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

Last updated: March 5, 2025
Sponsor: Organon and Co
Overall Status: Active - Not Recruiting

Phase

2

Condition

Endometriosis

Treatment

OG-6219

Placebo

Clinical Study ID

NCT05560646
OG-6219-P001
  • Ages 18-49
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pre-menopausal females of age 18 to 49 years old (inclusive) at the time of signingInformed 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 surgicalprocedures for treatment of endometriosis during study participation.

  • Normal breast exam at V1. In participants of ≥40 years mammography orcontrast-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 thepresent 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-relatedactivities

  • Has demonstrated compliance with ≥75% of eDiary entries

  • Has a negative pregnancy test

Exclusion

Exclusion Criteria:

  • Surgical history of hysterectomy and/or bilateral oophorectomy

  • Chronic pelvic and/or non-pelvic pain not caused by endometriosis that requireschronic analgesic or other chronic therapy

  • Undiagnosed (unexplained), abnormal vaginal bleeding not associated withendometriosis within the past 6 months before screening.

  • Presence of high-risk human papillomavirus (HPV).

  • Has an active sexually transmitted infection (STI) (eg, gonorrhea, chlamydia, ortrichomonas).

  • Intends to become pregnant or breast feed during study participation or has a knownor suspected pregnancy.

  • History of malignancy (except for basal cell or squamous cell skin cancer) beforesigning informed consent.

  • History of family history of hereditary abnormal hemoglobin or an enzyme deficiencythat 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 stronginhibitor or inducer of CYP3A4 within 30 days or 10 half-lives (whichever is longer)prior to the planned first day of dosing.

Study Design

Total Participants: 380
Treatment Group(s): 2
Primary Treatment: OG-6219
Phase: 2
Study Start date:
October 25, 2022
Estimated Completion Date:
May 31, 2025

Study Description

This is a global multicenter, Phase 2a/b, randomized, double-blind, Placebo-controlled study to assess the efficacy, safety, and tolerability of 3 dose levels of OG-6219, in pre-menopausal women 18 to 49 years of age (inclusive), who have been surgically diagnosed with endometriosis with moderate to severe endometriosis-related pain. This study includes treatment lasting approximately 16 weeks in total and is followed by a Safety Follow-up visit.

Pre-menopausal females aged 18 to 49 years old (inclusive), who have been surgically diagnosed with endometriosis will be screened and randomly assigned to study treatment. A minimum subset of 10 participants per treatment group (including Placebo group) will be voluntarily enrolled for optional intensive PK sampling for the entire duration of the study.

Connect with a study center

  • Cliniques Universitaires Saint-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Cliniques Universitaires de Bruxelles Hopital Erasme

    Bruxelles, 1070
    Belgium

    Site Not Available

  • AZ Jan Palfijn Gent

    Gent, 9000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Ghent

    Gent, 9000
    Belgium

    Site Not Available

  • Jessa Ziekenhuis Hospital

    Hasselt, 3500
    Belgium

    Site Not Available

  • CHU de Tivoli

    La Louvière, 7100
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • MHAT - Blagoevgrad, EOOD

    Blagoevgrad, 2700
    Bulgaria

    Site Not Available

  • Medical Center Repromed EOOD

    Pleven, 5800
    Bulgaria

    Site Not Available

  • UMHAT "Sv. Georgi", EAD

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • DCC " Ascendent" EAD

    Sofia, 1202
    Bulgaria

    Site Not Available

  • DCC "Alexandrovska", EOOD

    Sofia, 1431
    Bulgaria

    Site Not Available

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

    Sofia, 1606
    Bulgaria

    Site Not Available

  • MHAT for women's health - Nadezhda, OOD

    Sofia, 1330
    Bulgaria

    Site Not Available

  • Medical Center Hera EOOD

    Sofia, 1510
    Bulgaria

    Site Not Available

  • SHATOD - Sofia District, EOOD

    Sofia, 1233
    Bulgaria

    Site Not Available

  • Second SHATGO Sheynovo

    Sofia, 1504
    Bulgaria

    Site Not Available

  • MHAT NiaMed OOD

    Stara Zagora, 6000
    Bulgaria

    Site Not Available

  • Acibadem City Clinic MC Varna EOOD

    Varna, 9002
    Bulgaria

    Site Not Available

  • Fakultni nemocnice Brno

    Brno, 602 00
    Czechia

    Site Not Available

  • Fertimed s.r.o.

