Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study

Strowitzki T, Thomas Strowitzki, T. Strowitzki, Thomas Faustmann, Faustmann T, Christoph Gerlinger, Christian Seitz
European journal of obstetrics, gynecology, and reproductive biology · 2010 · vol. 151(2) , pp. 193–198 · doi:10.1016/j.ejogrb.2010.04.002 · PMID:20444534 · W2079070934
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This 12-week, randomized, double-blind, placebo-controlled study investigated the efficacy of dienogest in treating endometriosis-associated pelvic pain.

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Abstract

ObjectiveTo investigate the efficacy and safety of oral dienogest 2mg compared with placebo in the treatment of endometriosis-associated pelvic pain (EAPP).Study designThis was a 12-week, randomized, double-blind, placebo-controlled, multicenter (n=33) study in Germany, Italy, and Ukraine of 198 women aged 18-45 years with laparoscopically confirmed endometriosis and EAPP score > or =30 mm on a visual analog scale (VAS). Dienogest 2mg or placebo was administered orally once daily. The primary efficacy variable was absolute change in EAPP from baseline to Week 12, as determined by the target variables of change in VAS score and change in intake of supportive analgesic medication (ibuprofen) for pelvic pain.ResultsMean reductions in VAS score between baseline and Week 12 in the full analysis set were 27.4 mm and 15.1mm in the dienogest and placebo groups, respectively-a significant score difference of 12.3 mm in favor of dienogest (P<0.0001). Changes in intake of supportive analgesic medication were modest in both groups. The primary efficacy measure of absolute change in EAPP demonstrated the superiority of dienogest over placebo. Dienogest was generally well tolerated and few adverse events were associated with therapy.ConclusionsDienogest at a dose of 2mg daily for 12 weeks was significantly more effective than placebo for reducing EAPP.

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Condition tags

endometriosischronic_pelvic_pain

MeSH descriptors

Endometriosis Nandrolone Pelvic Pain Progesterone Congeners Adolescent Adult Double-Blind Method Endometriosis Endometriosis Europe Female Humans Middle Aged Nandrolone Nandrolone Pain Measurement Pain Measurement Pelvic Pain Pelvic Pain Progesterone Congeners

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