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NCT05560646 · ClinicalTrials.gov registry record · Phase 2

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 2 study, sponsored by Organon and.

Completed
Registry status
Phase 2
Development phase
354
Enrollment target

NCT05560646: Completed Phase 2 study, sponsored by Organon and.

NCT05560646 is a Phase 2 study that has completed, run by Organon and. The registered enrollment target is 354 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (166% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05560646, a Phase 2 study, has completed, sponsored by Organon and.

COMPLETED
Registry status
Phase 2
Development phase
354 participants
Enrollment target

Study 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.

Primary Outcome

Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dysmenorrhea or NMPP, and dyspareunia. Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The mean OPP score was derived by the pain score for the dysmenorrhea and NMPP items, and score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. Baseline cycle O

Interventions

  • DRUG Placebo
  • DRUG OG-6219

Trial Details

FieldValue
Enrollment Target 354 participants
Start Date 2022-10-25
Est. Completion 2025-05-28
Phase Phase 2
Organon and

15 total trials

What the finished NCT05560646 record still lists

NCT05560646 is an interventional study that assigns participants to a tested intervention. The registered 354 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (166% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05560646 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05560646 about?

NCT05560646 is a clinical study titled "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". 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.

What is the current status of trial NCT05560646?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 354 participants. The study started on 2022-10-25. Estimated completion is 2025-05-28.

What interventions are being tested in trial NCT05560646?

The interventions under investigation include: Placebo (DRUG), OG-6219 (DRUG).

Who is sponsoring clinical trial NCT05560646?

This trial is sponsored by Organon and, which has 15 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05560646's enrollment target sits among peer trials

354 128th of 2000 higher than 1,872 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05560646, the US trial registry maintained by the National Library of Medicine. NCT05560646 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.