    Olomouc, 77900
    Czechia

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    Praha 10, 100 34
    Czechia

    Site Not Available

  • Femina Sana s.r.o.

    Praha 3, 130 00
    Czechia

    Site Not Available

  • Ustav pro peci o matku a dite

    Praha 4, 147 10
    Czechia

    Site Not Available

  • Hôpital Beaujon

    Clichy cedex, Hauts De Seine 92110
    France

    Site Not Available

  • Hopital Saint Joseph Paris

    Paris Cedex 14, Paris 75674
    France

    Site Not Available

  • Hopital Tenon

    Paris, 75020
    France

    Site Not Available

  • Hôpital Cochin

    Paris, 75014
    France

    Site Not Available

  • Hospital of Hautepierre

    Strasbourg, 67200
    France

    Site Not Available

  • Universitaetsklinikum Duesseldorf AoeR

    Duesseldorf, Nordrhein Westfalen 40225
    Germany

    Site Not Available

  • Charité - Campus Benjamin Franklin

    Berlin, 13353
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Universitätsklinikum des Saarlandes

    Homburg, D-66421
    Germany

    Site Not Available

  • Universitaetsklinikum Muenster

    Muenster, 48149
    Germany

    Site Not Available

  • LMU-Campus Innenstadt

    Munich, 81377
    Germany

    Site Not Available

  • Aranyklinika Budapest

    Budapest, 1051
    Hungary

    Site Not Available

  • Clinexpert Kft.

    Budapest, 1033
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1082
    Hungary

    Site Not Available

  • Debreceni Egyetem

    Debrecen, 4032
    Hungary

    Site Not Available

  • Szent Anna Maganrendelo

    Debrecen, 4024
    Hungary

    Site Not Available

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400
    Hungary

    Site Not Available

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz

    Nyíregyháza, 4400
    Hungary

    Site Not Available

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6725
    Hungary

    Site Not Available

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Seriate, Milano 20122
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Roma 168
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    Bologna, 40138
    Italy

    Site Not Available

  • Università di Cagliari-Presidio Policlinico Monserrato

    Monserrato, 09042
    Italy

    Site Not Available

  • University of Siena Policlinico

    Siena, 53100
    Italy

    Site Not Available

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

    Verona, 37134
    Italy

    Site Not Available

  • Dr. Vasaraudze's Private Clinic

    Riga, LV-1011
    Latvia

    Site Not Available

  • Latvian Maritime Medical Centre

    Riga, LV-1005
    Latvia

    Site Not Available

  • Vitols & Vitols, Ltd.

    Riga, LV-1006
    Latvia

    Site Not Available

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

    Wroclaw, Dolnoslask 54-034
    Poland

    Site Not Available

  • Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian

    Bialystok, 15-267
    Poland

    Site Not Available

  • Specjalistyczna Poradnia Ginekologiczna Janusz Tomaszewski Spółka Komandytowa

    Bialystok, 15-224
    Poland

    Site Not Available

  • NZOZ Artemida - Centrum Ginekologii, Endokrynologii i Medycyny Rozrodu

    Białystok, 15-464
    Poland

    Site Not Available

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85-065
    Poland

    Site Not Available

  • Clinical Medical Research Sp. z o.o.

