title: Evaluation of a low-dose oral contraceptive pill for primary dysmenorrhea: a placebo-controlled, double-blind, randomized trial.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of low-dose oral contraceptives (IKH-01; 0.035 mg ethinyl estradiol and 1 mg norethisterone) for patients with primary dysmenorrhea.
  
  
  METHODS
  Placebo-controlled, double-blind, randomized trial.
  
  
  METHODS
  Clinical trial sites in Japan.
  
  
  METHODS
  One hundred fifteen patients with primary dysmenorrhea.
  
  
  METHODS
  Patients randomly assigned to receive IKH-01 or placebo for four cycles.
  
  
  METHODS
  Total dysmenorrhea score, verbal rating scale defining pain according to limited ability to work and need for analgesics, and visual analog scale (VAS).
  
  
  RESULTS
  Reduction in total dysmenorrhea score and VAS before and after treatment was significantly higher in the IKH-01 group than in the placebo group. Total dysmenorrhea score and VAS in the IKH-01 group significantly decreased from cycles 2 to 5. Overall incidence of adverse events was significantly higher in the IKH-01 group. Incidence decreased over time in the IKH-01 group; it was invariable in the placebo group. No serious adverse events occurred.
  
  
  CONCLUSIONS
  IKH-01 could be used as a single agent or in combination with analgesics for treatment of primary dysmenorrhea.
authors.affiliation: Department of Obstetrics and Gynecology, Tottori University School of Medicine, Yonago, Japan. tasuku@grape.med.tottori-u.ac.jp
authors.forename: Tasuku
authors.initials: T
authors.lastname: Harada
authors.forename: Mikio
authors.initials: M
authors.lastname: Momoeda
authors.forename: Naoki
authors.initials: N
authors.lastname: Terakawa
authors.forename: Yuji
authors.initials: Y
authors.lastname: Taketani
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Hoshiai
mesh_terms: D000328:Adult; D000465:Algorithms; D003276:Contraceptives, Oral / Q000008:administration & dosage* / Q000009:adverse effects; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004412:Dysmenorrhea / Q000188:drug therapy*; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007564:Japan; D009640:Norethindrone / Q000008:administration & dosage* / Q000009:adverse effects; D010919:Placebos; D013607:Tablets; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003276:Contraceptives, Oral; D003277:Contraceptives, Oral, Combined; D010919:Placebos; D013607:Tablets; D004997:Ethinyl Estradiol; D009640:Norethindrone