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Sample records for oral contraceptive tablets

  1. Oral Contraceptives and Cancer Risk

    MedlinePlus

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

  2. Estrogen and Progestin (Oral Contraceptives)

    MedlinePlus

    ... syndrome [AIDS]) and other sexually transmitted diseases.Some brands of oral contraceptives are also used to treat ... your doctor.Oral contraceptives come in many different brands. Different brands of oral contraceptives contain slightly different ...

  3. Oral Contraceptive Pill and PCOS

    MedlinePlus

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

  4. Oral contraceptive drug interactions.

    PubMed

    Baciewicz, A M

    1985-01-01

    Approximately 50 million women use oral contraceptives (OC). Studies and case reports demonstrate that OC failure may be caused by rifampin, anticonvulsant drugs, and possibly some antibiotics. Contraceptive steroids may interfere with the metabolism of the benzodiazepines, theophylline, and the glucocorticoids. Future investigation will document the clinical significance of other OC interactions as well as give rise to new interactions. PMID:2859674

  5. History of oral contraception.

    PubMed

    Dhont, Marc

    2010-12-01

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

  6. Progestin-Only Oral Contraceptives

    MedlinePlus

    Progestin-only oral contraceptives are used to prevent pregnancy. Progestin is a female hormone. It works by preventing the ... mucus and the lining of the uterus. Progestin-only oral contraceptives are a very effective method of ...

  7. Diabetes and oral contraception.

    PubMed

    Gourdy, Pierre

    2013-02-01

    The prevalence of diabetes mellitus is increasing dramatically worldwide, resulting in more and more women of reproductive age being affected by either type 1 or type 2 diabetes. Management of contraception is a major issue due to the specific risks associated with pregnancy and those potentially induced by hormonal contraceptives in diabetic women. This review emphasizes the urgent need to improve the use of contraception in women with diabetes. There is no consistent evidence that combined oral contraceptives significantly influence the risk of developing diabetes, even in women with a history of gestational diabetes. Furthermore, although data from specific studies remain sparse, no worsening effect has been reported in diabetic women, either in glycemic control or on the course of microvascular complications. Thus, the use of estroprogestive pills is now recognized as a safe and effective option for preconception care of women with uncomplicated diabetes. According to recent guidelines, these contraceptives must be avoided in case of associated cardiovascular risk factors, cardiovascular disease or severe microvascular complications such as nephropathy with proteinuria or active proliferative retinopathy. Prescription of combined hormonal contraception in type 2 diabetic women must also be considered with caution due to a frequent association with obesity and vascular risk factors which increase both thromboembolic and arterial risks. Thanks to their metabolic and vascular safety profile, progestin-only contraceptives, as well as non-hormonal methods, represent alternatives according to patient wishes. PMID:23384747

  8. Antibiotics and oral contraceptives.

    PubMed

    Rubin, D F

    1981-04-01

    Dermatologists often prescribe oral tetracycline for the control of acne, primarily, and to a much lesser extent, for the treatment of cutaneous infections. A number of the patients taking tetracycline are also taking birth control pills. A recent article in the British Medical Journal (1980;1:293) indicates that this combination can lead to a failure of the (OC) oral contraceptive. Such failure had been associated with ampicillin as well. It is believed that the mechanism for this was the disturbance in normal gut flora, with consequent effects on bacterial hydrolysis of steroid conjugates. This would interrupt the enterohepatic circulation of contraceptive steroids, resulting in a less than normal concentration of circulating steroids. It was recommended that women taking low-dose OCs take extra precautions against pregnancy during any cycle in which antibiotics are given. In regard to our care of and responsibilities to our patients, and in an era when malpractice suits for all types of reasons are more common, it certainly behooves dermatologists to recognize and be concerned about this potential consequence of prescribing oral antibiotics. PMID:7212735

  9. 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

  10. 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) ...

  11. 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. PMID:12278397

  12. [Effect of oral contraceptives on vaginal flora].

    PubMed

    Batashki, I; Markova, D; Milchev, N; Uchikova, E; Gŭrova, A

    2006-01-01

    The contraceptive and non contraceptive advantages of oral chormonal contraceptives as well as the good control on fertility, make it one of the most preffered method of contraception. The normal vaginal flora is a dynamic ecosystem and itsequilibrium and status of eubyosis amongst its inhabitants is an important mechanism against exogenous infections. The use of oral contraceptives is not associated with significant changes in the vaginal microbial flora; the normal concentration of the lactobacillli is preserved. PMID:16889189

  13. Nomegestrol acetate/estradiol: in oral contraception.

    PubMed

    Yang, Lily P H; Plosker, Greg L

    2012-10-01

    Nomegestrol acetate/estradiol is a combined oral contraceptive with approval in many countries. This fixed-dose combination tablet contains nomegestrol acetate, a highly selective progestogen, and estradiol, a natural estrogen. It is the first monophasic combined oral contraceptive to contain estradiol, and is taken in 28-day cycles, consisting of 24 active therapy days with 4 placebo days (i.e. 24/4-day cycles). In two large, 1-year, randomized, open-label, multicentre, phase III trials in healthy adult women (aged 18-50 years), nomegestrol acetate/estradiol was at least as effective as drospirenone/ethinylestradiol as contraceptive therapy, as the pregnancy rates in women aged 18-35 years (primary efficacy population) in terms of the Pearl Index (primary endpoint) were numerically lower with nomegestrol acetate/estradiol, although the between-group difference was not statistically significant. In both trials, nomegestrol acetate/estradiol was given in a 24/4-day cycle, and drospirenone/ethinylestradiol was given in a 21/7-day cycle. The criteria for using condoms in case of forgotten doses were less stringent in the nomegestrol acetate/estradiol group than in the drospirenone/ethinylestradiol group. Nomegestrol acetate/estradiol therapy for up to 1 year was generally well tolerated in healthy adult women, with an acceptable tolerability profile in line with that expected for a combined oral contraceptive. The most commonly reported adverse events were acne and abnormal withdrawal bleeding (most often shorter, lighter or absent periods). Overall, compared with drospirenone/ethinylestradiol, nomegestrol acetate/estradiol appeared to be associated with less favourable acne-related outcomes, and shorter, lighter or absent periods. PMID:22950535

  14. [The acceptability of different oral contraceptive methods].

    PubMed

    Klinger, G; Fritzsche, H; Hempel, E; Carol, W; Böhme, W; Scholz, B; Grass, M; Chemnitius, K H

    1975-05-01

    Results of a survey of contraceptive acceptability are reported. In formation on oral and depot hormonal contraceptives was distributed to 1064 Ovosiston or Nonovlon users, 110 women using depot contraceptives, and 609 women who had never used hormonal contraception. The women's preferences with regard to administration schedule, and their perceptions of effectiveness and safety were noted. Non-users considered daily, weekly, or monthly administration acceptable, while only 2/3 of those taking oral contraceptives thought daily administration convenient. 90.2% of Deposiston patients did not care for daily administration. Deposiston patients also had the greatest confidence in their method. The authors believe on the basis of this survey that weekly administration may be highly acceptable alternative t o conventional oral contraception. PMID:1140078

  15. 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

  16. Combination oral contraceptives and cancer risk.

    PubMed

    Gast, K; Snyder, T

    1990-07-01

    Substantial evidence exists to suggest that the use of oral contraceptives alters the risk for some types of cancer. Use of oral contraceptives for one year or more will reduce the risk of endometrial cancer and epithelial ovarian cancer by 50%, with the protective effect lasting for at least 10 years. The risk for developing cervical cancer in women who have used oral contraceptives appears to be slightly increased, although two independent studies actually found a protective effect associated with oral contraceptive use. The protective effect was probably related to the increased screening frequency found in oral contraceptive users and not related to a biologically protective effect. Therefore, women should be encouraged to undergo regular Pap tests. Data regarding breast cancer, in general, show no increased risk associated with oral contraceptive use. The latency associated with the development of breast cancer does not allow a definitive conclusion, and further study will be required. Oral contraceptives appear to increase the risk for developing benign hepatocellular adenoma, but not hepatocellular carcinoma. PMID:2202849

  17. Pharmacokinetic drug interactions with oral contraceptives.

    PubMed

    Back, D J; Orme, M L

    1990-06-01

    Oral contraceptive steroids are used by an estimated 60 to 70 million women world-wide. Over the past 20 years there have been both case reports and clinical studies on the topic of drug interactions with these agents. Some of the interactions are of definite therapeutic relevance, whereas others can be discounted as being of no clinical significance. Pharmacological interactions between oral contraceptive steroids and other compounds may be of 2 kinds: (a) drugs may impair the efficacy of oral contraceptive steroids, leading to breakthrough bleeding and pregnancy (in a few cases, the activity of the contraceptive is enhanced); (b) oral contraceptive steroids may interfere with the metabolism of other drugs. A number of anticonvulsants (phenobarbital, phenytoin, carbamazepine) are enzyme-inducing agents and thereby increase the clearance of the oral contraceptive steroids. Valproic acid has no enzyme-inducing properties, and thus women on this anticonvulsant can rely on their low dose oral contraceptive steroids for contraceptive protection. Researchers are now beginning to unravel the molecular basis of this interaction, with evidence of specific forms of cytochrome P450 (P450IIC and IIIA gene families) being induced by phenobarbital. Rifampicin, the antituberculous drug, also induces a cytochrome P450 which is a product of the P450IIIA gene subfamily. This isozyme is one of the major forms involved in 2-hydroxylation of ethinylestradiol. Broad spectrum antibiotics have been implicated in causing pill failure; case reports document the interaction, and general practitioners are convinced that it is real. The problem remains that there is still no firm clinical pharmacokinetic evidence which indicates that blood concentrations of oral contraceptive steroids are altered by antibiotics. However, perhaps this should not be a surprise, given that the incidence of the interaction may be very low. It is suggested that an individual at risk will have a low bioavailability

  18. [Interactions between oral contraceptives and other drugs].

    PubMed

    Hansen, T H; Jensen, S B

    1991-10-28

    Failures of oral contraceptives are possible when combined with rifampicin or antiepileptics, especially phenobarbitone and phenytoin. The mode of action is shown by clinical trials to be due to induction of hepatic enzymes thus increasing the steroid metabolism. Failure or oral contraceptives has occurred with the concomitant use of antibiotics, i.e. ampicillin and sulfonamides. Clinical trials have focused upon the changes in the intestinal flora induced by antibiotics. This might influence the enterohepatic circulation of estrogen and thereby decrease reabsorption of estrogen, but this has not been definitely proved. The failures may be caused by individual pharmacokinetics of oral contraceptives. Oral contraceptives are able to influence the pharmacodynamics of various other drugs metabolized by oxidation or conjugation but besides an increased pharmacological effect of prednisolone and increased toxicity of imipramine the clinical importance is uncertain. PMID:1949335

  19. Oral contraceptives and birth defects.

    PubMed

    Smithells, R W

    1981-06-01

    Although OCs (oral contraceptives) are not designed to be taken during pregnancy, in Europe and the U.S. they are taken by 2-5% of women in early pregnancy and by 1/4-1/3 of women 3-4 months prior to conception. The effects of OCs on folic acid and other vitamin metabolism are well known and provide a theoretical basis for possible teratogenicity, even when stopped prior to conception. Both hormone support therapy for threatened abortions and hormonal pregnancy tests have been abandoned in recent years, the first because it proved inefficacious, the second because there are better alternatives available. In neither of these cases were sex hormones shown to be teratogenic. Most cohort (prospective) and many case-control (retrospective) studies have shown no association between OC use and birth defects. Case-control methodology can be criticized because of recall bias and because of the difficulty of choosing entirely matched controls. Several studies have shown OC users to have characteristics slightly different from the general population, e.g., they are younger, more often unmarried, and are more likely to smoke during pregnancy. Any of these characteristics might influence the occurrence of teratogenicity. It is impossible to prove that OCs constitute a low-level teratogen. The author considers them nonteratogenic. PMID:7250546

  20. 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. PMID:12348250

  1. 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. PMID:3155374

  2. 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

  3. Assessment of Incremental Dosage Regimen of Combined Oestrogen-Progestogen Oral Contraceptive

    PubMed Central

    Brosens, I. A.; Robertson, W. B.; Van Assche, F. A.

    1974-01-01

    Eighty-six women of proved fertility used an incremental dosage regimen of a combined oral contraceptive for a total of 570 cycles over one year. A daily tablet containing 50 μg of ethinyloestradiol and 50 μg D-norgestrel was taken for 11 days and a daily tablet containing 50 μg ethinyloestradiol and 125 μg D-norgestrel for the next 10 days. Withdrawal bleeding occurred during the tabletfree interval of seven days. The new preparation proved to be an efficient contraceptive, well tolerated, and with few side effects. Women who had gained weight while taking other oral contraceptives lost weight when they changed to the new preparation. The regimen allowed a significant reduction in the cycle dose of progestogen, and these results suggest that a further reduction in the cycle dose of both oestrogen and progestogen may be possible without losing contraceptive efficiency. PMID:4441832

  4. [Oral contraceptives: knowledge and compliance].

    PubMed

    Koch, T; Marslew, U; Nielsen, M R

    1993-11-01

    One hundred and twenty (120) women, taking contraceptive pills, underwent a structured interview with a view elucidating their knowledge of the physiology of menstruation, the action and side effects of contraceptive pills and their compliance in the taking of contraceptive pills. The most important sources of information were the medical letters in magazines and the women's own doctors, while the teaching in the Folkeskole (primary and lower secondary school) had not had any major influence on the level of information. Well over one third of the interviewed women knew the most important action mechanism of the contraceptive pill, and half of the women could give a satisfactory explanation of the physiology of menstruation. Twenty-four percent (24%) thought that pregnancy could not occur until 1-2 months after the woman had ceased taking the pill. There was high compliance among the women i.e. that their behavior was correct when they had forgotten to take one or two contraceptive pills, when bleeding was irregular, and when beginning on a new package of pills. Eighty-three percent (83%) had experienced side effects that could be related to contraceptive pills. The investigation shows that there is a need for more efficient information about the effects of the Pill and about the physiology of menstruation. PMID:8236575

  5. 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. PMID:1411690

  6. Reassessment of the metabolic effects of oral contraceptives.

    PubMed

    Franklin, M

    1990-01-01

    During the 30 years of experience with oral contraceptives, dramatic changes have occurred in their formulations and in prescribing practices. This article analyzes the latest information on the metabolic effects of oral contraceptives and makes recommendations for practice. PMID:2286849

  7. In vitro uptake of oral contraceptive steroids by magnesium trisilicate.

    PubMed

    Khalil, S A; Iwuagwu, M

    1978-02-01

    Some steroids used in oral contraceptives were adsorbed significantly by magnesium trisilicate. The adsorption affinity followed the sequence: ethindrone greater than mestranol greater than norethindrone greater than ethinyl estradiol. Adsorption data obtained at relatively low initial concentrations fitted a Langmuir plot; the values for monolayer adsorption ranged between 0.24 and 0.32 mg/g. At higher concentrations of the steroids, multilayer adsorption occurred. The results of desorption experiments made at 37 degrees in water and 0.05 N HCl suggested that desorption was incomplete and depended on the amount of steroid adsorbed. During the dissolution testing of a brand of contraceptive tablets containing norethindrone acetate, the presence of 0.5% (w/v) magnesium trisilicate in the medium resulted in almost complete reduction in the amount of the steroid remaining in solution after 1 hr. PMID:202691

  8. 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

  9. Oral contraceptives in polycystic ovary syndrome.

    PubMed

    Helvaci, N; Yildiz, B O

    2014-09-01

    Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of women of reproductive age and combined oral contraceptives (OCs) are often the first-line treatment of the syndrome by improving hyperandrogenism and regulating menstrual cycles. Oral contraceptives have some cardiovascular and metabolic effects that varies among different formulations depending upon the dose and type of the both estrogen and progestin components. These cardiometabolic effects of OCs raise some concerns about their long-term use in PCOS, but available data suggest that the benefits outweigh the risks. More studies are needed to clarify the safety of long-term use of OCs in PCOS. PMID:25003228

  10. 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…

  11. Benefits and risks of oral contraceptives.

    PubMed

    Sherif, K

    1999-06-01

    The major benefits of modern low-dose oral contraceptives include relative safety and a high degree of efficacy, decreasing the need for abortion or surgical sterilization; reduced risks of bacterial (but not viral) pelvic inflammatory disease and of endometrial and ovarian cancer; improved menstrual regularity, with less dysmenorrhea and blood flow; and, when low-dose combination (not progestogen-only) oral contraceptives are used, reduced acne and hirsutism. Major risks are cardiovascular. Preliminary data from nonrandomized studies suggest that oral contraceptives containing third-generation progestogens are associated with increased risk of venous thromboembolism, particularly in carriers of the coagulation factor V Leiden mutation. The risk of arterial thrombosis, such as myocardial infarction or stroke, may be directly related to estrogen dose, particularly in women who have hypertension, smoke, or are >35 years old. Considering that only users aged >/=30 years who smoke >/=25 cigarettes/d have a higher estimated mortality rate than that of pregnant women, the benefits of oral contraceptives appear to outweigh their risks. PMID:10368519

  12. Zoely: a new combined oral contraceptive.

    PubMed

    2014-08-01

    ▼Zoely is the second estradiol-containing oral contraceptive formulated as an 'extended regimen' (pill-free interval <7 days) to be licensed in the UK. However, unlike the quadraphasic estradiol-containing contraceptive Qlaira, it is a monophasic preparation.1,2 It is postulated that combined oral contraceptives (COCs) containing synthetic estradiol, which is structurally identical to endogenous oestrogen,3 are potentially safer and better tolerated than those containing ethinylestradiol, the synthetic oestrogen most commonly used in COCs.4 The progestogen in Zoely is nomegestrol acetate, which is structurally related to progesterone,5 in contrast to the majority of progestogens in COCs that are derived from 19-nortestosterone6 and associated with androgenic effects.7 It is suggested that nomegestrol acetate, with its greater specificity for progesterone receptors, may minimise the potential for androgenic, oestrogenic and glucocorticoid effects.7 The company considers Zoely an option for women "who want a contraceptive with hormones similar to her own", and claims that it has a high level of contraceptive efficacy, produces shorter, lighter periods compared with a 21-day regimen of drospirenone 3mg/ethinylestradiol 30µg (Yasmin) and that most women report no negative impact on weight and skin.8 Here we review the effectiveness and place of Zoely. PMID:25104773

  13. [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. PMID:24100827

  14. Intracranial venous thrombosis complicating oral contraception

    PubMed Central

    Dindar, F.; Platts, M. E.

    1974-01-01

    Four days after the onset of a severe headache a 22-year-old woman who had been taking oral contraceptives for less than three weeks had a convulsion, followed by right hemiparesis. Other focal neurologic signs and evidence of raised intracranial pressure appeared, and she became comatose on the seventh day. A left craniotomy revealed extensive cerebral venous thrombosis. She died the next day. On postmortem examination extensive thrombosis of the superior sagittal sinus and draining cerebral veins, and multiple areas of cerebral hemorrhage and hemorrhagic infarction were seen. Some of the superficial cerebral veins showed focal necrosis of their walls, and the lateral lacunae of the superior sagittal sinus contained proliferating endothelial cells. The adrenal veins were also thrombosed. The significance of these findings is discussed. The literature on cerebrovascular complications of oral contraception, particularly cerebral venous thrombosis, is reviewed. ImagesFIG. 1FIG. 2FIG. 3FIG. 4FIG. 5FIG. 6 PMID:4413961

  15. Vertebral artery occlusion and oral contraceptives.

    PubMed Central

    Ask-Upmark, E; Bickerstaff, E R

    1976-01-01

    If vertebral artery occlusion occurs in degenerative arterial disease it is almost invariably left-sided, but in vertebral artery deficiency syndromes associated with oral contraceptives a striking preponderance of right-sided involvement has been shown. This observation adds support to the view that causes other than changes in the wall of the vessel at the site of occlusion must be sought as an explanation of the occlusion. PMID:1252812

  16. Changing convention in combination oral contraceptives: estradiol and nomegestrol acetate in a monophasic 24/4 regimen.

