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

NCT05560646 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: OG-6219-P001
• Study Type: interventional
• Target: 354
• Locations: 11 countries
• Sites: 86

Brief 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.

Conditions

Endometriosis

Keywords

Endometriosis Related Pain (ERP); Endometriosis; Pre-menopausal women

Outcome Measures

Primary Outcomes (3)

• Change From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3

  Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dysmenorrhea or NMPP, and dyspareunia. Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The mean OPP score was derived by the pain score for the dysmenorrhea and NMPP items, and score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. Baseline cycle OPP score was defined as the average daily OPP during baseline cycle.

  Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).

• Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

  An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered an investigational product and which does not necessarily have a causal relationship with this treatment. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. TEAEs were defined as events that first occur or worsen (increase in severity) after the first dose of study drug, during the treatment period, and up to 14 days (inclusive) after the last dose of study drug administration. Percentages are rounded off to the hundredth decimal place.

  From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days

• Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation

  An AE was defined as any untoward medical occurrence in a clinical study participant administered an investigational product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as events that first occur or worsen (increase in severity) after the first dose of study drug, during the treatment period, and up to 14 days (inclusive) after the last dose of study drug administration. The TEAEs leading to permanent discontinuation of study drug was identified by using the 'Action taken with study treatment' variable equal to 'Drug withdrawal' from the AE page of the electronic case report form. Percentages are rounded off to the hundredth decimal place.

  From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days

Secondary Outcomes (24)

• Change From Baseline Cycle in Mean Dysmenorrhea Score at Treatment Cycle 3

  Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).

• Change From Baseline Cycle in Mean Non-Menstrual Pelvic Pain Score at Treatment Cycle 3

  Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).

• Change From Baseline Cycle in Mean Dyspareunia Score at Treatment Cycle 3

  Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).

• Change From Baseline Cycle in Mean Number of Rescue Medication Tablets Used for Endometriosis-Related Pain at Treatment Cycles 1, 2 and 3

  Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).

• Change From Baseline Cycle in Percentage of Days With Participants Used Rescue Medication for Endometriosis-Related Pain at Treatment Cycles 1, 2 and 3

  Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).

Study Arms (4)

Group A: OG-6219 Dose 1

EXPERIMENTAL

Group A: OG-6219 Dose 1 BID

Drug: OG-6219

Group B: OG-6219 Dose 2

EXPERIMENTAL

Group B: OG-6219 Dose 2 BID

Drug: OG-6219

Group C: OG-6219 Dose 3

EXPERIMENTAL

Group C: OG-6219 Dose 3 BID

Drug: OG-6219

Group D: Placebo

PLACEBO COMPARATOR

Group D: Placebo BID

Drug: Placebo

Interventions

OG-6219 DRUG

OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.

Group A: OG-6219 Dose 1; Group B: OG-6219 Dose 2; Group C: OG-6219 Dose 3

Placebo DRUG

Participants will receive (orally) OG-6219 Placebo tablets BID during treatment cycles.

Group D: Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead
• IQVIA Pty Ltd: collaborator

Study Sites (86)

Central Research Associates LLC dba Flourish Research

Birmingham, Alabama, 35205, United States

Location

UAB Center for Women's Reproductive Health

Birmingham, Alabama, 35233, United States

Location

Olympia Clinical Trials

Los Angeles, California, 90036, United States

Location

Yale Fertility Center

Orange, Connecticut, 06477, United States

Location

Physician Care Clinical Research, LLC

Sarasota, Florida, 34239, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

MediSense Inc

Atlanta, Georgia, 30363, United States

Location

Paramount Research Solutions

College Park, Georgia, 30349, United States

Location

Infinite Clinical Trials

Morrow, Georgia, 30260, United States

Location

The Advanced Gynecologic Surgery Institute

Park Ridge, Illinois, 60068, United States

Location

Ochsner Health Center - Baptist McFarland Medical Plaza

New Orleans, Louisiana, 70115, United States

Location

Omni Fertility and Laser Institute

Shreveport, Louisiana, 71118, United States

Location

John Hopkins University

Baltimore, Maryland, 21205, United States

Location

Bosque Women's Care

Albuquerque, New Mexico, 87109, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-0502, United States

Location

Centricity Research Dublin

Dublin, Ohio, 43016, United States

Location

Penn State Health Women's Health Clinic

Hershey, Pennsylvania, 17033, United States

Location

Clinical Research of Philadelphia, LLC

Philadelphia, Pennsylvania, 19114, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, 29485, United States

Location

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, 37404, United States

Location

Cedar Health Research, LLC

Euless, Texas, 76040, United States

Location

The Women's Hospital of Texas

Houston, Texas, 77024, United States

Location

Clinical Trial Network LLC

Houston, Texas, 77074, United States

Location

Northeast Clinical Research of San Antonio

San Antonio, Texas, 78233, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Tidewater Clinical Research

