NCT02778399

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 328 (actual)
• Sponsor: ObsEva SA · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo tablets for oral administration once daily
DRUG	OBE2109	OBE2109 tablets for oral administration once daily

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-04-01
• Completion: 2019-07-01
• First posted: 2016-05-19
• Last updated: 2022-07-21
• Results posted: 2022-07-21

Locations

86 sites across 4 countries: United States, Poland, Russia, Ukraine