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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a global multicenter, Phase 2a/b, randomized, double-blind, Placebo-controlled study to assess the efficacy, safety, and tolerability of 3 dose levels of OG-6219, in pre-menopausal women 18 to 49 years of age (inclusive), who have been surgically diagnosed with endometriosis with moderate to severe endometriosis-related pain. This study includes treatment lasting approximately 16 weeks in total and is followed by a Safety Follow-up visit. Pre-menopausal females aged 18 to 49 years old (inclusive), who have been surgically diagnosed with endometriosis will be screened and randomly assigned to study treatment. A minimum subset of 10 participants per treatment group (including Placebo group) will be voluntarily enrolled for optional intensive PK sampling for the entire duration of the study.

Conditions

• Endometriosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-25
• Primary completion: 2025-05-28
• Completion: 2025-05-28
• First posted: 2022-09-29
• Last updated: 2025-05-29

Locations

86 sites across 11 countries: United States, Belgium, Bulgaria, Czechia, France, Germany, Hungary, Italy, Latvia, Poland, Sweden

Regulatory

• FDA-regulated drug study