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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
Sponsor: Organon and Co
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.
Official title: A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of OG-6219 in 3 Dose Levels, in Women 18 to 49 Years of Age With Moderate to Severe Endometriosis-related Pain
Key Details
Gender
FEMALE
Age Range
18 Years - 49 Years
Study Type
INTERVENTIONAL
Enrollment
354
Start Date
2022-10-25
Completion Date
2025-05-28
Last Updated
2026-05-08
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (86)
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