Comparison of two contraceptive pills containing drospirenone and 20 μg or 30 μg ethinyl estradiol for polycystic ovary syndrome

Objective: To compare the effects of 30 mu g and 20 mu g ethinyl estradiol (EE) among women with polycystic ovary syndrome (PCOS). Methods: In a randomized study, patients with PCOS, a history of six or fewer menstrual cycles in the previous 12 months, and abnormal body hair growth were enrolled at a center in Kolkata, India, between May 1, 2012, and January 31, 2014. Participants were randomly assigned (1:1) using a computer-generated randomization table to receive an oral contraceptive pill containing 3 mg drospirenone and either 30 mu g EE or 20 mu g EE. Patients were followed up after 6 and 12 months. The primary outcome was the absolute change in the free androgen index. Participants were masked to group assignment but investigators were not. Analyses were by intention to treat. Results: Overall, 112 patients were enrolled. At 6 months, the free androgen index had decreased by 4.96 +/- 6.01 among patients receiving 30 mu g (n = 55) and by 4.81 +/- 6.03 among those receiving 20 mu g (n = 57; P = 0.89). At 12 months, the decrease from baseline was 5.23 +/- 5.79 with 30 mu g and 4.99 +/- 5.86 with 20 mu g (P = 0.82). Conclusion: Among patients with PCOS, an oral contraceptive pill containing 20 mu g EE has similar effects on androgen levels to those of a pill containing 30 mu g. Clinical Trial Registration Number: CTRI/2012/04/002571 (C) 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.