    PubMed

    Shulman, Lee P

    2013-07-01

    Initial oral contraceptive regimens were characterised by high doses of ethinylestradiol (EE) and a progestogen in a 21-day regimen that either included seven additional hormone-free tablets or simply the 21 days of combination hormonal tablets. These regimens were developed to ensure high contraceptive effectiveness, regular and predictable withdrawal bleeding episodes to mimic a menstrual cycle, and minimal unscheduled vaginal bleeding. However, these regimens were associated with adverse tolerability and safety issues resulting from the dose and characteristics of their hormonal components. Attempts to ameliorate these adverse issues included the development of lower-dose EE regimens, the incorporation of new progestogens, multiphasic regimens, and reduced hormone-free interval regimens. However, the EE component has remained a constant until the recent approval of combination oral contraceptives with an estrogen component other than EE. The development and introduction of an estradiol-based oral contraceptive regimen is presented in this review. PMID:23709606

  17. 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…

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

    PubMed

    Golobof, Alexandra; Kiley, Jessica

    2016-05-01

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

  19. 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

  20. Factors related to choosing oral contraception at age 15.

    PubMed

    Kosunen, E; Laippala, P

    1996-12-01

    This report aims to identify factors which are related to use of oral contraceptives at an early age. A self-administered questionnaire was completed at schools in 1988 and 1992 in southern and western Finland (N = 1339). Sexually experienced girls (mean age 15.8 years) who had answered the question concerning their oral contraceptive use were included (N = 389). Logistic regression analysis was used to compare oral contraceptive users (N = 121) with the group of non-users. Total number of coital experiences was associated with oral contraceptive use: the odds ratio for those having at least 10 coital experiences was 6.30 compared with those with only one intercourse. The proportion was 73% among oral contraceptive users and 30% among non-users. Girls using oral contraceptives perceived more often (67%) that parents accept their sexual relationship (30% among non-users). Oral contraceptive users were less afraid of getting pregnant (9% compared with 31% among non-users) and felt more often that sex was very important in their life (31 and 13%, respectively). Other factors that entered the model were age at menarche, having a steady partner and frequency of disco visits. When a young girl asks for oral contraceptives, she is probably at true risk of pregnancy, and regular contraception should be considered both in view of effective prevention of pregnancies and sexually transmitted diseases. PMID:10163954

  1. Perceptions of contraceptive effectiveness and health effects of oral contraception.

    PubMed

    Tessler, S L; Peipert, J F

    1997-01-01

    The hypothesis that misperceptions about the effectiveness of contraceptive methods and the risks and benefits of oral contraceptive (OC) use are widespread in the US, even among the most educated population groups, was investigated in 147 women presenting to the Brown University (Providence, Rhode Island) health service and 189 students solicited by female volunteers on the campus. 90% of respondents correctly estimated the effectiveness of OCs in preventing pregnancy, but 32-34% inflated the pregnancy rates associated with subdermal implants and Depo-Provera. 60% overestimated the failure rate of the IUD. On the other hand, a majority underestimated the failure rates of barrier methods and spermicides. 41% believed OCs increase the risk of breast cancer and 33% thought the pill increases cervical cancer risk. 66% knew that OCs reduce dysmenorrhea and 50% were aware the pill decreases menstrual bleeding. However, the majority were unaware OCs reduce the risk of benign breast disease (95%), ectopic pregnancy (91%), pelvic inflammatory disease (90%), and anemia (89%). 81% were unaware of the protective effects of OCs against uterine cancer and 77% did not know they have a protective effect against ovarian cancer. In general, OC users were more aware of the health benefits of OCs than condom users. Finally, respondents were asked to rate their satisfaction with their current birth control method on a scale of 1-12. Mean satisfaction scores were significantly higher among OC users (10.3) than condom users (7.1). These findings indicate that, even among highly educated US women, misperceptions persist about the reliability of birth control, the risks of pregnancy, and the health effects of OCs. PMID:9439201

  2. Oral contraceptives in the immediate postpartum period.

    PubMed

    Hume, A L; Hijab, J C

    1991-04-01

    Although there is a critical need for effective contraception in the immediate postpartum period for women who are not breastfeeding, this need must be balanced against the inherent risks. The most effective form of contraceptive protection--oral contraceptives (OCs)--can present an increased risk of thromboembolism in the period after delivery. The thrombotic changes associated with pregnancy, and the statistics and vascular damage following a delivery, can combine to create greater potential for thromboembolism after delivery than during pregnancy. Reported here is the case of a 21-year-old woman who, 4 weeks postpartum, developed pain and swelling in the right lower calf and mottled discoloration extending from the proximal thigh to the toes. A diagnosis of deep venous thrombosis was made and heparin was administered. In the hospital, the patient experienced pleuritic chest pain and diaphoresis. A ventilation-perfusion scan indicated a pulmonary embolism. 1 week after delivery, the patient had initiated use of Triphasil. Although this woman had other risk factors (obesity, light cigarette smoking, and a sedentary life-style), OC use in the immediate postpartum period may have been the final factor precipitating the thromboembolic event. It is recommended that OC use should be delayed until at least 2 weeks postpartum in women without other risk factors for thromboembolism and until 4-6 weeks postpartum in those with such factors. PMID:2010744

  3. Spontaneous hepatic hemorrhage secondary to prolonged use of oral contraceptives.

    PubMed

    Jaffar, Reema; Pechet, Liberto; Whalen, Giles Francis; Banner, Barbara F

    2010-05-15

    Oral contraceptive pills (OCP) are the most commonly used form of contraception throughout the United States of America. The prolonged usage of oral contraceptives leads to a variety of complications, ranging from subclinical modifications of liver function tests to the development of benign and malignant tumors of the liver. Spontaneous hepatic hemorrhage secondary to oral contraceptive use was only reported once in the early 1980s. We report a case of spontaneous hepatic hemorrhage secondary to prolonged ingestion of combined OCPs followed by multiple pulmonary emboli without underlying thrombophilia. PMID:19577854

  4. 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. PMID:10029486

  5. 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…

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

    PubMed

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

    1990-06-23

    A healthy woman aged 21 years who used the oral contraceptive Trigynon became pregnant while being treated with Minocin (minocycline; 100 mg per day) for acne conglobata. While the risk of use of antibiotics such as this one reducing the efficacy of oral contraceptives is small, patients should nevertheless be informed that the risk exists. PMID:2143563

  7. Evaluation of extended and continuous use oral contraceptives

    PubMed Central

    Wright, Kristen Page; Johnson, Julia V

    2008-01-01

    Oral contraceptives are classically given in a cyclic manner with 21 days of active pills followed by 7 days of placebo. In the past 4 years, new oral contraceptives have been introduced which either shorten the placebo time, lengthen the active pills (extended cycle), or provide active pills every day (continuous). These concepts are not new; extended and continuous pills were first studied in the 1960s and 1970s and have been provided in an off-label manner by gynecologists to treat menstrual disorders, such as menorrhagia and dysmenorrhea, and gynecologic disorders, such as endometriosis. Now that extended and continuous combined oral contraceptives are available for all patients, it is critical for providers to understand the physiology, dosing, side effects, and benefits of this form of oral contraceptive. This article reviews the history and the potential uses of the new continuous combined oral contraceptive. PMID:19209272

  8. [Cholestatic icterus due to oral contraceptives].

    PubMed

    Pestel, M; Lambert, C; Jeanmougin, M

    1973-03-01

    A case report of cholestatic jaundice in a 25 year old woman, who had had jaundice at age 4 years, and had taken Stediril (a combined oral contraceptive) for 1 month, implicates either the pill or a possibly hereditary hyperlipidemia. The jaundice developed in 2 weeks with vomiting, epigastric pain, anorexia, then discolored urine and feces, and intense pruritus. On hospitalization the patient had moderate bilirubinemia (56 mg/1), low alkaline phosphatase (13 U.K.) and slightly high serum glutamate pyruvate transaminase (270 U.W.). There were elevated serum cholesterol (3 gm/1), triglycerides (2.05 gm/1), total lipids (10.6 gm/1), and a definitely increased pre-beta lipoprotein, suggesting hyperlipidemia type IV (Frederickson classification). Liver biopsy showed fibrosis of the portal spaces lymphocytic infiltration, canalicular and intrahepatocytic thrombi. On laparoscopy the liver had a regular lower border, normal volume color and surface. Albumin, prothrombin and flocculation tests were normal. The patient's jaundice lasted about 1 month, then liver function slowly improved, although pruritus remained intense. Probably this jaundice was due to oral contraceptives, in a patient predisposed either by jaundice in childhood or endogenous hyperlipidemia. PMID:4268576

  9. Contraceptives.

    PubMed

    1997-01-01

    This chart sets forth brief descriptions of 14 contraceptive methods: male condom, female condom, vaginal diaphragm and cap, spermicides, oral contraceptives, hormonal implants, injectables, IUD, natural family planning, fertility awareness, breast feeding, withdrawal, sterilization, and emergency contraception. After presenting a short description of each method, the chart rates its degree of protection from pregnancy, the protection provided against HIV and other sexually transmitted diseases, its availability, and the method's advantages and disadvantages. PMID:12348240

  10. Nomegestrol acetate-17b-estradiol for oral contraception.

    PubMed

    Burke, Anne

    2013-01-01

    Oral contraceptives remain a popular method of contraception over 50 years after their introduction. While safe and effective for many women, the failure rate of oral contraception is about 8%. Concerns about the risk of venous thromboembolism continue to drive the search for the safest oral contraceptive formulations. The oral contraceptive NOMAC-E2 contains nomegestrol acetate (NOMAC) 2.5 mg + 17b-estradiol (E2) 1.5 mg. The approved dosing regimen is 24 days of active hormone, followed by a 4-day hormone-free interval. NOMAC is a progestin derived from testosterone, which has high bioavailability, rapid absorption, and a long half-life. Estradiol, though it has a lower bioavailability, has been successfully combined with NOMAC in a monophasic oral contraceptive. Two recently published randomized controlled trials demonstrate that NOMAC-E2 is an effective contraceptive, with a Pearl Index less than one pregnancy per 100 woman-years. The bleeding pattern on NOMAC-E2 is characterized by fewer bleeding/spotting days, shorter withdrawal bleeds, and a higher incidence of amenorrhea than the comparator oral contraceptive containing drospirenone and ethinyl estradiol. The adverse event profile appears to be acceptable. Few severe adverse events were reported in the randomized controlled trials. The most common adverse events were irregular bleeding, acne, and weight gain. Preliminary studies suggest that NOMAC-E2 does not seem to have negative effects on hemostatic and metabolic parameters. While no one oral contraceptive formulation is likely to be the optimum choice for all women, NOMAC-E2 is a formulation with effectiveness comparable with that of other oral contraceptives, and a reassuring safety profile. PMID:23836965

  11. Nomegestrol acetate-17b-estradiol for oral contraception

    PubMed Central

    Burke, Anne

    2013-01-01

    Oral contraceptives remain a popular method of contraception over 50 years after their introduction. While safe and effective for many women, the failure rate of oral contraception is about 8%. Concerns about the risk of venous thromboembolism continue to drive the search for the safest oral contraceptive formulations. The oral contraceptive NOMAC-E2 contains nomegestrol acetate (NOMAC) 2.5 mg + 17b-estradiol (E2) 1.5 mg. The approved dosing regimen is 24 days of active hormone, followed by a 4-day hormone-free interval. NOMAC is a progestin derived from testosterone, which has high bioavailability, rapid absorption, and a long half-life. Estradiol, though it has a lower bioavailability, has been successfully combined with NOMAC in a monophasic oral contraceptive. Two recently published randomized controlled trials demonstrate that NOMAC-E2 is an effective contraceptive, with a Pearl Index less than one pregnancy per 100 woman-years. The bleeding pattern on NOMAC-E2 is characterized by fewer bleeding/spotting days, shorter withdrawal bleeds, and a higher incidence of amenorrhea than the comparator oral contraceptive containing drospirenone and ethinyl estradiol. The adverse event profile appears to be acceptable. Few severe adverse events were reported in the randomized controlled trials. The most common adverse events were irregular bleeding, acne, and weight gain. Preliminary studies suggest that NOMAC-E2 does not seem to have negative effects on hemostatic and metabolic parameters. While no one oral contraceptive formulation is likely to be the optimum choice for all women, NOMAC-E2 is a formulation with effectiveness comparable with that of other oral contraceptives, and a reassuring safety profile. PMID:23836965

  12. 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. PMID:26163075

  13. Do antibiotics decrease effectiveness of oral contraceptives?

    PubMed

    Cottet, C

    1996-09-01

    The number of accidental pregnancies occurring in oral contraceptive (OC) users who are concurrently taking certain antibiotics and antifungal agents exceeds the 1% failure rate associated with OCs, suggesting some form of drug interaction. Two mechanisms of action have been proposed to explain this phenomenon. First, drugs such as rifampin and griseofulvin induce liver enzymes that break down the estrogen and progestin contained in OCs, reducing plasma hormone levels. Second, changes in the intestinal bacterial flora induced by penicillin and tetracycline may reduce the gut's absorption of hormones, also compromising efficacy. Since rifampin and griseofulvin are the medications most frequently implicated in accidental pregnancies in OC users, the induction of liver enzymes is the more probable, potent cause of failure. Although the risk of pregnancy due to OC-antibiotic interactions is extremely small, OC users prescribed antibiotics should be warned to use condoms or spermicides until the antibiotics are discontinued. PMID:9006212

  14. [Hormonal contraception using the oral depot preparation, Deposiston].

    PubMed

    Vasilev, D

    1978-01-01

    The efficacy of a new contraceptive delayed-action preparation, Deposiston is reviewed. Deposiston is the estrogen-progestin preparation with predominant estrogen activity. The estrogen and progestin eomponents of the preparation are ehtinyl estradiol and norethindrone acetate, respectively. Contraceptive effect is associated with gonadotropic stimulation by estrogen component, while progestin component provides the thermogenic effect. Mutagenicity, carcinogenicity, and toxicity tests show safety of Deposiston. Clinical trials of Deposiston in 815 women over the period of 16,207 cycles (18.1 cycles/woman) confirm contraceptive efficacy of the preparation: pregnancy occurred in only 12 women. Side effects of Deposiston include nausea (16.06%), vomiting (3.7%), headache (5.08%), and vaginal discharge (11.86%). Each Deposiston package contains 3 white estrogen tablets and 2 red progestin tablets. A woman starts to take Deposiston on day 4 of the cycle: white tablets are taken on days 4, 11, and 18 and 2 red tablets are taken on day 25. On day 2-7 after the red progestin tablets, the woman experiences hemorrhage. Average duration of and the amount of blood loss during the hemorrhage do not differ from those during the normal menstruation. Deposiston is indicated for women with recurrent uterine hemorrhages, gastrointestinal disorders, and decreased libido. The preparation is contraindicated for adolescents younger than 16 years of age, for women with hormonal active tumors, thromboembolism, chronic liver diseases, and idiopathic jaundice. PMID:350070

  15. Does the use of oral contraception depress DZ twinning rates?

    PubMed

    Campbell, D; Thompson, B; Pritchard, C; Samphier, M

    1987-01-01

    Data based on total births from a geographically defined population with zygosity determined from blood samples and placentation and with data on the use of oral contraceptives routinely collected in early pregnancy showed no association between oral contraceptive use prior to pregnancy in either MZ or DZ twinning. Three mutually exclusive control groups of singletons were used to take account of age, parity and secular trends. PMID:3451649

  16. First time issue of oral hormonal contraception by nurses.

    PubMed

    Presho, M; Leadbetter, C

    1999-10-01

    This study aimed to assess whether introducing the issue of first time oral hormonal contraception by nurses could expand the role of the family planning nurse and improve the service to the client group. Nurse acceptability of, and adherence to, the protocol were examined. Results indicate that with appropriate training the first time issue of oral hormonal contraception is a valuable skill in enhancing the nurses' role, reduces waiting time for clients and is acceptable to clients. PMID:10567062

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

    PubMed

    Cianci, A; De Leo, V

    2007-08-01

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

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

    PubMed

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

    2015-01-01

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

  19. 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...

  20. 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...

  1. 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...

  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, 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...

