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

Abstract

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.

• Authors: Felice Petraglia, Daniela Hornung, Christian Seitz, Thomas Faustmann, Christoph Gerlinger, Stefano Luisi, Lucia Lazzeri, Thomas Strowitzki
• Journal: Archives of gynecology and obstetrics (Arch Gynecol Obstet) Vol. 285 Issue 1 Pg. 167-73 (Jan 2012) ISSN: 1432-0711 [Electronic] Germany
• PMID: 21681516 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Hormone Antagonists
• dienogest
• Nandrolone

Topics

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