ethisterone and Body-Weight

To evaluate the metabolic impact on lipids of a contraceptive patch that delivers norelgestromin (primary active metabolite of norgestimate) and ethinyl estradiol to the systemic circulation as compared with a placebo patch.. In this randomized, double-blind trial, healthy women received the contraceptive patch (n = 99) or placebo patch (n = 47) for up to 9 cycles. Fasting blood samples were obtained at baseline and cycles 3, 6 and 9 for determining the serum lipid profile.. At cycles 3, 6 and 9, mean increases from baseline in high-density lipoprotein (HDL) cholesterol, HDL3 cholesterol, total cholesterol and total triglycerides, and mean decreases in calculated (Friedewald) low-density lipoprotein (LDL)/HDL were observed in the contraceptive patch group (all P < .05 vs. placebo except for total cholesterol at cycle 6). Mean changes in HDL2 and calculated LDL cholesterol were minimal and comparable between treatments. Mean body weight increased from baseline to the end of treatment by 0.8 and 0.6 kg in the 2 groups, respectively; this difference was not significant.. The lipid changes seen with the contraceptive patch are consistent with those of oral contraceptives containing norgestimate and ethinyl estradiol.

Topics: Administration, Cutaneous; Adolescent; Adult; Body Weight; Cholesterol; Cholesterol, HDL; Cholesterol, LDL; Contraceptives, Oral, Combined; Double-Blind Method; Drug Combinations; Ethinyl Estradiol; Ethisterone; Female; Humans; Menstrual Cycle; Middle Aged; Norgestrel; Oximes; Reference Values; Time Factors; Triglycerides

To present efficacy and cycle control data pooled from three pivotal studies of the contraceptive patch (Ortho Evra/Evra).. Three multicenter, open-label, contraceptive studies that included up to 13 treatment cycles.. 183 centers.. 3,319 women.. Three consecutive 7-day patches (21 days) with 1 patch-free week per cycle.. Contraceptive efficacy and cycle control.. Overall and method failure life-table estimates of contraceptive failure through 13 cycles were 0.8% (95% CI, 0.3%-1.3%) and 0.6% (95% CI, 0.2%-0.9%), respectively. Corresponding Pearl indices were 0.88 (95% CI, 0.44-1.33) and 0.7 (95% CI, 0.31-1.10). Contraceptive failure among women with a body weight < 90 kg (<198 lb) was low and uniformly distributed across the weight range. A subgroup of women with body weight > or = 90 kg (> or = 198 lb) may have increased risk of pregnancy. The incidence of breakthrough bleeding was low and decreased over time.. In contraceptive patch users, the overall annual probability of pregnancy was 0.8% and the method failure probability was 0.6%. The efficacy of the patch was high and similar across age and racial groups. Among women < 90 kg (<198 lb), contraceptive failure was low and uniformly distributed across the range of body weights. In women > or = 90 kg (> or = 198 lb), contraceptive failures may be increased. Efficacy and cycle control have been shown to be comparable to an established oral contraceptive.

Topics: Administration, Cutaneous; Adolescent; Adult; Age Factors; Body Weight; Contraceptives, Oral, Combined; Drug Combinations; Drug Delivery Systems; Ethinyl Estradiol; Ethisterone; Female; Humans; Menstrual Cycle; Norgestrel; Oximes; Pregnancy; Proportional Hazards Models

Topics: Animals; Body Weight; Cartilage; Castration; Diethylstilbestrol; Estradiol; Ethisterone; Female; Male; Mice; Pregnancy; Sulfates; Sulfur Isotopes; Testosterone; Tritium

Topics: Anabolic Agents; Androstanes; Animals; Body Weight; Desoxycorticosterone; Digitoxin; Diuretics; Estradiol; Ethisterone; Ethylestrenol; Female; Fluoxymesterone; Hydrocortisone; Ketones; Methyltestosterone; Nandrolone; Norethandrolone; Norethynodrel; Organ Size; Oxandrolone; Oxymetholone; Poisoning; Pregnanes; Pregnenolone; Progesterone; Pyrazines; Rats; Spironolactone; Testosterone; Triamterene