New Type of Oral Contraceptive

Abstract

Preliminary clinical trials of Volidan (4 mg megestrol acetate and .15 mg ethinyl estradiol combined) were conducted on 183 volunteers for 1457 cycles to choose the optimum dose from a range of 2.5 mg megestrol acetate and .05-.1 mg ethinyl estradiol or .1 mg mestranol. There were no pregnancies due to drug failure including 70 cycles with 1-2 missed tablets but 2 pregnancies were ascribed to error. Side effects tabulated in percent of cycles at each of 7 dose formulations included nausea in 7-50% of first cycles 6-30% of all cycles apparently related to estrogen dose. Also tabulated were breast pain headache depression cycle control and weight change which was 3 pounds or more gained by 25%. The optimum dose was chosen as that causing the least nausea breakthrough bleeding and weight gain. The optimum dose (see above) gave 6% nausea 6% breakthrough bleeding 8% weight gain 1% amenorrhea. Neither thromboembolism nor atypical cytology was recorded in this trial.