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New pill could ease severe endometriosis pain

NCT ID NCT05560646

Symptom relief Sponsor: Organon and Co Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new medication called OG-6219 in 354 women aged 18 to 49 with moderate to severe endometriosis-related pain. The goal was to see if three different doses could safely reduce pelvic pain compared to a placebo. The trial is complete, and results will show how well the drug works and what side effects may occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

354 people

The number who actually took part.

Started

Oct 2022

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 49 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * 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 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. * 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.

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Conditions

The condition(s) this trial relates to.

endometriosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometriosis

Contacts and locations

Locations

  • AZ Jan Palfijn Gent

    Ghent, 9000, Belgium

  • Acibadem City Clinic MC Varna EOOD

    Varna, 9002, Bulgaria

  • Bosque Women's Care

    Albuquerque, New Mexico, 87109, United States

  • CHU de Tivoli

    La Louvière, 7100, Belgium

  • Cedar Health Research, LLC

    Euless, Texas, 76040, United States

  • Centra Medyczne Medyceusz

    Lodz, 91-053, Poland

  • Central Research Associates LLC dba Flourish Research

    Birmingham, Alabama, 35205, United States

  • Centricity Research Dublin

    Dublin, Ohio, 43016, United States

  • Centro Ricerche Cliniche di Verona s.r.l.

    Verona, 37134, Italy

  • Centrum Medyczne Chodzki HLK

    Lublin, 20-093, Poland

  • Charité - Campus Benjamin Franklin

    Berlin, 13353, Germany

  • Chattanooga Medical Research, LLC

    Chattanooga, Tennessee, 37404, United States

  • Clinexpert Kft.

    Budapest, 1033, Hungary

  • Clinical Medical Research Sp. z o.o.

    Katowice, 40-156, Poland

  • Clinical Research of Philadelphia, LLC

    Philadelphia, Pennsylvania, 19114, United States

  • Clinical Trial Network LLC

    Houston, Texas, 77074, United States

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • DCC " Ascendent" EAD

    Sofia, 1202, Bulgaria

  • DCC "Alexandrovska", EOOD

    Sofia, 1431, Bulgaria

  • Danderyd Sjukhus

    Stockholm, 182 88, Sweden

  • Dr. Vasaraudze's Private Clinic

    Riga, LV-1011, Latvia

  • ETYKA Osrodek Badan Klinicznych

    Olsztyn, 10-117, Poland

  • Etg Siedlce

    Siedlce, 08-110, Poland

  • Fakultni nemocnice Brno

    Brno, 602 00, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34, Czechia

  • Femina Sana s.r.o.

    Prague, 130 00, Czechia

  • Fertimed s.r.o.

    Olomouc, 77900, Czechia

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Seriate, Milano, 20122, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Roma, 168, Italy

  • Group practice for specialized medical care in the field of obstetrics and gynecology - Gin Art OOD

    Sofia, 1606, Bulgaria

  • Hopital Saint Joseph Paris

    Paris, Paris, 75674, France

  • Hopital Tenon

    Paris, 75020, France

  • Hospital of Hautepierre

    Strasbourg, 67200, France

  • Hôpital Cochin

    Paris, 75014, France

  • Infinite Clinical Trials

    Morrow, Georgia, 30260, United States

  • Jessa Ziekenhuis Hospital

    Hasselt, 3500, Belgium

  • John Hopkins University

    Baltimore, Maryland, 21205, United States

  • KO-MED Centra Kliniczne Lublin II

    Lublin, 20-362, Poland

  • Karolinska University Hospital

    Stockholm, 17176, Sweden

  • Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian

    Bialystok, 15-267, Poland

  • Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian

    Katowice, 40-081, Poland

  • Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian

    Szczecin, 70-225, Poland

  • Latvian Maritime Medical Centre

    Riga, LV-1005, Latvia

  • MHAT NiaMed OOD

    Stara Zagora, 6000, Bulgaria

  • MHAT for women's health - Nadezhda, OOD

    Sofia, 1330, Bulgaria

  • MICS Centrum Medyczne Torun

    Torun, 87-100, Poland

  • MediSense Inc

    Atlanta, Georgia, 30363, United States

  • Medical Center Hera EOOD

    Sofia, 1510, Bulgaria

  • Medical Center Repromed EOOD

    Pleven, 5800, Bulgaria

  • NZOZ Medem

    Katowice, 40-301, Poland

  • Northeast Clinical Research of San Antonio

    San Antonio, Texas, 78233, United States

  • Ochsner Health Center - Baptist McFarland Medical Plaza

    New Orleans, Louisiana, 70115, United States

  • Olympia Clinical Trials

    Los Angeles, California, 90036, United States

  • Omni Fertility and Laser Institute

    Shreveport, Louisiana, 71118, United States

  • PRATIA S.A. MTZ Clinical Research Powered by Pratia

    Warsaw, 02-172, Poland

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485, United States

  • Paramount Research Solutions

    College Park, Georgia, 30349, United States

  • Penn State Health Women's Health Clinic

    Hershey, Pennsylvania, 17033, United States

  • Physician Care Clinical Research, LLC

    Sarasota, Florida, 34239, United States

  • Przychodnia Wielospecjalistyczna Sk-Medica Spółka Z O.O.

    Wroclaw, Dolnoslask, 54-034, Poland

  • SHATOD - Sofia District, EOOD

    Sofia, 1233, Bulgaria

  • Seattle Women's: Health, Research, Gynecology

    Seattle, Washington, 98105, United States

  • Semmelweis Egyetem

    Budapest, 1082, Hungary

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400, Hungary

  • Specjalistyczna Poradnia Ginekologiczna Janusz Tomaszewski Spółka Komandytowa

    Bialystok, 15-224, Poland

  • Specjalistyczna Praktyka Lekar

    Warsaw, 00-144, Poland

  • Specjalistyczny Gabinet Ginekologiczno-Położniczy

    Lublin, 20-064, Poland

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz

    Nyíregyháza, 4400, Hungary

  • Szent Anna Maganrendelo

    Debrecen, 4024, Hungary

  • The Advanced Gynecologic Surgery Institute

    Park Ridge, Illinois, 60068, United States

  • The Women's Hospital of Texas

    Houston, Texas, 77024, United States

  • Tidewater Clinical Research

    Norfolk, Virginia, 23502, United States

  • UAB Center for Women's Reproductive Health

    Birmingham, Alabama, 35233, United States

  • UMHAT "Sv. Georgi", EAD

    Plovdiv, 4002, Bulgaria

  • Universitaetsklinikum Duesseldorf AoeR

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Universitair Ziekenhuis Ghent

    Ghent, 9000, Belgium

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0502, United States

  • University of Siena Policlinico

    Siena, 53100, Italy

  • University of South Florida

    Tampa, Florida, 33606, United States

  • Università di Cagliari-Presidio Policlinico Monserrato

    Monserrato, 09042, Italy

  • Universitätsklinikum des Saarlandes

    Homburg, D-66421, Germany

  • Ustav pro peci o matku a dite

    Prague, 147 10, Czechia

  • Vitols & Vitols, Ltd.

    Riga, LV-1006, Latvia

  • WIM Panstwowy Instytut Badawczy Centralny Szpital Kliniczny MON

    Warsaw, 04-141, Poland

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107, United States

  • Yale Fertility Center

    Orange, Connecticut, 06477, United States

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