‐DR4 allele, a susceptibility marker for both type 1 diabetes and rheumatoid arthritis. Participants visited a clinic where blood was drawn for rheumatoid factor testing, and exposure data were collected via questionnaires. A medical history and joint examination were performed to rule out rheumatoid arthritis. Participants and examiners were unaware of the participants' rheumatoid factor status at the time of examination and questionnaire. Results Use of oral contraceptives at any time was inversely associated with rheumatoid factor positivity (adjusted odds ratio (OR) 0.2, 95% confidence interval (CI) 0.07 to 0.52) independent of age, education and smoking. Smoking ⩾20 pack‐years was also associated with rheumatoid factor positivity (adjusted OR 56.38, 95% CI 4.31 to 736.98) compared with never smoking. Smoking 1–19 pack‐years was not associated with a positive rheumatoid factor. Conclusions Our results suggest that oral contraceptive use, and possibly cigarette smoking, act early in the development of the immune dysregulation that occurs in rheumatoid arthritis. PMID:16868018

  12. Deep vein thrombosis and the oestrogen content in oral contraceptives. An epidemiological analysis.

    PubMed

    Kierkegaard, A

    1985-01-01

    Epidemiological studies have pointed to a correlation between the oestrogen content of oral contraceptives and the risk of deep vein thrombosis (DVT). The correlation has been strongest in studies which partially consisted of adverse drug reaction reports to the Swedish Adverse Drug Reaction Advisory Committee (SADRAC). The present study analyzes the epidemiological basis of the adverse drug reaction reports on DVT in women on oral contraceptives to SADRAC. It verifies the reported correlation between the oestrogen content of the pills and the risk of DVT but it also demonstrates that this correlation probably was secondary to differences in the diagnostic standard of DVT, to differences in reporting policies to SADRAC and to an age difference between women on low-oestrogen-pills and those on high-oestrogen pills and is thus due to bias. It is concluded that adverse drug reaction reporting on oral contraceptives has been very unreliable, for which reason it cannot support any epidemiological conclusion concerning the relative thrombogenicity of high-oestrogen pills compared with that of low-oestrogen pills.

  13. Noncontraceptive benefits of the estradiol valerate/dienogest combined oral contraceptive: a review of the literature

    PubMed Central

    Nappi, Rossella E; Serrani, Marco; Jensen, Jeffrey T

    2014-01-01

    Combined oral contraceptives formulated to include estradiol (E2) have recently become available for the indication of pregnancy prevention. A combined estradiol valerate and dienogest pill (E2V/DNG), designed to be administered using an estrogen step-down and a progestin step-up regimen over 26 days of active treatment followed by 2 days of placebo (26/2-day regimen), has also undergone research to assess the potential for additional noncontraceptive benefits. Randomized, placebo-controlled studies have demonstrated that E2V/DNG is an effective treatment for heavy menstrual bleeding – a reduction in median menstrual blood loss approaching 90% occurs after 6 months of treatment. To date, E2V/DNG is the only oral contraceptive approved for this indication. Comparator studies have also demonstrated a reduction in hormone withdrawal-associated symptoms in users of E2V/DNG compared with a conventional 21/7-day regimen of ethinylestradiol/levonorgestrel. Other potential noncontraceptive benefits associated with E2V/DNG, like improvement in dysmenorrhea, sexual function, and quality of life, are comparable with those associated with other combined oral contraceptives and are discussed further in this review. PMID:25120376

  14. Life threatening pulmonary embolus in a factor V Leiden carrier on oral contraceptives: a case report.

    PubMed

    Saif, M W; Volpe, B T; Dailey, M; Tsongalis, G J

    1997-06-01

    Venous thromboembolism is a serious, potentially lethal health problem affecting one per 1,000 people annually. Major surgery, the use of oral contraceptives, complicated pregnancy, fractures, and immobilization increase the risk of thrombosis. In addition to these factors, thrombosis is associated with inherited deficiencies of antithrombin III, protein C, and protein S. Together these do not account for more than five to 10% of the cases. Hereditary activated protein C resistance has been recognized as a basis for a majority of cases of familial thrombosis. It accounted for more than a 10 times higher number than that of other known genetic defects. We describe a case of a young female who presented with a pulmonary embolism and was discovered to have activated protein C resistance. This patient had a heterozygous mutation for factor V Leiden and was taking oral contraceptives. This report underlines: 1) increased risk of venous thrombosis in oral contraceptive users who carry factor V Leiden mutation associated with functional resistance to the normal anticoagulation activities of protein C; 2) most episodes occurring in the young are minor, but pulmonary embolus can occur; 3) the importance of identifying other affected members of the family; and 4) the importance of anticoagulation prophylaxis at times of enhanced risk, particularly during pregnancy, postpartum, and major surgery.

  15. Lyophilized mucoadhesive-dendrimer enclosed matrix tablet for extended oral delivery of albendazole.

    PubMed

    Mansuri, Shakir; Kesharwani, Prashant; Tekade, Rakesh Kumar; Jain, Narendra Kumar

    2016-05-01

    Dendrimers are multifunctional carriers widely employed for delivering drugs in a variety of disease conditions including HIV/AIDS and cancer. Albendazole (ABZ) is a commonly used anthelmintic drug in human as well as veterinary medicine. In this investigation, ABZ was formulated as a "muco-dendrimer" based sustained released tablet. The mucoadhesive complex was synthesized by anchoring chitosan to fifth generation PPI dendrimer (Muco-PPI) and characterized by UV, FTIR, (1)H NMR spectroscopy and electron microscopy. ABZ was entrapped inside Muco-PPI followed by lyophilization and tableting as matrix tablet. A half-life (t1/2) of 8.06±0.15, 8.17±0.47, 11.04±0.73, 11.49±0.92, 12.52±1.04 and 16.9±1.18h was noted for ABZ (free drug), conventional ABZ tablet (F1), conventional ABZ matrix tablet (F2), PPI-ABZ complex, PPI-ABZ matrix tablet (F3) and Muco-PPI-ABZ matrix tablet (F4), respectively. Thus the novel mucoadhesive-PPI based formulation of ABZ (F4) increased the t1/2 of ABZ significantly by almost twofold as compared to the administration of free drug. The in vivo drug release data showed that the Muco-PPI based formulations have a significantly higher Cmax (2.40±0.02μg/mL) compared with orally administered free ABZ (0.19±0.07μg/mL) as well as conventional tablet (0.20±0.05μg/mL). In addition, the Muco-PPI-ABZ matrix tablet displayed increased mean residence time (MRT) and is therefore a potential candidate to appreciably improve the pharmacokinetic profile of ABZ. Copyright © 2015 Elsevier B.V. All rights reserved.

  16. Bioavailability of the Yuzpe and levonorgestrel regimens of emergency contraception: vaginal vs. oral administration.

    PubMed

    Kives, Sari; Hahn, Philip M; White, Emily; Stanczyk, Frank Z; Reid, Robert L

    2005-03-01

    Separate crossover studies compared the bioavailability of oral vs. vaginal routes of administration for the Yuzpe (n=5) and levonorgestrel regimens (n=4) of emergency contraception. Twice the standard dose of the Yuzpe regimen (200 microg of ethinyl estradiol, 1000 microg of levonorgestrel) or the levonorgestrel regimen (1500 microg of levonorgestrel) was self-administered vaginally. One week later, each subject received orally the standard dose of the assigned medication. Serial blood samples were collected over 24 h and assayed for levonorgestrel and ethinyl estradiol (for the Yuzpe regimen only). Paired t tests were used to compare oral vs. vaginal administration for maximum concentration (Cmax), time to maximum concentration (Tmax) and area under the curve over 24 h (AUC0-24). Relative bioavailability (vaginal/oral) was derived from AUC0-24. Vaginal administration of double the standard dose of the Yuzpe regimen resulted in a lower Cmax (vaginal=5.4 vs. oral=14.6 ng/mL, p=.038) and a later Tmax (5.9 vs. 2.0 h, p=.066) for levonorgestrel, compared to oral administration. Corresponding ethinyl estradiol concentrations were higher (786 vs. 391 pg/mL, p=.039) and peaked later (4.0 vs. 1.9 hr, p=.154) with vaginal administration. Relative bioavailabilities for levonorgestrel and ethinyl estradiol were 58% and 175%, respectively. Similarly, vaginal administration of the levonorgestrel regimen resulted in a lower Cmax (vaginal=5.4 vs. oral=15.2 ng/mL, p=.006) and a later Tmax (7.4 vs. 1.3 h, p=.037) for levonorgestel, compared to oral administration. The relative bioavailability was 62%. Our preliminary data suggest that vaginal administration of these emergency contraception regimens appears to require at least three times the standard oral dose to achieve equivalent systemic levonorgestrel concentrations.

  17. Hormonal manipulation with finasteride or oral contraception does not influence incidence of renal cell carcinoma.

    PubMed

    Kabra, Aashish; Gelfond, Jonathan; Liss, Michael A

    2017-03-23

    Androgens have been suspected to be involved in the initiation of renal cell carcinoma because of a two-fold increased risk in men compared with women. To investigate the role of self-reported finasteride or oral contraceptive use in the Prostate, Lung, Colorectal, and Ovarian (PCLO) to determine whether the androgen receptor reduces renal cancer development. We query the PCLO trial for predictor variables from the baseline questionnaire and follow-up questionnaires enquiring medication use, specifically the use of 5-α reductase inhibitors (dutasteride or finasteride) and oral contraceptive therapy. The primary outcome of this study was the incidence of renal cancer. Statistical analysis included Student's t-test for continuous variables, χ, or Fisher's exact tests for dichotomous or categorical variables, and multivariable analysis using Cox proportional hazards models. Eight percent (n=6117/73 694) of men in the PCLO trial reported the use of finasteride. 52 (10.6%) of the 492 men diagnosed with renal cancer had self-reported exposure to finasteride and this was not significant in univariable analysis (52/6169; 0.84% vs. 440/66 454; 0.67%, P=0.12) or multivariable main effects analysis (hazard ratio: 1.12; 95% confidence interval: 0.83-1.5; P=0.47). Approximately 54% of women (n=40 997/75 989) in the PCLO trial reported the use of oral contraceptives by questionnaire. 136 (52.1%) of the 261 women diagnosed with renal cancer had self-reported exposure to oral contraceptive therapy and this was not significant in univariable analysis (136/40 997; 0.33% vs. 125/34 992; 0.36%, P=0.36) or in multivariable main effects analysis (hazard ratio: 1.03; 95% confidence interval: 0.97-1.1; P=0.30). Self-reported use of finasteride or oral contraceptives is not associated with a reduced incidence of renal cancer.

