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

Completed · Phase 2 · Has a placebo group

Conditions studied: Endometriosis

In brief

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.

Key facts

Study ID

NCT05560646

Run by

Organon and Co

People needed

354

Starts

2022-10-25

Expected to finish

2025-05-28

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• agree to use 2 forms of non-hormonal contraception throughout the study
• Must be willing and able to provide signed informed consent before any study-related activities
• Has demonstrated compliance with ≥75% of eDiary entries
• Has a negative pregnancy test

You may not qualify if…

• 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.
• Has a medical condition associated with hemolytic anemia
• Known human immunodeficiency virus infection, and/or acute or active, recurrent/relapsing, or chronic infection (eg, hepatitis A, B, or C virus)
• Has a clinically significant abnormal ECG or QT interval prolongation
• Used any medication that is either a sensitive substrate, moderate, or strong inhibitor or inducer of CYP3A4 within 30 days or 10 half-lives (whichever is longer) prior to the planned first day of dosing.

Where it is running

• UAB Center for Women's Reproductive Health — Birmingham, Alabama, United States
• Olympia Clinical Trials — Los Angeles, California, United States
• Yale Fertility Center — Orange, Connecticut, United States
• Physician Care Clinical Research, LLC — Sarasota, Florida, United States
• University of South Florida — Tampa, Florida, United States
• MediSense Inc — Atlanta, Georgia, United States
• Paramount Research Solutions — College Park, Georgia, United States
• Infinite Clinical Trials — Morrow, Georgia, United States
• The Advanced Gynecologic Surgery Institute — Park Ridge, Illinois, United States
• Ochsner Health Center - Baptist McFarland Medical Plaza — New Orleans, Louisiana, United States
• Omni Fertility and Laser Institute — Shreveport, Louisiana, United States
• John Hopkins University — Baltimore, Maryland, United States
• Bosque Women's Care — Albuquerque, New Mexico, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Centricity Research Dublin — Dublin, Ohio, United States
• Penn State Health Women's Health Clinic — Hershey, Pennsylvania, United States
• Clinical Research of Philadelphia, LLC — Philadelphia, Pennsylvania, United States
• Palmetto Clinical Research — Summerville, South Carolina, United States
• Chattanooga Medical Research, LLC — Chattanooga, Tennessee, United States
• Cedar Health Research, LLC — Euless, Texas, United States
• The Women's Hospital of Texas — Houston, Texas, United States
• Clinical Trial Network LLC — Houston, Texas, United States
• Northeast Clinical Research of San Antonio — San Antonio, Texas, United States
• Wasatch Clinical Research — Salt Lake City, Utah, United States
• Central Research Associates LLC dba Flourish Research — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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