Efficacy and safety of a low-dose monophasic combination oral contraceptive containing 100 μg levonorgestrel and 20 μg ethinyl estradiol (Alesse®)

被引:43
作者
Archer, DF
Maheux, R
DelConte, A
O'Brien, FB
机构
[1] Eastern Virginia Med Sch, Jones Inst Reprod Med, Norfolk, VA 23507 USA
[2] St Francis dAssisi Hosp, Dept Obstet & Gynecol, Quebec City, PQ, Canada
[3] Wyeth Ayerst Res, Radnor, PA USA
关键词
Alesse; breakthrough bleeding; ethinyl estradiol; levonorgestrel; oral contraceptive;
D O I
10.1016/S0002-9378(99)70362-5
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
The efficacy and safety of a low-dose 21-day combination oral contraceptive containing 100 mu g levonorgestrel and 20 mu g ethinyl estradiol were evaluated in an open-label, multicenter trial. A total of 1708 subjects with regular menstrual cycles (27,011 cycles) were evaluated. The oral contraceptive was administered once a day for 21 days, followed by 7 days of placebo for a complete cycle. During 26,554 cycles evaluated for efficacy, 18 pregnancies occurred (Pearl index of 0.88); 6 of these events were attributable to subject noncompliance. After 30 cycles of exposure the cumulative rate of withdrawal as a result of accidental pregnancy was 1.9%. Breakthrough bleeding (with or without spotting) occurred in 12.9% of the cycles and spotting alone occurred in 10.1% of the cycles. The 2 most common adverse events cited as reasons for discontinuation were headache (2% of subjects) and metrorrhagia (2%). One serious event led to withdrawal of a subject. Overall, the results of this study demonstrate that the monophasic regimen of 100 mu g levonorgestrel and 20 mu g ethinyl estradiol offers effective contraception, acceptable cycle control, and a good tolerability profile.
引用
收藏
页码:S39 / S44
页数:6
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