title: [Efficacy and safety of a combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 µg in the treatment of premenstrual dysphoric disorder: a randomized, double blind placebo-controlled study].
abstract: OBJECTIVE
  To compare the efficacy and safety of a new low-dose oral contraceptive pill (YAZ) containing drospirenone 3 mg and ethinylestradiol 20 µg with placebo in reducing symptoms of premenstrual dysphoric disorder (PMDD).
  
  
  METHODS
  This multicenter, double- blind, randomized clinical trial consisted of 2 run- in and 3 treatment cycles (84 days) with daily symptom charting; 187 women with symptoms of PMDD were randomized to either placebo group (n = 94) or YAZ group (n = 93), and assessed with daily record of severity of problems scale (DRSP) and clinical global impressions scale (CGI) before, during and after the treatments. Hormones were administered for 24 days, followed by 4 days of inactive pills.
  
  
  RESULTS
  Compared with baseline level of DRSP, both groups got improvement after treatment; the YAZ group (median -28.7, range: -82.5 to 2.3) had greater improvement than that in the placebo group (median -23.7, range: -86.0 to 11.8), while there was not significant difference (P > 0.05). The main adverse effects of YAZ included intermenstrual bleeding [13% (12/93) versus 3% (3/94)], menorrhagia [9% (8/93) versus 1% (1/94)], nausea [5% (5/93) versus 4% (4/94)] and skin rash [4% (4/93) versus 2% (2/94)].
  
  
  CONCLUSIONS
  YAZ could improve symptoms of PMDD better than placebo, while without statistic significance in this study. The most common adverse effects are intermenstrual bleeding, menorrhagia, nausea and rash.
authors.affiliation: Peking University Institute of Mental Health, Beijing 100191, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Fu
authors.forename: Weifeng
authors.initials: W
authors.lastname: Mi
authors.forename: Lingzhi
authors.initials: L
authors.lastname: Li
authors.affiliation: Email: sally_zhy@sina.com.
authors.forename: Hongyan
authors.initials: H
authors.lastname: Zhang
authors.forename: Jia
authors.initials: J
authors.lastname: Wang
authors.forename: Wenjun
authors.initials: W
authors.lastname: Cheng
authors.forename: Lizhou
authors.initials: L
authors.lastname: Sun
authors.forename: Lingjiang
authors.initials: L
authors.lastname: Li
authors.forename: Shiping
authors.initials: S
authors.lastname: Xie
authors.forename: Jinbei
authors.initials: J
authors.lastname: Zhang
mesh_terms: D000736:Androstenes / Q000009:adverse effects / Q000627:therapeutic use*; D003276:Contraceptives, Oral; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004997:Ethinyl Estradiol / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008595:Menorrhagia; D008796:Metrorrhagia; D065446:Premenstrual Dysphoric Disorder / Q000188:drug therapy*; D011293:Premenstrual Syndrome; D012449:Safety; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000736:Androstenes; D003276:Contraceptives, Oral; D003277:Contraceptives, Oral, Combined; D004997:Ethinyl Estradiol; C035144:drospirenone