title: Dienogest is as effective as intranasal buserelin acetate for the relief of pain symptoms associated with endometriosis--a randomized, double-blind, multicenter, controlled trial.
abstract: OBJECTIVE
  To compare the efficacy and safety of dienogest (DNG) with intranasal buserelin acetate (BA) in patients with endometriosis.
  
  
  METHODS
  Phase III, randomized, double-blind, multicenter, controlled trial.
  
  
  METHODS
  Twenty-four study centers in Japan.
  
  
  METHODS
  Two hundred seventy-one patients with endometriosis.
  
  
  METHODS
  Dienogest (2 mg/day, orally) or BA (900 microg/day, intranasally) for 24 weeks.
  
  
  METHODS
  The pre- to posttreatment changes in the scores of five subjective symptoms during nonmenstruation (lower abdominal pain, lumbago, defecation pain, dyspareunia, and pain on internal examination) and two objective findings (induration in the pouch of Douglas and limited uterine mobility).
  
  
  RESULTS
  Dienogest reduced the scores of all symptoms and findings at the end of treatment, and the mean changes in the scores of all symptoms and findings except induration in the pouch of Douglas were comparable to those obtained with BA. Compared with BA, DNG was associated with irregular genital bleeding more frequently and with fewer hot flushes. The reduction in bone mineral density (BMD) during DNG treatment was significantly lower than that during BA treatment.
  
  
  CONCLUSIONS
  DNG is as effective as intranasal BA in alleviating endometriosis, and causes less BMD loss.
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: Yuji
authors.initials: Y
authors.lastname: Taketani
authors.forename: Takeshi
authors.initials: T
authors.lastname: Aso
authors.forename: Masao
authors.initials: M
authors.lastname: Fukunaga
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Hagino
authors.forename: Naoki
authors.initials: N
authors.lastname: Terakawa
mesh_terms: D015746:Abdominal Pain / Q000209:etiology / Q000517:prevention & control; D000281:Administration, Intranasal; D000284:Administration, Oral; D015519:Bone Density / Q000187:drug effects; D002064:Buserelin / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004414:Dyspareunia / Q000209:etiology / Q000517:prevention & control; D004715:Endometriosis / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007564:Japan; D017116:Low Back Pain / Q000209:etiology / Q000517:prevention & control; D009277:Nandrolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D010146:Pain / Q000209:etiology / Q000517:prevention & control*; D010147:Pain Measurement; D016896:Treatment Outcome
chemical_list: C023635:dienogest; D009277:Nandrolone; D002064:Buserelin