  4. Teenagers' perceptions of unplanned adolescent pregnancies and oral contraceptive use.

    PubMed

    White, J E; Kellinger, K G

    1989-01-01

    Adolescent women who are sexually active often do not use contraceptives consistently and correctly. Adolescents are sexually active for an average of 15 months before initiating regular contraceptive use and the majority of young women who initiate use discontinue within the first year after initiation. This study enrolled 50 young women who initiated oral contraceptive use and was designed to provide more understanding of their perceptions about the possibility of an unplanned pregnancy and about contraceptive use. They were again contacted 6 weeks after initiation of oral contraceptives to assess continuation. Findings revealed that 90% of the subjects were sexually active at the time of the first visit; the mean period of sexual activity was 15 months. Only 30% had used a nonprescription birth control method during this period. While perceiving themselves to be highly susceptible to pregnancy, many young women continue to have psychosocial barriers to contraceptive use. Follow-up contact revealed more than 10% of the subjects were not using oral contraceptives. PMID:2631927

  5. 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. PMID:2256523

  6. 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

  7. 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

  8. How can we improve oral contraceptive success in obese women?

    PubMed Central

    Cherala, Ganesh; Edelman, Alison

    2015-01-01

    Summary A rapid increase in obesity rates worldwide further underscores the importance of better understanding the pharmacokinetic alterations in this sub-population and the subsequent effects on pharmaco-therapeutics. Pharmacokinetics of contraceptive steroids are altered in obese oral contraceptive users which may in turn impact efficacy. Our work has identified several dosing strategies that offset these pharmacokinetic changes and may improve effectiveness for obese OC users. PMID:25354219

  9. Physiologic and psychologic symptoms associated with use of injectable contraception and 20 µg oral contraceptive pills

    PubMed Central

    Berenson, Abbey B.; Odom, Susan D.; Radecki Breitkopf, Carmen; Rahman, Mahbubur

    2013-01-01

    Objective To compare menstrual, physiologic, and psychologic symptoms over 2 years among women initiating use of depot medroxyprogesterone acetate or an oral contraceptive pill with a reduced pill-free interval, and those not using hormonal contraception. Methods A total of 608 women reported their experience regarding 17 symptoms prior to initiating contraception and every 6 months thereafter for 24 months. Longitudinal relationships between symptoms and contraceptives were assessed after adjusting for age, visits, and baseline status of symptoms. Results Oral contraceptive pills were protective against mastalgia (OR = 0.7), cramping (OR = 0.5), hair loss (OR = 0.6), acne (OR = 0.4), nervousness (OR = 0.5), and mood swings (OR = 0.7). DMPA was protective against bloating (OR = 0.5) and mood swings (OR = 0.7), but caused weight gain (OR = 2.3), bleeding episodes >20 days (OR = 13.4), and missed periods (OR = 96.9). Both methods caused intermenstrual bleeding. Conclusion Evidence-based data regarding beneficial and adverse symptoms associated with these methods may help clinicians counsel patients appropriately prior to contraceptive initiation. PMID:18599013

  10. Nonspecific side effects of oral contraceptives: nocebo or noise?

    PubMed

    Grimes, David A; Schulz, Kenneth F

    2011-01-01

    Side effects of combined oral contraceptives are the most common reason why women discontinue them. Over the past half century, an elaborate mythology about these ill effects has evolved, fueled by rumor, gossip and poor-quality research. In contrast, placebo-controlled randomized trials document that nonspecific side effects are not significantly more common with combined oral contraceptives than with inert pills. These reported nonspecific side effects may reflect the nocebo phenomenon (the inverse of a placebo): if women are told to expect noxious side effects, these complaints occur because of the power of suggestion. Alternatively, nonspecific complaints may simply reflect their background prevalence in the population. Because Level I evidence documents no important increase in nonspecific side effects with oral contraceptives, counseling about these side effects or including them in package labeling is unwarranted and probably unethical. When in doubt, clinicians should err on the side of optimism. PMID:21134497

  11. Comparison of recalled and validated oral contraceptive histories.

    PubMed

    Nischan, P; Ebeling, K; Thomas, D B; Hirsch, U

    1993-11-01

    From a case-control study of the relation between oral contraceptives and breast cancer carried out in East Germany during 1982-1986, the authors obtained information on oral contraceptive use through interviews of study subjects and from the records of prescribing gynecologists. The degree of agreement regarding information from these two sources was assessed for 234 breast cancer cases and 524 controls who had ever used oral contraceptives. Agreement between information obtained from medical records and that from interviews on total duration of use, number of episodes of use, and time since first and last use was reasonably good, and levels of agreement did not differ appreciably between cases and controls. Lower levels of agreement were observed for individual brand names and the duration of use of specific brands. Attempts should be made to obtain information on specific brands from medical records when investigating the effects of individual preparations. PMID:8237985

  12. Serum lipids and proteins during treatment with a new oral contraceptive combination containing desogestrel.

    PubMed

    Penttilä, I M; Bergink, E W; Holma, P; Hulkko, S; Makkonen, M; Pyörälä, T; Castrén, O

    1983-12-01

    The present study was carried out to measure lipid and protein levels in serum of healthy women during treatment with a new oral contraceptive combination containing 0.075 mg desogestrel (Org 2969, 17 alpha-ethinyl-18-methyl-11-methylene-4-estren-17-ol) plus 0.050 mg ethinyloestradiol per tablet. All 30 volunteers took 1 tablet daily for 21 consecutive days, followed by a tablet-free period of 7 days. Treatment lasted 3 months. At the end of treatment serum total cholesterol had increased by 0.26 mmol/l (5.0%), high-density lipoprotein-cholesterol by 0.22 mmol/l (15.2%) and triglycerides by 0.43 mmol/l (50%); the calculated low-density lipoprotein cholesterol had decreased by 0.16 mmol/l (4.9%). All lipid concentrations had returned to initial levels 2 months after treatment stopped. After 3 months treatment serum ceruloplasmin, cortisol-binding globulin capacity, sex-hormone-binding globulin capacity and thyroxine-binding globulin had significantly increased by 85.2, 133, 206 and 101%, respectively. All protein levels returned to normal 2 months after treatment stopped. The relationship between serum lipids and hormone-binding proteins has been discussed, as well as the significance of the high-density lipoprotein level with regard to contraceptive treatment. PMID:6232161

  13. 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

  14. Iron supplementation: oral tablets versus intramuscular injection.

    PubMed

    Dawson, Brian; Goodman, Carmel; Blee, Tanya; Claydon, Gary; Peeling, Peter; Beilby, John; Prins, Alex

    2006-04-01

    Non-anemic, iron depleted women were randomly assigned to an injection group (IG) or oral group (OG) to assess which method is more efficient for increasing iron stores over a short time period. IG received a course of 5 x 2 mL intramuscular injections over 10 d, and OG received one tablet daily for 30 d. Fourteen, 21 and 28 d after commencing supplementation, ferritin concentration in OG significantly increased from baseline (means +/- standard error: 27 +/- 3 to 40 +/- 5 to 41 +/- 5 to 41 +/- 5 microg/L; P < 0.01). Similarly, on days 15, 20, and 28 post the first injection, ferritin concentration in IG significantly increased from baseline (means +/- standard error: 20 +/- 2 to 71 +/- 17 to 63 +/- 11 to 63 +/- 7 microg/L; P < 0.01), and was also significantly greater than OG at day 15 and 28 (P < 0.05). Iron injections are significantly more effective (both in time and degree of increase) in improving ferritin levels over 30 d than oral tablets. PMID:16779924

  15. Oral contraceptives and venous thrombosis: end of the debate?

    PubMed

    Skouby, S O

    1998-06-01

    During the more than 30-year history of oral contraceptives, clinicians have received several official warnings issued by regulating agencies on cardiovascular risks. These have affected not only gynecological practice, but also generated research activities resulting in the refined third-generation products marketed in the 1970s. The alert sent out by the UK Committee on Safety of Medicines (CSM), October 1995, on increased risk of deep venous thrombosis during use of these compounds was, therefore, very much unexpected. The statements were referring to unpublished data and, thus, indicated new and highly alarming findings. However, during the following months, although four epidemiological studies reported a 2-4 fold relative increase compared with the second-generation oral contraceptives. This relative increase means, looking at absolute risks, an excess of 1-2 cases of deep venous thrombosis per 10,000 oral contraceptive users per year. In the academic discussions following the primary publication of the four papers, the possibility of confounding factors and bias was strongly emphasized and follow-up studies together with re-analysis of the original studies have not generated evidence for the suspicion of the increased risk with third-generation oral contraceptives. In contrast, a decreasing tendency was demonstrated for more serious events such myocardial infarction. Also, the biological plausibility for increased risk of deep venous thrombosis with third-generation products is lacking, although one study has pointed to a change in the natural anticoagulatory mechanism. Obviously, the authorities have a right to react on suspicion, but the psychological and social effects of the abrupt stopping of oral contraceptive use should not be ignored, and the public understanding of scientific results is manipulated by the mass media. Following confirmed evidence from both epidemiological and biological studies, with full acknowledgement of the contraceptive and non-contraceptive

  16. 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…

  17. 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

  18. Anatomical and Functional Changes Induced by Oral Contraception

    PubMed Central

    Lefebvre, Yves

    1970-01-01

    The hormonal contraceptives seem to have no direct effect on cervical carcinoma or dysplasia, but they are responsible for the appearance of glandular adenomatous hyperplasia of the endocervix. The long-term use of progestins is responsible for the inactive appearance of the ovaries, with thickening of the tunica albuginea, rare follicle growth, occasional fibrosis of the stroma and a decreased DNA formation. After stopping oral and injectable hormonal contraceptives the first cycle is usually long and cases of amenorrhea have been reported. The causes of secondary amenorrhea probably lie in the hypothalamus and/or the ovaries. The time lapse between cessation of oral contraception and conception is between 5.8 and 6.5 months. No increase in abortion has been noted, but abortuses and ova have an increased polyploid tendency and incidence of chromosome breaks. Further investigations of larger series are necessary to provide definite proof. Meanwhile it would seem advisable that after cessation of hormonal contraception there should be a time lapse of six to eight months before a patient becomes pregnant. ImagesFIG. 1FIG. 2 PMID:4908561

  19. Fibrinolytic response in women on low-dose oral contraceptive.

    PubMed

    Ishak, R; Ahmad, R; Gudum, H R; Hassan, K; Ang, E S

    1992-06-01

    Long term use of low doses of combination oral contraceptives appears to increase plasminogen level, thereby increasing fibrinolytic activity and reducing the risk of thromboembolism. Blood levels of plasminogen, tissue plasminogen activator (tPA), and plasminogen activator inhibitor (PAI), were measured before and after stress (5 minutes of stair climbing) in a group of 30 women, 23-40 years old, who had taken 30 mcg of ethinyl estradiol with 150 mcg of desogestrel or levonorgestrel for at least 1 year. Similar measurements were taken from a control group of 30 women matched for age, height, and weight. Plasminogen and tPA levels in both groups increased significantly after exercise. The level of PAI did not change significantly with stress in either group. The level of plasminogen was significantly higher in the group taking contraceptives, whether before or after exercise, when compared to the control group. Levels of tPA and PAI, although slightly increased in the oral contraceptive group, were not significantly different between the two groups. The increase in plasminogen may be due to the estrogen component of the contraceptives. Stress seems to increase fibrinolytic response. PMID:12345026

  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. 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

  2. Incidence of depressive symptoms in users of the oral contraceptive.

    PubMed

    Fleming, O; Seager, C P

    1978-05-01

    Evidence is presented that the incidence of depression among users of oral contraceptives is no higher than that among matched controls not taking such medication. There is an association between high depression scores and high neuroticism scores, more marked in controls than takers. Intensity of depression is related more to age, personality and occupation than to the use of oral contraceptives. A higher proportion of users than of controls experience sexual satisfaction. Past takers include a large number of individuals with a high neuroticism score. The incidence of depression symptoms in women increases with age. A higher proportion of housewives than of women going out to full-time work show depressive symptoms. PMID:656705

  3. Letter: Kilopascals. Control of oral contraceptive clinical trails.

    PubMed

    Mitchell, G D

    1975-02-01

    To deal with the confusion surrounding clinical acceptability of specific oral contraceptive preparations, a single set of forms for use in clinical research, together with a set of definitions, was recommended. Senior representatives of major pharmaceutical companies engaging in clinical trials in the United Kingdom were invited to cooperate. The Family Planning Research Unit of the University of Exeter was requested to provide facilities for meetings which began in 1972. An agreed set of forms has been designed and set of definitions has been developed to make the collection and interpretation of data more efficient. Organizations carrying out oral contraceptive clinical trials are invited to contact this unit. Forms, definitions, and further information will be provided on request. PMID:1089453

  4. The effect of a contraceptive vaginal ring and oral contraceptives on the vaginal flora.

    PubMed

    Roy, S; Wilkins, J; Mishell, D R

    1981-10-01

    Premenopausal women seeking a steroid contraceptive method were allowed to choose between a contraceptive vaginal ring (CVR) containing levonorgestrel and estradiol used in a 3-week in, 1-week out regimen (n=20) and an oral contraceptive (OC) containing levonorgestrel and ethinyl estradiol in a 28-day regimen (n = 10). Cultures from the posterior vaginal fornix were obtained before therapy in both groups and monthly for 6 months for the CVR group and after 1, 3, and 6 months for the OC group. These cultures were streaked on specific media to provide quantitative aerobic and anaerobic, lactobacillus, Candida sp., Gardnerella vaginalis and Neisseria gonorrhoeae counts in micro-organisms per milliliter. A comparison of the number and types of organisms isolated from vaginal cultures obtained initially and at 6 months demonstrated no statistically significant differences in colony counts between CVR and OC users. The results of this study suggest that the use of the CVR is not associated with a greater growth of pathogens than is oral administration of a progestin and estrogen combination. PMID:6797788

  5. Cerebral venous and sinus thrombosis associated with subcutaneous immunoglobulin injection and oral contraceptive use.

    PubMed

    Min, Jiangyong; Bhatt, Archit; Aburashed, Rany; Burton, Stephen

    2012-06-01

    Although patients of cerebral sinus thrombosis after intravenous immunoglobulin (IVIG) has been previously reported; reports of cerebral venous thrombosis secondary to subcutaneous injection of immunoglobulin (SIG) in conjunction with oral contraceptives are nonexistent in the current literature. We describe here a patient of cerebral venous and sinus thrombosis occurring after the combination of SIG and oral contraceptive use. Furthermore, we shall explore proper clinical precautions for someone who receives IG therapy, especially in conjunction with the use of oral contraceptives. PMID:21915646

  6. 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

    2013-12-01

    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. PMID:24136199

  7. Jordanian Muslim women's intention to use oral contraceptives.

    PubMed

    Kridli, Suha Al-Oballi; Schott-Baer, Darlene

    2004-01-01

    Oral contraceptives (OCs) are the second most popular method of contraception in Jordan; however, their use remains low compared with the intrauterine device. The purpose of this article is to report the effect of factors identified by The Theory of Planned Behavior (TPB) on Jordanian Muslim women's intention to use OCs. TPB was used to develop an investigator-developed instrument, the Intention to Use Oral Contraceptive Tool (IUOCT). The IUOCT measured attitude (general attitude and attitudinal beliefs), social norms and perceived behavioral control factors in a total of 83 women participants. A stepwise regression analysis was calculated using the IUOCT subscales as predictors of Jordanian Muslim women's intention to use OCs. The findings demonstrated that the attitude, specifically general attitude and positive beliefs, about OC use affect Jordanian Muslim women's intention to use OCs. However, the findings provide limited support for social norms and perceived behavioral control as factors influencing Jordanian Muslim women's intention to use OCs. The findings indicate that more attention should be devoted to health education programs on the benefits of using OCs rather than focusing only on correcting misinformation. Nursing implications and recommendations for future research are discussed. PMID:15776755

  8. Transcortin as an indicator of estrogenic potency in oral contraceptives.

    PubMed

    Carol, W; Börner, A; Klinger, G; Greinke, C

    1980-03-01

    Serum cortisol-binding globulin (CBG) was measured before, during and following a 21-day application period of 5 oral contraceptives used in the GDR. In a second group of patients determinations were carried out at the end of a 24-month treatment period and the end of the first post-treatment cycle. From a third group of volunteers blood samples were taken at the end of the first, second and third treatment cycles. All the drugs tested produced a marked increase of CBG in serum, reaching its maximum at the end of the second treatment cycle. Within four weeks following termination of application the level fell to the control range. There were no significant differences between the various contraceptives. PMID:6156820

  9. 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. PMID:26874323

  10. Risk of cancer with combined oral contraceptive use among Iranian women.

    PubMed

    Vaisy, Afasaneh; Lotfinejad, Shirin; Zhian, Faegh

    2014-01-01

    Oral contraceptive use is the most common type of contraception. More than 300 million women worldwide take oral contraceptives every day. However, there is a concern about the relationship with the incidence of cancer. This analytical retrospective study aimed to investigate the relationship between the incidence of cervical and breast cancers and oral contraceptive use in 128 Iranian patients with cervical cancer, 235 with breast cancer and equal numbers of controls. Data were collected through interviews with an organized set of questions. Details were also extracted from patient files. Data were analyzed using Student's t-test, chi-square and Fisher's exact tests, and Pearson's correlation analysis. The result revealed correlations between both cervical and breast cancers and history of contraceptive pills use. While cervical cancer significantly correlated with duration of use of pills, breast cancer had significant correlations with the type of oral contraceptive and age at first use. No significant relationships were found between the two types of cancer and age at discontinuation of oral contraceptives, patterns of use, and intervals from the last use. The use of oral contraceptives may triple the incidence of cervical cancer and doubles the incidence of breast cancer. Therefore, performing Pap smears every six months and breast cancer screening are warranted for long-term oral contraceptive users. PMID:25081657

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

    PubMed

    Milne, P Y; Thomas, R J

    1976-05-01

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

  12. Oral contraceptives and polyp regression in familial adenomatous polyposis.

    PubMed

    Giardiello, Francis M; Hylind, Linda M; Trimbath, Jill D; Hamilton, Stanley R; Romans, Katharine E; Cruz-Correa, Marcia; Corretti, Mary C; Offerhaus, G Johan A; Yang, Vincent W

    2005-04-01

    Epidemiologic and experimental reports suggest that female hormones protect against the development of colorectal cancer, but studies are limited. We describe a patient in the placebo arm of a 4-year primary chemoprevention trial who developed adenomatous polyps and then had eradication of polyps after the administration of oral contraceptives. No change in the prostaglandin levels in the colonic mucosa was noted after polyp elimination, making nonsteroidal anti-inflammatory drug ingestion unlikely as a cause. This report represents the regression of colorectal adenomas with the use of estrogen/progesterone compounds. PMID:15825088

  13. Perceived side effects of oral contraceptives among adolescent girls.

    PubMed

    Herold, E S; Goodwin, M S

    1980-11-22

    Knowledge and attitudes of adolescent females regarding the side effects of oral contraceptives were investigated. The data source was a large study of sexual and contraceptive attitudes and experience. The questionnaire responses of 486 single females attending 10 birth control and pregnancy counseling centers in Ontario, Canada were examined. The age range of the subjects was from 13-20; 71% were attending school and 69% were living at home. They were attending the centers in order to obtain contraceptives (55%), to renew OC prescriptions (20%), or to receive pregnancy counseling (25%). 29% of the subjects had used OCs before coming to the clinic, but 91% planned to use OC after their clinic visit. 8% were planning to use an IUD; 1% were planning to use a diaphragm; and less than 1% were planning to have their boyfriend use condoms. 85% of the subjects indicated that they had heard abut side effcts of OCs with weight gain as the best known side effect. Other side effects familiar to many included nausea, circulatory disorders, headaches, emotional changes, menstrual problems and cancer. About 1/2 of the subjects had learned about these side effects from the mass media or female friends, 25% from a school sex education class, 15% from their mothers, and 3% from a physician. Despite knowledge regarding side effects, most of the subjects had positive attitudes toward OCs with 59% believing that the advnatages outweighed any disadvantages. PMID:7448666

  14. [Zoely, a combined oral contraceptive, monophasic pill containing estradiol and nomegestrol acetate].

