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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2026-05-08

Study results available
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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.

Conditions

  • Endometriosis

Interventions

DRUG

OG-6219

OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.

DRUG

Placebo

Participants will receive (orally) OG-6219 Placebo tablets BID during treatment cycles.

Sponsors & Collaborators

  • IQVIA Pty Ltd

    collaborator INDUSTRY

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Clinical Lead Late-Stage Clinical Development · Organon and Co

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-25
Primary Completion
2025-05-28
Completion
2025-05-28
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Poland
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05560646 on ClinicalTrials.gov