At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 328 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
OBE2109 tablets for oral administration once dailyAI-extracted
Key inclusion· 4
- ✓Surgical and/or histological diagnosis of pelvic endometriosis within 10 years of screening
- ✓Moderate to severe endometriosis-associated pain during screening period
- ✓Regular menstrual cycles
- ✓BMI ≥18 kg/m²
Key exclusion· 5
- ✕Pregnant, breastfeeding, or planning pregnancy during treatment period
- ✕Interventional endometriosis surgery within 60 days before screening
- ✕Prior non-response to GnRH agonists or GnRH antagonists for endometriosis
- ✕History of osteoporosis or other metabolic bone disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Placebo and OBE2109 for Endometriosis. Completed, enrolled 328 participants across 86 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometriosis
CountriesPoland, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartJul 2016
Primary CompletionApr 2018
Study CompletionJul 2019
TodayJul 2026
First PostedMay 19, 2016
Enrollment StartJul 1, 2016
Primary CompletionApr 1, 2018
Study CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.1 years ago
Interventions
Placebodrug
Placebo tablets for oral administration once daily
OBE2109drug
OBE2109 tablets for oral administration once daily