    PubMed

    Pintiaux, A; Gaspard, U; Nisolle, M

    2012-03-01

    A new combined oral contraceptive called Zoely has just been marketed in Belgium. It contains nomegestrol acetate, a progestin known for its high contraceptive reliability based on its antigonadotropic power and long half-life. This progestin is associated with estradiol and Zoely is devoid of ethinyl estradiol, which is the usual component of the majority of combined oral contraceptives and is primarily responsible for thrombotic side effects of the pill. The compositon and type of regimen of this new oral contraceptive contribute to its efficacy and excellent clinical tolerance. PMID:22611833

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

    PubMed

    Sirakov, M; Tomova, E

    2015-01-01

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

  16. 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

  17. 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

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

    PubMed

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

    2016-01-01

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

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

    PubMed

    Amin, Mohamed E K

    2016-04-01

    Background Possessing correct therapeutic information on oral contraceptives is an important prerequisite for the provision of sound advice to women who are using these products. Objectives 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. Setting Community pharmacies throughout Alexandria, Egypt. Methods 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. Main outcome measure Pharmacists' aggregate scores for knowledge questions and pharmacists' interest in developing skills in providing counseling on oral contraceptive pills. Results 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

  20. Nomegestrol acetate, a novel progestogen for oral contraception.

    PubMed

    Mueck, Alfred O; Sitruk-Ware, Regine

    2011-05-01

    Nomegestrol acetate (NOMAC) is a potent, highly selective progestogen, which is structurally similar to 19-norprogesterone and characterized as a full agonist at the progesterone receptor, with no or minimal binding to other steroid receptors, including the androgen and glucocorticoid receptors. In animal models, NOMAC demonstrated moderate antiandrogenic activity and strong antiestrogenic activity. In clinical studies, the progestogen was associated with effective suppression of gonadotropic activity and ovulation in premenopausal women, and a neutral impact on hemostasis, lipids, and carbohydrate metabolism. In normal and cancerous human breast tissue, NOMAC has shown favorable effects on estrogen metabolism, and in human breast cancer cell lines in vitro, it does not stimulate cell proliferation. The pharmacologic profile of NOMAC suggested that it would be well suited for combination with a physiologic estrogen in a combined oral contraceptive (COC), with the aim of achieving effective contraception with good cycle control and a favorable safety profile. A monophasic COC containing NOMAC 2.5mg and 17β-estradiol (E2) 1.5mg, administered in a 24/4-day regimen, is currently under clinical investigation. In a phase III study, NOMAC/E2 provided consistent and robust ovulation inhibition, with contraceptive effects that compared favorably with those of drospirenone 3mg/ethinyl estradiol (EE) 30 μg. Investigators for a second phase III study reported less overall impact with NOMAC/E2 on hemostatic, lipid, inflammatory, and carbohydrate metabolism parameters than with levonorgestrel 150 μg/EE 30 μg. These clinical findings are promising; however, full publication of results from the pivotal phase III trials of NOMAC/E2 is pending. PMID:21335021

  1. Oral contraceptives as an over-the-counter medication.

    PubMed

    Halperin, E C

    1994-05-01

    Five physicians debate the pros and cons of changing the prescription requirement for oral contraceptives (OCs) to an over-the-counter (OTC) status. Three of the physicians are in favor of changing the present policy, while the other 2 physicians are in favor of keeping the present policy. Reasons supporting a change to OTC OCs are: the health risks from an unwanted pregnancy are greater than the risks from OC use; the prescription requirement puts an expensive and unnecessary burden on women; and other countries (e.g., India and South Africa) dispense OCs OTC. Reasons for keeping the prescription requirement are: the potential risks of self medication; the possibility of inappropriate use by relatively uninformed patients; and the loss of opportunity for women to obtain a health evaluation, physical examination, and counseling. One family practice physician supports OTC status because this change may reduce the teenage pregnancy rate. She acknowledges, however, that the change will not solve the problem of teenage pregnancy. An advantage of OTC OCs is that women could use them as a postcoital contraceptive. Another physician in favor of OTC status for OCs suggests that the US health department and Planned Parenthood clinics could offer OCs at lower than retail cost to women who undergo an annual health examination. Another physician calls for randomized clinical trials to generate sufficient data to make an informed decision about public and medical policy changes. PMID:8035888

  2. Consensus conference on combination oral contraceptives and cardiovascular disease.

    PubMed

    1999-06-01

    At the June 1998 conference of the International Federation of Fertility Societies (IFFS), a consensus was reached that there is no reason to advise selective prescribing of oral contraceptives (OCs) containing different progestins on the basis of their effects on cardiovascular disease. All currently available low-dose OCs, regardless of their progestin component, are more beneficial for a woman's short- or long-term health than the alternative of use of no contraception or use of a less effective method. The usual precautions in selecting appropriate candidates for OC use should be applied. This consensus was reached after several investigators presented the results of their studies on OC use and cardiovascular risk to an IFFS panel. Consolidation of the available research evidence produced annual cardiovascular mortality rates per 100,000 among women 15-24 years old of 1.2 in OC non-users, 2.1 in users of second-generation OCs, and 1.8-2.3 in users of third-generation OCs; among women 35-44 years old, these rates were 9.2, 20.4, and 15.5-17.8, respectively. PMID:10360623

  3. Effects of smoking and oral contraception on plasma beta-carotene levels in healthy women.

    PubMed

    Palan, P R; Romney, S L; Vermund, S H; Mikhail, M G; Basu, J

    1989-10-01

    Oral contraceptive use and smoking have been known to affect plasma vitamin levels. Total carotenoids have been studied with spectrophotometry, a relatively insensitive technique. In this study plasma concentrations of beta-carotene and retinol were measured in coded samples by sensitive high-pressure liquid chromatography in a cross-sectional study of 149 normal healthy women attending a family planning clinic. At the time of recruitment in the morning, a general health questionnaire was administered for patient age, methods of contraception, smoking habits, and food intake at breakfast. Of the 149 enrolled volunteers, 88 were oral contraceptive users and 61 were not users. Among users, 21 smoked cigarettes, and there were 18 smokers among nonusers. Oral contraceptive users had significantly lower plasma concentrations of beta-carotene (p less than 0.001) and higher retinol levels (p less than 0.0001). Plasma beta-carotene or retinol levels did not differ among users of intrauterine contraceptive devices or barrier methods of contraception. No association was noted between the plasma levels of these two micronutrients and age greater than or less than 30 years. Cigarette smoking alone was associated with significantly reduced plasma beta-carotene levels in nonusers (p less than 0.001). Combined cigarette smoking and oral contraceptive usage were associated with low plasma beta-carotene levels; the results appear to be additive. These findings suggest a possible synergistic effect on plasma beta-carotene levels from the use of both cigarette smoking and oral contraception. PMID:2801833

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

    PubMed

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

    2005-08-01

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

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

    PubMed

    Huber, Johannes; Walch, Katharina

    2006-01-01

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

  6. Hypertension among oral contraceptive users in El Paso, Texas.

    PubMed

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

    2013-11-01

    On the U.S.-Mexico border, residents frequently cross into Mexico to obtain medications or medical care. We previously reported relatively high prevalence of hypertension among Latina oral contraceptive users in El Paso, particularly those obtaining pills over the counter (OTC) in Mexico. Here, we examine factors associated with having hypertension among 411 OTC users and 399 clinic users. We also assess hypertension awareness and interest in using blood pressure kiosks. Women age 35 to 44 and who had BMI ≥ 30 kg/m2 had higher odds of having hypertension. 59% of hypertensive women had unrecognized hypertension, and 77% of all participants would use a blood pressure kiosk; there were no significant differences between clinic and OTC users. Alternative approaches to increase access to health screenings are needed in this setting, where OTC pill use among women with unrecognized hypertension confers unique health risks. PMID:24185148

  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. The return of fertility after discontinuation of oral contraception in Malaysian women.

    PubMed

    Hassan, J; Kulenthran, A; Thum, Y S

    1994-12-01

    The return of fertility after discontinuation of oral contraception was studied in a cross-sectional survey of 61 patients who were desirous of a further pregnancy. For controls, 380 women who did not take any oral contraception were used. Cumulative conception rates in the pill users were reduced but not significantly during the first three (p = 0.15) and six months (p = 0.20). By 12 months this difference was negligible (p = 0.28). We conclude that there is no significant delay in return of fertility following cessation of oral contraception in our group of Malaysian women. PMID:7674970

  10. 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

  11. Bioequivalence study of levothyroxine tablets compared to reference tablets and an oral solution.

    PubMed

    Koytchev, Rossen; Lauschner, Reinhard

    2004-01-01

    The study was designed to evaluate the bioequivalence of three levothyroxine sodium (CAS 51-48-9) formulations, i.e. a test and a reference tablet and an oral solution. A bioequivalence study was carried out in 25 healthy volunteers, who were administered a single dose of 600 microg levothyroxine in the form of the test formulation (levothyroxine sodium tablets 200 microg; Eferox), the originator product, and an oral solution. The trial was performed in one study center according to an open, randomized, three-way cross-over design with wash-out periods of 35 days between administration. Blood samples were taken up to 48 h post dose, the plasma was separated and the concentrations of levothyroxine and triiodothyronine were determined by radioimmunoassay with I125 labeling method. The levothyroxine mean Cmax were 112.0+/-17.3 ng/ml, 113.4+/-18.5 ng/ ml and 111.3+/-15.1 ng/ml, while the mean AUC0-24 were 2263.7+/-332.8 ng x h/ ml, 2307.3+/-351.3 ng x h/ml and 2286.1+/-331.0 ng x h/ml for the test and reference tablets as well as for the oral solution, respectively. No significant differences were found of principal pharmacokinetic parameters between the studied formulations. The 90%-confidence interval for the primary target parameters, intra-individual ratios of AUC0-24 and Cmax of levothyroxine were within the acceptance ranges for bioequivalence trials, i.e. AUC0-24 0.954-1.016 and 0.966-1.011 as well as Cmax 0.948-1.027 and 0.968-1.032 for test tablets versus reference tablets and the oral solution, respectively. Similar results were observed for triiodothyronine. In the light of the present study it can be concluded that the levothyroxine test tablet is bioequivalent to the reference formulation in respect of extent and rate of absorption. The results of the present trial confirm the findings of a previous study, performed under steady-state conditions with Eferox tablets 100 microg in patients without thyroid function. PMID:15553108

  12. A chewable low-dose oral contraceptive: a new birth control option?

    PubMed Central

    Weisberg, Edith

    2012-01-01

    A new chewable combined oral contraceptive pill containing ethinyl estradiol (EE) 0.025 mg and norethindrone (NE) 0.8 mg in a 24/4 regimen was approved for marketing in December 2010. Each of the four inactive tablets contains 75 mg ferrous fumarate, which has no therapeutic benefit. The tablet can be taken with food but not water as this affects the absorption of EE. The Pearl index based on intention to treat women aged 18–35 years has been reported at 2.01 (confidence interval [CI] 1.21, 3.14) and for the whole population 1.65 (CI 1.01, 2.55). The effect of a body mass index of >35 was not studied. Regular withdrawal bleeding occurred for 78.6% of women in Cycle 1, but by Cycle 13 almost half the women failed to have a withdrawal bleed. This new formulation provides an intermediate dose of an EE/NE combination that will be useful for women experiencing breakthrough bleeding on the lower-dose EE/NE pill. The convenience of a low-dose pill, which can be chewed without the need for water, will be useful to enable women who have forgotten a pill to take one whenever they remember, provided they carry it with them. The advantage of a 24/4 regimen is better suppression of follicular development in the pill-free interval and may be beneficial for women who experience menstrual cycle-related problems, such as heavy bleeding or dysmenorrhea. PMID:22573934

  13. Oral contraception in the former Czech and Slovak Federal Republic: attitudes and use.

    PubMed

    Ketting, E; Visser, A P; Uzel, R; Lehert, P

    1993-06-01

    This paper presents and discusses data on oral contraception from a national representative survey (n = 1072) on knowledge, attitudes and practice with regard to contraceptive use in the Czech and Slovak Federal Republic (CSFR). Only 7% of the women at risk of unplanned pregnancy used the pill. The low rate of use seems to be due to the general negative image of oral contraception, reinforced by the experiences of past users and opinions expressed by relative, friends, doctors, and the media. In particular, perceived psychological disadvantages have an important bearing on the decision not to use the method, whereas perceived advantages have hardly any impact. It is likely that this negative image is closely linked with the types of oral contraceptives that have been available in the country and also with the limited choice. Second- and third-generation oral contraceptives have only very recently become available. It is recommended that balanced information on the advantages and disadvantages of oral contraception be made available to doctors and to the general public on a large scale and through a variety of channels. PMID:8237567

  14. Using Changes in Binding Globulins to Assess Oral Contraceptive Compliance

    PubMed Central

    Westhoff, Carolyn; Petrie, K.A.; Cremers, S.

    2012-01-01

    Background Validity of oral contraceptive pill (OCP) clinical trial results depends on participant compliance. Ethinyl estradiol (EE2) induces increases in hepatic binding globulin (BG) levels. Measuring these BG increases may provide an effective and convenient approach to distinguishing non-compliant from compliant OCP users in research settings. This analysis evaluated the usefulness of measuring increases in corticosteroid, sex hormone and thyroxine binding globulins (CBG, SHBG, TBG) as measures of OCP compliance. Methods We used frozen serum from a trial that compared ovarian suppression between normal weight and obese women randomized to one of two OCPs containing EE2 and levonorgestrel (LNG). Based on serial LNG measurements during the trial, 17% of participants were non-compliant. We matched non-compliant participants with compliant participants by age, BMI, ethnicity and OCP formulation. We measured CBG, SHBG and TBG levels, and compared change from baseline to 3-month follow-up between the non-compliant and compliant participants. Construction of receiver operator characteristic (ROC) curves allowed comparison of various BG measures. Results Changes in CBG and TBG distinguished OCP non-compliant users from compliant users (area under the ROC curve (AUROC), 0.86 and 0.89, p < 0.01). Changes in SHBG were less discriminating (AUROC 0.69) Conclusions EE2 induced increases in CBG and TBG provide a sensitive integrated marker of compliance with an LNG-containing OCP. PMID:22795088

  15. 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

  16. Treatment of recurrent toxic shock syndrome with oral contraceptive agents.

    PubMed

    McIvor, M E; Levin, M L

    1982-09-01

    The case of a 20-year old woman who was hospitalized for toxic shock syndrome (TSS) for 4 consecutive months despite use of conventional therapy for prevention of recurrence is described. Following discharge after the 4th episode she was started on oral contraceptives (OCs), and her next 8 menstrual cycles were uneventful despite continued use of tampons. She since discontinued use of tampons and remains asymptomatic. TSS recurrences occur in 30-64% of patients and can follow the initial episode by up to 41 months. The experience of this patient demonstrates the limitations of using antistaphyloccal antibiotics at the end of each menstrual cycle but suggests that hormonal manipulation may be an effective alternative therapy for TSS recurrences. Epidemiological studies show TSS patients use OCs less frequently than controls. Whether OCs suppress the vaginal flora, as some evidence suggests, or make conditions less favorable for the development of TSS in some other way is unknown. OC therapy for recurrences of TSS should receive further study. PMID:7144265

  17. 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. PMID:24671004

  18. Affective responsiveness is influenced by intake of oral contraceptives.

    PubMed

    Radke, Sina; Derntl, Birgit

    2016-06-01

    Despite the widespread use of oral contraceptive pills (OCs), little is known about their impact on psychological processes and emotional competencies. Recent data indicate impaired emotion recognition in OC users compared to naturally cycling females. Building upon these findings, the current study investigated the influence of OC use on three components of empathy, i.e., emotion recognition, perspective-taking, and affective responsiveness. We compared naturally cycling women to two groups of OC users, one being tested in their pill-free week and one in the phase of active intake. Whereas groups did not differ in emotion recognition and perspective-taking, an effect of pill phase was evident for affective responsiveness: Females currently taking the pill showed better performance than those in their pill-free week. These processing advantages complement previous findings on menstrual cycle effects and thereby suggest an association with changes in endogenous and exogenous reproductive hormones. The current study highlights the need for future research to shed more light on the neuroendocrine alterations accompanying OC intake. PMID:27039036

  19. 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. PMID:12527182

  20. 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. PMID:8372477

  1. Oral thyroxine: variation in biologic action and tablet content.

    PubMed

    Sawin, C T; Surks, M I; London, M; Ranganathan, C; Larsen, P R

    1984-05-01

    Thirty-two patients with primary hypothyroidism were given oral thyroxine as Levothroid or Synthroid to see if the two preparations had similar effects. The serum thyroxine was used as an index of bioavailability and the serum thyrotrophin as an index of biologic activity. The serum thyroxine was lower in all 32 patients when taking Synthroid than when taking Levothroid. In 15 patients the serum thyroxine level fell low enough to raise the serum thyrotrophin; in all 15 the serum thyrotrophin rose when taking Synthroid. Direct measurement of thyroxine in the tablets showed that the tablets of Synthroid contained 20% to 30% less thyroxine than their stated content. Thus, the decreased bioavailability (lower serum thyroxine) and decreased biologic action (higher serum thyrotrophin) of Synthroid were due to the lower content of thyroxine. An incidental observation is that the range of serum thyroxine in treated hypothyroid patients is 7.6 to 16.6 micrograms/dL, higher than in normal persons. Because oral thyroxine is widely used, a cooperative effort among manufacturers, the United States Pharmacopeia and Food and Drug Administration, and clinicians to ensure the potency and biologic action of oral thyroxine is in order. Meanwhile, it seems reasonable to use oral thyroxine that is close to the stated content. PMID:6546843

  2. Bioprostethic mitral valve thrombosis due to oral contraceptive drug use and management with ultra-slow thrombolytic therapy.

    PubMed

    Yesin, Mahmut; Kalçik, Macit; Gündüz, Sabahattin; Astarcioğlu, Mehmet Ali; Gürsoy, Mustafa Ozan; Karakoyun, Süleyman; Özkan, Mehmet

    2016-03-01

    Prosthetic valve thrombosis is a severe complication, which usually occurs in inadequately anticoagulated patients. Mechanical valve thrombosis is more common than bioprosthetic valve thrombosis (BVT). Oral contraceptive drugs are associated with increased risk of thromboembolism in women. The possible association between oral contraceptive drug use and BVT has never been reported before. We present a case of obstructive BVT occurring after the use of an oral contraceptive drug and successful management with ultra-slow thrombolytic therapy. PMID:26378817

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  5. Oral contraceptives and the risk of endometrial cancer.

    PubMed

    Levi, F; La Vecchia, C; Gulie, C; Negri, E; Monnier, V; Franceschi, S; Delaloye, J F; De Grandi, P

    1991-03-01

    The relationship between the use of combination oral contraceptives (OCs) and the risk of endometrial cancer was assessed in a case-control study conducted in the Swiss Canton of Vaud between 1 January 1988 and 31 July 1990. Subjects included 122 women aged 75 or less with histologically confirmed endometrial cancer, and 309 control women in hospital for acute conditions unrelated to OC use. Overall, 14 percent of cases and 27 percent of controls had ever used OCs, corresponding to a multivariate relative risk (RR) of 0.5 (95 percent confidence interval [CI]: 0.3, 0.8). The risk of endometrial cancer was found to be related inversely to duration of OC use: RR = 1.0 for less than two years of OC use; 0.5 for two to five years; and 0.3 (95 percent CI: 0.1, 0.7) for more than five years. The protection appeared greater within 20 years since last use, and the RR rose to 0.8 after 20 or more years since last use; numbers are too small, however, for reliable inference from these subanalyses. No significant interaction or modifying effect was observed with other major factors related to endometrial cancer, including parity, body mass index, estrogen replacement therapy, and cigarette smoking. While this study provides further evidence for the protective effect of OCs against risk of endometrial cancer, the relationship requires continued evaluation to assess the long-term implications and public health impact of OC use. PMID:1873443

  6. 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.

  7. 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. PMID:27015775

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

    PubMed

    Norris, L A; Bonnar, J

    1994-05-01

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

  9. 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. PMID:22010981

  10. Statement on postcoital contraception.

    PubMed

    1981-12-01

    For the woman exposed to a single unexpected and unprotected act of sexual intercourse, postcoital contraception can be used to avoid an unwanted pregnancy. Since the mid-1960s postcoital contraception using orally administered hormones has been found to be highly effective. This should be, however, considered as a 1-time procedure rather than a routine approach to contraception. The recommended oral methods are combined oral contraceptives (OCs) containing ethinyl estradiol 50 mcg and levonorgestrel 0.25 mg. Other similar formulations may also have high efficacy. The dosage schedule is 2 tablets at once followed by 2 tablets after 12 hours. This method is indicated in women exposed to unexpected and unprotected sexual intercourse, such as in cases of rape. It is effective only if it is instituted within 72 hours of the exposure. Data suggest this regime is as effective as that using diethylstilbestrol but with fewer side effects. As with all hormonal contraceptives, the method is contraindicated where a pregnancy is already established. Possible side effects include nausea and vomiting, irregular uterine bleeding, breast tenderness, and headache. The woman should be advised to return after 1 month to reinforce the need for elective contraception or, in the case of failure, to diagnose pregnancy and initiate counseling. In the event of a pregnancy, the woman should be reassured that no evidence exists to associate this regime of OC steroid administration with teratogenesis. Recent evidence indicates that effective postcoital contraceptive can be achieved by the insertion of a copper-containing IUD within 5 days of unprotected, mid-cycle sexual intercourse. PMID:12263975

  11. 77 FR 1695 - Determination That AVALIDE (Hydrochlorothiazide and Irbesartan), Oral Tablets, 25 Milligrams/300...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-11

    ...The Food and Drug Administration (FDA) has determined that AVALIDE (hydrochlorothiazide and irbesartan), oral tablets, 25 milligrams (mg)/300 mg and 12.5 mg/75 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for hydrochlorothiazide and irbesartan, oral tablets, 25 mg/300 mg and 12.5......

