Continuous administration of 100 μg levonorgestrel and 20 μg ethinyl estradiol for elimination of menses: a randomized trial

Abstract

Objective: To evaluate the efficacy and safety of continuous 20-μg oral contraceptive pill use, compared with cyclic use of the same pill, for the elimination of menses as measured by daily menstrual bleeding diaries. Methods: This was an open-label prospective randomized trial to compare 28-day–cycle monthly arm (MA) subjects with continuous arm (CA) subjects. Outcomes measured are bleeding and spotting, pill-taking compliance, method satisfaction, estrogen symptoms, and hemoglobin. Endometrial histology and ultrasonographic measurements are being collected on a subset of subjects at randomization and after nine study cycles are completed. Results: Beginning February 2000, 94 subjects enrolled for a ‘wash-in‘ cycle. Eighty subjects were then randomized either to MA or CA study assignment. The ongoing study has 75 continuing subjects, with 57 women on their fourth or subsequent pill cycle in the study. Reasons for study discontinuation among MA subjects have included irregular bleeding and weight gain, and some were lost to follow-up; among CA subjects, reasons for study discontinuation have been a desire to conceive and bloating. Conclusion: This randomized trial will compare the experience of women taking continuous low-estrogen oral contraceptives with the experience of women undergoing a monthly hormonal withdrawal period. We will present detailed bleeding and spotting profiles for women during their first 6 months of continuous oral contraceptive use. Rates of amenorrhea, infrequent bleeding, and irregular bleeding will be reported to confirm the efficacy and acceptability of menstrual suppression.