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
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
- Endometriosis
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group A: OG-6219 Dose 1 |
Group A: OG-6219 Dose 1 BID |
|
|
Experimental Group B: OG-6219 Dose 2 |
Group B: OG-6219 Dose 2 BID |
|
|
Experimental Group C: OG-6219 Dose 3 |
Group C: OG-6219 Dose 3 BID |
|
|
Placebo Comparator Group D: Placebo |
Group D: Placebo BID |
|
Recruiting Locations
Birmingham, Alabama 35233
More Details
- Status
- Recruiting
- Sponsor
- Organon and Co
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.