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
NCT ID: NCT05560646
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
354 participants
INTERVENTIONAL
2022-10-25
2025-05-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A: OG-6219 Dose 1
Group A: OG-6219 Dose 1 BID
OG-6219
OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.
Group B: OG-6219 Dose 2
Group B: OG-6219 Dose 2 BID
OG-6219
OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.
Group C: OG-6219 Dose 3
Group C: OG-6219 Dose 3 BID
OG-6219
OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.
Group D: Placebo
Group D: Placebo BID
Placebo
Participants will receive (orally) OG-6219 Placebo tablets BID during treatment cycles.
Interventions
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OG-6219
OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.
Placebo
Participants will receive (orally) OG-6219 Placebo tablets BID during treatment cycles.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
49 Years
FEMALE
No
Sponsors
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Iqvia Pty Ltd
INDUSTRY
Organon and Co
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Lead Late-Stage Clinical Development
Role: STUDY_DIRECTOR
Organon and Co
Locations
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Central Research Associates LLC dba Flourish Research
Birmingham, Alabama, United States
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
Tidewater Clinical Research
Norfolk, Virginia, United States
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, United States
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
AZ Jan Palfijn Gent
Ghent, , Belgium
Universitair Ziekenhuis Ghent
Ghent, , Belgium
Jessa Ziekenhuis Hospital
Hasselt, , Belgium
CHU de Tivoli
La Louvière, , Belgium
Medical Center Repromed EOOD
Pleven, , Bulgaria
UMHAT "Sv. Georgi", EAD
Plovdiv, , Bulgaria
DCC " Ascendent" EAD
Sofia, , Bulgaria
SHATOD - Sofia District, EOOD
Sofia, , Bulgaria
MHAT for women's health - Nadezhda, OOD
Sofia, , Bulgaria
DCC "Alexandrovska", EOOD
Sofia, , Bulgaria
Medical Center Hera EOOD
Sofia, , Bulgaria
Group practice for specialized medical care in the field of obstetrics and gynecology - Gin Art OOD
Sofia, , Bulgaria
MHAT NiaMed OOD
Stara Zagora, , Bulgaria
Acibadem City Clinic MC Varna EOOD
Varna, , Bulgaria
Fakultni nemocnice Brno
Brno, , Czechia
Fertimed s.r.o.
Olomouc, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Femina Sana s.r.o.
Prague, , Czechia
Ustav pro peci o matku a dite
Prague, , Czechia
Hopital Saint Joseph Paris
Paris, Paris, France
Hôpital Cochin
Paris, , France
Hopital Tenon
Paris, , France
Hospital of Hautepierre
Strasbourg, , France
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf, North Rhine-Westphalia, Germany
Charité - Campus Benjamin Franklin
Berlin, , Germany
Universitätsklinikum des Saarlandes
Homburg, , Germany
Clinexpert Kft.
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Szent Anna Maganrendelo
Debrecen, , Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Nyíregyháza, , Hungary
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Seriate, Milano, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Roma, Italy
Università di Cagliari-Presidio Policlinico Monserrato
Monserrato, , Italy
University of Siena Policlinico
Siena, , Italy
Centro Ricerche Cliniche di Verona s.r.l.
Verona, , Italy
Latvian Maritime Medical Centre
Riga, , Latvia
Vitols & Vitols, Ltd.
Riga, , Latvia
Dr. Vasaraudze's Private Clinic
Riga, , Latvia
Przychodnia Wielospecjalistyczna Sk-Medica Spółka Z O.O.
Wroclaw, Dolnoslask, Poland
Specjalistyczna Poradnia Ginekologiczna Janusz Tomaszewski Spółka Komandytowa
Bialystok, , Poland
Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
Bialystok, , Poland
Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
Katowice, , Poland
Clinical Medical Research Sp. z o.o.
Katowice, , Poland
NZOZ Medem
Katowice, , Poland
Centra Medyczne Medyceusz
Lodz, , Poland
Specjalistyczny Gabinet Ginekologiczno-Położniczy
Lublin, , Poland
Centrum Medyczne Chodzki HLK
Lublin, , Poland
KO-MED Centra Kliniczne Lublin II
Lublin, , Poland
ETYKA Osrodek Badan Klinicznych
Olsztyn, , Poland
Etg Siedlce
Siedlce, , Poland
Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
Szczecin, , Poland
MICS Centrum Medyczne Torun
Torun, , Poland
Specjalistyczna Praktyka Lekar
Warsaw, , Poland
PRATIA S.A. MTZ Clinical Research Powered by Pratia
Warsaw, , Poland
WIM Panstwowy Instytut Badawczy Centralny Szpital Kliniczny MON
Warsaw, , Poland
Karolinska University Hospital
Stockholm, , Sweden
Danderyd Sjukhus
Stockholm, , Sweden
Countries
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Related Links
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Related Info
Other Identifiers
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OG-6219-P001
Identifier Type: -
Identifier Source: org_study_id
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