Ethinylestradiol and levonorgestrel preparations on the Belgian market: a comparative study.

Preparations formulated as coated or film-coated tablets, containing levonorgestrel and the combination ethinylestradiol/levonorgestrel, were evaluated in a comparative study. This study comprised in vitro dissolution, assay and content uniformity. The analytical methods were previously validated according to international guidelines. All examined products complied with the postulated requirements.

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

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

[The statement of Polish Gynecological Society experts on oral use of contraceptive 75 microg desogestrel minipill in different clinical cases--state of art in 2008]. / Stanowisko Zespolu Ekspertów Polskiego Towarzystwa Ginekologicznego dotyczace zastosowania antykoncepcyjnej minitabletki gestagennej zawierajacej 75 microg dezogestrelu w wybranych sytuacjach klinicznych--stan wiedzy na 2008 rok.

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

Combined administration of low-dose gossypol acetic acid with desogestrel/mini-dose ethinylestradiol/testosterone undecanoate as an oral contraceptive for men.

To evaluate the efficacy and feasibility of a new regimen of low-dose gossypol acetic acid (GA) combined with desogestrel/ethinylestradiol and testosterone undecanoate (DSG/E/TU) as a male contraceptive, adult male rats were fed orally with GA (12.5 mg/kg/day) and DSG (0.125 mg/kg)/E (0.025 mg/kg)/TU (100 mg/kg) daily for 8 weeks as loading dose until infertility, and a similar low dose of GA alone for infertility maintenance. Control animals were administered a single low dose of GA (12.5 mg/kg/day) or DSG (0.125 mg/kg)/E (0.025 mg/kg)/TU (100 mg/kg), and vehicle, respectively. Results demonstrated that the combined dosage regimen could damage epididymal sperm motility and density, and induce infertility within 8 weeks in rats; the infertility could be consistently sustained by giving single GA (12.5 mg/kg/day), and was reversible in about 8 weeks following withdrawal of gossypol. The regimen rendered treated male rats with spermiation failure within a period of 6-20 weeks of treatment. Also, the serum luteinizing hormone, follicle-stimulating hormone and testicular interstitial fluid testosterone levels showed a transient decrease at the end of 6 or 8 weeks, which returned to control levels after 8 weeks of recovery phase. No hypokalemia or other adverse effects in viscera were observed. These results provide a promising approach to using the new regimen for the development of an effective and reversible oral male contraceptive.

Oral contraception: current use and attitudes.

Oral contraception (OC) has been available for almost four decades. During this time, changes in contraceptive use in general and OC in particular have occurred. Knowledge and attitudes about OC may not always reflect trends in use. Contraceptive use data from 1965-1995 show that OC continue to be the method chosen consistently by more than one-quarter of women contraceptors. Probably even more women would use the pill if they had more accurate information regarding the higher failure rates with barrier methods (especially the condom), if misperceptions about OC safety were put to rest, and if greater awareness of the noncontraceptive health benefits of OC could be achieved. Increased education and awareness of women as well as their healthcare providers has the potential to positively affect future contraceptive use.

PIP: During the four decades that oral contraceptives (OCs) have been available to US women, important changes have occurred in their use patterns. The mass media, health care providers, and health insurance companies all have shaped these patterns. The media continue to emphasize the health risks of OC use, despite the fact that changes in the steroid content of OCs and identification of patient risk factors have eliminated or minimized many adverse outcomes. Educational efforts by health care providers on the noncontraceptive benefits of OC use have been inadequate to counteract media-promoted public misperceptions. Inaccurate information may lead women to select a method that lacks the appropriate degree of effectiveness and a consequent increased risk of unintended pregnancy. Two measures of socioeconomic status--income and education--exert a major influence on the choice of a contraceptive method by US women. Low-income women with a high school education or less are more likely to use female sterilization and less likely to use OCs than women with more education and income. Future contraceptive trends in the US will depend on factors such as the changing age distribution of women, revised upper age limits for OC use, the effects of delayed childbearing and sterilization, the impact of new methods, the availability of abortion, and concerns about HIV infection and other sexually transmitted diseases.

