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

NCT05560646 ↗

Phase 2 Completed 354 enrolled Organon and Co IQVIA Pty Ltd · collab
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

EvaluationDrugModalityDoseRoute
Subject OG-6219 Unknown — Oral

Indications