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

    PubMed

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

    2016-09-01

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

  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. PMID:24818612

  14. Oral contraception, parity, breast feeding, and severity of rheumatoid arthritis.

    PubMed Central

    Jorgensen, C; Picot, M C; Bologna, C; Sany, J

    1996-01-01

    OBJECTIVE: To investigate the influence of breast feeding, use of the oral contraceptive pill (OCP), and parity on rheumatoid arthritis (RA). METHODS: One hundred and seventy six women with RA were compared with 145 control subjects; all had at least one child. RA patients were classified as having severe (n = 82) or mild disease (n = 89) according to clinical joint evaluation, radiological score, biological inflammation, and the presence of HLA-DR1 or -DR4 alleles. RESULTS: The mean age of RA patients was 58 years, and the mean age at the time of diagnosis of RA was 46 years. The mean time between onset of RA and the first birth was 23.6 (SD 3.8) years. The OCP user rates were 33% in the RA group and 47.6% in the control group (p < 0.02). OCP use was related to the mother's year of birth. The relative risk for developing RA was 0.598 (95% confidence interval (CI) 0.33 to 1.1) in women who had used OCP for more than five years compared with those who had never used OCPs. In contrast, the age at which the first pregnancy occurred, the number of children breast fed, and the duration of breast feeding were comparable in RA patients and healthy subjects. Among the RA patients, parity, duration of breast feeding, and the number of breast fed children were significantly increased in those with severe disease. Having more than three children increased the risk of developing severe disease 4.8-fold when adjusted for age and OCP use. Forty six percent of women with severe RA had a history of breast feeding duration greater than six months before disease onset, compared with 26% of patients with mild disease (p < 0.008). Having more than three breast fed children increased the risk of poor disease prognosis 3.7-fold. In contrast, OCP use had a protective role in the course of RA (44% of RA patients with mild disease were OCP users, compared with 21.7% of those with severe RA; p < 0.001). Among those using OCP for more than five years, the relative risk of developing severe

  15. Cerebral venous sinus thrombosis with ophthalmic manifestations in 18-year-olds on oral contraceptives.

    PubMed

    Tan, Jeffrey J; Hassoun, Ameer; Elmalem, Valerie I

    2014-08-01

    Cerebral venous sinus thrombosis (CVST) is a rare and potentially life-threatening cause of stroke. In the past few decades, the incidence and patient demographics have changed because of many factors, including the widespread use of oral contraceptives, improved detection of prothrombotic conditions, and advancement of imaging technology. The presentation of CVST is varied and can include ocular signs and symptoms. We present 2 cases of oral contraceptive-induced CVST in 18-year-old women, whose main presenting findings were ophthalmologic. PMID:24803635

  16. 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. PMID:24458845

  17. Examining the use of oral contraceptives in the management of acne

    PubMed Central

    Salvaggio, Heather L; Zaenglein, Andrea L

    2010-01-01

    Combined oral contraceptive pills (cOCPs) are often used in the treatment of acne in females. They are effective, safe, and easy to use in appropriate patients in combination with more conventional acne therapies. This article will briefly address the physiologic rationale for the use of cOCPs in the treatment of acne. It will also review efficacy by examining relevant clinical trials. Safety considerations and the adverse event profile for oral contraceptives will be presented. Finally, practical considerations for prescribing cOCPs will be discussed. PMID:21072299

  18. 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. PMID:3381225

  19. The effect of a biphasic desogestrel-containing oral contraceptive on carbohydrate metabolism and various hormonal parameters.

    PubMed

    Kuhl, H; Jung-Hoffmann, C; Weber, J; Boehm, B O

    1993-01-01

    During 6 cycles of treatment of 19 women, the effect of a low-dose biphasic oral contraceptive containing 40 micrograms ethinylestradiol + 25 micrograms desogestrel (7 tablets) and 30 micrograms ethinylestradiol + 125 micrograms desogestrel (15 tablets) on various hormonal parameters and glucose metabolism was compared with the values of the pre- and post-treatment cycle. There was a profound reduction in gonadotropin secretion and ovarian steroid synthesis. The serum levels of testosterone were reduced by 35%, free testosterone by 55%, and DHEA-S by 30%. Cortisol increased by 100%, SHBG by 250%, and TBG by 60%, while FT3 and FT4 were only marginally influenced. Fasting levels of glucose and insulin did not change significantly, but the glucose load revealed a slight impairment of glucose tolerance. Three weeks after termination of pill intake, the various parameters returned to pretreatment levels, except for SHBG and TBG which were still elevated by 20 to 30%. The results demonstrate a marked preponderance of the effect of the estrogen component, a reliable inhibition of ovulation and very good cycle control during treatment with the biphasic formulation. PMID:8436002

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

    PubMed

    Stoltenberg, I; Breitkreutz, J

    2011-08-01

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

  1. [Pregnancy under oral contraceptives after treatment with tetracycline].

    PubMed

    Lequeux, A

    1980-01-01

    A 35 year old woman on hormonal contraception became pregnant during prolonged tetracycline treatment to cure acne. There is only 1 similar case published in the literature. Tetracycline may have been responsible for alterations in the intestinal flora, thus impairing the enterohepatic cycle of mestranol. An enzymatic microsomal induction is also possible, with acceleration of estrogen metabolization at the hepatic level. PMID:12336602

  2. Mortality among oral contraceptive users: 20 year follow up of women in a cohort study.

    PubMed Central

    Vessey, M. P.; Villard-Mackintosh, L.; McPherson, K.; Yeates, D.

    1989-01-01

    OBJECTIVE--To see whether the use of oral contraceptives influences mortality. DESIGN--Non-randomised cohort study of 17,032 women followed up on an annual basis for an average of nearly 16 years. SETTING--17 Family planning clinics in England and Scotland. SUBJECTS--Women recruited during 1968-74. At the time of recruitment each woman was aged 25-39, married, a white British subject, willing to participate, and either a current user of oral contraceptives or a current user of a diaphragm or intrauterine device (without previous exposure to the pill). MAIN OUTCOME MEASURES--Overall mortality and cause specific mortality. RESULTS--238 Deaths occurred during the follow up period. The main analyses concerned women entering the study while using either oral contraceptives or a diaphragm or intrauterine device. The overall relative risk of death in the oral contraceptive users was 0.9 (95% confidence interval 0.7 to 1.2). Though the numbers of deaths were small in most individual disease categories, the trends observed were generally consistent with findings in other reports. Thus the relative risk of death in the oral contraceptive users was 4.9 (95% confidence interval 0.7 to 230) for cancer of the cervix, 3.3 (95% confidence interval 0.9 to 17.9) for ischaemic heart disease, and 0.4 (95% confidence interval 0.1 to 1.2) for ovarian cancer. There was a linear trend in the death rates from cervical cancer and ovarian cancer (in opposite directions) with total duration of oral contraceptive use. Death rates from breast cancer (relative risk 0.9; 95% confidence interval 0.5 to 1.4) and suicide and probable suicide (relative risk 1.1; 95% confidence interval 0.3 to 3.6) were much the same in the two contraceptive groups. In 1981 the relative risk of death in oral contraceptive users from circulatory diseases as a group was reported to be 4.2 (95% confidence interval 2.3 to 7.7) in the Royal College of General Practitioners oral contraception study. The corresponding

  3. 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

  4. 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

  5. [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. PMID:19300853

  6. 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

  7. 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…

  8. 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. PMID:21391160

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

    PubMed

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

    2000-03-01

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

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

    PubMed

    Maia, Hugo; Haddad, Clarice; Casoy, Julio

    2013-01-01

    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

  11. Effect of formulated ingredients on rapidly disintegrating oral tablets prepared by the crystalline transition method.

    PubMed

    Sugimoto, Masaaki; Narisawa, Shinji; Matsubara, Koji; Yoshino, Hiroyuki; Nakano, Minoru; Handa, Tetsurou

    2006-02-01

    The aim of this article was to determine the optimal ingredients for the rapidly disintegrating oral tablets prepared by the crystalline transition method (CT method). The effect of ingredients (diluent, active drug substance and amorphous sugar) on the characteristics of the tablets was investigated. The ingredients were compressed and the resultant tablets were stored under various conditions. The oral disintegration time of the tablet significantly depended on diluents, due to differences in the penetration of a small amount of water in the mouth and the viscous area formed inside the tablet. The oral disintegration time was 10-30 s for tablets with a tensile strength of approximately 1 MPa, when erythritol, mannitol or xylitol was used as the diluent. The increase in the tensile strength of tablets containing highly water-soluble active drug substances during storage was as large as that of tablets without active drug substances, while the increase in the tensile strength of tablets containing low water-soluble active drug substances was small. It was therefore found that highly water-soluble active drug substances were more suitable for the formulation prepared by the CT method than low water-soluble active drug substances. Irrespective of the type of amorphous sugar (amorphous sucrose, lactose or maltose) used, the porosity of tablets with 1 MPa of tensile strength was 30-40%, and their oral disintegration time was 10-20 s. The optimal ingredients for rapidly disintegrating oral tablets with reasonable tensile strength and disintegration time were therefore determined from these results. PMID:16462059

  12. [A comparative study of the incidence of Gardnerella vaginalis in users of IUD and oral contraceptives].

    PubMed

    Aleixo Neto, A; Peixoto, M L; Cabral, A C

    1987-07-01

    Leukorrhea constitutes one of the most frequent complaints by women visiting out-patient gynecological clinics. The most common etiological agents are Gardnerella vaginalis, Trichomonas vaginalis, Neisseria gonorrhoea and Candida albicans. Some authors have been able to verify an increased presence of certain pathogenic germs in the vaginal flora for users of contraceptive methods, e.g., for users of IUD, Kivijarvi et al. demonstrated a significantly increased presence of Gardnerella vaginalis considered responsible for a large number of inflammatory diseases of the pelvis in woman. In order to establish the frequency of colpo-cervicitis in users of contraceptive methods a study was initiated of women attending the Family Planning Clinic of the Department of Medicine at UFMG during the period January-December 1986. 305 cytological smears obtained from 111 users of oral hormonal contraceptives and from 194 users of IUD were studied by using the Papanicolaou staining method. A microscopic examination enabling the detection of cells that indicate the presence of Gardnerella vaginalis, trichomonas, Candida, papilloma, and dysplastic cells was performed. The results are listed in two tables. In 34.5% of cases a significant association was established between users of IUD and cells indicating the presence of Gardnerella vaginalis. For users of oral contraceptives that figure was lower, 28.8%. This circumstance has been attributed to probable epithelial lesions caused by incorrect insertion of the IUD and more abundant menstrual flux provoked b the IUD in combination with the hemophilic characteristics of Gardnerella vaginalis. A significant prevalence of papilloma and trichomonas was also noted for women using IUD as opposed to those oral contraceptives. The results demonstrate the necessity of frequent clinical attendance and laboratory tests for women using contraceptive methods, particularly the IUD. PMID:12282423

  13. 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

  14. Oral contraceptive use and mortality after 36 years of follow-up in the Nurses’ Health Study: prospective cohort study

    PubMed Central

    Charlton, Brittany M; Rich-Edwards, Janet W; Colditz, Graham A; Missmer, Stacey A; Rosner, Bernard A; Hankinson, Susan E; Speizer, Frank E

    2014-01-01

    Objective To determine whether use of oral contraceptives is associated with all cause and cause specific mortality. Design Prospective cohort study. Setting Nurses’ Health Study, data collected between 1976 and 2012. Population 121 701 participants were prospectively followed for 36 years; lifetime oral contraceptive use was recorded biennially from 1976 to 1982. Main outcome measures Overall and cause specific mortality, assessed throughout follow-up until 2012. Cox proportional hazards models were used to calculate the relative risks of all cause and cause specific mortality associated with use of oral contraceptives. Results In our population of 121 577 women with information on oral contraceptive use, 63 626 were never users (52%) and 57 951 were ever users (48%). After 3.6 million person years, we recorded 31 286 deaths. No association was observed between ever use of oral contraceptives and all cause mortality. However, violent or accidental deaths were more common among ever users (hazard ratio 1.20, 95% confidence interval 1.04 to 1.37). Longer duration of use was more strongly associated with certain causes of death, including premature mortality due to breast cancer (test for trend P<0.0001) and decreased mortality rates of ovarian cancer (P=0.002). Longer time since last use was also associated with certain outcomes, including a positive association with violent or accidental deaths (P=0.005). Conclusions All cause mortality did not differ significantly between women who had ever used oral contraceptives and never users. Oral contraceptive use was associated with certain causes of death, including increased rates of violent or accidental death and deaths due to breast cancer, whereas deaths due to ovarian cancer were less common among women who used oral contraceptives. These results pertain to earlier oral contraceptive formulations with higher hormone doses rather than the now more commonly used third and fourth generation formulations

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    1997-09-01

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

  17. Efficacy and safety of a 24-day regimen of drospirenone-containing combined oral contraceptive in Korean women

    PubMed Central

    Kim, Nayoung; Yoo, Ha-Na; Hyun, Hye Sun; Yoon, Byung-Koo; Choi, Doo-Seok

    2015-01-01

    This study assesses the efficacy and safety of a 24-day regimen of drospirenone-containing combined oral contraceptive, and demonstrates that it is an effective and safe option for contraception, releasing symptom of premenstrual dysphoric disorder and acne in Korean women. PMID:26430665

  18. 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…

  19. Formulation development, evaluation and comparative study of effects of super disintegrants in cefixime oral disintegrating tablets.

    PubMed

    Remya, Ks; Beena, P; Bijesh, Pv; Sheeba, A

    2010-07-01

    The present work was aimed at formulation development, evaluation and comparative study of the effects of superdisintegrants in Cefixime 50 mg oral disintegrating tablets. The superdisintegrants used for the present study were sodium starch glycolate and crosscarmellose sodium. The formulated tablets were evaluated for various tableting properties, like hardness, thickness, friability, weight variation, disintegration time and dissolution rate. Comparative evaluation of the above-mentioned parameters established the superiority of the tablets formulated with crosscarmellose sodium to those formulated with sodium starch glycolate. PMID:21042477

  20. Formulation Development, Evaluation and Comparative Study of Effects of Super Disintegrants in Cefixime Oral Disintegrating Tablets

    PubMed Central

    Remya, KS; Beena, P; Bijesh, PV; Sheeba, A

    2010-01-01

    The present work was aimed at formulation development, evaluation and comparative study of the effects of superdisintegrants in Cefixime 50 mg oral disintegrating tablets. The superdisintegrants used for the present study were sodium starch glycolate and crosscarmellose sodium. The formulated tablets were evaluated for various tableting properties, like hardness, thickness, friability, weight variation, disintegration time and dissolution rate. Comparative evaluation of the above-mentioned parameters established the superiority of the tablets formulated with crosscarmellose sodium to those formulated with sodium starch glycolate. PMID:21042477

  1. 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

    2011-01-01

    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

  2. Why do inadvertent pregnancies occur in oral contraceptive users? Effectiveness of oral contraceptive regimens and interfering factors.

    PubMed

    Fraser, I S; Jansen, R P

    1983-06-01

    Inadvertent pregnancies in combined pill users are not uncommon, and are usually due to errors of tablet taking. However, many factors may contribute to 'pill failure'. In this review the endocrine pharmacology of pill use and the changes reported with missed pills have been considered in detail. The influences of other factors including drug interactions have been reviewed and a series of recommendations made for reducing the risk of pregnancy in each of these circumstances. PMID:6413129

  3. Oral contraceptive pill use and menstrual cycle phase are associated with altered resting state functional connectivity.

    PubMed

    Petersen, Nicole; Kilpatrick, Lisa A; Goharzad, Azaadeh; Cahill, Larry

    2014-04-15

    At rest, brain activity can be characterized not by an absence of organized activity but instead by spatially and temporally correlated patterns of activity. In this experiment, we investigated whether and to what extent resting state functional connectivity is modulated by sex hormones in women, both across the menstrual cycle and when altered by oral contraceptive pills. Sex hormones have been shown to have important effects on task-related activity, but few studies have investigated the extent to which they can influence the behavior of functional networks at rest. These hormones are dramatically altered by the use of hormonal contraception, which is used by approximately 100 million women worldwide. However, potential cognitive side effects of hormonal contraception have been given little attention. Here, we collected resting state data for naturally-cycling women (n=45) and women using combined oral contraceptive pills (n=46) and evaluated the differences in resting state activity between these two groups using independent component analysis. We found that in the default mode network and in a network associated with executive control, resting state dynamics were altered both by the menstrual cycle and by oral contraceptive use. Specifically, the connectivity of the left angular gyrus, the left middle frontal gyrus, and the anterior cingulate cortex were different between groups. Because the anterior cingulate cortex and left middle frontal gyrus are important for higher-order cognitive and emotional processing, including conflict monitoring, changes in the relationship of these structures to the functional networks with which they interact may have important consequences for attention, affect, and/or emotion regulation. PMID:24365676

  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. 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. PMID:14666232

  6. 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

  7. [Monoclonal human immunoglobulin (IgG lambda) with antiethinylestradiol activity, oral contraceptives, and arterial pulmonary thrombosis].

    PubMed

    Beaumont, J L; Lemort, N

    1975-06-23

    In a 36-year-old woman taking an oral contraceptive containing 50 mug of ethinyloestradiol each day, a pulmonary arterial thrombosis and a monoclonal gammapathia were associated. The monoclonal IgI lambda Mai... was prepared. When purified, this IgG lambda binds ethinyloestradiol with strong affinity (Ka= 2.7 times 10(7)M-1) and also 17-beta-oestradiol with a little less affinity (Ka = 0.4 times 10(7)M-1. For those ligands each IgG lambda Mai... molecule has two sites of same affinity and specificity so that a Scatchard plot of the experimental values gives a straight line. It is likely that the antibody sites of the IgG lambda Mai... are the binding sites. These facts support the hypothesis of an immunological mechanism of the thromboembolic disease which may be induced by oral contraceptives. PMID:808320

  8. 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

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

    PubMed

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

    2014-08-19

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

  10. Sexual and reproductive life events in relation to duration of oral contraceptive use.

    PubMed

    Lidegaard, O; Helm, P

    1988-07-01

    In order to disclose differences between users and non-users of oral contraceptives (OC), 620 women aged 15-54 were invited to participate in an in depth interview about sexual, contraceptive, and reproductive life events. Of the 585 women who participated, 459 were consecutive gynecological in- or outpatients, and 126 were selected from visitors in general practice. Data was analysed by multivariate test statistics. After correction for present age and social class, the duration of use of OC (DOC) among women 15-34 years of age correlated negatively to age at menarche and coital debut and positively to number of sexual partners, oral-genital sexual practice, and number of pelvic inflammatory diseases. Among women over 35, DOC was positively associated only to cigarette smoking. No correlation was found to coital frequency (whether earlier, present or during pregnancy or menstruation), number of births and abortions, or to social classification. In epidemiological research on benefits and risks of oral contraceptives, confounding influence of one or more variables is of crucial importance. The present findings point at sexual and life-style habits as potential confounders in the study of OC and associated diseases. PMID:3168446

  11. Comparative study of the effects of combined oral contraceptives in hemostatic variables: an observational preliminary study.

