Comparison of efficacy, cycle control, and tolerability of two low-dose oral contraceptives in a multicenter clinical study

This study compares the contraceptive reliability, cycle control, and toler ability of two oral contraceptive preparations containing 20 mu g of ethiny l estradiol combined with either 75 mu g of gestodene (EE/GSD) or 150 mu g of desogestrel (EE/DSG). Women received the trial preparations daily for 21 days, followed by a 7-day pill-free interval. Contraceptive efficacy,cycle control, and tolerability were evaluated over a period of 12 cycles. Effic acy data of 14,700 treatment cycles (EE/GSD: 7299; EE/DSG: 7401) were obtai ned from 1476 women (EE/GSD, n = 740; EE/DSG, n = 736). Both preparations p rovided effective contraception and good cycle control with a similarly low incidence of both spotting and breakthrough bleeding. The spotting rates i n both treatment groups decreased from 35.1% (EE/GSD) and 37.5% (EE/DSG) in the first treatment cycle to approximately 10% in the fourth treatment cyc le. The spotting incidence as percent of the total number of cycles was 12. 7% for EE/GSD and 14.3% for EE/DSG. The breakthrough bleeding incidence was 5.2% of all cycles for EE/GSD and 6.0% of all cycles for EE/DSG. For 84.7% of the cycles in the gestodene group and for 82.5% of the cycles in the de sogestrel group, neither spotting nor breakthrough bleeding were recorded. Overall, the spotting and breakthrough bleeding incidence tended to be lowe r with EE/GSD than with EE/DSG. However, the difference was not statistical ly significant. Amenorrhea was recorded in 2.7% of the cycles with EE/GSD a nd in 2.9% with EE/DSG. Both preparations were well tolerated and showed a similar pattern of adverse events. Move than 83% of the women in both group s either did not gain weight or lost more than 2 kg Both preparations had a beneficial effect on dysmenorrhea. Both regimens provided reliable contrac eption and good cycle control. The incidence of adverse events was relative ly low and both preparations were well tolerated. CONTRACEPTION 1999;60:269 -274 (C) 1999 Elsevier Science Inc. All rights reserved.