Contraceptive efficacy and safety of a monophasic oral contraceptive containing 150 μg desogestrel and 30 μg ethinyl estradiol: United States clinical experience using a “Sunday start” approach

Abstract

To report on experience in the United States with a monophasic oral contraceptive (OC) containing 150 micrograms desogestrel and 30 micrograms ethinyl E2 (EE). The results of a multicenter evaluation of efficacy, cycle control, and safety over 6 months of exposure using a "Sunday start" regimen is evaluated. Multicenter. Open noncomparative study. Study subjects were a mean age of 25 years, and the majority were educated, nonobese, white, nulliparous, and previously had used OCs. A total of 809 women were exposed to study medication for a total of 4,096 cycles (equivalent to 341.3 women-years of use). Efficacy was excellent. One user-failure pregnancy occurred (Pearl index 0.32); there were no method-failure pregnancies. Study medication was well tolerated; 6.6% of the subjects discontinued treatment because of drug-related adverse events. The study medication exhibited no adverse effects on blood pressure, body weight, or laboratory variables. Cycle control was evaluated in 697 subjects. In a total of 3,640 cycles, the incidences of intermenstrual bleeding, breakthrough bleeding, breakthrough spotting, and absence of withdrawal bleeding were 9.8%, 1.7%, 8.1%, and 1.4%, respectively, indicating appropriate cycle control. Patient acceptability was high; seven subjects (1%) discontinued the study because of menstrual irregularity (metrorrhagia). The results of this study, comparable to those demonstrated in a recent European multicenter study, add further documentation to the published data on the safety, efficacy, cycle control, and acceptability of this monophasic desogestrel-containing combined OC using a "Sunday start" approach.