Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment

Arch Gynecol Obstet. 2012 Jan;285(1):167-73. doi: 10.1007/s00404-011-1941-7. Epub 2011 Jun 17.


Purpose: 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Drug Administration Schedule
  • Endometriosis / drug therapy*
  • Female
  • Follow-Up Studies
  • Germany
  • Hormone Antagonists / administration & dosage*
  • Humans
  • Italy
  • Middle Aged
  • Nandrolone / administration & dosage
  • Nandrolone / analogs & derivatives*
  • Pelvic Pain
  • Ukraine
  • Young Adult


  • Hormone Antagonists
  • dienogest
  • Nandrolone