OG-6219 for Endometriosis
(ELENA Trial)

Recruiting in Palo Alto (17 mi)

+108 other locations

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Organon and Co

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new medication called OG-6219 to see if it can help pre-menopausal women aged 18 to 49 who suffer from moderate to severe endometriosis-related pain. The medication likely works by reducing inflammation or altering hormones to relieve pain.

Eligibility Criteria

This trial is for pre-menopausal women aged 18 to 49 with surgically diagnosed endometriosis and moderate to severe pain related to it. Participants must be able to follow study procedures and use two non-hormonal contraception methods. Those with a history of certain blood disorders or chronic pain not caused by endometriosis are excluded.

Inclusion Criteria

My endometriosis was confirmed through surgery.

I am a woman aged 18-49 and have not gone through menopause.

Able and willing to adhere to study procedures, including agree to use 2 forms of non-hormonal contraception throughout the study

Exclusion Criteria

I have long-term pelvic or body pain not due to endometriosis, needing regular pain treatment.

I have had unexplained vaginal bleeding in the last 6 months.

My family has a history of blood conditions that could lead to methemoglobinemia.

+1 more

Participant Groups

The trial is testing the effectiveness, safety, and tolerability of three different doses of OG-6219 compared with a placebo in managing endometriosis-related pain. This global Phase 2 study involves pre-menopausal women who will receive either the drug or placebo twice daily (BID).

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Group C: OG-6219 Dose 3Experimental Treatment1 Intervention

Group C: OG-6219 Dose 3 BID

Group II: Group B: OG-6219 Dose 2Experimental Treatment1 Intervention

Group B: OG-6219 Dose 2 BID

Group III: Group A: OG-6219 Dose 1Experimental Treatment1 Intervention

Group A: OG-6219 Dose 1 BID

Group IV: Group D: PlaceboPlacebo Group1 Intervention

Group D: Placebo BID