Effects of a progestogen-only pill (Exluton) and an intrauterine device (Multiload Cu250) on breastfeeding.

The objective was to compare the effects of Exluton with those of Multiload Cu250, in an open-label, bi-center, randomized study in breastfeeding women. Subjects were randomized to one of the treatment groups 6 weeks after delivery. Women and their infants returned to the study site monthly and follow-up data regarding qualitative and quantitative characteristics of the breast milk, infant growth and infant and maternal health were obtained. There were no statistically significant differences between groups with regard to: (1) amount of milk drunk, amount of milk production, and number of daily breastfeedings; (2) mean milk concentrations of nutritional constituents (except higher milk levels of calcium and magnesium with Exluton during the first month); (3) infant anthropometric parameters. There were no between-group differences with regard to systolic or diastolic blood pressure. During the study, the mean maternal body weight in the Exluton group was significantly lower than in the Multiload Cu250 group. There were no differences between groups with regard to child or maternal health, except a lower incidence of child illness after 6 months in the Exluton group. This study confirms that both Exluton and Multiload Cu250 are acceptable and safe contraceptive methods in breastfeeding women.

A multicentred, two-year, phase III clinical trial of norethisterone enanthate 50 mg plus estradiol valerate 5 mg as a monthly injectable contraceptive.

Norethisterone enanthate (NET-EN) 50 mg combined with estradiol valerate (EV) 5 mg was studied as a once-a-month injectable contraceptive with regard to effectiveness, cycle control, adverse events and acceptability. In eight Family Planning Centres from 5 Latin American countries, 652 fertile women were followed-up for a period of 24 months, providing a total of 10,689 woman-months of experience. Only 1 pregnancy occurred, in the first treated month a few days before the second injection (failure rate 0.11 per 100 woman-years). Under treatment, the first cycle was drastically shortened in most cases, but thereafter cycles tended to recover to pre-treatment patterns. There was a significant decrease of hypermenorrhea and dysmenorrheic cycles. Intracyclic bleeding and spotting appeared in 1.2% and 2.4%, respectively, and amenorrhea in 2.5% of cycles. Incidence of other adverse events was very low with the exception of weight gain of 2 Kg (28%). Continuation rate at 12 months was 64.7%. The cumulative discontinuation rate due to bleeding problems was 7.4% and 10.7% due to adverse events at 24 months.

Effect of long-acting progestagen-only injectable contraceptives on carbohydrate metabolism and its hormonal profile.

Two groups, each composed of 20 women, who used depomedroxyprogesterone acetate (DMPA) or norethisterone enanthate (NET-EN) injectable contraceptives were investigated for changes in 75-g OGTT and in the fasting and two-hour post oral glucose load (2-hours) levels of serum insulin, growth hormone, glucagon, cortisol and blood pyruvate. Samples were taken before and 3, 6 and 12 months after use of injectables. DMPA and NET-EN caused significant changes in mean blood glucose and pyruvate and in mean serum insulin, growth hormone and glucagon, but not in mean fasting cortisol. Changes with NET-EN started after 3 months, became maximal after 6 months and reverted to normal after 12 months of use, due to more frequent administration during the first 6 months of use (every 60 +/- 5 days) and to more spacing of the injections (every 84 +/- 5 days) after that. Changes with DMPA started after 3 months, and increased with the duration of use to become maximal after 12 months. Maximal changes were similar with DMPA and NET-EN and consisted of: a significant increase in fasting blood glucose and pyruvate and serum insulin; a significant increase in 2-hour blood glucose and pyruvate, serum insulin, growth hormone and glucagon. Although significant changes in blood glucose levels occurred with both DMPA and NET-EN, yet they did not reach the lower cut-off levels for impaired glucose tolerance in any user. With the same spacing of injections, i.e. every 84 +/- 5 days for NET-EN and every 90 +/- 5 days for DMPA, the effects on various parameters studied were less with NET-EN.