title: Ethinyl estradiol 20μg/drospirenone 3mg 24/4 oral contraceptive for the treatment of functional impairment in women with premenstrual dysphoric disorder.
abstract: OBJECTIVE
  To determine the effects of ethinyl estradiol (EE)/drospirenone in a 24/4 regimen (24days of active and 4days of inactive pills) on functional impairment (affecting work, partnership, and social activities) in women with premenstrual dysphoric disorder (PMDD).
  
  
  METHODS
  The present study was a secondary analysis of a double-blind, randomized, parallel-design multicenter trial. Women received EE 20μg/drospirenone 3mg (n=232) or placebo (n=218) and completed the Daily Record of Severity of Problems (DRSP) scale daily.
  
  
  RESULTS
  The decrease in mean scores for all 3 DRSP functional impairment items (work, partnership, and social activities) from baseline to cycle 3 mirrored changes in the total DRSP symptom score; the greatest decreases were observed in cycle 1 with further small reductions through to cycle 3. The proportional mean decreases from baseline to cycle 1 for the 3 functional items ranged from 47% to 48%. For all 3 functional items, the mean reductions from baseline to cycle 1 (but not from cycle 1 to cycles 2 and 3) were significantly greater with EE/drospirenone than with placebo (P<0.05).
  
  
  CONCLUSIONS
  Ethinyl estradiol 20μg/drospirenone 3mg in a 24/4 regimen significantly improved functional impairment in women with PMDD. Symptoms improved in parallel.
authors.affiliation: Global Clinical Development, Women's Healthcare, Bayer, Berlin, Germany. joachim.marr@bayer.com
authors.forename: Joachim
authors.initials: J
authors.lastname: Marr
authors.forename: Klaas
authors.initials: K
authors.lastname: Heinemann
authors.forename: Michael
authors.initials: M
authors.lastname: Kunz
authors.forename: Andrea
authors.initials: A
authors.lastname: Rapkin
mesh_terms: D000328:Adult; D000736:Androstenes / Q000008:administration & dosage / Q000494:pharmacology*; D003277:Contraceptives, Oral, Combined / Q000494:pharmacology*; D004311:Double-Blind Method; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000494:pharmacology*; D005260:Female; D006801:Humans; D011293:Premenstrual Syndrome / Q000188:drug therapy*; D011594:Psychometrics; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000736:Androstenes; D003277:Contraceptives, Oral, Combined; D004997:Ethinyl Estradiol; C035144:drospirenone