An overview of four studies of a continuous oral contraceptive (levonorgestrel 90
mcg/ethinyl estradiol 20 mcg) on premenstrual dysphoric disorder and premenstrual
syndrome.
Author(s): Freeman EW, Halbreich U, Grubb GS, Rapkin AJ, Skouby SO, Smith L, Mirkin S,
Constantine GD.
Affiliation(s): Department of Obstetrics and Gynecology, University of Pennsylvania Medical
Center, Philadelphia, PA 19104, USA. freemane@mail.med.upenn.edu
Publication date & source: 2012, Contraception. , 85(5):437-45
BACKGROUND: This article presents an overview of four studies that evaluated a
continuous oral contraceptive (OC) containing levonorgestrel (90 mcg) and ethinyl
estradiol (20 mcg; LNG/EE) for managing premenstrual dysphoric disorder (PMDD)
and premenstrual syndrome (PMS).
STUDY DESIGN: Three randomized, double-blind, placebo-controlled trials and one
open-label, single-treatment substudy examined mean changes from baseline in the
Daily Record of Severity of Problems (DRSP) or Penn Daily Symptom Rating (DSR).
RESULTS: Improvements from baseline in mean DRSP and DSR scores were observed,
but results were not consistent among the studies. Mean percent improvement of
premenstrual symptoms ranged from 30% to 59% in controlled trials and 56% to 81%
in an open-label substudy. A large placebo effect was also observed in the
placebo-controlled studies. Continuous LNG/EE yielded a favorable safety profile.
CONCLUSIONS: These data, although not consistent, indicate that continuous LNG/EE
may reduce the symptoms of PMDD and PMS, providing an option for women who are
appropriate candidates for a continuous OC as a contraceptive, the approved
indication for this medication.
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