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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05560646
Other study ID # OG-6219-P001
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 25, 2022
Est. completion date December 2024

Study information

Verified date February 2024
Source Organon and Co
Contact Toll Free Number
Phone 551-430-6000
Email OG-6219-P001@IQVIA.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 380
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 49 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Country Name City State
Belgium Cliniques Universitaires de Bruxelles Hopital Erasme Bruxelles
Belgium Cliniques Universitaires Saint-Luc Bruxelles
Belgium AZ Jan Palfijn Gent Gent
Belgium Universitair Ziekenhuis Ghent Gent
Belgium Jessa Ziekenhuis Hospital Hasselt
Belgium CHU de Tivoli La Louvière
Belgium UZ Leuven Leuven
Bulgaria MHAT - Blagoevgrad, EOOD Blagoevgrad
Bulgaria Medical Center Repromed EOOD Pleven
Bulgaria UMHAT "Sv. Georgi", EAD Plovdiv
Bulgaria DCC " Ascendent" EAD Sofia
Bulgaria DCC "Alexandrovska", EOOD Sofia
Bulgaria Group practice for specialized medical care in the field of obstetrics and gynecology - Gin Art OOD Sofia
Bulgaria Medical Center Hera EOOD Sofia
Bulgaria MHAT for women's health - Nadezhda, OOD Sofia
Bulgaria Second SHATGO Sheynovo Sofia
Bulgaria SHATOD - Sofia District, EOOD Sofia
Bulgaria MHAT NiaMed OOD Stara Zagora
Bulgaria Acibadem City Clinic MC Varna EOOD Varna
Czechia Fakultni nemocnice Brno Brno
Czechia Fertimed s.r.o. Olomouc
Czechia Fakultni nemocnice Kralovske Vinohrady Praha 10
Czechia Femina Sana s.r.o. Praha 3
Czechia Ustav pro peci o matku a dite Praha 4
France Hôpital Beaujon Clichy cedex Hauts De Seine
France Hôpital Cochin Paris
France Hopital Tenon Paris
France Hopital Saint Joseph Paris Paris Cedex 14 Paris
France Hospital of Hautepierre Strasbourg
Germany Charité - Campus Benjamin Franklin Berlin
Germany Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden
Germany Universitaetsklinikum Duesseldorf AoeR Duesseldorf Nordrhein Westfalen
Germany Universitätsklinikum des Saarlandes Homburg
Germany Universitaetsklinikum Muenster Muenster
Germany LMU-Campus Innenstadt Munich
Hungary Aranyklinika Budapest Budapest
Hungary Clinexpert Kft. Budapest
Hungary Semmelweis Egyetem Budapest
Hungary Debreceni Egyetem Debrecen
Hungary Szent Anna Maganrendelo Debrecen
Hungary Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvár
Hungary Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyíregyháza
Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szeged
Italy Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS Bologna
Italy Università di Cagliari-Presidio Policlinico Monserrato Monserrato
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Roma
Italy Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico Seriate Milano
Italy University of Siena Policlinico Siena
Italy Centro Ricerche Cliniche di Verona s.r.l. Verona
Latvia Dr. Vasaraudze's Private Clinic Riga
Latvia Latvian Maritime Medical Centre Riga
Latvia Vitols & Vitols, Ltd. Riga
Poland Klinika Leczenia Nieplodnosci, Ginekologii i Poloznictwa Bocian Bialystok
Poland NZOZ Artemida - Centrum Ginekologii, Endokrynologii i Medycyny Rozrodu Bialystok
Poland Specjalistyczna Poradnia Ginekologiczna Janusz Tomaszewski Spólka Komandytowa Bialystok
Poland MICS Centrum Medyczne Bydgoszcz Bydgoszcz
Poland Clinical Medical Research Sp. z o.o. Katowice
Poland Klinika Leczenia Nieplodnosci, Ginekologii i Poloznictwa Bocian Katowice
Poland NZOZ Medem Katowice
Poland Centra Medyczne Medyceusz Lódz
Poland Centrum Medyczne Chodzki HLK Lublin
Poland KO-MED Centra Kliniczne Lublin II Lublin
Poland Specjalistyczny Gabinet Ginekologiczno-Polozniczy Lublin
Poland ETYKA Osrodek Badan Klinicznych Olsztyn
Poland Etg Siedlce Siedlce
Poland Centrum Medyczne Pratia Poznan Skórzewo
Poland Klinika Leczenia Nieplodnosci, Ginekologii i Poloznictwa Bocian Szczecin
Poland MICS Centrum Medyczne Torun Torun
Poland PRATIA S.A. MTZ Clinical Research Powered by Pratia Warszawa
Poland Specjalistyczna Praktyka Lekar Warszawa
Poland WIM Panstwowy Instytut Badawczy Centralny Szpital Kliniczny MON Warszawa
Poland Przychodnia Wielospecjalistyczna Sk-Medica Spólka Z O.O. Wroclaw Dolnoslask
United States Bosque Women's Care Albuquerque New Mexico
United States MediSense Inc Atlanta Georgia
United States Augusta University Medical Center Augusta Georgia
United States John Hopkins University Baltimore Maryland
United States Central Research Associates LLC dba Flourish Research Birmingham Alabama
United States UAB Center for Women's Reproductive Health Birmingham Alabama
United States Medical University of South Carolina (MUSC) Charleston South Carolina
United States Chattanooga Medical Research, LLC Chattanooga Tennessee
United States University of Cincinnati Cincinnati Ohio
United States Paramount Research Solutions College Park Georgia
United States Centricity Research Dublin Dublin Ohio
United States Cedar Health Research, LLC Euless Texas
United States Penn State Health Women's Health Clinic Hershey Pennsylvania
United States Clinical Trial Network LLC Houston Texas
United States The Women's Hospital of Texas Houston Texas
United States TMC Life Research, Inc. Houston Texas
United States Olympia Clinical Trials Los Angeles California
United States Clinical Trials Management, LLC Metairie Louisiana
United States Infinite Clinical Trials Morrow Georgia
United States Ochsner Health Center - Baptist McFarland Medical Plaza New Orleans Louisiana
United States Tidewater Clinical Research Norfolk Virginia
United States Velocity Clinical Research, Norfolk Norfolk Nebraska
United States Yale Fertility Center Orange Connecticut
United States The Advanced Gynecologic Surgery Institute Park Ridge Illinois
United States Clinical Research of Philadelphia, LLC Philadelphia Pennsylvania
United States Penn Medicine - Penn Fertility Care Philadelphia Pennsylvania
United States Sundance Clinical Research Saint Louis Missouri
United States Wasatch Clinical Research Salt Lake City Utah
United States Northeast Clinical Research of San Antonio San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Physician Care Clinical Research, LLC Sarasota Florida
United States Seattle Women's: Health, Research, Gynecology Seattle Washington
United States Omni Fertility and Laser Institute Shreveport Louisiana
United States Palmetto Clinical Research Summerville South Carolina
United States University of South Florida Tampa Florida
United States MedStar Washington Hospital Center Washington District of Columbia
United States Unified Women's Clinical Research-Lyndhurst Clinical Research Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Organon and Co Iqvia Pty Ltd

