Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 49 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group A: OG-6219 Dose 1
Group A: OG-6219 Dose 1 BID
  • Drug: OG-6219
    OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.
Experimental
Group B: OG-6219 Dose 2
Group B: OG-6219 Dose 2 BID
  • Drug: OG-6219
    OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.
Experimental
Group C: OG-6219 Dose 3
Group C: OG-6219 Dose 3 BID
  • Drug: OG-6219
    OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.
Placebo Comparator
Group D: Placebo
Group D: Placebo BID
  • Drug: Placebo
    Participants will receive (orally) OG-6219 Placebo tablets BID during treatment cycles.

Recruiting Locations

UAB Center for Women's Reproductive Health
Birmingham, Alabama 35233
Contact:
Janeen Arbuckle
(205) 934-8865
jarbuckle@uabmc.edu

More Details

Status
Recruiting
Sponsor
Organon and Co

Study Contact

Toll Free Number
551-430-6000
OG-6219-P001@IQVIA.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.