Contraception. 2005 Dec;72(6):414-21. Epub 2005 Nov 2.

Treatment of premenstrual dysphoric disorder with a new drospirenone-containing oral contraceptive formulation.

Authors:

Pearlstein TB,Bachmann GA,Zacur HA,Yonkers KA.

Department of Psychiatry and Human Behavior, Brown Medical School, Providence, RI 02905, USA.teri-pearlstein@brown.edu

Purpose

This multicenter, double-blind, placebo-controlled crossover study evaluated the efficacy of a new oral contraceptive (OC) formulation containing drospirenone 3 mg and ethinyl estradiol (EE) 20 mug in treating symptoms of premenstrual dysphoric disorder (PMDD).

Method:

The OC formulation or placebo was administered for 24 days in a 28-day cycle (24/4), rather than the usual 21-day active treatment, 7-day inert-pill regimen. Participants (N=64) were randomized to either study treatment for three cycles and then after a washout period of one treatment-free cycle switched to the alternate treatment.

Results:

The mean decrease from baseline for total Daily Record of Severity of Problems (DRSP) scores while using drospirenone/EE was significantly greater than for placebo (-12.47, 95% CI=-18.28, -6.66; p<.001). A positive response (i.e., a score of 1 or 2 in the Clinical Global Impressions-Improvement scale) occurred in 61.7% and 31.8% of subjects while taking drospirenone/EE and placebo, respectively (p=.009).

Conclusion:

Drospirenone/EE, given in a 24/4 regimen, was superior to placebo for improving symptoms associated with PMDD.

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