A multicenter efficacy and safety study of an oral contraceptive containing 150 μg desogestrel and 30 μg ethinyl estradiol

Abstract

The study reported herein is the primary efficacy and safety study conducted to support U.S. registration of an oral contraceptive containing 150 μg desogestrel and 30 μg ethinyl estradiol. A large multicenter study enrolled 1,221 women at 50 centers in the United Kingdom. A total of 11,656 cycles of exposure was accumulated, corresponding to approximately 879 women-years of use. Contraceptive efficacy was high; no subject conceived as a result of method failure. The product was generally well tolerated with excellent cycle control, causing fewer than 2% of the subjects to discontinue because of bleeding irregularities. The study medication demonstrated no adverse effects on cervical cytology, blood pressure, body weight or laboratory variables, while pre-existing benign breast disease generally improved. The study did not identify any medication-related adverse experiences. This study confirmed that the monophasic oral contraceptive with 150 μg desogestrel and 30 μg ethinylestradiol is a safe and effective oral contraceptive with excellent cycle control and patient acceptability.