Phase
Condition
Endometriosis
Treatment
OG-6219
Placebo
Clinical Study ID
Ages 18-49 Female
Study Summary
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
Study Description
Connect with a study center
Cliniques Universitaires Saint-Luc
Bruxelles, 1200
BelgiumSite Not Available
Cliniques Universitaires de Bruxelles Hopital Erasme
Bruxelles, 1070
BelgiumSite Not Available
AZ Jan Palfijn Gent
Gent, 9000
BelgiumSite Not Available
Universitair Ziekenhuis Ghent
Gent, 9000
BelgiumSite Not Available
Jessa Ziekenhuis Hospital
Hasselt, 3500
BelgiumSite Not Available
CHU de Tivoli
La Louvière, 7100
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
MHAT - Blagoevgrad, EOOD
Blagoevgrad, 2700
BulgariaSite Not Available
Medical Center Repromed EOOD
Pleven, 5800
BulgariaSite Not Available
UMHAT "Sv. Georgi", EAD
Plovdiv, 4002
BulgariaSite Not Available
DCC " Ascendent" EAD
Sofia, 1202
BulgariaSite Not Available
DCC "Alexandrovska", EOOD
Sofia, 1431
BulgariaSite Not Available
Group practice for specialized medical care in the field of obstetrics and gynecology - Gin Art OOD
Sofia, 1606
BulgariaSite Not Available
MHAT for women's health - Nadezhda, OOD
Sofia, 1330
BulgariaSite Not Available
Medical Center Hera EOOD
Sofia, 1510
BulgariaSite Not Available
SHATOD - Sofia District, EOOD
Sofia, 1233
BulgariaSite Not Available
Second SHATGO Sheynovo
Sofia, 1504
BulgariaSite Not Available
MHAT NiaMed OOD
Stara Zagora, 6000
BulgariaSite Not Available
Acibadem City Clinic MC Varna EOOD
Varna, 9002
BulgariaSite Not Available
Fakultni nemocnice Brno
Brno, 602 00
CzechiaSite Not Available
Fertimed s.r.o.
Olomouc, 77900
CzechiaSite Not Available
Fakultni nemocnice Kralovske Vinohrady
Praha 10, 100 34
CzechiaSite Not Available
Femina Sana s.r.o.
Praha 3, 130 00
CzechiaSite Not Available
Ustav pro peci o matku a dite
Praha 4, 147 10
CzechiaSite Not Available
Hôpital Beaujon
Clichy cedex, Hauts De Seine 92110
FranceSite Not Available
Hopital Saint Joseph Paris
Paris Cedex 14, Paris 75674
FranceSite Not Available
Hopital Tenon
Paris, 75020
FranceSite Not Available
Hôpital Cochin
Paris, 75014
FranceSite Not Available
Hospital of Hautepierre
Strasbourg, 67200
FranceSite Not Available
Universitaetsklinikum Duesseldorf AoeR
Duesseldorf, Nordrhein Westfalen 40225
GermanySite Not Available
Charité - Campus Benjamin Franklin
Berlin, 13353
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307
GermanySite Not Available
Universitätsklinikum des Saarlandes
Homburg, D-66421
GermanySite Not Available
Universitaetsklinikum Muenster
Muenster, 48149
GermanySite Not Available
LMU-Campus Innenstadt
Munich, 81377
GermanySite Not Available
Aranyklinika Budapest
Budapest, 1051
HungarySite Not Available
Clinexpert Kft.
Budapest, 1033
HungarySite Not Available
Semmelweis Egyetem
Budapest, 1082
HungarySite Not Available
Debreceni Egyetem
Debrecen, 4032
HungarySite Not Available
Szent Anna Maganrendelo
Debrecen, 4024
HungarySite Not Available
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400
HungarySite Not Available
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Nyíregyháza, 4400
HungarySite Not Available
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6725
HungarySite Not Available
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Seriate, Milano 20122
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Roma 168
ItalySite Not Available
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, 40138
ItalySite Not Available
Università di Cagliari-Presidio Policlinico Monserrato
Monserrato, 09042
ItalySite Not Available
University of Siena Policlinico
Siena, 53100
ItalySite Not Available
Centro Ricerche Cliniche di Verona s.r.l.
Verona, 37134
ItalySite Not Available
Dr. Vasaraudze's Private Clinic
Riga, LV-1011
LatviaSite Not Available
Latvian Maritime Medical Centre
Riga, LV-1005
LatviaSite Not Available
Vitols & Vitols, Ltd.
Riga, LV-1006
LatviaSite Not Available
Przychodnia Wielospecjalistyczna Sk-Medica Spółka Z O.O.
Wroclaw, Dolnoslask 54-034
PolandSite Not Available
Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
Bialystok, 15-267
PolandSite Not Available
Specjalistyczna Poradnia Ginekologiczna Janusz Tomaszewski Spółka Komandytowa
Bialystok, 15-224
PolandSite Not Available
NZOZ Artemida - Centrum Ginekologii, Endokrynologii i Medycyny Rozrodu
Białystok, 15-464
PolandSite Not Available
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, 85-065
PolandSite Not Available
Clinical Medical Research Sp. z o.o.