    Katowice, 40-156
    Poland

    Site Not Available

  • Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian

    Katowice, 40-081
    Poland

    Site Not Available

  • NZOZ Medem

    Katowice, 40-301
    Poland

    Site Not Available

  • Centrum Medyczne Chodzki HLK

    Lublin, 20-093
    Poland

    Site Not Available

  • KO-MED Centra Kliniczne Lublin II

    Lublin, 20-362
    Poland

    Site Not Available

  • Specjalistyczny Gabinet Ginekologiczno-Położniczy

    Lublin, 20-064
    Poland

    Site Not Available

  • ETYKA Osrodek Badan Klinicznych

    Olsztyn, 10-117
    Poland

    Site Not Available

  • Etg Siedlce

    Siedlce, 08-110
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Poznan

    Skórzewo, 60-185
    Poland

    Site Not Available

  • Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian

    Szczecin, 70-225
    Poland

    Site Not Available

  • MICS Centrum Medyczne Torun

    Torun, 87-100
    Poland

    Site Not Available

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

    Warszawa, 02-172
    Poland

    Site Not Available

  • Specjalistyczna Praktyka Lekar

    Warszawa, 00-144
    Poland

    Site Not Available

  • WIM Panstwowy Instytut Badawczy Centralny Szpital Kliniczny MON

    Warszawa, 04-141
    Poland

    Site Not Available

  • Centra Medyczne Medyceusz

    Łódź, 91-053
    Poland

    Site Not Available

  • Danderyd Sjukhus

    Stockholm, 182 88
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Stockholm, 17176
    Sweden

    Site Not Available

  • Norrlands Universitetssjukhus

    Umeå, 90185
    Sweden

    Site Not Available

  • Central Research Associates LLC dba Flourish Research

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • UAB Center for Women's Reproductive Health

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Olympia Clinical Trials

    Los Angeles, California 90036
    United States

    Site Not Available

  • Yale Fertility Center

    Orange, Connecticut 06477
    United States

    Site Not Available

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Physician Care Clinical Research, LLC

    Sarasota, Florida 34239
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • MediSense Inc

    Atlanta, Georgia 30363
    United States

    Site Not Available

  • Augusta University Medical Center

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Paramount Research Solutions

    College Park, Georgia 30349
    United States

    Site Not Available

  • Infinite Clinical Trials

    Morrow, Georgia 30260
    United States

    Site Not Available

  • The Advanced Gynecologic Surgery Institute

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Clinical Trials Management, LLC

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Ochsner Health Center - Baptist McFarland Medical Plaza

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Omni Fertility and Laser Institute

    Shreveport, Louisiana 71118
    United States

    Site Not Available

  • John Hopkins University

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Sundance Clinical Research

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Sundance Clinical Research

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Meridian Clinical Research, LLC

    Norfolk, Nebraska 68701
    United States

    Active - Recruiting

  • Velocity Clinical Research, Norfolk

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • Bosque Women's Care

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Unified Women's Clinical Research-Lyndhurst Clinical Research

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45267-0502
    United States

    Site Not Available

  • Centricity Research Dublin

    Dublin, Ohio 43016
    United States

    Site Not Available

  • Penn State Health Women's Health Clinic

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Clinical Research of Philadelphia, LLC

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Penn Medicine - Penn Fertility Care

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Palmetto Clinical Research

    Summerville, South Carolina 29485
    United States

    Site Not Available

  • Chattanooga Medical Research, LLC

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Cedar Health Research, LLC

    Euless, Texas 76040
    United States

    Site Not Available

  • Cedar Health Research, LLC

    Fort Worth, Texas 76132-4120
    United States

    Site Not Available

  • Clinical Trial Network LLC

    Houston, Texas 77074
    United States

    Site Not Available

  • TMC Life Research, Inc.

    Houston, Texas 77054
    United States

    Site Not Available

  • The Women's Hospital of Texas

    Houston, Texas 77024
    United States

    Site Not Available

  • Northeast Clinical Research of San Antonio

    San Antonio, Texas 78233
    United States

    Site Not Available

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Wasatch Clinical Research

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Tidewater Clinical Research

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Tidewater Clinical Research

    Virginia Beach, Virginia 23456
    United States

    Site Not Available

  • Seattle Women's: Health, Research, Gynecology

    Seattle, Washington 98105
    United States

    Site Not Available

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