  18. Oral contraceptives and systemic lupus erythematosus: what should we advise to our patients?

    PubMed

    Duarte, Cátia; Inês, Luís

    2010-01-01

    Oral contraceptives (OC) are the contraceptive method of choice for the majority of Western world women. Decision on giving OC to patients with Systemic Lupus Erythematosus (SLE) puts special issues and concerns. In fact, OC have been evocated as etiologic risk factors for SLE and also associated with an increased risk of flares. During periods of active disease an effective contraception is mandatory, but OC puts safety problems in this setting. On the other hand, many SLE patients will be on a low activity or remission state with much less aggressive medication for most of the time. Cumulative damage due to SLE and comorbidities such as cardiovascular disease, antiphospholipid syndrome/ antibodies also has to be considered for pregnancy and contraception decisions. Advice on the benefits and risks of OC is an important and difficult aspect of the care of women with SLE. This advice should be done based on the best evidence and always considering our particular subject and its changing risk profile. This review will focus on OC in SLE women and particularly on current evidence on safety.

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

    PubMed

    Rahnama, Parvin; Hidarnia, Alireza; Shokravi, Farkhondeh Amin; Kazemnejad, Anoushiravan; Oakley, Deborah; Montazeri, Ali

    2010-05-28

    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. 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. 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. 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.

  20. Noncontraceptive use of oral combined hormonal contraceptives in polycystic ovary syndrome-risks versus benefits.

    PubMed

    Dokras, Anuja

    2016-12-01

    The use of steroid sex hormones for noncontraceptive benefits has been endorsed by several medical societies. In women with polycystic ovary syndrome (PCOS), hormonal contraceptives are first-line therapy for concurrent treatment of menstrual irregularity, acne, and hirsutism. The association of PCOS with obesity, diabetes, and dyslipidemia frequently brings up the debate regarding risks versus benefits of hormonal contraceptives in this population. In women with PCOS, the lack of large-scale studies evaluating the risks with varying doses of ethinyl estradiol, types of progestins, and presence of confounding factors such as obesity, smoking, and other cardiometabolic comorbidities is a significant limitation in these deliberations. Although it is important to assess the absolute risk for major morbidities including cardiovascular events, currently, there are a paucity of long-term data for these outcomes in PCOS. Most of the current studies do not suggest an increase in risk of prediabetes/diabetes, clinically significant dyslipidemia, inflammatory changes, or depressive/anxiety symptoms with oral contraceptive pill use. Screening of women with PCOS for cardiometabolic and psychiatric comorbidities is routinely recommended. This information should be used by health care providers to individualize the choice of hormonal contraceptive treatment, adequately counsel patients regarding risks and benefits, and formulate an appropriate follow-up plan.

  1. Influence of transdermal rotigotine on ovulation suppression by a combined oral contraceptive

    PubMed Central

    Braun, Marina; Elshoff, Jan-Peer; Andreas, Jens-Otto; Müller, Louise Ischen; Horstmann, Rolf

    2009-01-01

    AIMS To assess the influence of the transdermally applied dopamine agonist rotigotine on ovulation suppression by a combined oral contraceptive (0.03 mg ethinyloestradiol and 0.15 mg levonorgestrel) in a randomized, double-blind crossover study in 40 healthy females. METHODS Treatment A consisted of the combined oral contraceptive for 28 days plus rotigotine for the first 13 days (2 mg (24 h)−1 on days 1–3, 3 mg (24 h)−1 maintenance dose thereafter). During treatment B, subjects received matching placebo patches instead of rotigotine. Pharmacodynamic parameters (progesterone, oestradiol, luteinizing hormone, and follicle stimulating hormone serum concentrations), pharmacokinetic parameters for ethinyloestradiol/levonorgestrel and rotigotine, and safety and tolerability of the treatment were assessed. RESULTS Progesterone serum concentrations remained below 2 ng ml−1 in all subjects during the luteal phase. Median serum concentrations of all other pharmacodynamic parameters were similar during both treatments. Pharmacokinetic parameters Cmax,ss and AUC(0,24 h)ss at steady state were similar with or without co-administration of rotigotine for both ethinyloestradiol and levonorgestrel with geometric mean ratios close to 1 and 90% confidence intervals within the acceptance range of bioequivalence (0.8, 1.25): Cmax,ss 1.05 (0.93, 1.19), AUC(0,24 h)ss 1.05 (0.9, 1.22) for ethinyloestradiol; Cmax,ss 1.01 (0.96, 1.06), AUC(0,24 h)ss 0.98 (0.95, 1.01) for levonorgestrel. Mean plasma concentrations of unconjugated rotigotine remained stable throughout the patch-on period (day 13). CONCLUSIONS Concomitant administration of 3 mg (24 h)−1 transdermal rotigotine had no impact on the pharmacodynamics and pharmacokinetics of a combined oral contraceptive containing 0.03 mg ethinyloestradiol and 0.15 mg levonorgestrel, suggesting that the dopamine agonist does not influence contraception efficacy. PMID:19740396

  2. The effect of pycnogenol on patients with dysmenorrhea using low-dose oral contraceptives

    PubMed Central

    Maia, Hugo; Haddad, Clarice; Casoy, Julio

    2014-01-01

    Objective Menstrual symptoms such as dysmenorrhea usually occur during the hormone-free interval in oral contraceptive users. Progestin withdrawal activates NF-κB transcription factor, which upregulates both vascular endothelial growth factor (VEGF) and Cox-2 expression in the endometrium. The use of natural NF-κB inhibitors such as pycnogenol may block this response, improving dysmenorrhea. Patients and methods Twenty-four patients with severe dysmenorrhea were allocated to one of two treatment groups. In Group A (n=13), women were treated with an oral contraceptive containing 15 μg of ethinyl estradiol and 60 mg of gestodene (Adoless®) in a 24/4 regimen for three consecutive cycles. Women in Group B (n=11) used the same contraceptive regimen together with 100 mg of pycnogenol (Flebon®) continuously for 3 months. Pain scores were graded using a visual analog scale (VAS) before and during the hormone-free interval at the end of the third treatment cycle. Results Before treatment, VAS pain scores for dysmenorrhea were 8 and 9 in Groups A and B, respectively. However, by the end of the third treatment cycle, pain scores had decreased significantly (P<0.05) both in groups A and B. The final pain scores were 6 in Group A and 2 in Group B, a difference that was statistically significant (P<0.0001). In Group B, 27% of the patients became pain-free, while in Group A, none of the women reported complete disappearance of this symptom. The number of bleeding days was also lower in Group B. Discussion Pycnogenol effectively decreased pain scores and the number of bleeding days when administered concomitantly with a low-dose 24/4 oral contraceptive containing gestodene. PMID:25525393

  3. Lipids, cardiovascular disease, and oral contraceptives: a practical perspective.

    PubMed

    Upton, G V

    1990-01-01

    Figure 9 is an attempt to summate the influences of life-style on lipid parameters. Based on the work of Nikkila, it shows the source of the production of HDL and LDL, the factors that can affect these lipoprotein levels, and where in the cascade of lipoprotein metabolism these factors exert influence. The source of HDL production is the liver and the intestine. At this stage, diet, exercise, hormones, genetics, drugs, and certain disease states can affect HDL levels. Lecithin-cholesterol acyl transferase (LCAT) esterifies HDL-free cholesterol in plasma, and HDL3 is formed that in turn is transformed to HDL2. At the same time, VLDL from the gut and the liver will be converted, under the influence of LPL, to HDL2 and LDL. Thus HDL2 is being formed by the breakdown of VLDL and from the transformation of HDL3 to HDL2. Insulin, exercise, alcohol, fats, drugs, and diet affect lipoprotein lipase and consequently influence levels of LDL and HDL2 indirectly. Progestogens increase and estrogens decrease hepatic endothelial lipase, thus affecting the HDL2 concentration. It is at this point that combination OCs influence HDL2. The balance between estrogen and progestogen in a given contraceptive determines the extent and direction of HDL2 concentration. A separate pathway in the liver also catabolizes HDL2 and HDL3. LDL is generated partly from catabolism of VLDL and is partly secreted from the liver. The removal of LDL is mediated by receptors in both the liver and peripheral tissues. It is here that the Brown-Goldstein theory plays a major role. If LDL receptors are present in an insufficient number or are defective, then the C will accumulate and atherosclerosis may follow. Thus two key enzymes, LCAT and LPL, control the production of HDL2 and LDL, whereas a third enzyme, hepatic endothelial lipase, catabolizes HDL2.

