title: 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.
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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Global Clinical Development, Women's Healthcare, Bayer Schering Pharma AG, Berlin, Germany. joachim.marr@bayer.com
authors.forename: Joachim
authors.initials: J
authors.lastname: Marr
authors.forename: Minoo
authors.initials: M
authors.lastname: Niknian
authors.forename: Lee P
authors.initials: LP
authors.lastname: Shulman
authors.forename: Richard
authors.initials: R
authors.lastname: Lynen
mesh_terms: D000328:Adult; D000736:Androstenes / Q000494:pharmacology / Q000627:therapeutic use*; D001823:Body Composition / Q000187:drug effects; D017326:Clinical Trials, Phase III as Topic; D004311:Double-Blind Method; D004644:Emotions / Q000187:drug effects; D004997:Ethinyl Estradiol / Q000494:pharmacology / Q000627:therapeutic use*; D005247:Feeding Behavior / Q000187:drug effects; D005260:Female; D006801:Humans; D015337:Multicenter Studies as Topic; D011293:Premenstrual Syndrome / Q000188:drug therapy*; D012102:Reproductive Control Agents / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D000736:Androstenes; D012102:Reproductive Control Agents; C534342:drospirenone and ethinyl estradiol combination; D004997:Ethinyl Estradiol