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
← catalyst calendarSponsored by Organon and Co (industry) · OGN — their whole pipeline →. With IQVIA Pty Ltd.
Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
354actual
Sites
86
Countries
Belgium, Bulgaria, Czechia +8
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-10-25 | actual | When the study began enrolling |
| Primary completion | 2025-05-28 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-05-28 | actual | The whole study's end, after follow-up |
| First posted | 2022-09-29 | actual | When this record first appeared on the registry |
| Results posted | 2026-05-08 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-05-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Endometriosis
Interventions
- Drug: OG-6219
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFChange From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3
measured Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
measured From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation
measured From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-02-16 · 12.5 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-06-09 · 4.8 MB · SAP_001.pdf
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