  4. Effect of progestin vs. combined oral contraceptive pills on lactation: A double-blind randomized controlled trial

    PubMed Central

    Espey, Eve; Ogburn, Tony; Leeman, Larry; Singh, Rameet; Schrader, Ronald

    2013-01-01

    Objective To estimate the effect of progestin-only vs. combined hormonal contraceptive pills on rates of breastfeeding continuation in postpartum women. Secondary outcomes include infant growth parameters, contraceptive method continuation and patient satisfaction with breastfeeding and contraceptive method. Methods In this randomized controlled trial, postpartum breastfeeding women who desired oral contraceptives were assigned to progestin-only vs. combined hormonal contraceptive pills. At two and eight weeks postpartum, participants completed in-person questionnaires that assessed breastfeeding continuation and contraceptive use. Infant growth parameters including weight, length and head circumference were assessed at eight weeks postpartum. Telephone questionnaires assessing breastfeeding, contraceptive continuation and satisfaction were completed at 3-7 weeks and 4 and 6 months. Breastfeeding continuation was compared between groups using Cox proportional hazards regression. Differences in baseline demographic characteristics and in variables between the two intervention groups were compared using chi-square tests, Fisher’s Exact test, or two-sample t-tests as appropriate. Results Breastfeeding continuation rates, contraceptive continuation, and infant growth parameters did not differ between users of progestin-only and combined hormonal contraceptive pills. Infant formula supplementation and maternal perception of inadequate milk supply were associated with decreased rates of breastfeeding in both groups. Conclusions Choice of combined or progestin-only birth control pills administered two weeks postpartum did not adversely affect breastfeeding continuation. PMID:22143258

  5. Prediction of oral disintegration time of fast disintegrating tablets using texture analyzer and computational optimization.

    PubMed

    Szakonyi, G; Zelkó, R

    2013-05-20

    One of the promising approaches to predict in vivo disintegration time of orally disintegrating tablets (ODT) is the use of texture analyzer instrument. Once the method is able to provide good in vitro in vivo correlation (IVIVC) in the case of different tablets, it might be able to predict the oral disintegration time of similar products. However, there are many tablet parameters that influence the in vivo and the in vitro disintegration time of ODT products. Therefore, the measured in vitro and in vivo disintegration times can occasionally differ, even if they coincide in most cases of the investigated products and the in vivo disintegration times may also change if the aimed patient group is suffering from a special illness. If the method is no longer able to provide good IVIVC, then the modification of a single instrumental parameter may not be successful and the in vitro method must be re-set in a complex manner in order to provide satisfactory results. In the present experiment, an optimization process was developed based on texture analysis measurements using five different tablets in order to predict their in vivo disintegration times, and the optimized texture analysis method was evaluated using independent tablets. Copyright © 2013 Elsevier B.V. All rights reserved.

  6. Risperidone oral disintegrating mini-tablets: A robust-product for pediatrics.

    PubMed

    El-Say, Khalid M; Ahmed, Tarek A; Abdelbary, Maged F; Ali, Bahaa E; Aljaeid, Bader M; Zidan, Ahmed S

    2015-12-01

    This study was aimed at developing risperidone oral disintegrating mini-tablets (OD-mini-tablets) as age-appropriate formulations and to assess their suitability for infants and pediatric use. An experimental Box-Behnken design was applied to assure high quality of the OD-mini-tablets and reduce product variability. The design was employed to understand the influence of the critical excipient combinations on the production of OD-mini-tablets and thus guarantee the feasibility of obtaining products with dosage form uniformity. The variables selected were mannitol percent in Avicel (X1), swelling pressure of the superdisintegrant (X2), and the surface area of Aerosil as a glidant (X3). Risperidone-excipient compatibilities were investigated using FTIR and the spectra did not display any interaction. Fifteen formulations were prepared and evaluated for pre- and post-compression characteristics. The prepared OD-mini-tablet batches were also assessed for disintegration in simulated salivary fluid (SSF, pH 6.2) and in reconstituted skimmed milk. The optimized formula fulfilled the requirements for crushing strength of 5 kN with minimal friability, disintegration times of 8.4 and 53.7 s in SSF and skimmed milk, respectively. This study therefore proposes the risperidone OD-mini-tablet formula having robust mechanical properties, uniform and precise dosing of medication with short disintegration time suitable for pediatric use.

  7. Design and evaluation of microwave-treated orally disintegrating tablets containing polymeric disintegrant and mannitol.

    PubMed

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

    2013-05-01

    Microwave (MW) treatment was used to develop a formulation process for the preparation of wet molded orally disintegrating tablets (ODTs) consisting of mannitol and polymeric disintegrant with improved hardness and disintegration properties. The wet molded tablets were prepared in accordance with the conventional methods and subsequently heated by MW irradiation to induce the swelling of the tablet. Croscarmellose sodium, crospovidone, and low-substituted hydroxypropylcellulose (L-HPC) were evaluated for their use with this technology. NBD-020, which is a grade of L-HPC, provided the better hardness and disintegration results. In addition, the crystalline forms of mannitol impacted on hardness and disintegration properties of the ODT upon MW irradiation. The effects of the disintegrant ratio, δ and β crystalline mannitol ratio, amount of water, and compression force on the ODT properties were evaluated using the design of experiment method. MW-induced swelling was enhanced by an increase in the disintegrant ratio. Although the hardness of the tablet increased following MW treatment, the disintegration time became less than that of the MW-untreated tablets as the β-mannitol ratios increased. Taken together, the results indicated that the polymeric disintegrant greatly improved the properties of the molded tablets in combination with MW treatment.

  8. Utilization of and Adherence to Oral Contraceptive Pills and Associated Disparities in the United States: A Baseline Assessment for the Impact of the Affordable Care Act of 2010.

    PubMed

    Lin, Hsien-Chang; Lee, Hsiao-Yun

    2015-01-01

    This study investigated sociological factors that may influence women's utilization of and adherence to oral contraceptive pills. This was a retrospective cross-sectional study using the 2010-2012 Medical Expenditure Panel Survey. Female adults aged 18-50 years were included. Logistic regression was performed to discern women's decisions to use oral contraceptive pills or not. Ordinary least squares and Poisson regressions were conducted to examine the number of oral contraceptive pills received, refill frequency, and annual out-of-pocket expenditure on oral contraceptive pills. Covariates were based on the Andersen model of health care utilization. Among the study sample (weighted n = 207,007,531), 14.8% were oral contraceptive pill users. Factors positively related to oral contraceptive pill use included non-Hispanic white ethnicity, younger age, not currently married, having private insurance, residing in the Midwest, higher education level, and higher annual family income. Being non-Hispanic white and having a higher education level were positively related to oral contraceptive pill adherence. Our findings therefore demonstrate disparities in oral contraceptive pill utilization and adherence, especially according to women's race/ethnicity and educational level. This study serves as a baseline assessment for the impact of the Affordable Care Act on oral contraceptive pill utilization and adherence for future studies.

  9. 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.

  10. Fasting plasma lipids, lipoproteins and apolipoproteins in Nigerian women using combined oral and progestin-only injectable contraceptives.

    PubMed

    Oyelola, O O

    1993-05-01

    Fasting plasma lipid, lipoprotein, and apolipoprotein (apo) profiles were determined in Nigerian women using a low-dose combined oral (Lo-Feminal + Fe) (n = 18), a progestin-only injectable (Depo-Provera) (n = 16) contraceptives and matched controls (n = 18). The mean of plasma total and low-density lipoprotein (LDL) cholesterol, apo B and Lp(a) were significantly higher (p < 0.01) in women using contraceptives than the controls. The mean of total and LDL-cholesterol and apo B were also significantly higher in the oral contraceptive users than those on progestin-only injectables. Furthermore, the mean of cardiovascular disease (CVD) risk indices, total/HDL-cholesterol (p < 0.05) and LDL/HDL-cholesterol (p < 0.01), were significantly higher in women on oral contraceptives than the controls. There were no statistically significant differences between the indices in the women using progestin-only injectables and the controls. Based on this finding, it is concluded that the use of steroidal contraceptives is associated with alterations of lipid and apolipoprotein profiles in Nigerian women and that the use of low-dose combined oral contraceptives may be associated with an increased CVD risk.

  11. 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

  12. Investigation of Formulation and Process of Lyophilised Orally Disintegrating Tablet (ODT) Using Novel Amino Acid Combination

    PubMed Central

    AlHusban, Farhan; ElShaer, Amr M.; Kansara, Jiteen H.; Smith, Alan M.; Grover, Liam M.; Perrie, Yvonne; Mohammed, Afzal R.

    2010-01-01

    Lyophilised orally disintegrating tablets (ODTs) have achieved a great success in overcoming dysphagia associated with conventional solid dosage forms. However, the extensive use of saccharides within the formulation limits their use in treatment of chronic illnesses. The current study demonstrates the feasibility of using combination of proline and serine to formulate zero sacharide ODTs and investigates the effect of freezing protocol on sublimation rate and tablets characteristics. The results showed that inclusion of proline and serine improved ODT properties when compared to individual counterparts. Additionally, annealing the ODTs facilitated the sublimation process and shortened the disintegration time. PMID:27721339

  13. Pill power: oral contraceptives hold top spot in family planning arsenal.

    PubMed

    1998-10-01

    Results of the 1998 "Contraceptive Technology Update" Pill Survey indicate that oral contraceptives (OCs) remain the top birth control choice for US women. More than 70% of providers who responded to the survey reported that at least 50 women leave their offices each month with an OC prescription. When asked to cite their first OC choice, for a 21-year-old nonsmoking woman, Ortho Tri-Cyclen was selected by 43.6% of providers. This OC is considered an excellent choice for young women because of its ease of use, good cycle control, and beneficial effect on acne. The top choices for a 42-year-old nonsmoking woman were Loestrin (26.5%) and Alesse (21.1%), both of which have low estrogen doses. 25% of providers indicated they had prescribed OCs specifically to decrease the ovarian cancer risk in genetically predisposed women.

