Efficacy of a New Low-Dose Oral Contraceptive With Drospirenone in Premenstrual Dysphoric Disorder

Yonkers, Kimberly A. MD1; Brown, Candace RN, PharmD2; Pearlstein, Teri B. MD3; Foegh, Marie MD, DSc4; Sampson-Landers, Carole MD4; Rapkin, Andrea MD5

Obstetrics & Gynecology:
doi: 10.1097/01.AOG.0000175834.77215.2e
Original Research
Abstract

Objective: To compare the efficacy of a new low-dose oral contraceptive pill (OCP) formulation with placebo in reducing symptoms of premenstrual dysphoric disorder.

Methods: This multicenter, double-blind, randomized clinical trial consisted of 2 run-in and 3 treatment cycles with daily symptom charting; 450 women with symptoms of premenstrual dysphoric disorder were randomized to either placebo or an OCP formulation containing drospirenone 3 mg and ethinyl estradiol 20 μg. Hormones were administered for 24 days, followed by 4 days of inactive pills (24/4).

Results: Scores on the total Daily Record of Severity of Problems decreased by –37.49 in the drospirenone/ethinyl estradiol group and by –29.99 in the placebo group (adjusted mean difference –7.5, 95% confidence interval [CI] –11.2 to –3.8; P < .001 by rank analysis of covariance). Mood symptom scores were reduced by –19.2 and –15.3 in active-treatment and placebo groups, respectively (adjusted mean difference –3.9, 95% CI –5.84 to –2.01; P = .003); physical symptom scores were reduced by –10.7 and –8.6 in active-treatment and placebo groups, respectively (adjusted mean difference –2.1, 95% CI –3.3 to –0.95; P < .001); and behavioral symptom scores were reduced by –7.7 and –6.2 in active-treatment and placebo groups, respectively (adjusted mean difference –1.5, 95% CI –2.251 to –0.727; P < .001). Response, defined as a 50% decrease in daily symptom scores, occurred in 48% of the active-treatment group and 36% of the placebo group (relative risk 1.7, 95% CI 1.1 to 2.6; P = .015) and corresponds to a number-needed-to-treat of 8 patients.

Conclusion: A 24/4 regimen of drospirenone 3 mg and ethinyl estradiol 20 μg improves symptoms associated with premenstrual dysphoric disorder.

Level of Evidence: I

In Brief

A new low-dose oral contraceptive formulation containing drospirenone is effective in treating symptoms of premenstrual dysphoric disorder.

Author Information

From the 1Departments of Psychiatry and Epidemiology and Public Health, Yale University, New Haven, Connecticut; 2Departments of Pharmacy, Obstetrics and Gynecology, and Psychiatry, University of Tennessee Health Science Center, Memphis, Tennessee; 3Department of Psychiatry and Human Behavior, Brown Medical School, Providence, Rhode Island; 4Berlex Incorporated, Montville, New Jersey; and 5Department of Obstetrics and Gynecology, University of California Los Angeles, Los Angeles, California.

Corresponding author: Kimberly A. Yonkers, MD, Departments of Psychiatry and Epidemiology and Public Health, Yale University School of Medicine, 142 Temple Street, Suite 301, New Haven, CT 06510; e-mail: kimberly.yonkers@yale.edu.

Financial Disclosure Schering AG (Berlin, Germany) provided the financial support for this study, which was conducted by Berlex Incorporated (U.S. affiliate). Drs. Foegh and Sampson-Landers are employees of Berlex Incorporated and own stock and hold stock options in Schering AG.

© 2005 The American College of Obstetricians and Gynecologists