title: Detailed analysis of a randomized, multicenter, comparative trial of dienogest versus leuprolide acetate in endometriosis.
abstract: OBJECTIVE
  To analyze the secondary efficacy and safety outcomes from a recent trial comparing dienogest (DNG) with leuprolide acetate (LA) in women with endometriosis.
  
  
  METHODS
  A 24-week, open-label, randomized, multicenter study of DNG versus LA in women with endometriosis-related pain was assessed for outcomes such as responder rates (using predefined thresholds of pain relief), changes in single symptoms/signs and sum scores from the Biberoglu and Behrman (B&B) scale, clinical laboratory parameters, and measures of quality of life.
  
  
  RESULTS
  Dienogest was non-inferior to LA for treatment response using all predefined thresholds of pain relief and provided equivalent improvements in B&B symptoms and signs. No clinically relevant changes in laboratory parameters were observed during DNG treatment, whereas estrogen levels decreased in the LA group. Compared with LA, DNG was associated with pronounced improvements in specific quality-of-life measures.
  
  
  CONCLUSIONS
  The analyses provide supportive evidence that the efficacy of DNG is equivalent to that of LA for treating endometriosis symptoms, with specific quality-of-life benefits and a favorable safety profile.
authors.affiliation: Department of Gynecological Endocrinology and Reproductive Medicine, University of Heidelberg, Vossstrasse 9, 69115 Heidelberg, Germany. thomas_strowitzki@med.uni-heidelberg.de
authors.forename: Thomas
authors.initials: T
authors.lastname: Strowitzki
authors.forename: Joachim
authors.initials: J
authors.lastname: Marr
authors.forename: Christoph
authors.initials: C
authors.lastname: Gerlinger
authors.forename: Thomas
authors.initials: T
authors.lastname: Faustmann
authors.forename: Christian
authors.initials: C
authors.lastname: Seitz
mesh_terms: D000293:Adolescent; D000328:Adult; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D004412:Dysmenorrhea / Q000188:drug therapy / Q000209:etiology; D004715:Endometriosis / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D004967:Estrogens / Q000097:blood; D005260:Female; D006801:Humans; D016729:Leuprolide / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009277:Nandrolone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D017699:Pelvic Pain / Q000188:drug therapy / Q000209:etiology; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D018931:Antineoplastic Agents, Hormonal; D004967:Estrogens; C023635:dienogest; D009277:Nandrolone; D016729:Leuprolide