  14. 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

  15. Oral contraceptives: therapeutic uses and quality-of-life benefits--case presentations.

    PubMed

    Sulak, P J

    1999-01-01

    Numerous studies have shown that oral contraceptives (OC) provide protection against a wide variety of illnesses and conditions, including loss of bone density, ovarian cysts, menstrual cycle irregularities, dysmenorrhea and menorrhagia, ectopic pregnancy, pelvic inflammatory disease, benign breast disease, endometrial cancer, and ovarian cancer. How OC can be used not only for contraception but also to improve health among women throughout their reproductive years is illustrated by four case presentations: an adolescent with menstrual problems; a 25-year-old mulligravida who wishes to delay childbearing; a 35-year-old who has completed her family and requests tubal ligation; and a 45-year-old with perimenopausal symptoms. In view of their numerous health benefits, OC are to reproductive-age women as hormone replacement therapy is to menopausal women.

  16. Review of the new delayed-release oral tablet and intravenous dosage forms of posaconazole.

    PubMed

    Guarascio, Anthony J; Slain, Douglas

    2015-02-01

    The triazole antifungal posaconazole was first approved as an oral suspension formulation. Despite pharmacokinetic target attainment and clinical efficacy in premarketing trials, postmarketing analyses indicated unpredictable bioavailability resulting in subtherapeutic concentrations and reports of breakthrough fungal infections. The newly approved posaconazole delayed-release tablet and intravenous formulations display more consistent bioavailability in the presence of concomitant disease states, medications, and dietary considerations that classically alter drug concentrations of the oral suspension. Both the delayed-release tablet and intravenous formulation display a similar adverse-effect profile to the oral suspension. The posaconazole delayed-release oral tablet is not significantly affected by gastric acid suppression therapy, and the intravenous dosage form provides an option for patients who are intubated or unable to tolerate oral medications. Pharmacoeconomic considerations, particularly with intravenous posaconazole, will likely play a role in dosage form selection and frequency of use. Due to sustained, higher drug concentrations, the new posaconazole formulations hold promise for greater efficacy in antifungal prophylaxis and bring opportunity for further study in the treatment of invasive mycoses.

  17. 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.

  18. Improved anticoagulant effect of fucosylated chondroitin sulfate orally administered as gastro-resistant tablets.

    PubMed

    Fonseca, Roberto J C; Sucupira, Isabela D; Oliveira, Stephan Nicollas M C G; Santos, Gustavo R C; Mourão, Paulo A S

    2017-04-03

    Fucosylated chondroitin sulfate (FucCS) is a potent anticoagulant polysaccharide extracted from sea cucumber. Its anticoagulant activity is attributed to the presence of unique branches of sulfated fucose. Although this glycosaminoglycan exerts an antithrombotic effect following oral administration, high doses are necessary to achieve the maximum effect. The diminished activity of FucCS following oral administration is likely due to its degradation in the gastrointestinal tract and its limited ability to cross the intestinal cell membranes. The latter aspect is particularly difficult to overcome. However, gastro-resistant tablet formulation may help limit the degradation of FucCS in the gastrointestinal tract. In the present work, we found that the oral administration of FucCS as gastro-resistant tablets produces a more potent and prolonged anticoagulant effect compared with its administration as an aqueous solution, with no significant changes in the bleeding tendency or arterial blood pressure. Experiments using animal models of arterial thrombosis initiated by endothelial injury demonstrated that FucCS delivered as gastro-protective tablets produced a potent antithrombotic effect, whereas its aqueous solution was ineffective. However, there was no significant difference between the effects of FucCS delivered as gastro-resistant tablets or as aqueous solution in a venous thrombosis model, likely due to the high dose of thromboplastin used. New oral anticoagulants tested in these experimental models for comparison showed significantly increased bleeding tendencies. Our study provides a framework for developing effective oral anticoagulants based on sulfated polysaccharides from marine organisms. The present results suggest that FucCS is a promising oral anticoagulant.

  19. 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.

  20. Formulation and evaluation of clozapine orally disintegrating tablets prepared by direct compression.

    PubMed

    Olmez, S S; Vural, I; Sahin, S; Ertugrul, A; Capan, Y

    2013-02-01

    In this study, clozapine orally disintegrating tablets (ODTs) were prepared by direct compression method. Disintegration time, resistance to crushing of tablets, porosity, friability, dissolution tests were performed and dissolution profiles of ODTs were investigated. Morphological and interaction studies were also performed. Friability values were found to be less than 1%. All tablet formulations disintegrated within 1 min and fulfilled the 3 min disintegration time required for ODTs given in the European Pharmacopoeia. More than 85% of the labeled amount of clozapine was dissolved in 15 min from the ODTs. No interaction or changes were found between active substance and excipients. As a result of the studies, ODT formulations developed in this study can be suggested as promising formulations, which assist development and manufacturing a generic product of clozapine.

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

    PubMed

    Wright, K P; Badia, P

    1999-09-01

    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. 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.

  3. 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.

  4. Extemporaneous procedures for dissolving risedronate tablets for oral administration and for feeding tubes.

    PubMed

    Dansereau, Richard J; Crail, Debbie J

    2005-01-01

    Risedronate (Actonel, Procter & Gamble Pharmaceuticals) is commercially available only as film-coated tablets. Extemporaneous procedures for dissolving tablets for feeding tubes and for preparation of an oral liquid have not previously been evaluated. To evaluate procedures for dissolving risedronate sodium tablets for administration in liquid form and drug recovery following dissolution in cups and following passage through different types of feeding tubes. Tablets (5 and 35 mg) were individually dispersed in 2 oz of water. After 2 minutes, the solution was stirred for 30 seconds, dispensed, and rinsed with an additional 4 oz of water. The sample was filtered and analyzed by HPLC. Ten replicates were performed using the various cups. Gastrostomy and nasoenteric tubes were flushed with 1 oz of water. Individual tablets were dispersed in 2 oz of water; after 2 minutes, the solution was stirred for 30 seconds and poured through the tube and flushed with 1 oz of water. Samples were filtered and analyzed by HPLC. Ten replicates were performed for each type of feeding tube. For cups, the mean amount of drug recovered ranged from 95.7% to 100.5% of the label claim, with a relative standard deviation (RSD) range of 1.1-6.3%. For gastrostomy and nasoenteric tubes, the mean amount of drug recovered ranged from 98.3% to 101.9% of label claim, with an RSD range of 0.9-3.3%. A simple and accurate procedure was developed for dissolving risedronate tablets in water to prepare a liquid formulation for administration orally or through feeding tubes.

  5. 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

  6. Design and in vitro evaluation of zidovudine oral controlled release tablets prepared using hydroxypropyl methylcellulose.

    PubMed

    Ravi, Punna Rao; Ganga, Sindhura; Saha, Ranendra Narayan

    2008-04-01

    Oral controlled release matrix tablets of zidovudine were prepared using different proportions and different viscosity grades of hydroxypropyl methylcellulose. The effect of various formulation factors like polymer proportion, polymer viscosity and compression force on the in vitro release of drug were studied. In vitro release studies were carried out using United States Pharmacopeia (USP) type 1 apparatus (basket method) in 900 ml of pH 6.8 phosphate buffer at 100 rpm. The release kinetics were analyzed using Zero-order model equation, Higuchi's square-root equation and Ritger-Peppas' empirical equation. Compatibility of drug with various formulations excipients used was studied. In vitro release studies revealed that the release rate decreased with increase in polymer proportion and viscosity grade. Increase in compression force was found to decrease the rate of drug release. Matrix tablets containing 10% hydroxypropyl methylcellulose (HPMC) 4000 cps were found to show a good initial drug release of 21% in the first hour and extended the release upto 16 h. Matrix tablets containing 20% HPMC 4000 cps and 10% HPMC 15000 cps showed a first hour release of 18% and extended the release upto 20 h. Mathematical analysis of the release kinetics indicated that the nature of drug release from the matrix tablets followed non-Fickian or anomalous release. No incompatibility was observed between the drug and excipients used in the formulation of matrix tablets. The developed controlled release matrix tablets of zidovudine, with good initial release (17-25% in first hour) and which extend the release upto 16-20 h, can overcome the disadvantages of conventional tablets of zidovudine.

  7. Use of oral contraceptives blunts the calciuric effect of caffeine in young adult women.

    PubMed

    Ribeiro-Alves, Mirna A; Trugo, Luiz C; Donangelo, Carmen M

    2003-02-01

    Caffeine consumption increases the urinary excretion of calcium and other minerals. Factors that affect caffeine metabolism such as steroid hormones may modify this effect. The purpose of this study was to evaluate the influence of oral contraceptive (OC) use on the 4-h urinary excretion of calcium, phosphorus, magnesium, zinc, sodium, potassium and caffeine metabolites in response to a high caffeine dose given as coffee beverage. Adult women, 20-29 y, users (+OC, n = 15) and nonusers (-OC, n = 15) of oral contraceptives, with calcium intake approximately 500 mg/d, participated in two tests, caffeine load (5 mg/kg body weight) and no-caffeine control, in a randomized crossover design. The net increase (caffeine load corrected by no caffeine) in urinary excretion of most minerals was significantly higher in -OC than in +OC (P < 0.05), with the larger group difference for calcium (ninefold) followed by magnesium (twofold), zinc (onefold) and potassium (onefold). Net increases in urinary excretion of 1-methylurate and paraxanthine were about three- and fivefold higher, respectively, in -OC than in +OC (P < 0.05) whereas net increases in urinary excretion of 5-acetylamino-6-formylamino-3-methyluracil (AFMU) and 1,7-dimethylurate were over twofold higher in the +OC than in -OC (P < 0.05). Following the caffeine load, most urinary minerals showed negative correlation with urinary 1-methylurate in -OC (R Oral contraceptives appear to limit the renal effect of caffeine on mineral excretion possibly by reducing paraxanthine excretion, the most active caffeine metabolite.

