Ethinyl estradiol 20 μg/drospirenone 3 mg 24/4 oral contraceptive for the treatment of functional impairment in women with premenstrual dysphoric disorder

Objective: To determine the effects of ethinyl estradiol (EE)/drospirenone in a 24/4 regimen (24 days of active and 4 days of inactive pills) on functional impairment (affecting work, partnership, and social activities) in women with premenstrual dysphoric disorder (PMDD). Methods: The present study was a secondary analysis of a double-blind, randomized, parallel-design multicenter trial. Women received EE 20 mu g/drospirenone 3 mg (n = 232) or placebo (n = 218) and completed the Daily Record of Severity of Problems (DRSP) scale daily. Results: The decrease in mean scores for all 3 DRSP functional impairment items (work, partnership, and social activities) from baseline to cycle 3 mirrored changes in the total DRSP symptom score: the greatest decreases were observed in cycle 1 with further small reductions through to cycle 3. The proportional mean decreases from baseline to cycle 1 for the 3 functional items ranged from 47% to 48%. For all 3 functional items, the mean reductions from baseline to cycle 1 (but not from cycle] to cycles 2 and 3) were significantly greater with EE/drospirenone than with placebo (P<0.05). Conclusion: Ethinyl estradiol 20 mu g/drospirenone 3 mg in a 24/4 regimen significantly improved functional impairment in women with PMDD. Symptoms improved in parallel. (C) 2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.