The trial is taking place at:
P

Palmetto Clinical Research | Summerville, SC

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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 (ELENA)

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Organon

Status and phase

Enrolling
Phase 2

Conditions

Endometriosis

Treatments

Drug: Placebo
Drug: OG-6219

Study type

Interventional

Funder types

Industry

Identifiers

NCT05560646
OG-6219-P001

Details and patient eligibility

About

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.

Full 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.

Enrollment

380 estimated patients

Sex

Female

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

380 participants in 4 patient groups, including a placebo group

Group A: OG-6219 Dose 1
Experimental group
Description:
Group A: OG-6219 Dose 1 BID
Treatment:
Drug: OG-6219
Group B: OG-6219 Dose 2
Experimental group
Description:
Group B: OG-6219 Dose 2 BID
Treatment:
Drug: OG-6219
Group C: OG-6219 Dose 3
Experimental group
Description:
Group C: OG-6219 Dose 3 BID
Treatment:
Drug: OG-6219
Group D: Placebo
Placebo Comparator group
Description:
Group D: Placebo BID
Treatment:
Drug: Placebo

Trial contacts and locations

87

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Central trial contact

Toll Free Number

Data sourced from clinicaltrials.gov

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