title: Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment.
abstract: OBJECTIVE
  To investigate the efficacy and safety of dienogest as a long-term treatment in endometriosis, with follow-up after treatment discontinuation. The study included women with endometriosis, who had previously completed a 12-week, placebo-controlled study of dienogest, who participated in an open-label extension study for up to 53 weeks. Thereafter, a patient subgroup was evaluated in a 24-week follow-up after treatment discontinuation.
  
  
  METHODS
  A multicenter study performed in Germany, Italy and Ukraine. Women with endometriosis were enrolled at completion of the placebo-controlled study (n = 168). All women received dienogest (2 mg once daily, orally) and changes in pelvic pain (on a visual analog scale), bleeding pattern, adverse events and laboratory parameters were evaluated during and after treatment.
  
  
  RESULTS
  The completion rate among women who entered the open-label extension study was 90.5% (n = 152). A significant decrease in pelvic pain was shown during continued dienogest treatment (P < 0.001). The mean frequency and intensity of bleeding progressively decreased. Adverse events, rated generally mild or moderate, led to withdrawal in four patients (2.4%). No clinically relevant changes in laboratory parameters were observed. During treatment-free follow-up (n = 34), the reduction in pelvic pain persisted, while bleeding frequency and intensity returned to normal patterns.
  
  
  CONCLUSIONS
  Long-term dienogest showed a favorable efficacy and safety profile, with progressive decreases in pain and bleeding irregularities during continued treatment; the decrease of pelvic pain persisted for at least 24 weeks after treatment cessation.
authors.affiliation: Department of Pediatrics, Obstetrics and Reproductive Medicine, University of Siena, Viale R. Bracci N. 16, 53100, Siena, Italy. petraglia@unisi.it
authors.forename: Felice
authors.initials: F
authors.lastname: Petraglia
authors.forename: Daniela
authors.initials: D
authors.lastname: Hornung
authors.forename: Christian
authors.initials: C
authors.lastname: Seitz
authors.forename: Thomas
authors.initials: T
authors.lastname: Faustmann
authors.forename: Christoph
authors.initials: C
authors.lastname: Gerlinger
authors.forename: Stefano
authors.initials: S
authors.lastname: Luisi
authors.forename: Lucia
authors.initials: L
authors.lastname: Lazzeri
authors.forename: Thomas
authors.initials: T
authors.lastname: Strowitzki
mesh_terms: D000293:Adolescent; D000328:Adult; D004334:Drug Administration Schedule; D004715:Endometriosis / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006727:Hormone Antagonists / Q000008:administration & dosage*; D006801:Humans; D007558:Italy; D008875:Middle Aged; D009277:Nandrolone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D017699:Pelvic Pain; D014455:Ukraine; D055815:Young Adult
chemical_list: D006727:Hormone Antagonists; C023635:dienogest; D009277:Nandrolone