  8. Case-control study of oral contraceptive use and risk of breast cancer.

    PubMed

    Rosenberg, L; Palmer, J R; Rao, R S; Zauber, A G; Strom, B L; Warshauer, M E; Harlap, S; Shapiro, S

    1996-01-01

    The relation of oral contraceptive use to the risk of breast cancer in white women aged 25-59 years was assessed with data collected during 1977-1992 in a case-control surveillance system in hospitals in Boston, New York, and Philadelphia. A total of 3,540 cases with breast cancer were compared with 4,488 controls with nonmalignant nongynecologic conditions unrelated to oral contraceptive use. Relative risk estimates were obtained by unconditional logistic regression with control for major risk factors. For at least 1 year of use relative to less than 1 year, the multivariate relative risk estimate was 1.7 (95% confidence interval (CI) 1.3-2.3) in women aged 25-34 years, 0.9 (95% CI 0.7-1.0) in women aged 35-44 years, and 1.2 (95% CI 1.0-1.4) in women aged 45-59 years (p < 0.01 for the difference across age). Among women aged 25-34 years, the relative risk estimates were greatest for use of long duration, but the trend was not statistically significant (p = 0.17); in addition, the duration of use was correlated with the recency of use, and it was not possible to distinguish their effects. Among women aged 35-44 years, the relative risk estimate decreased with increasing duration of use (p = 0.01). Among women aged 45-59 years, some relative risk estimates were increased, but there was no consistent pattern. The results add to the evidence of an association between oral contraceptive use and an increased risk of breast cancer at young ages.

  9. 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

  10. Use of medicated drops and oral tablets in glaucoma treatment.

    PubMed

    Greenwell, C; Spillman, D

    1996-04-01

    This paper addresses the many forms of treatment for glaucoma. We studied particularly the topical drops and oral medications that are most frequently prescribed by ophthalmologists, specifically examining the reasons for the side effects experienced by certain patients taking topical drops and oral medications. Some of the side effects and interactions are discussed, and the importance of proper procedure for application of topical eye drops is stressed. Finally, we emphasize that proper drug usage is critical to the well being of the patient.

  11. Comparison of scales for evaluating premenstrual symptoms in women using oral contraceptives.

    PubMed

    Coffee, Andrea L; Kuehl, Thomas J; Sulak, Patricia J

    2008-05-01

    To compare two scales used in research to evaluate daily premenstrual mood symptoms during use of a monophasic oral contraceptive. Subanalysis of data from a prospective study. University-affiliated medical center. SUBJECTS; One hundred two reproductive-aged (18-48 yrs) women taking a monophasic oral contraceptive containing ethinyl estradiol and drospirenone in the standard 21-7 fashion (21 days of hormones followed by 7 days of placebo), and who had self-identified premenstrual symptoms of headache, mood changes, or pelvic pain. Subjects completed a single-item questionnaire, the Scott & White Daily Diary of Symptoms, and a multiple-item questionnaire, the Penn State Daily Symptom Report (DSR), to assess their premenstrual symptoms. The Scott & White diary used a visual analog scale of 0-10 to assess pelvic pain, headache, and mood (a composite of anxiety, depression, and irritability). The Penn State DSR contained 17 items: 10 behavioral and seven physical components, each rated on a scale of 0-4, with one item that specifically rated mood swings. Scores from the two scales were compared by using Spearman correlation coefficients, the Kendall W for concordance, and linear regression of ranked sums for study cycles. The Scott & White mood score significantly correlated with the total of the 17 items on the Penn State DSR, as well as the 10 behavioral items, the seven physical items, and the single mood-swing item (p<0.0001); specific coefficients of concordance were 0.44, 0.23, 0.10, and 0.28, respectively, and R2 values were 0.39, 0.39, 0.30, and 0.34, respectively. The daily Scott & White mood score was positively correlated with all 17 elements of the Penn State DSR (0.25-0.57). The greatest correlation was seen with the mood-swing element. Both instruments demonstrated the same patterns during the 21-7 oral contraceptive cycle, with symptoms increasing immediately before and peaking during the 7-day hormone-free interval. A single-item daily mood score using

  12. Hepatocellular carcinoma associated with precocious puberty and oral contraceptives. A case report.

    PubMed

    Mansvelt, B; Etienne, P Y; Bertrand, C; Henrion, J; Gerard, R

    2003-08-01

    A 36-year-old woman presented with sudden abdominal pain and vomiting. Computed tomography showed a tumour of the right hepatic lobe with possible signs of acute haemorrhage. Her medical history revealed precocious puberty when she was a 5-year-old and the use of oral contraceptives for 18 years. Bisegmentectomy was performed and histological examination revealed hepatocellular carcinoma. The role of male and female sex hormones in the development of hepatic tumours has been well documented but, to our knowledge, association with precocious puberty has not yet been described.

  13. Procoagulant changes induced by oral contraceptives are balanced by an increased fibrinolytic tendency.

    PubMed

    Mackie, I J; Campbell, S; Gallimore, M; Robinson, G; Machin, S J

    1992-01-01

    Oral contraceptives caused increased fibrinogen, FVII, FX, and fibrinolysis. The latter was associated with elevated FXII and PKK, while C1-INH was decreased, ATIII and alpha 2M were unchanged; it could not be accounted for by changes in t-PA, u-PA, PAI, plasminogen, alpha 2-AP, proteins C or S. HCII and alpha 1-PI were increased and may regulate the availability of thrombin and FXIa. The increased FXII/PKK dependent fibrinolytic potential and HCII may offset any increase in thrombin generation, while alpha 1-PI limits intrinsic coagulation.

  14. Peripheral arterial disease in a female using high-dose combined oral contraceptive pills.

    PubMed

    Pallavee, P; Samal, Sunita; Samal, Rupal

    2013-01-01

    The association between oral contraceptive (OC) pills and vascular diseases is well-known, although, the present generation of pills is considered to be relatively safer in this regard. Hormonal treatment for severe abnormal uterine bleeding is usually considered after ruling out malignancy, when such bleeding is resistant to all other forms of treatment. We report a case of severe peripheral arterial disease in a female, who had been on high-dose OC pills for an extended period of time for severe uterine bleeding.

  15. How Oral Contraceptives Impact Social-Emotional Behavior and Brain Function.

    PubMed

    Montoya, Estrella R; Bos, Peter A

    2017-02-01

    Millions of women worldwide use oral contraceptives ('the pill'; OCs), often starting at a pubertal age when their brains are in a crucial developmental stage. Research into the social-emotional effects of OCs is of utmost importance. In this review, we provide an overview of studies that have emerged over the past decade investigating how OCs, and their main ingredients estradiol (E) and progesterone (P), influence social-emotional behaviors and underlying brain functions. Based on this overview, we present a heuristic model that postulates that OCs modulate core social-emotional behaviors and brain systems. Research domains and challenges for the future, as well as implications, are discussed.

  16. Sucralose as co-crystal co-former for hydrochlorothiazide: development of oral disintegrating tablets.

    PubMed

    Arafa, Mona F; El-Gizawy, Sanaa A; Osman, Mohamed A; El Maghraby, Gamal M

    2016-08-01

    Development of oral disintegrating tablets requires enhancement of drug dissolution and selection of sweetener. Co-crystallization of drugs with inert co-former is an emerging technique for enhancing dissolution rate. The benefit of this technique will become even greater if one of the sweeteners can act as co-crystal co-former to enhance dissolution and mask the taste. Accordingly, the objective of this work was to investigate the efficacy of sucralose as a potential co-crystal co-former for enhancing the dissolution rate of hydrochlorothiazide. This was extended to prepare oral disintegrating tablets. Co-crystallization was achieved after dissolving hydrochlorothiazide with increasing molar ratios of sucralose in the least amount of acetone. The co-crystallization products were characterized using Fourier transform infrared spectroscopy, differential thermal analysis and powder X-ray diffraction. These measurements indicated that co-crystallization process started at a drug sucralose molar ratio of 1:1 and completed at 1:2. The developed co-crystals exhibited faster drug dissolution compared with the control, with co-crystal containing the drug with sucralose at 1:2 molar ratio being optimum. The later was used to prepare fast disintegrating tablets. These tablets had acceptable physical characteristics and showed fast disintegration with subsequent rapid dissolution. The study introduced sucralose as co-crystal co-former for enhanced dissolution and masking the taste.

  17. Bioequivalence study with lapatinib powder for oral suspension and the original tablet formulation in cancer patients.

    PubMed

    Koch, Kevin M; Ferron-Brady, Geraldine; Lemmon, Colleen; Cartee, Leanne; Hollyfield, Hedy; D'Amelio, Anthony M; Piepszak, Alexandra; Swaby, Ramona F; Curran, David; Arya, Niki

    2015-01-01

    Lapatinib is approved for use in various therapeutic combinations for treating metastatic breast cancers that over-express HER2. To deliver the approved doses, up to six large tablets need to be ingested with the current 250-mg tablets. For ease of ingestion, a powder for oral suspension was developed. This study was an open-label, randomized, adaptive design, two-period crossover bioequivalence study of the powder for suspension relative to the commercial tablet at steady state following once daily dosing for 7 days in patients with advanced cancer. To minimize the number of cancer patients required for a pivotal bioequivalence study (144 in this case), a four-stage adaptive group sequential design with interim analyses after every 36 subjects was implemented to allow for early termination. Bioequivalence for the oral suspension relative to the commercial tablet was demonstrated in both the first (and only) interim analysis and the final analysis, as the 90% confidence intervals for the treatment comparison ratios for both AUC0-24 and Cmax were contained within the acceptance criteria (0.80, 1.25). Additionally, there was no statistical difference in tlag or tmax , suggesting no difference in the absorption rate between treatments. There were no unexpected safety findings during this study.

  18. Ovarian Follicular Development During the Use of Oral Contraception: A Review

    PubMed Central

    Baerwald, Angela R.; Pierson, Roger A.

