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

What this trial studies

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 in scope

• Endometriosis

Interventions

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

Who can join

Women only · Ages 18 Years to 49 Years

Inclusion criteria

• Pre-menopausal females of age 18 to 49 years old (inclusive) at the time of signing Informed Consent (V1).
• Surgically (laparoscopy or laparotomy) diagnosed with endometriosis
• Moderate to severe endometriosis-related pelvic pain
• Regular menstrual cycles
• Is not expected to undergo a planned gynecological surgery or other surgical procedures for treatment of endometriosis during study participation.
• Normal breast exam at V1. In participants of ≥40 years mammography or contrast-enhanced breast MRI performed within the last 12 months prior to Screening (V1) without clinically significant abnormal findings.
• Agree not to participate in another interventional study while participating in the present study.
• Able and willing to adhere to study procedures, including

Exclusion criteria

• Surgical history of hysterectomy and/or bilateral oophorectomy
• Chronic pelvic and/or non-pelvic pain not caused by endometriosis that requires chronic analgesic or other chronic therapy
• Undiagnosed (unexplained), abnormal vaginal bleeding not associated with endometriosis within the past 6 months before screening.
• Presence of high-risk human papillomavirus (HPV).
• Has an active sexually transmitted infection (STI) (eg, gonorrhea, chlamydia, or trichomonas).
• Intends to become pregnant or breast feed during study participation or has a known or suspected pregnancy.
• History of malignancy (except for basal cell or squamous cell skin cancer) before signing informed consent.
• History of family history of hereditary abnormal hemoglobin or an enzyme deficiency that can result in methemoglobinemia.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Showing the first 10 of 86 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE2
• Start date: 2022-10-25
• Primary completion: 2025-05-28
• Last update posted: 2026-05-08
• First posted: 2022-09-29

Sponsor & contact

Lead sponsor: Organon and Co (Industry)

Collaborators: IQVIA Pty Ltd

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3 (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).)
  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…
• Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) (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)
  An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered an investigational product and which does not necessarily have a causal relationship with this treatment. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or…
• Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation (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)
  An AE was defined as any untoward medical occurrence in a clinical study participant administered an investigational product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as events that first occur or worsen (increase in severity) after the first dose of study drug, during the treatment period, and up to 14 days (inclusive)…

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