    PubMed

    Stocco, Bianca; Fumagalli, Helen F; Franceschini, Silvio A; Martinez, Edson Z; Marzocchi-Machado, Cleni M; de Sá, Marcos Felipe S; Toloi, Maria Regina T

    2015-01-01

    Thrombotic risk is associated with the estrogen dose and type of progestin in combined oral contraceptives. Studies published since 1990 showed that third-generation progestins have larger risk to contribute to thrombosis development than the second-generation. However, there are conflicts in the literature regarding the thrombotic risk associated to the drospirenone progestin. So, this study aimed to evaluate the effects of 3 formulations of contraceptives containing ethinylestradiol (EE) (20 and 30 μg) combined with drospirenone versus levonorgestrel combined with EE (30 μg) in hemostatic parameters. This cross-sectional study included 70 healthy women between 18 and 30 years, BMI 19 to 30 kg/m², not pregnant, non-smokers, and users or non-users (control) of contraceptives for a minimum period of 6 months. The following parameters were assessed: prothrombin time (PT), Factor VII, activated partial thromboplastin time (aPTT), Factor XII, fibrinogen, Factor 1 + 2, Protein C, Protein S, antithrombin, D-dimers, and plasminogen activator inhibitor-1. Significant alterations were found in PT, aPTT, fibrinogen, D-dimers, and protein S, all favoring a state of hypercoagulation for contraceptive containing DRSP/20EE. Both contraceptives containing DRSP/30EE and LNG/30EE promoted changes that favor the hypercoagulability in the coagulant variable PT and in the anticoagulant variables Protein S and Protein C, respectively. We suggest that the progestin drospirenone can contribute to an inadequate balance among procoagulant, anticoagulant, and fibrinolytic factors, since that the contraceptive containing the lowest dose of estrogen and drospirenone (DRSP/20EE) caused a higher number of hemostatic changes. PMID:25634167

  12. Effect of preparation method on properties of orally disintegrating tablets made by phase transition.

    PubMed

    Kuno, Yoshio; Kojima, Masazumi; Ando, Shuichi; Nakagami, Hiroaki

    2008-05-01

    In order to evaluate the effect of preparation method on the properties of orally disintegrating (OD) tablets, OD tablets were prepared by compressing a mixture of high melting point sugar alcohol (HMP-SA) and low melting point sugar alcohol (LMP-SA) and subsequent heating. In the direct compression method (DCM) where the LMP-SA was added as a powder, both hardness and disintegration time were increased by decreasing the particle size of the LMP-SA. In the wet granule compression method (WGCM), where the LMP-SA was added as an aqueous binder solution, the tablets became harder with less heating compared to tablets prepared by DCM. Using 1% xylitol as the LMP-SA provided tablets with sufficient hardness when prepared by WGCM, as opposed to DCM where 5% xylitol was necessary to prepare tablets with similar hardness. These results suggest that uniformly distributed LMP-SA on the surface of HMP-SA particles in WGCM might diffuse more easily during the heating process compared to mechanically mixed LMP-SA in DCM, resulting in an increase in tablet hardness even with a short heating time and low content of LMP-SA. In addition, disintegration and hardness stability of the tablets were affected by the LMP-SA content when prepared by WGCM, suggesting that the LMP-SA content should be regulated to assure the stability of OD tablet characteristics. PMID:18182258

  13. 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

  14. 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. PMID:24134326

  15. 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. PMID:23798782

  16. Relationship between premenstrual symptoms and oral contraceptive use: a controlled study.

    PubMed

    Walker, A; Bancroft, J

    1990-01-01

    Patterns of menstrual cycle-related change were compared in three groups of women differing in their use of oral contraceptives and being matched for age, occupation, and parity. These groups were: a "monophasic group" (n = 35) established on low dose "combined" pills with stable levels of estrogen and progestagen. a "triphasic group" (n = 30) on low dose pills with escalating progestagen dosage, and a "non-pill control group" (n = 57) using nonsteroidal contraceptives. Each woman kept visual analogue ratings of mood, irritability, energy, tension, breast tenderness, bloating, and sexual interest for two or three cycles. Cyclicity was evident in all variables assessed, but the only variable to show a clear difference between groups was breast tenderness; the "monophasic group" showed less premenstrual breast tenderness than the other two groups. The monophasic group also showed a tendency to menstrual rather than premenstrual symptoms. In view of the similarity of timing of most cyclical symptoms in the three groups, it is difficult to attribute such cyclical phenomena to the effects of either ovulation or variation in corpus luteum function. For most subjects, the cyclical changes were relatively mild, and these findings need to be replicated in women suffering from severe premenstrual syndrome. However, alternative explanations need to account for changes in women both taking and not taking oral contraceptives. PMID:2305025

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

    PubMed

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

    2016-07-01

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

  18. 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

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

    PubMed

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

    2015-01-01

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

  20. 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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2011-11-01

    The aim of this study was to formulate cost effective taste-masked orally disintegrating tablets of ondansetron, a bitter drug using different superdisintegrants by a wet granulation technique. Microcrystalline cellulose (Avicel) as a diluent and disintegrant in addition to aspartame as a sweetener were used in all formulations. The prepared tablets were evaluated for weight variation, thickness, hardness, friability, drug content, water content, in vitro disintegration time and in vitro drug release. The tablets' hardness was maintained in the range of 2-3 kg and friability was <1% for all batches. All tablet formulations disintegrated rapidly in vitro within 5.83 to 33.0 sec. The optimized formulation containing 15% Polyplasdone XL-10 released more than 90% of drug within 5 min and the release was comparable to that of a commercial product. In human volunteers, optimized formulation was found to have a pleasant taste and mouth feel and they disintegrated in the oral cavity within 12 sec. The stability results were also satisfactory. A pharmacokinetic study with the optimized formulation was performed in comparison with a reference (Zofer MD 8®) and they were found to be bioequivalent. In conclusion, a cost effective ondansetron orally disintegrating tablet was successfully prepared with acceptable hardness, desirable taste and rapid disintegration in the oral cavity. PMID:22139694

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

    PubMed Central

    Bergmann, Julie N.; Stockman, Jamila K.

    2015-01-01

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

  4. 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.

  5. Evaluation of a unique oral contraceptive in the treatment of premenstrual dysphoric disorder.

    PubMed

    Freeman, E W; Kroll, R; Rapkin, A; Pearlstein, T; Brown, C; Parsey, K; Zhang, P; Patel, H; Foegh, M

    2001-01-01

    Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome (PMS). This is the first trial of a unique oral contraceptive containing a combination of drospirenone (DRSP, 3 mg) and ethinyl estradiol (EE, 30 microg) for the treatment of PMDD. DRSP is a spironolactone-like progestin with antiandrogenic and antimineralocorticoid activity. Spironolactone has been shown to be beneficial in PMS, whereas oral contraceptives have shown conflicting results. In this double-blind, placebo-controlled trial, 82 women with PMDD (Diagnostic and Statistical Manual of Mental Disorders, 4th ed. [DSM IV]) were randomized to receive DRSP/EE or placebo for three treatment cycles. The primary end point was change from baseline in luteal phase symptom scores as assessed on the Calendar of Premenstrual Experiences (COPE) scale. Patients treated with DRSP/EE showed a numerically greater change from baseline compared with those treated with placebo on each of the 22 COPE items and each of the 4 symptom factors. Between-group differences in symptom improvement reached statistical significance in factor 3 only (appetite, acne, and food cravings, p = 0.027). The secondary end points, Beck Depression Inventory (BDI) and Profile of Mood States (PMS), were consistent with the primary end point in that patients treated with the oral contraceptive showed a numerically greater improvement from baseline compared with those treated with placebo. The results of this study show a consistent trend in the reduction of symptoms that suggested a beneficial effect of DRSP/EE for the treatment of PMDD, despite limitations of the study design. PMID:11559453

  6. 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

  7. Latent structure analysis of the process variables and pharmaceutical responses of an orally disintegrating tablet.

    PubMed

    Hayashi, Yoshihiro; Oshima, Etsuko; Maeda, Jin; Onuki, Yoshinori; Obata, Yasuko; Takayama, Kozo

    2012-01-01

    A multivariate statistical technique was applied to the design of an orally disintegrating tablet and to clarify the causal correlation among variables of the manufacturing process and pharmaceutical responses. Orally disintegrating tablets (ODTs) composed mainly of mannitol were prepared via the wet-granulation method using crystal transition from the δ to the β form of mannitol. Process parameters (water amounts (X(1)), kneading time (X(2)), compression force (X(3)), and amounts of magnesium stearate (X(4))) were optimized using a nonlinear response surface method (RSM) incorporating a thin plate spline interpolation (RSM-S). The results of a verification study revealed that the experimental responses, such as tensile strength and disintegration time, coincided well with the predictions. A latent structure analysis of the pharmaceutical formulations of the tablet performed using a Bayesian network led to the clear visualization of a causal connection among variables of the manufacturing process and tablet characteristics. The quantity of β-mannitol in the granules (Q(β)) was affected by X(2) and influenced all granule properties. The specific surface area of the granules was affected by X(1) and Q(β) and had an effect on all tablet characteristics. Moreover, the causal relationships among the variables were clarified by inferring conditional probability distributions. These techniques provide a better understanding of the complicated latent structure among variables of the manufacturing process and tablet characteristics. PMID:22878814

  8. 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. PMID:25272892

  9. Combined oral contraceptives for the treatment of acne: a practical guide.

    PubMed

    Arrington, Elizabeth A; Patel, Nishit S; Gerancher, Karen; Feldman, Steven R

    2012-08-01

    Many therapies exist in the arsenal of drugs available to dermatologists for the treatment of acne vulgaris. Among them, hormonal therapy stands out as a unique and highly efficacious treatment modality. Although some dermatologists may be hesitant to prescribe hormonal therapies, they can be safely and appropriately used in eligible female patients to treat acne vulgaris. Herein, current issues regarding the hormonal treatment of acne in the form of combined oral contraceptives (COCs) are presented, and a practical method for implementing this therapy is proposed. Specifically, drug selection, associated risks, benefits, monitoring, and counseling are discussed, with emphasis on the practicality of use in the clinical setting. PMID:22988652

  10. 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

  11. The dynamics of oral contraceptive use in The Netherlands 1990-1993.

    PubMed

    Oddens, B J; Arnolds, H T; Van Maris, M G; Van Lunsen, H W

    1994-09-01

    Data from an ongoing series of surveys on contraceptive use in the Netherlands were analyzed with respect to the percentages of oral contraceptive (OC) users who annually started use, discontinued use or switched to another OC type. The surveys had been conducted between 1990 and 1993 among samples of women aged 15-49 who belonged to a survey panel. Response rates of the surveys were 89-90% and the sample sizes ranged from 4560 to 4621 women. The assessed OC use rates reflected those of the Dutch population reasonably well. Of all respondents who had used OCs during the 12 months prior to the surveys, 12-15% discontinued use within this period, mainly in order to get pregnant, 12-16% were starters and 9-14% switchers. Of all starters 37% switched to another OC type within the first 12 months after starting. Switching was mainly related to the experience of perceived side-effects and wishes for better cycle control. The results highlighted the relevance of closely monitoring the individual woman's satisfaction with her OC. Since OC use appeared in many cases to be characterized by an active seeking for the most acceptable OC type, a wide range of OC types available and the development and introduction of new types is highly relevant for tailoring contraceptive use to individual needs. PMID:7863842

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

    PubMed Central

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

    2012-01-01

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

  13. 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

  14. 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) PMID:1362187

  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. PMID:26563727

  16. Mirtazapine orally disintegrating tablet versus sertraline: a prospective onset of action study.

    PubMed

    Behnke, Kirsten; Søgaard, Jesper; Martin, Stephen; Bäuml, Josef; Ravindran, Arun V; Agren, Hans; Vester-Blokland, Estelle D

    2003-08-01

    This multinational, randomized, double-blind study was specifically designed to prospectively compare the onset of antidepressant efficacy of mirtazapine orally disintegrating tablets and sertraline at dosages commonly used in clinical practice. A total of 345 patients with major depressive episode (DSM-IV) received mirtazapine (30-45 mg/d) or sertraline (50-150 mg/d) for 8 weeks. Mirtazapine was administered in the newly developed fast dissolving, orally disintegrating tablet formulation. Assessments were performed at baseline and on days 4, 7, 10, 14, 28, 42, and 56. The primary efficacy variable (mean absolute change from baseline in the Hamilton Depression Rating Scale [HAMD] total score [17 items]) showed that mirtazapine was significantly (P < 0.05) more effective than sertraline at all assessments during the first 2 weeks of the study. After this time, HAMD total scores were similar in both groups. These findings were supported by analysis of the HAMD response rate (ie, > or =50% reduction in HAMD total score from baseline), HAMD remission rate (HAMD total score of < or =7), and the Montgomery-Asberg Depression Rating Scale (MADRS). Both treatments were well tolerated. In addition, mirtazapine had a greater effect than sertraline on sexual functioning. In conclusion, this first prospective onset of action study using the orally disintegrating tablet indicates that mirtazapine has a faster onset of therapeutic effect than sertraline. The orally disintegrating tablet formulation of mirtazapine used in this study is known to enhance the convenience and compliance by the patient. PMID:12920411

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

    NASA Technical Reports Server (NTRS)

    Sandoval, Darleen A.; Matt, Kathleen S.

    2003-01-01

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

  18. 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

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

    PubMed

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

    2011-12-01

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

  20. Masculinizing effects on otoacoustic emissions and auditory evoked potentials in women using oral contraceptives.

    PubMed

    McFadden, D

    2000-04-01

    The otoacoustic emissions (OAEs) and auditory evoked potentials (AEPs) measured in two separate large scale studies were examined retrospectively for potential differences between those women using, and those not using, oral contraception (OC). Fourteen dependent variables were examined, all of which exhibited substantial sex differences. For 13 of those 14 dependent variables, the means for the users of OC were shifted away from the means of the non-users in the direction of the males. Specifically, for four different measures of OAE strength, for seven of eight measures of AEP latency or amplitude, and for two cognitive tests (mental rotation and water level), the means for the users of OC were located intermediate to those of the non-users of OC and the males. Few of these differences between users and non-users of OC achieved statistical significance, but the near universality of the direction of the difference suggests that oral contraceptives do produce a weak masculinizing effect on some auditory structures. These weak masculinizing effects appear to run contrary to the facts that the levels of both free testosterone and estradiol are lower in women using OC than in normal-cycling women. Past findings on auditory sex differences may have underestimated those sex differences. PMID:10748325

  1. 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

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

    PubMed

    Reiger, Jamie; Yingling, Vanessa R

    2016-01-01

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

  3. Influence of Body Weight, Ethnicity, Oral Contraceptives, and Pregnancy on the Pharmacokinetics of Azithromycin in Women of Childbearing Age

    PubMed Central

    Habibi, Mitra; Kilpatrick, Sarah J.; Tuomala, Ruth E.; Shier, Janice M.; Wollett, Lori; Fischer, Patricia A.; Khorana, Kinnari S.; Rodvold, Keith A.

    2012-01-01

    Women of childbearing age commonly receive azithromycin for the treatment of community-acquired infections, including during pregnancy. This study determined azithromycin pharmacokinetics in pregnant and nonpregnant women and identified covariates contributing to pharmacokinetic variability. Plasma samples were collected by using a sparse-sampling strategy from pregnant women at a gestational age of 12 to 40 weeks and from nonpregnant women of childbearing age receiving oral azithromycin for the treatment of an infection. Pharmacokinetic data from extensive sampling conducted on 12 healthy women were also included. Plasma samples were assayed for azithromycin by high-performance liquid chromatography. Population data were analyzed by nonlinear mixed-effects modeling. The population analysis included 53 pregnant and 25 nonpregnant women. A three-compartment model with first-order absorption and a lag time provided the best fit of the data. Lean body weight, pregnancy, ethnicity, and the coadministration of oral contraceptives were covariates identified as significantly influencing the oral clearance of azithromycin and, except for oral contraceptive use, intercompartmental clearance between the central and second peripheral compartments. No other covariate relationships were identified. Compared to nonpregnant women not receiving oral contraceptives, a 21% to 42% higher dose-adjusted azithromycin area under the plasma concentration-time curve (AUC) occurred in non-African American women who were pregnant or receiving oral contraceptives. Conversely, azithromycin AUCs were similar between pregnant African American women and nonpregnant women not receiving oral contraceptives. Although higher levels of maternal and fetal azithromycin exposure suggest that lower doses be administered to non-African American women during pregnancy, the consideration of azithromycin pharmacodynamics during pregnancy should guide any dose adjustments. PMID:22106226

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

    PubMed

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

    2016-01-01

    Glucosamine (GS) is commonly administered as a nutritional supplement to support joint function. Although many supplements are available, the effect of formulation on oral absorption in dogs is unknown. The purpose of this study was to determine the relative bioavailability of GS for liquid, chewable, and tablet formulations containing GS sulfate or hydrochloride and chondroitin sulfate. In a randomized cross-over design, supplements were administered daily for 8 days with a 1 wk washout period between treatments. Liquid or Tablet A was administered to four dogs, whereas Liquid or Tablet B was administered to four additional dogs. When nutraceutical exposure was normalized to the administered dose of GS free base, similar relative bioavailabilities were determined for all three formulations. However, the dose-normalized maximum plasma GS concentration was higher for the liquid supplement (5.5 ± 0.5 μg/mL) than for the two tablets (3.1 ± 0.6 and 2.1 ± 0.6 μg/mL, P < 0.001). Similarly, the time at which maximal plasma GS concentrations occurred was shorter for the liquid formulation (0.7 ± 0.5 hr) than for the two tablets (4.2 ± 0.6 and 5.0 ± 0.6 hr, P < 0.001). These data show that the formulation of joint supplements affects the oral absorption of GS in dogs. PMID:26808433

  5. Effectiveness and acceptability of progestogens in combined oral contraceptives – a systematic review

    PubMed Central

    Kulier, Regina; Helmerhorst, Frans M; Maitra, Nandita; Gülmezoglu, A Metin

    2004-01-01

    Background The progestogen component of oral contraceptives (OCs) has undergone changes since it was recognized that their chemical structure can influence the spectrum of minor adverse and beneficial effects. Methods The objective of this review was to evaluate currently available low-dose OCs containing ethinylestradiol and different progestogens in terms of contraceptive effectiveness, cycle control, side effects and continuation rates. The Cochrane Controlled Trials Register, MEDLINE and EMBASE databases were searched. Randomized trials reporting clinical outcomes were considered for inclusion and were assessed for methodological quality and validity. Results Twenty–two trials were included in the review. Eighteen were sponsored by pharmaceutical companies and in only 5 there was an attempt for blinding. Most comparisons between different interventions included one to three trials, involving usually less than 500 women. Discontinuation was less with second-generation progestogens compared to first–generation (RR 0.79; 95% CI 0.69–0.91). Cycle control appeared to be better with second-compared to first-generation progestogens for both, mono-and triphasic preparations (RR 0.69; 95% CI 0.52–0.91) and (RR 0.61; 95% CI 0.43–0.85), respectively. Intermenstrual bleeding was less with third- compared to second-generation pills (RR 0.71; 95% CI 0.55–0.91). Contraceptive effectiveness of gestodene (GSD) was comparable to that of levonorgestrel (LNG), and had similar pattern of spotting, breakthrough bleeding and absence of withdrawal bleeding). Drospirenone (DRSP) was similar compared to desogestrel (DSG) regarding contraceptive effectiveness, cycle control and side effects. Conclusion The third- and second-generation progestogens are preferred over first generation in all indices of acceptability. Current evidence suggests that GSD is comparable to LNG in terms of contraceptive effectiveness and for most cycle control indices. GSD is also comparable to DSG

  6. [The choice of oral contraception in 1984: general indications and specific cases].