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Czechia,  France,  Germany,  Hungary,  Italy,  Latvia,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from first treatment cycle to last planned treatment cycle in the mean OPP (endometriosis-related overall pelvic pain) score. The OPP measures endometriosis-related pain using NRS with range 0 (no pain) to 10 (worst imaginable). First treatment cycle to last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Primary Safety and tolerability of OG-6219 Safety and tolerability of the treatment is assessed by proportion of participants who experienced any AEs/SAEs, abnormalities in clinical laboratory assessments, vital signs, and physical examination, and by proportion of participants who prematurely discontinued study treatment due to AEs/SAEs. First treatment cycle through completion of follow-up, an average of 20 weeks (each cycle is approximately 28 days).
Secondary Change from first treatment cycle to last planned treatment cycle in the mean DYS score First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Secondary Change from first treatment cycle to last planned treatment cycle in the mean Non-menstrual pelvic pain (NMPP) scores. NMPP is a Numeric rating scale (NRS) that measures pain severity on a scale of 0 (no pain) to 10 (worst pain imaginable) where a lower value represents a better outcome. First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Secondary Change from first treatment cycle to last planned treatment cycle in the mean dyspareunia score. Dyspareunia score is measured by the Endometriosis Pain Daily Diary on a numerical rating scale of 0-10 where 0=No Pain and 10=Worst Pain Imaginable. A lower value represents a better outcome. First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Secondary Change from first treatment cycle to remaining treatment cycles in the mean number of tablets of rescue medication for endometriosis-related pain (ERP) and in the proportion of days participant has used rescue medication for ERP. First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Secondary Change in Patient Global Impression of Severity (PGI-S) Score from V4 to Phone Contact 1, V6, and V7. The PGI-S is a 4-point response scale, over a 7-day recall period, measuring the overall severity of pelvic pain as: 0=none, 1=Mild, 2=Moderate, 3=Severe. Visit 4 through V7, an average of 12 weeks (each cycle is approximately 28 days).
Secondary Percentage of participants with any improvement on the Patient Global Impression of Change at second, third and last planned treatment cycle. Visit 4 through V7, an average of 12 weeks (each cycle is approximately 28 days).
Secondary Change from first treatment cycle to last planned treatment cycle in the Endometriosis Health Profile-30 (EHP-30) Domain Scores. The EHP-30 consists of 30 items measured on a scale from 0 = Never to 4 = Always where the lower number represents a better outcome. First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days
Secondary Mean change from Visit 1 to Visit 7 in bone biomarker levels Screening through end of treatment, an average of 24 weeks.
Secondary Proportion of participants with clinical parameters of significance from Visit 1 to Visit 5, Visit 6, Visit 7, and Visit 8. Screening through safety follow-up, an average of 28 weeks.
Secondary Mean change from first treatment cycle to second, third and fourth treatment cycles in the percentage of days with vaginal bleeding First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Secondary ECG parameter changes at each of the four treatment cycle visits First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Secondary Mean change from V1 to V7 in serum hormone levels Screening through end of treatment, an average of 24 weeks
Secondary Serum hormone levels at V5 comparing each treatment group Visit 5
Secondary Serum hormone levels at V7 comparing each treatment group At V7 approximately 24 weeks after patient consents to the study.
Secondary Plasma concentrations of OG-6219 and FOR-1011 at scheduled assessments using sparse PK sampling. Second treatment cycle through completion of last planned treatment cycle, an average of 12 weeks (each cycle is approximately 28 days).
Secondary Cmax, for both OG-6219 and FOR-1011. At 2 visits approximately 3 weeks apart beginning at second treatment cycle.
Secondary Tmax for both OG-6219 and FOR-1011 At 2 visits approximately 3 weeks apart beginning at second treatment cycle
Secondary AucTAU for both OG-6219 and FOR-1011 At 2 visits approximately 3 weeks apart beginning at second treatment cycle
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