title: A dose-ranging study to determine the efficacy and safety of 1, 2, and 4mg of dienogest daily for endometriosis.
abstract: OBJECTIVE
  To compare the efficacy and safety of dienogest at doses of 1, 2, and 4mg/day orally in the treatment of endometriosis.
  
  
  METHODS
  An open-label, randomized, multicenter, 24-week comparative trial in women with histologically confirmed endometriosis. Efficacy was assessed by second-look laparoscopy and patient-reported symptoms. Statistical tests included chi(2) and Wilcoxon signed rank tests.
  
  
  RESULTS
  Dienogest reduced mean revised American Fertility Society scores from 11.4 to 3.6 (n=29; P<0.001) in the 2-mg group and from 9.7 to 3.9 (n=35; P<0.001) in the 4-mg group. Dienogest at 2 and 4mg/day was associated with symptom improvements in substantial proportions of women. Both dienogest doses were generally well tolerated, with low rates of treatment discontinuation due to adverse events. The 1-mg dose arm was discontinued owing to insufficient bleeding control.
  
  
  CONCLUSIONS
  Dienogest at 2mg once a day is recommended as the optimal dose in future studies of endometriosis.
authors.affiliation: Department of Gynecology and Obstetrics, University of Greifswald, Greifswald, Germany. koehlerg@uni-greifswald.de
authors.forename: Günter
authors.initials: G
authors.lastname: Köhler
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Faustmann
authors.forename: Christoph
authors.initials: C
authors.lastname: Gerlinger
authors.forename: Christian
authors.initials: C
authors.lastname: Seitz
authors.forename: Alfred O
authors.initials: AO
authors.lastname: Mueck
mesh_terms: D000328:Adult; D004305:Dose-Response Relationship, Drug; D004715:Endometriosis / Q000188:drug therapy*; D005260:Female; D005298:Fertility / Q000187:drug effects; D006727:Hormone Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D010535:Laparoscopy; D009277:Nandrolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D006727:Hormone Antagonists; C023635:dienogest; D009277:Nandrolone