Katowice, 40-156
PolandSite Not Available
Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
Katowice, 40-081
PolandSite Not Available
NZOZ Medem
Katowice, 40-301
PolandSite Not Available
Centrum Medyczne Chodzki HLK
Lublin, 20-093
PolandSite Not Available
KO-MED Centra Kliniczne Lublin II
Lublin, 20-362
PolandSite Not Available
Specjalistyczny Gabinet Ginekologiczno-Położniczy
Lublin, 20-064
PolandSite Not Available
ETYKA Osrodek Badan Klinicznych
Olsztyn, 10-117
PolandSite Not Available
Etg Siedlce
Siedlce, 08-110
PolandSite Not Available
Centrum Medyczne Pratia Poznan
Skórzewo, 60-185
PolandSite Not Available
Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
Szczecin, 70-225
PolandSite Not Available
MICS Centrum Medyczne Torun
Torun, 87-100
PolandSite Not Available
PRATIA S.A. MTZ Clinical Research Powered by Pratia
Warszawa, 02-172
PolandSite Not Available
Specjalistyczna Praktyka Lekar
Warszawa, 00-144
PolandSite Not Available
WIM Panstwowy Instytut Badawczy Centralny Szpital Kliniczny MON
Warszawa, 04-141
PolandSite Not Available
Centra Medyczne Medyceusz
Łódź, 91-053
PolandSite Not Available
Danderyd Sjukhus
Stockholm, 182 88
SwedenSite Not Available
Karolinska University Hospital
Stockholm, 17176
SwedenSite Not Available
Norrlands Universitetssjukhus
Umeå, 90185
SwedenSite Not Available
Central Research Associates LLC dba Flourish Research
Birmingham, Alabama 35205
United StatesSite Not Available
UAB Center for Women's Reproductive Health
Birmingham, Alabama 35233
United StatesSite Not Available
Olympia Clinical Trials
Los Angeles, California 90036
United StatesSite Not Available
Yale Fertility Center
Orange, Connecticut 06477
United StatesSite Not Available
MedStar Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
Physician Care Clinical Research, LLC
Sarasota, Florida 34239
United StatesSite Not Available
University of South Florida
Tampa, Florida 33606
United StatesSite Not Available
MediSense Inc
Atlanta, Georgia 30363
United StatesSite Not Available
Augusta University Medical Center
Augusta, Georgia 30912
United StatesSite Not Available
Paramount Research Solutions
College Park, Georgia 30349
United StatesSite Not Available
Infinite Clinical Trials
Morrow, Georgia 30260
United StatesSite Not Available
The Advanced Gynecologic Surgery Institute
Park Ridge, Illinois 60068
United StatesSite Not Available
Clinical Trials Management, LLC
Metairie, Louisiana 70006
United StatesSite Not Available
Ochsner Health Center - Baptist McFarland Medical Plaza
New Orleans, Louisiana 70115
United StatesSite Not Available
Omni Fertility and Laser Institute
Shreveport, Louisiana 71118
United StatesSite Not Available
John Hopkins University
Baltimore, Maryland 21205
United StatesSite Not Available
Sundance Clinical Research
Saint Louis, Missouri 63141
United StatesSite Not Available
Sundance Clinical Research
St. Louis, Missouri 63141
United StatesSite Not Available
Meridian Clinical Research, LLC
Norfolk, Nebraska 68701
United StatesActive - Recruiting
Velocity Clinical Research, Norfolk
Norfolk, Nebraska 68701
United StatesSite Not Available
Bosque Women's Care
Albuquerque, New Mexico 87109
United StatesSite Not Available
Unified Women's Clinical Research-Lyndhurst Clinical Research
Winston-Salem, North Carolina 27103
United StatesSite Not Available
University of Cincinnati
Cincinnati, Ohio 45267-0502
United StatesSite Not Available
Centricity Research Dublin
Dublin, Ohio 43016
United StatesSite Not Available
Penn State Health Women's Health Clinic
Hershey, Pennsylvania 17033
United StatesSite Not Available
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania 19114
United StatesSite Not Available
Penn Medicine - Penn Fertility Care
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425
United StatesSite Not Available
Palmetto Clinical Research
Summerville, South Carolina 29485
United StatesSite Not Available
Chattanooga Medical Research, LLC
Chattanooga, Tennessee 37404
United StatesSite Not Available
Cedar Health Research, LLC
Euless, Texas 76040
United StatesSite Not Available
Cedar Health Research, LLC
Fort Worth, Texas 76132-4120
United StatesSite Not Available
Clinical Trial Network LLC
Houston, Texas 77074
United StatesSite Not Available
TMC Life Research, Inc.
Houston, Texas 77054
United StatesSite Not Available
The Women's Hospital of Texas
Houston, Texas 77024
United StatesSite Not Available
Northeast Clinical Research of San Antonio
San Antonio, Texas 78233
United StatesSite Not Available
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
Wasatch Clinical Research
Salt Lake City, Utah 84107
United StatesSite Not Available
Tidewater Clinical Research
Norfolk, Virginia 23502
United StatesSite Not Available
Tidewater Clinical Research
Virginia Beach, Virginia 23456
United StatesSite Not Available
Seattle Women's: Health, Research, Gynecology
Seattle, Washington 98105
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.