    2010-01-01

    Over the past 40 years, alterations to the composition of oral contraceptives (OCs) have been made in attempts to reduce adverse effects and to improve patient compliance while maintaining contraceptive efficacy. However, there is growing evidence to indicate that reducing the estrogen dose to minimize adverse effects may have compromised the degree of hypothalamo-pituitary-ovarian suppression, particularly during the hormone-free interval (HFI) or following missed doses. Follicle development during OC use appears to occur in association with a loss of endocrine suppression during the HFI. This information provides a rationale for reducing or eliminating the HFI in OC regimens. There is also evidence for an increased risk of follicle development and ovulation in women who use delayed OC initiation schemes, such as the “Sunday Start” method. It is not currently known why some follicles ovulate during OC use while others regress or form anovulatory follicle cysts. Continued research about follicle development during OC use would provide insight into understanding the precise mechanisms of action underlying combined OCs, as well as those of continuous OC formulations and emergency contraceptive regimens. PMID:14715122

  19. The interaction of phenytoin and carbamazepine with combined oral contraceptive steroids.

    PubMed Central

    Crawford, P; Chadwick, D J; Martin, C; Tjia, J; Back, D J; Orme, M

    1990-01-01

    Patients taking oral contraceptive steroids (OCS) are known to suffer contraceptive failure while taking anticonvulsants such as phenobarbitone, phenytoin and carbamazepine. We have studied the single dose kinetics of ethinyloestradiol (EE2); 50 micrograms, and levonorgestrel (Ng); 250 micrograms in groups of women before and 8-12 weeks after starting therapy with phenytoin (n = 6) and carbamazepine (n = 4). The area under the plasma concentration-time curve (AUC) was measured over a 24 h period for each steroid and significant reductions were seen with both anticonvulsants. Phenytoin reduced the AUC for EE2 from 806 +/- 50 (mean +/- s.d.) to 411 +/- 132 pg ml-1 h (P less than 0.05) and for Ng from 33.6 +/- 7.8 to 19.5 +/- 3.8 ng ml-1 h (P less than 0.05). Carbamazepine reduced the AUC for EE2 from 1163 +/- 466 to 672 +/- 211 pg ml-1 h (P less than 0.05) and for Ng from 22.9 +/- 9.4 to 13.8 +/- 5.8 ng ml-1 h (P less than 0.05). These changes are compatible with the known enzyme inducing effects of phenytoin and carbamazepine. Patients taking these anticonvulsants will need to be given increased doses of OCS (equivalent to 50-100 micrograms EE2 daily) to achieve adequate contraceptive effects. PMID:2126946

  20. Sexual and Contraceptive Behaviors among Adolescents Requesting Emergency Contraception.

    PubMed

    Cwiak, Carrie; Howard, Brandon; Hsieh, Jennifer; Ricciotti, Nancy; Sucato, Gina S

    2016-12-01

    Unintended pregnancy rates in the United States remain high among adolescents. Emergency contraception (EC) provides the only option for pregnancy prevention after unprotected sex. To better define the population of adolescents who request and use EC pills, we performed a post hoc analysis of an over-the-counter simulation study of EC pills. Teen reproductive health clinics in 5 cities. Adolescents between the ages of 13 and 17 years who requested EC. Single-tablet levonorgestrel 1.5 mg. We calculated the correlations between age and baseline sexual and contraceptive behaviors. χ(2) Tests were used to compare behaviors of first-time and repeat EC users. Overall, the most commonly reported contraceptive methods ever used were condoms, oral contraceptives, none, and withdrawal; the most common method ever used in each age group was no method for 13- to 14-year-olds and condom for 15-, 16-, and 17-year-olds. The percentage of participants who had never used contraception before requesting EC decreased with age (53% [20/28] of 13- to 14-year-olds vs 15% [10/65] of 17-year-olds). First-time EC users were more likely to report no previous contraceptive use compared with repeat EC users (42% [88/208] vs 10% [13/135]; P < .001). Regardless of age, the most commonly reported reason for requesting EC was nonuse of any contraceptive method (ie, "unprotected sex"). Adolescents who requested EC most commonly reported ever-use of contraceptive methods that rely on user adherence or no method at all, with younger adolescents more likely than older adolescents to have used no previous method. The provision of EC presents an opportunity to provide education and access to highly effective, long-term contraceptive methods. Copyright © 2016 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

  1. [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.

  2. Effect of betel chewing on the frequency of sister chromatid exchanges in pregnant women and women using oral contraceptives.

    PubMed

    Ghosh, P K; Ghosh, R

    1988-06-01

    The incidence of sister chromatid exchange (SCE) was investigated in the lymphocyte chromosomes of betel chewing and non-chewing normal women, pregnant women, and women using oral contraceptives. The frequency of SCE was found to be 7.82 +/- 0.24 and 8.27 +/- 0.27 in non-chewing pregnant women and women using oral contraceptives respectively, which were significantly higher than the mean value of 5.21 +/- 0.18 observed in non-chewing normal women. Betel chewing induced higher SCE in pregnant women and women using oral contraceptives, the frequencies being 11.79 +/- 0.38 and 12.51 +/- 0.44, respectively, which were significantly higher than the SCE frequency of 6.28 +/- 0.21 found in normal betel chewing females.

  3. Are oral contraceptive use and menstrual cycle phase related to anterior cruciate ligament injury risk in female recreational skiers?

    PubMed

    Ruedl, Gerhard; Ploner, Patrick; Linortner, Ingrid; Schranz, Alois; Fink, Christian; Sommersacher, Renate; Pocecco, Elena; Nachbauer, Werner; Burtscher, Martin

    2009-09-01

    Oral contraceptive use and menstrual cycle phase are suggested to influence the risk of anterior cruciate ligament (ACL) injuries in female athletes. However, only few data are available for recreational sports. Therefore, female recreational skiers with a non-contact ACL injury and age-matched controls completed a self-reported questionnaire relating to menstrual history, oral contraceptive use and previous knee injuries. Menstrual history data were used to group subjects into either preovulatory or postovulatory phases of menstrual cycle. Our findings suggest that oral contraceptive use did not show any protective effect against ACL injuries nor did self-reported previous knee injuries show any association with ACL injury rate in recreational alpine skiing. Analysis of menstrual history data revealed that recreational skiers in the preovulatory phase were significantly more likely to sustain an ACL injury than were skiers in the postovulatory phase.

  4. Factors associated with the contraindicated use of oral contraceptives in Brazil.

    PubMed

    Corrêa, Daniele Aparecida Silva; Felisbino-Mendes, Mariana Santos; Mendes, Mayara Santos; Malta, Deborah Carvalho; Velasquez-Melendez, Gustavo

    2017-01-12

    To estimate the prevalence of the contraindicated use of oral contraceptives and the associated factors in Brazilian women. 20,454 women who answered the VIGITEL survey in 2008 also participated in this study, of which 3,985 reported using oral contraceptives. We defined the following conditions for the contraindicated use of contraceptives: hypertension; cardiovascular diseases such as heart attack, stroke/cerebrovascular accident; diabetes mellitus; being smoker and 35 years old or older. We estimated the prevalence and 95% confidence intervals of contraindicated use in users of oral contraceptives and the factors associated with contraindication by prevalence ratio and 95% confidence intervals. In the total population, 21% (95%CI 19.7-21.9) of women showed some contraindication to the use of oral contraceptives, of which 11.7% (95%CI 10.6-13.7) belonged to the group of users of oral contraceptives. The most frequent contraindication in users of oral contraceptives was hypertension (9.1%). The largest proportion of women with at least one contraindication was aged between 45 and 49 years (45.8%) and with education level between zero and eight years (23.8%). The prevalence of contraindication to oral contraceptives was higher in women less educated (zero to eight years of study) (PR = 2.46; 95%CI 1.57-3.86; p < 0.05) and with age between 35-44 years (PR = 4.00; 95%CI 2.34-6.83) and 45-49 years (PR = 5.59; 95%CI 2.90-10.75). Age greater than or equal to 35 and low education level were demographic and iniquity factors, respectively, in the contraindicated use of oral contraceptives. Estimar a prevalência de contraindicação ao uso de anticoncepcionais orais e os fatores associados em mulheres brasileiras. Participaram 20.454 mulheres que responderam ao inquérito Vigitel em 2008, das quais 3.985 reportaram uso de contraceptivos orais. Definiu-se como uso contraindicado de anticoncepcionais quando presente pelo menos uma condição: hipertensão; doen

  5. 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)

  6. 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

  7. Effects of transdermal and oral contraceptives on estrogen-sensitive hepatic proteins.

    PubMed

    White, Terry; Ozel, Begüm; Jain, John K; Stanczyk, Frank Z

    2006-10-01

    The purpose of this study was to evaluate the effects of the contraceptive patch and an oral contraceptive (OC) on serum concentrations of estrogen-sensitive hepatic proteins, ethinyl estradiol (EE) and levonorgestrel (LNG). Twenty-four women were randomized to receive three cycles of a contraceptive patch that delivers EE 20 microg/day and norelgestromin 150 microg/day or an OC that contains EE 35 microg and norgestimate 250 microg. Blood samples were taken at baseline and at the end of Cycle 3. Serum levels of sex-hormone-binding globulin (SHBG), thyroxine-binding globulin (TBG), corticosteroid-binding globulin (CBG) and C-reactive protein (CRP) were quantified by immunoassay methods. EE and LNG levels in patch users were measured by radioimmunoassay (RIA) and liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay. The paired t test and Student's t test were used for statistical analysis. Nineteen women completed the study (patch, n=10; OC, n=9). Treatment with both the patch and OC resulted in significant increases from baseline in SHBG, TBG and CBG. The increase in CRP was significant in the patch group and approached significance in the OC group. The increases in SHBG and TBG observed with the patch were significantly greater than those associated with the OC. By way of RIA and LC-MS/MS assay methods, the patch was associated with mean EE levels of 114 and 111 pg/mL, respectively. The serum concentrations of estrogen-sensitive hepatic proteins and EE associated with the patch suggest that this new contraceptive system may have relatively large net estrogen effects.

