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A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis — EDELWEISS  

Endometriosis Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Phase 2b Dose-ranging Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis Associated Pain

Clinical Trial Summary

The primary objective of this study is to assess the efficacy and safety of a range of oral doses of OBE2109 versus placebo, in reducing endometriosis associated pain.

Clinical Trial Description

The study is a prospective, dose-finding, randomized, parallel group, double-blind, placebo-controlled phase 2b study investigating the efficacy and safety of OBE2109 in the treatment of 330 women with moderate-to-severe endometriosis associated pain. Subject will be randomized to one of 6 treatment groups in a 1:1:1:1:1:1 ratio (1 placebo group, 5 dose groups with different dosage/regimen). Eligible subjects will be offered the opportunity to continue treatment with OBE2109 in an extension phase. Subjects who do not continue in the extension will enter the treatment-free follow-up phase of the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02778399
Study type Interventional
Source ObsEva SA
Contact
Status Completed
Phase Phase 2
Start date July 2016
Completion date July 1, 2019
View Details
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