Ethinyl estradiol 20mug/drospirenone 3mg 24/4 oral contraceptive for the treatment of functional impairment in women with premenstrual dysphoric disorder.
Author(s): Marr J, Heinemann K, Kunz M, Rapkin A
Affiliation(s): Global Clinical Development, Women's Healthcare, Bayer, Berlin, Germany. joachim.marr@bayer.com
Publication date & source: 2011-05, Int J Gynaecol Obstet., 113(2):103-7. Epub 2011 Feb 19.
Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
OBJECTIVE: To determine the effects of ethinyl estradiol (EE)/drospirenone in a 24/4 regimen (24days of active and 4days 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 20mug/drospirenone 3mg (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 1 to cycles 2 and 3) were significantly greater with EE/drospirenone than with placebo (P<0.05). CONCLUSION: Ethinyl estradiol 20mug/drospirenone 3mg in a 24/4 regimen significantly improved functional impairment in women with PMDD. Symptoms improved in parallel. Copyright (c) 2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
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