HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Yonkers, K. A. Articles by Rapkin, A. Search for Related Content PubMed PubMed Citation Articles by Yonkers, K. A. Articles by Rapkin, A.

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

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.

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

This article has been cited by other articles:

				S. Thys-Jacobs, D. McMahon, and J. P. Bilezikian Differences in Free Estradiol and Sex Hormone-Binding Globulin in Women with and without Premenstrual Dysphoric Disorder J. Clin. Endocrinol. Metab., January 1, 2008; 93(1): 96 - 102. [Abstract] [Full Text] [PDF]

				E. W. Freeman, M. D. Sammel, H. Lin, C. R. Gracia, and S. Kapoor Symptoms in the Menopausal Transition: Hormone and Behavioral Correlates Obstet. Gynecol., January 1, 2008; 111(1): 127 - 136. [Abstract] [Full Text] [PDF]

				Three New Oral Contraceptives Obstet. Gynecol., January 1, 2007; 109(1): 193 - 195. [Full Text] [PDF]

				New Hormonal Contraceptives Offer Patients More Choices Journal Watch Women's Health, August 31, 2006; 2006(831): 1 - 1. [Full Text]

				Premenstrual Dysphoric Disorder: An OC Offers Some Relief Journal Watch Psychiatry, January 25, 2006; 2006(125): 12 - 12. [Full Text]

				Premenstrual Dysphoric Disorder: An OC Offers Some Relief Journal Watch Women's Health, November 1, 2005; 2005(1101): 7 - 7. [Full Text]