Premenstrual dysphoric disorder symptom cluster improvement by cycle with the combined oral contraceptive ethinylestradiol 20 mcg plus drospirenone 3 mg administered in a 24/4 regimen

Contraception. 2011 Jul;84(1):81-6. doi: 10.1016/j.contraception.2010.10.010. Epub 2010 Dec 17.

Abstract

Background: A combined oral contraceptive comprising ethinylestradiol (EE) 20 mcg/drospirenone 3 mg in a 24/4 regimen has been clinically shown to alleviate the symptoms associated with premenstrual dysphoric disorder (PMDD). However, previous studies did not report data according to cycle-by-cycle improvement.

Study design: This was a subanalysis of a Phase III, double-blind, multicenter, United States-based study. Women with confirmed PMDD were randomized to EE 20 mcg/drospirenone 3 mg 24/4 or placebo for three treatment cycles. Ten of the 21 emotional and physical items on the Daily Record of Severity of Problems scale were grouped to define three symptom clusters: (a) negative emotions, (b) food cravings and (c) water retention-related symptoms. The change from baseline at each treatment cycle was compared between groups using a weighted analysis of covariance model.

Results: The full analysis set comprised 449 women. Daily Record of Severity of Problems scores for each symptom cluster were significantly reduced from baseline with both EE 20 mcg/drospirenone 3 mg 24/4 and placebo (p<.0001 for all). The greatest symptom improvements were achieved within the first cycle of treatment and continued throughout cycles 2 to 3. The mean between-treatment difference was significant in favor of EE 20 mcg/drospirenone 3 mg 24/4 for all three symptom clusters in all three treatment cycles (p≤.0001 vs. placebo in percent change from baseline).

Conclusion: Ethinylestradiol 20 mcg/drospirenone 3 mg 24/4 improved commonly recognizable PMDD symptom clusters relating to negative emotions, food cravings and water retention-related symptoms to a significantly greater extent than placebo during all three cycles of treatment.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Androstenes / pharmacology
  • Androstenes / therapeutic use*
  • Body Composition / drug effects
  • Clinical Trials, Phase III as Topic
  • Double-Blind Method
  • Emotions / drug effects
  • Ethinyl Estradiol / pharmacology
  • Ethinyl Estradiol / therapeutic use*
  • Feeding Behavior / drug effects
  • Female
  • Humans
  • Multicenter Studies as Topic
  • Premenstrual Syndrome / drug therapy*
  • Reproductive Control Agents / pharmacology
  • Reproductive Control Agents / therapeutic use*

Substances

  • Androstenes
  • Reproductive Control Agents
  • drospirenone and ethinyl estradiol combination
  • Ethinyl Estradiol