  8. Clinical comparison of monophasic oral contraceptive preparations of gestodene/ethinyl estradiol and desogestrel/ethinyl estradiol. Latin American Oral Contraceptive Study Group.

    PubMed

    1994-09-01

    The efficacy, cycle control, subjective complaints, and safety of monophasic preparations of the oral contraceptives containing gestodene 75 mcg plus ethinyl estradiol 30 mcg versus desogestrel 150 mcg plus ethinyl estradiol 30 mcg were compared in a 6-cycle, open-label, parallel, randomized, multicenter phase IV clinical study in Latin America. Of a total of 176 women in each group, 163 in the gestodene group and 160 in the desogestrel group completed 6 cycles, providing data for 1,015 and 1,006 cycles, respectively. Subject compliance was excellent; pills were missed during only 6.9% of the cycles in each group. No woman became pregnant during the study. Gestodene group exhibited significantly better cycle control as evidenced by the lower incidence of breakthrough bleeding and spotting. Spotting in some cycles was reported by 11.9% of women taking the gestodene-combination compared with 21% of women taking the desogestrel-combination. Based on number of women, 86.4% of the gestodene group reported all cycles were normal (no BTB) compared with 76.7% of the desogestrel group. Also, the women in the gestodene group reported a significantly lower incidence of nuisance side effects during treatment cycles. No amenorrhea was observed for either group. There were no clinically significant differences between groups with respect to body weight, blood pressure, or laboratory evaluations. Seven women withdrew from the gestodene group and 8 women withdrew from the desogestrel group because of adverse reactions. The results of this study indicate that, although both OCs provided effective contraception, in comparison to the desogestrel-combination, the gestodene-containing OC is associated with better cycle control, less bleeding, and fewer subjective complaints.

  9. [Influence of the use of oral contraceptives as risk factors for human papillomavirus infection and cervical intraepithelial neoplasia].

    PubMed

    Salazar, E Lucia; González, J Luis; Olmos, Alejandro; Calzada, Leobardo

    2005-02-01

    To study the influence of oral contraception use as risk factor for human papillomavirus infection (HPV) and progression to cervical intraepithelial neoplasia (CIN). A prospective, transversal and comparative study of 84 female patients in reproductive age that had used oral contraception for more than three years as birth control method and who had CIN mild (CIN I), moderate (CIN II) or severe (CIN III) associated or not to HPV infection documented by colposcopy, pathology and cytology was done. 84 cases and 60 controls submitted to a directed interrogation were studied. Differences among groups were determined by linear regression, multivariance and logistic regression tests, p <0.05 was considered statistically significant. Average age for cases and controls was 37.5 and 36.2 years, respectively. The 70% of patients started their active sexual life in the second decade of their life. The most frequent age was 18 and 19 years. 50.6% of these patients had more than one sexual partner, two in average. 67.8% of cases had HPV infection and applying the multivariance analysis: sexual partners (p < 0.05), age at first pregnancy (p < 0.05) and oral contraception use (p < 0.05) were considered statistically significant. According to the CIN grade, the HPV presence was found as highly statistically significant (p < 0.001). Oral contraception use was found as risk factor for HPV infection by logistic regression (p = 0.0242); OR = 3.2714; CI = 1.1670-9.1702. As for the CIN degree, HPV presence was found as highly significant (p = 0.0001); OR = 2.4158; CI = 1.7150-3.4028. A high incidence of HPV was found in our study. This is an important risk factor during cellular transformation, so the use of oral contraception as birth control method could accelerate the viral oncogenes expression present in HPV cellular genome. It is highly recommended to discard HPV infection before prescribing oral contraception as birth control method.

  10. Norethindrone acetate 1.0 milligram and ethinyl estradiol 10 micrograms as an ultra low-dose oral contraceptive.

    PubMed

    Archer, David F; Nakajima, Steven T; Sawyer, Allan T; Wentworth, Jeffrey; Trupin, Suzanne; Koltun, William D; Gilbert, Richard D; Ellman, Herman

    2013-09-01

    To assess the efficacy, safety, and tolerability of an extended-duration, combined hormonal oral contraceptive pill (OCP) that reduces the estrogen exposure by almost half compared with other OCPs. This open-label, uncontrolled, multicenter study used an ultra low-dose OCP (1.0 mg norethindrone acetate and 10 micrograms ethinyl E2). The OCP was administered in a regimen of 24 days of a 28-day cycle followed by 10 micrograms ethinyl E2 for 2 days and an inactive tablet for 2 days. The study included healthy, heterosexually active women aged 18-45 years who were at risk of pregnancy. The discontinuation rate was 41.7% (692/1,660 patients). Twenty-six pregnancies occurred in 1,555 participants during 15,596 at-risk cycles, resulting in a Pearl Index of 2.2 and a cumulative pregnancy rate of 2.1 for the overall population. Participants experienced an average of 2.6 days of intracyclic (unscheduled) bleeding or spotting per cycle over treatment cycles 213. Intracyclic bleeding was more common in users new to OCPs than in users switching from another OCP and in women aged 18-35 years compared with those aged 36 years or older. The frequency of bleeding episodes decreased after cycle 2 and throughout treatment in all subpopulations. The findings of this study demonstrate that this ultra low-dose OCP regimen is effective in preventing pregnancy with a safety and tolerability profile that is comparable with that reported for other low-dose OCPs. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00391807. III.

  11. Emergency contraception.

    PubMed

    1994-01-01

    Two oral postcoital contraceptive agents are currently available. The first is a 2 x 2 pill; the second is a 5 x 5. Both release a higher dose of hormones than conventional contraceptive pills. Success rates range between 96% and 99%. They must be taken within 72 hours of intercourse. Side effects include nausea and vomiting. Contraindications are the same as for the common oral contraceptives. The contraceptive mode of action can be any of the following: 1) by making the lining of the uterus unreceptive; 2) by slowing the movement of the egg in the fallopian tube; or 3) by affecting the release of the egg. Emergency contraceptive pills have no effect once implantation takes place. The IUD can be used as an emergency postcoital contraceptive method if placed within 10 days of coitus. They are usually placed within 5-7 days because of laws regarding when birth control becomes abortion. One failure has been reported in Great Britain (December, 1993). Side effects are the same as with regular use. RU486/PG may be used in the future as an emergency contraceptive agent. Research is in progress on success rates and side effects. This agent could potentially be used at any time. Currently, emergency contraception can only be obtained by prescription. Limited hours and interrogating staff are obstacles in such emergencies. British women's groups are asking that emergency oral contraceptive pills be made available over the counter with advice from the pharmacist.

  12. Venous Thromboembolism Due to Oral Contraceptive Intake and Spending Nights in a Vehicle -A Case from the 2016 Kumamoto Earthquakes-

    PubMed Central

    Sueta, Daisuke; Akahoshi, Rika; Okamura, Yoshinori; Kojima, Sunao; Ikemoto, Tomokazu; Yamamoto, Eiichiro; Izumiya, Yasuhiro; Tsujita, Kenichi; Kaikita, Koichi; Katabuchi, Hidetaka; Hokimoto, Seiji

    2017-01-01

    A 40-year-old woman experiencing sudden dyspnea went to her personal doctor for advice. She was previously diagnosed with endometriosis and prescribed oral contraceptives for treatment. During earthquakes, she spent 7 nights sleeping in a vehicle. The patient had swelling and pain in her left leg and high D-dimer concentration levels. A contrast-enhanced computed tomography scan revealed a contrast deficit in the bilateral pulmonary artery and in the left lower extremity. She was diagnosed with pulmonary thromboembolism (PTE), and anticoagulation therapy was initiated. This present case is the first report of PTE attributed to the use of oral contraceptives after earthquakes. PMID:28202862

  13. Venous Thromboembolism Due to Oral Contraceptive Intake and Spending Nights in a Vehicle -A Case from the 2016 Kumamoto Earthquakes.

    PubMed

    Sueta, Daisuke; Akahoshi, Rika; Okamura, Yoshinori; Kojima, Sunao; Ikemoto, Tomokazu; Yamamoto, Eiichiro; Izumiya, Yasuhiro; Tsujita, Kenichi; Kaikita, Koichi; Katabuchi, Hidetaka; Hokimoto, Seiji

    2017-01-01

    A 40-year-old woman experiencing sudden dyspnea went to her personal doctor for advice. She was previously diagnosed with endometriosis and prescribed oral contraceptives for treatment. During earthquakes, she spent 7 nights sleeping in a vehicle. The patient had swelling and pain in her left leg and high D-dimer concentration levels. A contrast-enhanced computed tomography scan revealed a contrast deficit in the bilateral pulmonary artery and in the left lower extremity. She was diagnosed with pulmonary thromboembolism (PTE), and anticoagulation therapy was initiated. This present case is the first report of PTE attributed to the use of oral contraceptives after earthquakes.

  14. 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.

  15. Efficacy and safety of a levonorgestrel enteric-coated tablet as an over-the-counter drug for emergency contraception: a Phase IV clinical trial

    PubMed Central

    Chen, Q.-J.; Xiang, W.-P.; Zhang, D.-K.; Wang, R.-P.; Luo, Y.-F.; Kang, J.-Z.; Cheng, L.-N.

