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

✍ Scribed by Teri B. Pearlstein; Gloria A. Bachmann; Howard A. Zacur; Kimberly A. Yonkers

• Book ID: 116381275
• Publisher: Elsevier Science
• Year: 2005
• Tongue: English
• Weight: 557 KB
• Volume: 72
• Category: Article
• ISSN: 0010-7824
• DOI: 10.1016/j.contraception.2005.08.021

✦ Synopsis

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.