Norfolk, Virginia, 23502, United States

Location

Seattle Women's: Health, Research, Gynecology

Seattle, Washington, 98105, United States

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

AZ Jan Palfijn Gent

Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Ghent

Ghent, 9000, Belgium

Location

Jessa Ziekenhuis Hospital

Hasselt, 3500, Belgium

Location

CHU de Tivoli

La Louvière, 7100, Belgium

Location

Medical Center Repromed EOOD

Pleven, 5800, Bulgaria

Location

UMHAT "Sv. Georgi", EAD

Plovdiv, 4002, Bulgaria

Location

DCC " Ascendent" EAD

Sofia, 1202, Bulgaria

Location

SHATOD - Sofia District, EOOD

Sofia, 1233, Bulgaria

Location

MHAT for women's health - Nadezhda, OOD

Sofia, 1330, Bulgaria

Location

DCC "Alexandrovska", EOOD

Sofia, 1431, Bulgaria

Location

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

Location

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

Sofia, 1606, Bulgaria

Location

MHAT NiaMed OOD

Stara Zagora, 6000, Bulgaria

Location

Acibadem City Clinic MC Varna EOOD

Varna, 9002, Bulgaria

Location

Fakultni nemocnice Brno

Brno, 602 00, Czechia

Location

Fertimed s.r.o.

Olomouc, 77900, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Femina Sana s.r.o.

Prague, 130 00, Czechia

Location

Ustav pro peci o matku a dite

Prague, 147 10, Czechia

Location

Hopital Saint Joseph Paris

Paris, Paris, 75674, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hopital Tenon

Paris, 75020, France

Location

Hospital of Hautepierre

Strasbourg, 67200, France

Location

Universitaetsklinikum Duesseldorf AoeR

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Charité - Campus Benjamin Franklin

Berlin, 13353, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, D-66421, Germany

Location

Clinexpert Kft.

Budapest, 1033, Hungary

Location

Semmelweis Egyetem

Budapest, 1082, Hungary

Location

Szent Anna Maganrendelo

Debrecen, 4024, Hungary

Location

Somogy Varmegyei Kaposi Mor Oktato Korhaz

Kaposvár, 7400, Hungary

Location

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz

Nyíregyháza, 4400, Hungary

Location

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Seriate, Milano, 20122, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Roma, 168, Italy

Location

Università di Cagliari-Presidio Policlinico Monserrato

Monserrato, 09042, Italy

Location

University of Siena Policlinico

Siena, 53100, Italy

Location

Centro Ricerche Cliniche di Verona s.r.l.

Verona, 37134, Italy

Location

Latvian Maritime Medical Centre

Riga, LV-1005, Latvia

Location

Vitols & Vitols, Ltd.

Riga, LV-1006, Latvia

Location

Dr. Vasaraudze's Private Clinic

Riga, LV-1011, Latvia

Location

Przychodnia Wielospecjalistyczna Sk-Medica Spółka Z O.O.

Wroclaw, Dolnoslask, 54-034, Poland

Location

Specjalistyczna Poradnia Ginekologiczna Janusz Tomaszewski Spółka Komandytowa

Bialystok, 15-224, Poland

Location

Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian

Bialystok, 15-267, Poland

Location

Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian

Katowice, 40-081, Poland

Location

Clinical Medical Research Sp. z o.o.

Katowice, 40-156, Poland

Location

NZOZ Medem

Katowice, 40-301, Poland

Location

Centra Medyczne Medyceusz

Lodz, 91-053, Poland

Location

Specjalistyczny Gabinet Ginekologiczno-Położniczy

Lublin, 20-064, Poland

Location

Centrum Medyczne Chodzki HLK

Lublin, 20-093, Poland

Location

KO-MED Centra Kliniczne Lublin II

Lublin, 20-362, Poland

Location

ETYKA Osrodek Badan Klinicznych

Olsztyn, 10-117, Poland

Location

Etg Siedlce

Siedlce, 08-110, Poland

Location

Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian

Szczecin, 70-225, Poland

Location

MICS Centrum Medyczne Torun

Torun, 87-100, Poland

Location

Specjalistyczna Praktyka Lekar

Warsaw, 00-144, Poland

Location

PRATIA S.A. MTZ Clinical Research Powered by Pratia

Warsaw, 02-172, Poland

Location

WIM Panstwowy Instytut Badawczy Centralny Szpital Kliniczny MON

Warsaw, 04-141, Poland

Location

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Danderyd Sjukhus

Stockholm, 182 88, Sweden

Location

Related Links

• Related Info

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Clinical Lead, Late-Stage Clinical Development
• Organization: Organon LLC, a subsidiary of Organon and Co.

pdrl@organon.com

551-430-6000

Study Officials

• Clinical Lead Late-Stage Clinical Development

  Organon and Co

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 29, 2022
• Study Start: October 25, 2022
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: May 8, 2026
• Results First Posted: May 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (27); DE (3); SE (2); BE (5); FR (4); CZ (5); HU (5); IT (5); BU (10); LA (3); PL (17)