    PubMed

    Gaspard, U

    1984-04-01

    Oral contrceptives (OCs), usd by over 30% of reproductive aged women in Belgium, are by far the most widely used contraceptive in that country. The various types of OCs include monophasic, biphasic, and triphasic combinations of an estrogen and a progestin, sequentials containing estrogen only for 7-14 days followed by a progestin through the 21st day; macrodose or microdose progestin only formulations, 3-month injectable progestins, and the morning after pill. Side effects of OCs are mainly due to metabolic effects on coagulation factors, the renin-angiotensin system, glucose tolerance, or the lipid profile. Users of OCs face increased risks of cholelithiases, thrombophlebitis, thromboembolism, cerebrovascular accidents, myocardial infarcts (among smokers over 35 years of age), and hepatic adenomas. The most troubling secondary effect is the excess cardiovascular morbidity and mortality show by contraceptive users, not just those who are obese, hypertensive, or who have histories of vascular pathology, but also those over 40 years of age and smokers. Lenght of use of OCs does not increase vascular risks. Epidemiologic studies demonstrate that vascular risks are reduced in lower dose formulations. Absolute contraindications to OC use include serious cardiovascular problems, severe hepatic pathology, estrogen-dependent tumors, pregnancy and undiagnosed gynecologic problems, and significant hyperlipidemia. Relative contraindications include severe headaches, cholelithiase, previous cholestasis of pregnancy, severe renal disease, fibromyomas, benign breast disease, age over 40 years, smoking, surgery anticipated within 4 weeks, infectious mononucleosis, falciform anemia, and immediate postpartum and lactation. Epilepsy, diabetes, depression, and varicose veins are not strictly speaking contraindications but require additonal surveillance. Lower dose formulations should be prescribed if possible. OC users should be followed up every 6-12 months. Among other steroidal

  7. The effects of oral contraceptives on well-being and sexuality.

    PubMed

    Bancroft, J; Sartorius, N

    1990-01-01

    The extent to which the high discontinuation rate for oral contraceptives is due to adverse effects of mood, well-being and sexuality is explored, taking into account early studies on high dose combined and sequential pills, recent studies on low-dose combined and triphasics, experimental design factors, effects of OCs on free androgen levels, psychosocial factors and reasons for choosing or stopping pills, effects on depressive illness, premenstrual syndrome, sexuality, and possible mechanisms for direct effects of steroids on mood and sexuality. Study design is complicated by selection of early or late oral contraceptive users, types of controls, and unknown confounding factors such as reason for choice of pills, effect of a reliable contraceptive on the sexual relationship, prior history of depression and premenstrual tension. Furthermore virtually all topics reviewed here resulted in inconsistent or contradictory findings, making a case for individual variation and subgroups of women with different responses regarding the end point being examined. Examples include whether progestogen alter female sexual desire or male attraction; and whether rising or falling free testosterone levels affect sexual response. Factors affecting experimental design include culture, language, life-cycle, type of relationship, personal qualities affecting contraceptive choice, manner of eliciting reports of side effects, steroid dose, whether ovulation was blocked, initial or established pill-use, possibility of missed pills, and type of controls. Current pill users seem to discontinue for depression and low libido less frequently than did users of higher dose pills, and severity scores of adverse effects are lower. Premenstrual and other cyclic events may be altered in timing, and premenstrual symptoms are relieved in most women, but worsened in some who take pills. It is likely that women with depressive and premenstrual complaints tend to discontinue pills, leaving the remaining

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

    PubMed

    Desai, Samixa; Poddar, Aditi; Sawant, Krutika

    2016-01-01

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

  9. Oral contraceptives, reproductive history and risk of colorectal cancer in the European Prospective Investigation into Cancer and Nutrition

    PubMed Central

    Tsilidis, K K; Allen, N E; Key, T J; Bakken, K; Lund, E; Berrino, F; Fournier, A; Olsen, A; Tjønneland, A; Overvad, K; Boutron-Ruault, M-C; Clavel-Chapelon, F; Byrnes, G; Chajes, V; Rinaldi, S; Chang-Claude, J; Kaaks, R; Bergmann, M; Boeing, H; Koumantaki, Y; Stasinopoulou, G; Trichopoulou, A; Palli, D; Tagliabue, G; Panico, S; Tumino, R; Vineis, P; Bueno-de-Mesquita, H B; van Duijnhoven, F J B; van Gils, C H; Peeters, P H M; Rodríguez, L; González, C A; Sánchez, M-J; Chirlaque, M-D; Barricarte, A; Dorronsoro, M; Borgquist, S; Manjer, J; van Guelpen, B; Hallmans, G; Rodwell, S A; Khaw, K-T; Norat, T; Romaguera, D; Riboli, E

    2010-01-01

    Background: Oral contraceptive use and reproductive factors may initiate long-term changes to the hormonal milieu and thereby, possibly influence colorectal cancer risk. Methods: We examined the association of hormonal and reproductive factors with risk of colorectal cancer among 337 802 women in the European Prospective Investigation into Cancer and Nutrition, of whom 1878 developed colorectal cancer. Results: After stratification for center and age, and adjustment for body mass index, smoking, diabetes mellitus, physical activity and alcohol consumption, ever use of oral contraceptives was marginally inversely associated with colorectal cancer risk (hazard ratio (HR), 0.92; 95% confidence interval (CI), 0.83–1.02), although this association was stronger among post-menopausal women (HR, 0.84; 95% CI: 0.74–0.95). Duration of oral contraceptive use and reproductive factors, including age at menarche, age at menopause, type of menopause, ever having an abortion, parity, age at first full-term pregnancy and breastfeeding, were not associated with colorectal cancer risk. Conclusion: Our findings provide limited support for a potential inverse association between oral contraceptives and colorectal cancer risk. PMID:21045829

  10. 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

  11. 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. PMID:23469682

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

    PubMed

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

    2016-01-01

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

  13. [Medication of the month. A new combined oral contraceptive containing estradiol valerate and dienogest (Qlaira)].

    PubMed

    Gaspard, U; Pintiaux, A; Kridelka, F

    2010-12-01

    In combined oral contraception (OC), a drastic reduction of both ethinylestradiol and androgenic progestins mostly derived from 19 NOR testosterone, allowed to moderately reduce the adverse impact of classical combined pills on metabolism and circulation (both arterial and venous). However, the marked hepatic action of ethinylestradiol, even in small dosages, lessens the expected risk reduction. For the first time, an OC has been developed, which contains estradiol valerate (with reduced hepatic action because of lack of a 17alpha ethinyl group) with dienogest, a 19 NOR testosterone-derived nonandrogenic progestin, which powerfully inhibits endometrial proliferation. Thanks to a dynamic modulation of estrogen and progestin doses (26 active days + 2 placebo days), an adequate contraceptive effectiveness, a good cycle control and drug tolerance are achieved, similar to those obtained with a classical low-dose OC. Recent data indicate that this new combination reduces the usually observed metabolic impact. An adequate cycle control (with 20% amenorrhea) is achieved for the first time with estradiol valerate + progestin,, in opposition with prior catastrophic results with other formulations containing 17beta-estradiol. A second combination containing estradiol + nomegestrol acetate (monophasic, 24 active days + 4 placebo days) is under study and seems also to yield promising results. Of course, in-depth study of metabolic and vascular effects of these new combinations is mandatory - and ongoing. PMID:21287768

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

    PubMed Central

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

    1981-01-01

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

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

    PubMed Central

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

    2008-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  18. No association between body size and frequency of sexual intercourse among oral contraceptive users

    PubMed Central

    Brunner Huber, Larissa R.; Stanley, Whitney A.; Broadhurst, Leah; Dmochowski, Jacek; Vick, Tara M.; Scholes, Delia

    2014-01-01

    Purpose This study aimed to describe frequency of sexual intercourse and whether body size was associated with weekly sexual intercourse among a diverse group of women using oral contraceptives. Methods This longitudinal, prospective cohort study recruited participants (n=185) from several clinics in Charlotte, NC. Body mass index (BMI) and waist-to-hip ratio (WHR) were used as measures of body size and sexual intercourse frequency was determined from self-reported information provided on daily diaries. Mean monthly frequencies of sexual intercourse were calculated and linear mixed models were used to assess if means remained constant over time. Generalized estimating equations were used to calculate odds ratios (ORs) and 95% confidence intervals (CIs). Results Mean monthly frequency of sexual intercourse was similar for women classified as normal/underweight or obese by BMI during each month of data collection, but was highest for women classified as overweight. After adjustment, obesity-sexual intercourse associations were attenuated (BMI ≥30 vs. <25.0: OR=0.78, 95% CI: 0.43, 1.42 and WHR ≥0.85 vs. <0.85: OR=1.11; 95% CI: 0.62, 2.01). Conclusions This study found no association between BMI or WHR and weekly sexual intercourse. However, more research is warranted given the importance of this possible relationship for future studies of fertility, contraceptive effectiveness, and sexual health. PMID:25034574

  19. Effects of oral contraceptive pill use on vaginal flora and vaginal epithelium.

    PubMed

    Eschenbach, D A; Patton, D L; Meier, A; Thwin, S S; Aura, J; Stapleton, A; Hooton, T M

    2000-09-01

    The objective of this study was to examine the effect of oral contraceptive (OC) use on vaginal discharge, epithelium, and flora. Thirty women who planned to use OC for contraception were evaluated before and 2 months after the start of OC use. At both visits, genital symptoms and exposures were assessed by questionnaire; vaginal signs were assessed by speculum examination and colposcopy; vaginal microflora was evaluated by quantitative culture; and a vaginal biopsy was obtained for histopathologic evaluation. Variables were compared between the initial visit and after 2 months of OC use. It was found that OC use did not change the gross, colposcopic, or histologic appearance of the vaginal epithelium or characteristics of vaginal or cervical discharge. Vaginal flora essentially remained unchanged after 2 months of OC use, except that a small decrease occurred in the number of subjects with > or =10(5) colony forming units/mL of H(2)O(2) producing Lactobacillus from 16 at baseline to 9 (p = 0.04) and in the total number of subjects with Ureaplasma urealyticum from 17 at baseline to 10 of 29 (p = 0.04). The results indicate minimal effect of OC use on the vaginal epithelium and vaginal and cervical discharge, and a small effect on vaginal flora. PMID:11124356

  20. Development and optimization of buspirone oral osmotic pump tablet.

    PubMed

    Derakhshandeh, K; Berenji, M Ghasemnejad

    2014-01-01

    The aim of the current study was to design a porous osmotic pump-based drug delivery system for controlling the release of buspirone from the delivery system. The osmotic pump was successfully developed using symmetric membrane coating. The core of the tablets was prepared by direct compression technique and coated using dip-coating technique. Drug release from the osmotic system was studied using USP paddle type apparatus. The effect of various processing variables such as the amount of osmotic agent, the amount of swellable polymer, concentration of the core former, concentration of the plasticizer, membrane thickness, quantum of orifice on drug release from osmotic pump were evaluated. Different kinetic models (zero order, first order and Higuchi model) were applied to drug release data in order to establish the kinetics of drug release. It was found that the drug release was mostly affected by the amount of NaCl as osmotic agent, the swellable polymer; hydroxy propyl methyl cellulose (HPMC), the amount of PEG-400 and cellulose acetate in the coating solution and thickness of the semipermeable membrane. The optimized formulation released buspirone independent of pH and orifice quantum at the osmogen amount of 42%, hydrophilic polymer of 13% and pore size of 0.8 mm on the tablet surface. The drug release of osmotic formulation during 24 h showed zero order kinetics and could be suggested that this formulation as a once-daily regimen improves pharmacokinetic parameters of the drug and enhances patient compliance. PMID:25657794

  1. The relationship between oral contraceptive use and sensitivity to olfactory stimuli.

    PubMed

    Renfro, Kaytlin J; Hoffmann, Heather

    2013-03-01

    The present study examined differences in olfactory sensitivity between 16 naturally cycling (NC) women and 17 women taking monophasic oral contraceptives (OCs) to six odors: lemon, peppermint, rose, musk, androstenone and androsterone. Thresholds were assessed twice for both groups of women (during the periovulatory and luteal phases of their cycles) via a forced-choice discrimination task. NC women in the periovulatory phase were significantly more sensitive to androstenone, androsterone, and musk than women taking OCs. These findings give support to odor-specific hormonal modulation of olfaction. Further, due to the social and possibly sexual nature of these odors, future work should address whether there is a relationship between decreased sensitivity to these odors and reported behavioral side effects among women taking OCs. PMID:23321429

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

    PubMed Central

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

    1992-01-01

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

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

    PubMed Central

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

    2011-01-01

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

  4. Combined oral contraceptive synergistically activates mineralocorticoid receptor through histone code modifications.

    PubMed

    Igunnu, Adedoyin; Seok, Young-Mi; Olatunji, Lawrence A; Kang, Seol-Hee; Kim, Inkyeom

    2015-12-15

    Clinical studies have shown that the use of combined oral contraceptive in pre-menopausal women is associated with fluid retention. However, the molecular mechanism is still elusive. We hypothesized that combined oral contraceptive (COC) ethinyl estradiol (EE) and norgestrel (N) synergistically activates mineralocorticoid receptor (MR) through histone code modifications. Twelve-week-old female Sprague-Dawley rats were treated with olive oil (control), a combination of 0.1µg EE and 1.0µg N (low COC) or 1.0µg EE and 10.0µg N (high COC) as well as 0.1 or 1.0µg EE and 1.0 or 10.0µg N daily for 6 weeks. Expression of MR target genes in kidney cortex was determined by quantitative real-time polymerase chain reaction. MR was quantified by western blot. Recruitment of MR and RNA polymerase II (Pol II) on promoters of target genes as well as histone code modifications was analyzed by chromatin immunoprecipitation assay. Treatment with COC increased renal cortical expression of MR target genes such as serum and glucocorticoid-regulated kinase 1 (Sgk-1), glucocorticoid-induced leucine zipper (Gilz), epithelial Na(+)channel (Enac) and Na(+)-K(+)-ATPase subunit α1 (Atp1a1). Although COC increased neither serum aldosterone nor MR expression in kidney cortex, it increased recruitment of MR and Pol II in parallel with increased H3Ac and H3K4me3 on the promoter regions of MR target genes. However, treatment with EE or N alone did not affect renal cortical expression of Sgk-1, Gilz, Enac or Atp1a1. These results indicate that COC synergistically activates MR through histone code modifications. PMID:26506558

  5. 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. PMID:26555927

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

    PubMed

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

    2016-01-01

    A 34-year-old woman who had been using oral contraceptives for 10 years developed hypertensive crisis with papilloedema after an upper respiratory infection. Laboratory data showed hyperreninemic hyperaldosteronism and elevated levels of fibrinogen, fibrin, and fibrinogen degradation products. Echocardiography demonstrated two masses (18 mm) in the left ventricle. On the fourth hospital day, cerebral infarction, renal infarction, and upper mesenteric artery occlusion suddenly occurred despite the blood pressure being well-controlled using anti-hypertensive drugs. Echocardiography revealed the disappearance of the left ventricular masses, which suggested left ventricular thrombi. Cessation of the contraceptives and administration of heparin, warfarin, and anti-platelets drugs improved her general condition. PMID:26726092

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

    PubMed

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

    2016-01-01

    Findings on women's sexuality across the menstrual cycle are inconsistent. One relatively consistent finding is a midcycle and premenstrual peak in sexual desire in freely cycling women. Results on the cycle-related effects on sexual behavior are less clear. Large proportions of reproductive-aged women use combined oral contraception (COC), but studies on potential cycle-related shifts in sexual desire and behavior are sparse. A prospective diary study assessed sexual desire, sexual behavior, and mood in 89 heterosexual couples. Women were using one of four contraceptive methods: (1) nonhormonal contraception, (2) low-dose COC containing 20 mcg ethinylestradiol and 75 mcg gestoden or desogestrel, (3) COC containing 35 mcg ethinylestradiol and 2 mg cyproteronacetate, and (4) COC containing 30 mcg ethinylestradiol and 3 mg drospirenone. No cycle effects of sexual desire were established in the COC group, but frequency of sexual intercourse declined in the last days of active pill taking. These results were similar in both female and male partners. Negative affect did not covary with sexual desire. PMID:25420716

  8. In vitro and in vivo evaluation of oral tablet formulations prepared with ketoconazole and hydroxypropyl-beta-cyclodextrin.

    PubMed

    Taneri, Filiz; Ozcan, Ipek; Guneri, Tamer

    2010-04-01

    The objective of this study was to enhance the solubility, dissolution rate, and oral bioavailability of a very poorly water-soluble anti-fungal agent, ketoconazole (KET), by inclusion complexation with a highly-soluble cyclodextrin derivative, hydroxypropyl-beta cyclodextrin (HP-beta-CD). Two groups of tablets containing KET alone and KET:HP-beta-CD (1:2) kneaded product (KP) including magnesium stearate and lactopress (anhydrous and spray-dried) as excipients were prepared by direct compression method. After the characterization studies, the in vitro dissolution studies of these tablets in simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) were carried out. To evaluate the in vivo bioavailability, the tablets were administered orally to rabbits and drug levels in serum were determined by HPLC. Tablets containing the cyclodextrin complex showed a higher in vitro dissolution rate and bioavailability compared to the tablets containing KET alone. PMID:20148713

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

    PubMed Central

    2016-01-01

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

  10. New Generation of Orally Disintegrating Tablets for Sustained Drug Release: A Propitious Outlook.

    PubMed

    Elwerfalli, Arwa Matoug; Ghanchi, Zabir; Rashid, Fatema; Alany, Raid G; ElShaer, Amr

    2015-01-01

    Orally disintegrating tablets (ODTs) or orodispersible tablets are solid dosage forms that disintegrate within 3 minutes in the mouth into a paste that can be easily swallowed. ODTs have improved over the past years, in an attempt to produce a safe and efficient substitute to the conventional oral dosage forms, particularly for dysphagia patients. Since its introduction in the market in the 1980s, ODTs expanded rapidly and achieved revenues over $3 billion in 2006 and sustaining 20% annual growth. It is therefore evident that ODTs carry good commercial value, however there is potential for improvement. Current sustained-release technologies may be exploited and incorporated into an ODT to provide greater therapeutic value by reducing the need for multiple daily dosing regimens and improving patient adherence. A number of technologies such as polymer coated nanoparticles, stimuli-responsive polymers and ion-exchange resins have emerged to produce robust, sustained release orally disintegrating tablets (SR-ODT). The purpose of this review is to highlight these various approaches and techniques and how they have been utilised in an ODT formulation to extend differentiated line, market exclusivity and patent life. The review also explores future perspective and the potential challenges that SR-ODTs will face. PMID:25760951

  11. Modern trends in contraception.

    PubMed

    Burkman, R T

    1990-12-01

    Substantial improvements have been made in oral contraceptives, a new injectable contraceptive (Norplant), and the intrauterine device (IUD). Major risks with oral contraceptives have declined substantially, and a number of noncontraceptive health benefits have been discovered. Norplant is probably the first new contraceptive in recent years, and offers long-term contraception with high efficacy and modest risks. The IUD, by carefully selecting users, is a safe and efficacious contraceptive method. The major risk, pelvic inflammatory disease (PID), is far less common if one avoids use in the presence of risk factors for PID. PMID:2128711

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    2016-06-01

    Macitentan, a dual endothelin receptor antagonist used in pulmonary arterial hypertension, induces cytochrome P450 (CYP) 3A at supratherapeutic concentrations in vitro. Most combined oral hormonal contraceptives (OCs) are CYP3A substrates and their efficacy can be affected by CYP3A inducers. This randomized crossover study assessed possible pharmacokinetic (PK) interactions between macitentan and an OC containing ethinyl estradiol and norethindrone (or norethisterone). Twenty-six healthy women received a single oral dose of OC alone (reference) and concomitantly with 10 mg macitentan at steady state (test). No PK interaction was concluded if the 90% confidence intervals (CIs) of geometric mean ratios (GMRs; test/reference) of the peak plasma concentration (Cmax ) and the exposure from 0 to infinity (AUC0 - ∞ ) to the OC components were within the equivalence limits of 0.8 to 1.25. Cmax and AUC0-∞ of the OC were within the equivalence limits. For ethinyl estradiol, GMRs (90%CIs) of Cmax and AUC0-∞ were 0.92 (0.85-0.99) and 0.95 (0.90-0.99). For norethindrone, these values were 1.02 (0.95-1.09) and 1.04 (0.98-1.09), respectively. Overall, study treatments were well tolerated. No major changes from baseline in safety parameters were reported in either treatment. Macitentan does not affect the PK of OCs. PMID:26381054

  14. Pro/antioxidant status in young healthy women using oral contraceptives.

    PubMed

    Kowalska, Katarzyna; Milnerowicz, Halina

    2016-04-01

    The aim of the study was to analyze the effects of oral contraceptives (OCs) on pro/antioxidant status in the blood of healthy women aged 20-25 years. Individuals were divided into OCs users and OCs nonusers. Markers of oxidative stress in the blood such as Cu, Cu/Zn ratio, malondialdehyde (MDA), glutathione oxidized (GSSG), and gamma-glutamyl transpeptidase (GGT) were determined. Antioxidants such as glutathione reduced (GSH), catalase (CAT), glutathione reductase (GR), glutathione peroxidase (GPx), glutathione S-transferase (GST), and superoxide dismutase (SOD) were estimated. Higher Cu concentrations, Cu/Zn ratio and GGT activity in women taking OCs were noted. A significant increase in MDA concentrations in oral OCs users was observed. Heightened activity of CAT in plasma was observed in OCs users, whereas SOD activity remained unchanged in plasma and erythrocyte lysate. A decline of GSH and GSSG in whole blood and glutathiono-dependent enzymes (GPx in plasma, GR in plasma and GST in lysate) was shown. Use of OCs leads to a pro/antioxidant imbalance. The results in the present study confirmed that GGT is an early marker of oxidative stress. Catalase is the main antioxidant, involved in the removal of free radicals in OCs users. PMID:26921793

  15. Matched-pairs analysis of ovarian suppression during oral versus vaginal hormonal contraceptive use

    PubMed Central

    Petrie, Kelsey A.; Torgal, Anu H.; Westhoff, Carolyn L.

