Continuous oral levonorgestrel/ethinyl estradiol for treating premenstrual dysphoric disorder.
Author(s): Halbreich U, Freeman EW, Rapkin AJ, Cohen LS, Grubb GS, Bergeron R, Smith L, Mirkin S, Constantine GD
Affiliation(s): Departments of Psychiatry and Gynecology and Obstetrics, University of Buffalo (SUNY-AB), Buffalo, NY; 14214, USA.
Publication date & source: 2012-01, Contraception., 85(1):19-27. Epub 2011 Jul 13.
BACKGROUND: The study was conducted to investigate continuous daily levonorgestrel 90 mcg/ethinyl estradiol 20 mcg (LNG/EE) on premenstrual dysphoric disorder (PMDD). STUDY DESIGN: In this multicenter, randomized, double-blind, placebo-controlled study, women with PMDD received LNG/EE (n=186) or placebo (n=181) daily for 112 days and completed the Daily Record of Severity of Problems (DRSP). RESULTS: Mean DRSP change from baseline to late luteal phase was significantly greater with LNG/EE than placebo at the late luteal phase of the first estimated cycle (-30.52+/-1.73 [SE] vs. -22.47+/-1.77; p<.001) and the worst 5 days during the last on-therapy estimated cycle (-26.77+/-1.83 vs. -20.89+/-1.82; p=.016). Other primary end points were not statistically significant. Significantly more subject taking LNG/EE (52%) than placebo (40%) responded (>/=50% improvement in the DRSP 7-day late luteal phase score and Clinical Global Impression of Severity score of >/=1 improvement) at last on-therapy cycle (p=.025). CONCLUSIONS: Continuous daily LNG 90 mcg/EE 20 mcg was well tolerated and may be useful for managing the physical, psychological and behavioral symptoms and loss of work productivity related to PMDD. Copyright (c) 2012 Elsevier Inc. All rights reserved.