Contraceptive efficacy and acceptability of a monophasic oral contraceptive containing 30 microg ethinyl estradiol and 150 microg desogestrel in Latin-American women.

Contraceptive efficacy, subject acceptability (cycle control, side-effects, acne score and weight gain) and blood pressure of a monophasic oral contraceptive containing 30 microg ethinyl estradiol plus 150 microg desogestrel (Marvelon) were assessed in an open-label 6-cycle multicenter study in Argentina (7 centers) and Venezuela (5 centers). Of the 407 participating women, 389 (95.6%) completed six cycles of treatment, providing data for a total of 2383 cycles. No pregnancies occurred during the course of the study, confirming the high contraceptive reliability of Marvelon. Cycle control was excellent; the duration of withdrawal bleeding decreased during consecutive treatment cycles and the incidence of spotting and breakthrough bleeding was low. The desogestrel/ethinyl estradiol combination was well tolerated and the incidence of minor side-effects, which was already low in the first treatment cycle, in most cases decreased during the subsequent cycles. The preparation was effective in reducing pre-existing acne, whereas it did not induce clinically relevant changes in blood pressure and body weight. Marvelon was shown to provide effective oral contraception, with good tolerance and excellent cycle control in Latin-American women.

Clinical evaluation of a new combined oral contraceptive desogestrel--ethinylestradiol.

A clinical study was performed with a new progestogen, desogestrel, in a 0.15 mg dose associated with 0.03 mg of ethinylestradiol and was administered cyclically during 21 days; 632 cycles were evaluated in 56 women. Side-effects were scarce and generally of a mild nature. Monthly bleeding was normal and present in all cycles. Patients with irregular cycles were normalized to 28/29 days. The intermenstrual bleeding (spotting) was an isolated event in 16 cycles. Mastalgia, the most frequent symptom, disappeared spontaneously in the majority of patients. In only 2 cases was it necessary to stop medication because of side-effects. The contraceptive effect was excellent; no pregnancies occurred. A progestative effect was evident in the cervical mucus and the endometrium. The patients who started treatment with acne improved noticeably. In the mild cases, acne disappeared completely. A discrete improvement in hirsutism was reported. The body-weight variation was not significant. Biochemical studies revealed an increase in HDL-C and a decrease in the ratio LDL-C/HDL-C. Cholesterol and triglycerides did not show variations, which could indicate a lesser cardiovascular risk.