At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 354 enrolled
Drug / intervention
OG-6219 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of OG-6219 in 3 Dose Levels, in Women 18 to 49 Years of Age With Moderate to Severe Endometriosis-related Pain
In Brief
A Phase 2 clinical trial evaluating OG-6219 and Placebo for Endometriosis. Completed, enrolled 354 participants across 86 sites in 11 countries.
Detailed Summary
The purpose of this global Phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe endometriosis-related pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometriosis
CountriesBelgium, Bulgaria, Czechia, France, Germany, Hungary, Italy, Latvia, Poland, Sweden, United States
CollaboratorsIQVIA Pty Ltd
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedSep 2022
Enrollment StartOct 2022
Primary CompletionMay 2025
TodayJul 2026
First PostedSep 29, 2022
Enrollment StartOct 25, 2022
Primary CompletionMay 28, 2025
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 3.8 years ago
Interventions
OG-6219drug
OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.
Placebodrug
Participants will receive (orally) OG-6219 Placebo tablets BID during treatment cycles.