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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Organon and Co
• Collaborator: Iqvia Pty Ltd

Criteria

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

• 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 ≤5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

• 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, with active, recurrent, 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.