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 μg and 20 μg 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 3mg drospirenone and either 30 μg EE or 20 μg 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 μg (n=55) and by 4.81±6.03 among those receiving 20 μg (n=57; P=0.89). At 12 months, the decrease from baseline was 5.23±5.79 with 30 μg and 4.99±5.86 with 20 μg (P=0.82).

CONCLUSION

Among patients with PCOS, an oral contraceptive pill containing 20 μg EE has similar effects on androgen levels to those of a pill containing 30 μg.

CLINICAL TRIAL REGISTRATION NUMBER: CTRI/2012/04/002571.