For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Pre-menopausal females of age 18 to 49 years old (inclusive) at the time of signing Informed Consent (V1).
  2. Surgically (laparoscopy or laparotomy) diagnosed with endometriosis
  3. Moderate to severe endometriosis-related pelvic pain
  4. Regular menstrual cycles
  5. Is not expected to undergo a planned gynecological surgery or other surgical procedures for treatment of endometriosis during study participation.
  6. 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.
  7. Agree not to participate in another interventional study while participating in the present study.
  8. Able and willing to adhere to study procedures, including
  9. agree to use 2 forms of non-hormonal contraception throughout the study
  10. Must be willing and able to provide signed informed consent before any study-related activities
  11. Has demonstrated compliance with ≥75% of eDiary entries
  12. Has a negative pregnancy test

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Surgical history of hysterectomy and/or bilateral oophorectomy
  2. Chronic pelvic and/or non-pelvic pain not caused by endometriosis that requires chronic analgesic or other chronic therapy
  3. Undiagnosed (unexplained), abnormal vaginal bleeding not associated with endometriosis within the past 6 months before screening.
  4. Presence of high-risk human papillomavirus (HPV).
  5. Has an active sexually transmitted infection (STI) (eg, gonorrhea, chlamydia, or trichomonas).
  6. Intends to become pregnant or breast feed during study participation or has a known or suspected pregnancy.
  7. History of malignancy (except for basal cell or squamous cell skin cancer) before signing informed consent.
  8. History of family history of hereditary abnormal hemoglobin or an enzyme deficiency that can result in methemoglobinemia.
  9. Has a medical condition associated with hemolytic anemia
  10. Known human immunodeficiency virus infection, and/or acute or active, recurrent/relapsing, or chronic infection (eg, hepatitis A, B, or C virus)
  11. Has a clinically significant abnormal ECG or QT interval prolongation
  12. 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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 551-430-6000Email iconEmail Study Center

Study Details


Contition

Endometriosis

Age

18+

Phase

PHASE2

Participants Needed

380

Est. Completion Date

Dec 31, 2024

Treatment Type

INTERVENTIONAL


Sponsor

Organon and Co

ClinicalTrials.gov NCT Identifier

NCT05560646

Study Number

OG-6219-P001

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