    2011-01-01

    Background This study was conducted to compare ovarian suppression during oral versus vaginal hormonal contraceptive use. Secondary aims included comparison of endometrial thickness and bleeding patterns. Methods In two open-label trials assessing ovarian suppression, 33 compliant women completed both studies. They first used OCs [randomized to either 20 mcg ethinyl estradiol (EE)/100 mcg levonorgestrel (LNG) or 30 mcg EE/150 mcg LNG] and subsequently used contraceptive vaginal rings (CVR) (daily release of 15 mcg EE/120 mcg etonogestrel), all 21/7 day regimens. Participants had at least one run-in cycle using each contraceptive method prior to evaluation. During one cycle of each method, women underwent bi-weekly transvaginal sonography to measure ovarian follicular diameters and endometrial thickness. We also noted presence of a corpus luteum or a ruptured follicle as a marker of ovulation. Participants recorded bleeding days on paper calendars. We used matched pairs analyses as appropriate. Results During follow-up, we identified at least one ovarian follicle ≥8 mm in 20/33 (61%) OC users and 12/33 (36%) CVR users (matched pairs analysis, p=0.02). Similar trends were seen for larger follicles; however we had limited statistical power to evaluate these differences. Median follicular diameter among OC users was larger than median follicular diameter among CVR users (p=0.01). We did not observe a corpus luteum or ruptured follicle in any participant during either study. Endometrial thickness was similar during OC and CVR use (mean 4.1 ± 1.4 mm versus 4.1 ± 1.6 mm, p=0.9) as was the number of bleeding or spotting days (mean 2.1 ± 2.4 versus 1.9 ± 2.1, p=0.8). OC dose was unrelated to follicle diameter, endometrial thickness, or bleeding. Conclusions Ovarian follicles ≥8 mm were more common in 33 compliant women during OC use than during CVR use indicating CVR use results in greater ovarian suppression than OC use. PMID:22018131

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

    PubMed

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

    2015-11-01

    Few studies have evaluated the association between pregravid oral contraceptive (OC) use and birth weight, and findings have been conflicting. We conducted a prospective cohort study of 5921 pregnancy planners in Denmark to evaluate recency, duration, and type of OC used before conception in relation to infant birth weight. Participants completed online questionnaires and reported detailed information on contraceptive history and covariates at baseline. Participants completed bimonthly follow-up questionnaires to update their pregnancy status for up to 12 months or until conception occurred. Birth weight data were ascertained from the Danish Medical Birth Registry for 4046 live births delivered by study participants between 2008 and 2010. We used multivariable linear and log-binomial regression analyses to control for confounding. Mean birth weight was higher among women who had used OCs within 0-1 months (mean difference = 97 g, CI 26, 168) or 2-6 months (mean difference = 40 g, CI -5, 85) before conception, compared with more than 12 months before conception. Mean birth weight was lower among women who had used OCs for long durations (mean difference comparing ≥12 with <4 years of OC use = -85 g, CI -158, -11). Our findings indicate that pregravid OC use within 6 months of conception may be associated with a small increase in birth weight, but that long duration of use may have the opposite effect. Results were stronger among male infants, among 2nd and 4th generation OC users, and among users of OCs with a higher estrogen dose. PMID:26076921

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

    PubMed

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

    2015-09-01

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

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

    PubMed Central

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

    2015-01-01

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

  19. Serum metabolomic profiles suggest influence of sex and oral contraceptive use

    PubMed Central

    Ruoppolo, Margherita; Campesi, Ilaria; Scolamiero, Emanuela; Pecce, Rita; Caterino, Marianna; Cherchi, Sara; Mercuro, Giuseppe; Tonolo, Giancarlo; Franconi, Flavia

    2014-01-01

    Aim: Considering that the effects of sex and oral contraceptives (OCs) on blood metabolites have been scarcely studied and the fact that protocol designs for clinical trials emphasise the use of contraception for women of childbearing potential, we examined if OCs and sex affect the serum levels of the physiologically relevant amino acids, carnitine and acylcarnitines, using metabolomics approaches. Methods: Healthy adult men and women were enrolled. They were drug free with the exception of women taking cyclic format OCs (ethinylestradiol + different progestins). OCs-free women were analysed during the follicular phase, and amino acids, free carnitine and acylcarnitines were measured using HPLC or LC-MS/MS, respectively. Results: Men had significantly higher leucine, isoleucine, methionine, asparagine, proline, valine, tyrosine, glutamine+glutamate, glutamate, histidine and citrulline than OCs-free women, while tryptophan was significantly lower in men. OCs use significantly decreased the levels of glycine, proline, histidine, lysine, hydroxyproline and ornithine and increased isoleucine levels when compared with non-user women. OCs use reduced, although not significantly, carnitine levels in women. Total esterified carnitines were higher in untreated women than in OCs users. Globally, the effect of OCs and sex was specific for the individual esterified carnitine. The observed metabolic changes were not attributable to renal or hepatic functions or to differences in body weight. Conclusions: The assessed parameters were specifically influenced by sex, highlighting the need to have reference values for women and men. The major novelty of this study is the demonstration that OCs specifically change the profiles of serum amino acids and carnitine, which suggests that OCs users and non-users should be represented in clinical trials. PMID:25360225

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

    PubMed

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

    2005-03-23

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

  1. Emergency contraception.

    PubMed

    Grimes, David A; Raymond, Elizabeth G

    2002-08-01

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

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

    SciTech Connect

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

    1984-03-01

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

  3. Effect of oral contraceptives and hormone replacement therapy on bone mineral density in premenopausal and perimenopausal women: a systematic review

    PubMed Central

    Liu, S L; Lebrun, C M

    2006-01-01

    Seventy five articles on the effect of oral contraceptives and other hormone replacement on bone density in premenopausal and perimenopausal women were reviewed. The evidence was appraised using the Oxford Centre for Evidence‐Based Medicine levels of evidence. There is good evidence for a positive effect of oral contraceptives on bone density in perimenopausal women, and fair evidence for a positive effect in “hypothalamic” oligo/amenorrhoeic premenopausal women. There is limited evidence for a positive effect in healthy and anorexic premenopausal women. In hypothalamic oligo/amenorrhoeic women, baseline bone density has been shown to be significantly lower than that in healthy controls, therefore the decision to treat is clinically more important. The ideal formulation(s) and duration of treatment remain to be determined by further longitudinal and prospective randomised controlled trials in larger subject populations. PMID:16371485

  4. [Technical scheme of real-time evaluation of traditional Chinese medicine orally disintegrating tablets].

    PubMed

    Qin, Dong; Chen, Xu-dong; Feng, Liang; Gu, Jun-fei; Yuan, Jia-rui; Jia, Xiao-bin

    2014-12-01

    Orally disintegrating tablets (ODT), a kind of new solid tablet that rapidly disintegrates to work in the mouth, has became the hot form of new drug research in recent years with many advantages, such as the convenient taking, a widely applicable people, fast acting, high bioavailability, good compliance, and so on. ODT has been widely used in chemical medicines, while the application of it in traditional Chinese medicines (TCMs) is still in the stage of development The development of TCMs ODT provides a new direction for the research of Chinese medicine new dosage, accelerates the pace of connecting to the world and modernization of Chinese medicine. This dosage has a broad market prospect, and its quality control and assessment standards, taste, the disintegration time in vitro and evaluation method are the key factors that affect the industrialization, standardization of Chinese medicine ODT. Therefore, this paper reviewed the characteristics, preparation, taste masking technology and quality evaluation with new technology of ODT. Meantime, numerous application examples of ODT used in traditional Chinese medicine were described. We expect to provide the reference and utilization for the development of traditional Chinese medicine orally disinteeratine tablets. PMID:25898566

  5. A new modified wetting test and an alternative disintegration test for orally disintegrating tablets.

    PubMed

    Hooper, Patrick; Lasher, Jason; Alexander, Kenneth S; Baki, Gabriella

    2016-02-20

    Industrial manufacturing of solid oral dosage forms require quality tests, such as friability, hardness, and disintegration. The United States Pharmacopeia (USP) disintegration test uses 900mL of water. However, recent studies of orally disintegrating tablets (ODTs) have shown that this volume does not accurately portray the oral environment. In our study, various tests were conducted with a more moderate amount of water that accurately resembles the oral environment. A simulated wetting test was performed to calculate the water absorption ratio. Results showed that wetting was comparable to disintegration. Although the wetting test worked for most types of ODTs, it had limitations that produced inaccurate results. This led to the use of a modified shaking water bath test. This test was found to work for all types of ODT products and was not subject to the limitations of the wetting test. The shake test could provide disintegration times rather than water permeation times; however, it could not be used to calculate the water absorption ratio. A strong correlation was observed between the standardized shake test and the USP disintegration times for the tablets. This shake test could be used during the development stages and quality tests for ODTs with relative ease. PMID:26774944

  6. [Benefit of the Internet as an information tool in case of oral contraceptive miss. Survey of 1964 women visiting the website www.g-oubliemapilule.com].

    PubMed

    Lemaître, Sophie; Collier, Francis; Hulin, Vincent

    2009-12-20

    The aim of the study is to evaluate the utility of the website http://www.g-oubliemapilule.com/ that contains the recommendations of the French Haute Autorité de santé in case of oral contraceptive pill missing. This epidemiologic prospective study was conducted using an online questionnaire available at http://www.g-oubliemapilule.com/. The results emphasize the poor quality of information provided by the physicians. 40% of the physicians don't provide information about what to do in case of oral contraceptive pill missing during the first medical visit for oral contraceptive prescription and the physicians don't inquire about oral contraceptive pill missing during the follow-up in 3/4 of the cases. Furthermore, when women find information about what to do in case of oral contraceptive pill missing, a majority of them won't follow the advice provided even if it is fully understood. 60% of the women who should use the condom during the 7 days following the oral contraceptive pill missing don't use it and 86% of the women who should use the emergency contraceptive pill don't use it. The reason mostly invoked (1/3 of the cases) to support that behaviour is the assumption that the risk of pregnancy is too low. The results help to understand the gap between theoretical efficacy (Pearl Index: 0.3%) and real efficacy (8%) of the oral contraceptive pill. Finally, the website http://www.g-oubliemapilule.com/ is a useful well understood additional tool but can't replace the medical follow-up. PMID:20085215

  7. Bioequivalence of ondansetron oral soluble film 8 mg (ZUPLENZ) and ondansetron orally disintegrating tablets 8 mg (ZOFRAN) in healthy adults.

    PubMed

    Dadey, Eric

    2015-01-01

    Oral formulations of ondansetron are used to prevent nausea and vomiting associated with chemotherapy, radiotherapy, and surgery. An oral soluble film formulation of ondansetron (OND OSF) was developed using MonoSol Rx's proprietary PharmFilm technology and was formulated to dissolve rapidly on the tongue, without the need for water. This product provides an oral antiemetic treatment option for patients who experience difficulty swallowing. The purpose of this study was to compare the bioequivalence of OND OSF 8 mg (ZUPLENZ, Monosol Rx, Warren, NJ) with ondansetron orally disintegrating tablets (OND ODT) 8 mg (ZOFRAN, GlaxoSmithKline, Research Triangle Park). In 3 individual open-label, randomized studies, healthy adult subjects received a single dose of OND OSF 8 mg and a single dose of OND ODT 8 mg, under fasted conditions (study 1, n = 48), fed conditions (study 2, n = 48), and fasted with and without water (study 3, n = 18). Each dosing period was followed by a 3- or 7-day washout period. Ondansetron pharmacokinetics were assessed predose to 24 hours postdose for the single 8-mg doses of OND OSF and OND ODT. All analyses were conducted on natural log-transformed pharmacokinetic parameters for OND OSF and OND ODT. Under both fasted and fed conditions, the 90% confidence interval for the comparisons of OND OSF and OND ODT plasma ondansetron area under the curve from time 0 to the last measured concentration (AUC0-t), area under the concentration vs. time curve from time 0 to infinity (AUC0-∞), and maximum plasma concentration (Cmax) were within the 80%-125% range, indicating bioequivalence between the formulations. With features designed to make it portable and easy to take, OND OSF 8 mg provides an alternative treatment option, particularly for patients with dysphagia and others who find it difficult to take oral tablets. PMID:25581856

  8. Design, development, and optimization of orally disintegrating tablets of etoricoxib using vacuum-drying approach.

    PubMed

    Patel, Dharmesh; Shah, Mohit; Shah, Sunny; Shah, Tejal; Amin, Avani

    2008-01-01

    Etoricoxib is a cyclooxygenase 2 (COX-2) inhibitor that selectively inhibits the COX-2 enzyme and decreases the incidences of side effects associated with these agents. It is commonly prescribed for acute pain, gouty arthritis, and rheumatoid arthritis. Conventional tablets of etoricoxib are not capable of rapid action, which is required for faster drug effect onset and immediate relief from pain. Thus, the aim of the present investigation is to formulate orally disintegrating tablets (ODTs) of etoricoxib. A combination of the superdisintegrants with a sublimation technique was used to prepare the tablets. Tablets were prepared using a direct compression method employing superdisintegrants such as low substituted hydroxylpropyl methyl cellulose (L-HPMC), low substituted hydroxyl-propyl cellulose (L-HPC), crospovidone, croscarmellose sodium, and sodium starch glycolate. Tablets of etoricoxib prepared using L-HPC exhibited the least friability and disintegration time (approximately 65 s). To decrease the disintegration time further, a sublimation technique was used along with the superdisintegrants for the preparation of ODTs. The use of sublimating agents including camphor, menthol, and thymol was explored. The addition of camphor lowered the disintegration time (approximately 30 s) further, but the percent friability was increased. A 3(2) full factorial design was employed to study the joint influence of the amount of superdisintegrant (L-HPC) and the amount of sublimating agent (camphor) on the percent of friability and the disintegration time. The results of multiple linear regression analysis revealed that for obtaining an effective ODT of etoricoxib, higher percentages of L-HPC and camphor should be used. Checkpoint batches were prepared to validate the evolved mathematical model. A response surface plot is also presented to graphically represent the effect of the independent variables on the percent of friability and the disintegration time. The approach using

  9. Formulation design for orally disintegrating tablets containing enteric-coated particles.

    PubMed

    Okuda, Yutaka; Okamoto, Yasunobu; Irisawa, Yosuke; Okimoto, Kazuto; Osawa, Takashi; Yamashita, Shinji

    2014-01-01

    The purpose of this study was to investigate the applicability of our newly developed technology (RACTAB® technology) for preparing orally disintegrating tablets (ODTs) containing enteric-coated particles. Tamsulosin hydrochloride (TAM) was used as a model drug contained in the enteric-coated particles. Enteric-coated particles containing TAM (ECP-T) were prepared by spray coating a mixture of TAM with controlled-release materials. ECP-T was then mixed with rapidly disintegrating granules (RDGs), which were prepared using the suspension spray-coating method, and was tableted to form ODTs (ODTRAC). ODTRAC was evaluated for its hardness, thickness, internal structure (X-ray-CT scanning), functional properties (controlled-release profile), and in vivo disintegration time. Since RDGs with micronized ethylcellulose (MEC) increased tablet hardness by increasing the contact frequency between granules, ODTRAC containing ECP-T exhibited high hardness (>50 N) and low friability (<0.5%) with a relatively low compression force. After tableting, the structure of ECP-T in ODTRAC remained intact and no damage was observed on the surface. ECP-T recovered from ODTRAC showed the same dissolution profile of TAM in Japanese Pharmacopoeia (JP) 1st and JP 2nd media as that of intact ECP-T, which indicated that the tableting process did not affect the acid-resistibility of the particle. In addition, ODTRAC rapidly disintegrated in vivo (< 30 s), even at a high compression force (at 9 kN). These findings clearly suggest that RACTAB® technology is a useful approach to prepare ODTs containing enteric-coated particles. PMID:24789923

  10. Effects of Orally Administered Lactoferrin and Lactoperoxidase-Containing Tablets on Clinical and Bacteriological Profiles in Chronic Periodontitis Patients

    PubMed Central

    Shimizu, Eiju; Kobayashi, Tetsuo; Wakabayashi, Hiroyuki; Yamauchi, Koji; Iwatsuki, Keiji; Yoshie, Hiromasa

    2011-01-01

    This study was undertaken to evaluate the effect of oral administration of lactoferrin (LF) and lactoperoxidase-(LPO-)containing tablet on periodontal condition. Seventy-two individuals with chronic periodontitis were randomly assigned to take either bovine LF and LPO-containing tablets (test group, n = 37) or control tablets (control group, n = 35) every day for 12 weeks. Periodontal parameters and levels of subgingival plaque bacteria, human and bovine LF, and endotoxin in gingival crevicular fluid (GCF) were evaluated at baseline, 1 week, 4 weeks, and 12 weeks. Significant differences were observed in GCF levels of bovine LF between the test and control groups throughout the study (P < .05). However, clinical and bacteriological parameter values proved comparable between the two groups at 1 week to 12 weeks. Therefore, the effect of oral administration of LF and LPO-containing tablets might be weak on periodontal and bacteriological profile in this study. PMID:21747858