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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.

Page last updated: 2011-12-09

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