drugset / Trial / NCT05560646
A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 to 49 With Moderate to Severe Endometriosis-related Pain
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2022-10-25
- Primary completion
- 2025-05-28
- Completion
- 2025-05-28
Outcome
Missed primary endpoint
release “Phase 2 ELENA proof-of-concept study evaluating the investigational candidate OG-6219 in endometriosis-related pain did not meet its primary efficacy endpoint.” organon.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OG-6219 | Unknown | — | Oral |