A NEW LOW-DOSE MONOPHASIC COMBINATION ORAL-CONTRACEPTIVE (ALESSE(TM))WITH LEVONORGESTREL-100-MU-G AND ETHINYL-ESTRADIOL-20-MU-G

The efficacy and safety of a new, low-dose, 21-day combination oral co ntraceptive containing 100 mu g of levonorgestrel and 20 mu g of ethin yl estradiol were evaluated in an open-label, multicenter trial. A tot al of 1477 subjects were enrolled and had 7870 cycles of exposure as o f the data cutoff of this interim report. Of these, 792 subjects had c ompleted six cycles of treatment. A total of five pregnancies occurred during treatment during 7720 efficacy cycles, for a Pearl index of 0. 84. To date, 415 (28 %) subjects have been withdrawn from the study fo r any reason, including 131 (9%) due to adverse events. The cumulative life table pregnancy rate was 0.0041 per woman entering the sixth cyc le. Breakthrough bleeding alone occurred in 4.3 % of the cycles and br eakthrough bleeding and spotting occurred together during 11% of the c ycles. Of the cycles evaluable, 2.6% were amenorrheic. The most common ly reported adverse verse events in this trial considered at least pos sibly drug related were headache (14%) and metrorrhagia (8%). This for mulation provides contraceptive efficacy similar to higher-dose oral c ontraceptives, while maintaining a safety and common OC side effect pr ofile that is consistent with prior years of reported use with levonor gestrel-containing products. (C) 1997 Elsevier Science Inc.