    2011-01-01

    BACKGROUND An enteric-coated levonorgestrel emergency contraceptive pill (E-LNG-ECP) is an improved formulation, in terms of side effects, which both dissolves and is absorbed in the intestine. Our aim was to evaluate the efficacy and safety of E-LNG-ECP as an over-the-counter (OTC) drug for emergency contraception (EC) in Chinese women. METHODS A Phase IV clinical trial was conducted in five family planning clinics in China. Women seeking EC within 72 h after unprotected sexual intercourse or contraceptive failure who met the inclusion criteria were recruited. The efficacy of contraception (primary end-point was pregnancy rate), side effects (i.e. safety) and the value of E-LNG-ECP for EC were investigated. RESULTS Of 2445 women (aged 15–48 years) who took E-LNG-ECP with follow-up to determine pregnancy, only five pregnancies (0.2%) occurred. The efficacy of contraception was 95.3%. In total, 6.5% of women reported at least one adverse event after taking E-LNG-ECP, and no serious adverse events were reported. Only four subjects (0.16%) reported vomiting. The incidence of menstrual cycle disturbance was 20.1% after taking E-LNG-ECP. Subjects who had previously taken ECPs (54.4% of these women) rated the acceptability of E-LNG-ECP at 9.36 (on a 10-point scale) higher (P<0.05) than the rating of other LNG-EC pills taken previously. CONCLUSIONS The study found that E-LNG-ECP was effective, safe and well tolerated as an OTC drug. However, an randomized controlled trial should be performed to compare standard LNG tablets with E-LNG-ECP. PMID:21672924

  16. Effects of switching from oral to transdermal or transvaginal contraception on markers of thrombosis

    PubMed Central

    Jensen, Jeffrey T.; Burke, Anne E.; Barnhart, Kurt T.; Tillotson, Carrie; Messerle-Forbes, Marci; Peters, Dawn

    2009-01-01

    Background The study was conducted to determine the impact of switching from oral to transdermal patch or vaginal ring contraception on biomarkers of thrombosis. Study Design Current healthy oral contraceptive (OC) users were randomized to switch to either a contraceptive ring (CR) or patch (CP) and underwent phlebotomy to measure surrogate biomarkers of thrombosis (sex hormone binding globulin (SHBG), free protein S, and activated protein C-resistance (APC-r)) before switching, and during the 4th cycle of use of the new method. Results Of 142 reproductive age women enrolled, 120 sample pairs were available for analysis. SHBG increased significantly from baseline in CP users (mean change (95% CI) +29.9 nM (9.6, 50) but not in CR users −1.6 (−16.6, 13.5). Protein S decreased significantly from baseline in CP users (mean change −7.1% (−12.1, −2.1), but increased significantly in CR users +5.3% (1.1, 9.6). The APC-r ratio did not undergo a significant change from baseline in either group [CP +0.06 (−0.06, 0.18), CR +0.02 (−0.10, 0.14)] Compared to CR users, subjects using the CP had significantly higher SHBG (187.5 (167.0, 208), 146 (132.6,159.4), p = 0.012), significantly lower protein S (81.8 (76.8, 86.8), 93.6 (89.1, 98.1), p = 0.001), and similar APC-r ratios (2.99 (2.85,3.14), 3.09 (2.96, 3.22), p = 0.3) at the cycle 4 visit. Conclusion OC users who switch to the ring exhibit beneficial changes in biomarkers of thrombosis while those switching to the patch display a shift favoring clot formation. PMID:19014790

  17. 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

  18. Deep vein thrombosis in a woman taking oral combined contraceptive pills.

    PubMed

    Piparva, Kiran G; Buch, Jatin G

    2011-07-01

    Oral combined contraceptive pill (OCCP) is popular as birth control pills. Like all other drugs, they are not free from risks. Women taking certain types of OCCP have higher risk of developing deep vein thrombosis (DVT). A 29 year old married woman had taken OCCP for 3.5 months, developed deep vein thrombosis of left leg. Hereditary and acquired causes of DVT were excluded. She was treated with parenteral and oral anticoagulants simultaneously and was advised to discontinue OCCP. Initially the risk of blood clot was believed to be due to dose of estrogen but recent study relates it to the type of progesterone involved in OCCP. Thus, it is still a matter of debate, whether to associate risk of DVT to the amount of estrogen alone or also to the type of progestin. Apart from careful selection of patients, one should also look for the risk of venous thromboembolism irrespective of type of OCCP prescribed.

  19. 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

  20. Oral contraceptive use by teenage women does not affect peak bone mass: a longitudinal study.

    PubMed

    Lloyd, T; Taylor, D S; Lin, H M; Matthews, A E; Eggli, D F; Legro, R S

    2000-10-01

    To determine the effect of oral contraceptive pill (OCP) use during adolescence on peak bone mass. Longitudinal observational study. Academic clinical research center. Sixty-two non-Hispanic, white females in The Penn State Young Women's Health Study, who were studied for 8 years during ages 12-20. There were 28 OCP users, who used OCPs for a minimum of 6 months and were still using at age 20, and 34 nonusers who had never used OCPs. Total body bone, dedicated hip bone, and body composition measurements were made by dual-energy roentgenogram absorptiometry. The OCP users and nonusers did not differ at entry in anthropometric, body composition, or total body bone measurements. By age 20, the average duration of OCP use by the user group was 22 months. At age 20, the groups remained indistinguishable in anthropometric, body composition, total body, and hip bone measures, and in age of menarche and sports exercise scores. Oral contraceptive pill use by healthy, white, teenage females does not affect acquisition of peak bone mass.

  1. Oral contraceptives and their influence on porphyrin concentrations in erythrocytes and urine.

    PubMed

    Kansky, A; Gregorc, J; Pavlic, M

    1978-01-01

    In 15 females who have never before taken oral contraceptives, the porphyrin concentration in erythrocytes and in urine were investigated. The laboratory assays were performed before and after being on the oral contraceptive Stediril during 5 months (2 women took Stediril during only 3 months). The mean PP concentration in the erythrocytes increased from 16.4 microgram (before) to 24.1 microgram/100 ml of erythrocytes after taking Stediril regularly for 5 months. A statistical evaluation with the Student's test showed that at the level of 2%, the t(exp) = 2.58 was larger than the theoretical t(0.02) = 2.47. The difference of the mean CP concentration in the erythrocytes before and after taking Stediril was not statistically significant at the level of 5%. The mean concentration of CP in urine increased from 119.2 to 137.1 microgram in 1,000 ml. This difference was, however, not statistically significant at the level of 5% when assayed with the same test. There was no increase in UP concentration in urine.

  2. Effect of synthetic oestrogens and progestagens in oral contraceptives on bile lipid composition.

    PubMed Central

    Down, R H; Whiting, M J; Watts, J M; Jones, W

    1983-01-01

    The prevalence of cholesterol gall stones in young women has increased since the introduction of oral contraceptives. The synthetic female sex hormones used in these preparations, increase the degree of cholesterol saturation in bile. To determine whether oestrogens, progestagens, or both, are responsible for the change in biliary cholesterol saturation index, a prospective randomised, controlled study was performed. A significant increase in the cholesterol saturation index of bile was observed when either 30 micrograms ethinyloestradiol plus 150 micrograms norgestrel (p = 0.01) or 50 micrograms ethinyloestradiol plus 250 micrograms norgestrel (p less than 0.01) were ingested daily for two months. No change in the cholesterol saturation index was observed when 30 micrograms ethinyloestradiol alone, or 30 micrograms ethinyloestradiol plus 2.5 mg norethisterone were used. The mechanism for the increase in cholesterol saturation index did not appear to involve bile acid metabolism. These results indicate that the progestagen, norgestrel, and not as previously thought the oestrogen, ethinyloestradiol, is responsible for the increase in cholesterol saturation of bile which accompanies the use of oral contraceptives. PMID:6826111

  3. Modification of corporal weight, body fat distribution, blood lipids and glucose levels in oral contraceptive users.

    PubMed

    Carranza-Lira, S; Bueno Fontal, J P

    2000-01-01

    The association between oral contraceptives and the modification of corporal weight and body fat distribution is controversial. The characteristics of the menstrual cycle, lipids and glucose levels were also analyzed. Thirty women who received ethinylestradiol 0.035 mg and norethindrone 0.400 mg for one year were studied. The following variables were analyzed every 3 months: weight, body mass index (BMI), hip perimeter, waist perimeter, waist-hip ratio (WHR), duration of menstrual cycle, quantity of uterine bleeding, as well as blood levels of cholesterol, triglycerides and glucose. Waist and hip perimeters increased during the third evaluation; as well as the BMI starting from the second evaluation. The triglycerides levels rose from the first evaluation. No modifications were found in the WHR, glucose and cholesterol levels and the duration of the menstrual cycle, but the quantity of uterine bleeding decreased from the third month. The oral contraceptive significantly increased BMI and triglycerides level, but no changes were detected in body fat distribution, cholesterol and glucose levels. Uterine bleeding decreased from the first evaluation.

  4. Paracetamol interaction with oral contraceptive steroids: increased plasma concentrations of ethinyloestradiol.

    PubMed Central

    Rogers, S M; Back, D J; Stevenson, P J; Grimmer, S F; Orme, M L

    1987-01-01

    The effect of a single dose of paracetamol (1 g) on plasma concentrations of the oral contraceptive steroids ethinyloestradiol (EE2) and levonorgestrel (LNG) has been studied in six healthy female volunteers. The area under the plasma concentration-time curve (AUC0-24) of EE2 was significantly increased following paracetamol administration by 22% (control 2221 +/- 291; following paracetamol, 2702 +/- 452 pg ml-1 h; mean +/- s.d.; P less than or equal to 0.05). The greatest effect was evident in the time period 0-3 h. There was a significant decrease in the AUC of EE2-sulphate after paracetamol (7736 +/- 3791 pg ml-1 h) compared with control (13161 +/- 4535 pg ml-1 h; P less than or equal to 0.05). Plasma concentrations of LNG were unaltered by concurrent paracetamol administration. We conclude that the administration of a single 1 g dose of paracetamol causes an increase in plasma concentrations of EE2 as a result of a reduction in the sulphation of the steroid. This interaction may be of clinical significance in women on oral contraceptive steroids who regularly take paracetamol. PMID:3111513

  5. 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 wi