OG-6219 for Endometriosis

(ELENA Trial)

Recruiting at 108 trial locations

Overseen By Sarah Artman

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Organon and Co

Must not be taking: CYP3A4 inhibitors, inducers

Disqualifiers: Hysterectomy, Chronic pain, HPV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 16 weeks

380 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot use any medication that affects the CYP3A4 enzyme within 30 days or 10 half-lives before starting the trial.

How is the drug OG-6219 different from other treatments for endometriosis?

The drug OG-6219 is unique because it may offer a novel approach to treating endometriosis, potentially involving a different mechanism of action or administration compared to existing treatments like GnRH agonists, which suppress ovarian estrogen production, or surgical options like laparoscopic excision. ^{1 2 3 4 5}

Research Team

Clinical Lead Late-Stage Clinical Development

Principal Investigator

Organon and Co

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three dose levels of OG-6219 or placebo for endometriosis-related pain

16 weeks

Regular visits throughout treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 Safety Follow-up visit

Treatment Details

Interventions

• OG-6219
• Placebo

Trial Overview 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).

Participant Groups

Group I: Group C: OG-6219 Dose 3 Experimental Treatment 1 Intervention

Group C: OG-6219 Dose 3 BID

Group II: Group B: OG-6219 Dose 2 Experimental Treatment 1 Intervention

Group B: OG-6219 Dose 2 BID

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

Group A: OG-6219 Dose 1 BID

Group IV: Group D: Placebo Placebo Group 1 Intervention

Group D: Placebo BID

Who Is Running the Clinical Trial?

Organon and Co

Lead Sponsor

Trials

492

Recruited

1,733,000+

Juan Camilo Arjona Ferreira

Organon and Co

Chief Medical Officer since 2023

MD

Kevin Ali

Organon and Co

Chief Executive Officer since 2021

MBA from Santa Clara University, BA from the University of California, Berkeley

Iqvia Pty Ltd

Industry Sponsor

Trials

120

Recruited

177,000+

Ari Bousbib

Iqvia Pty Ltd

Chief Executive Officer since 2016

MBA from Columbia University, Master of Science in Mathematics and Mechanical Engineering from Ecole Superieure des Travaux Publics, Paris

Jeffrey Spaeder

Iqvia Pty Ltd

Chief Medical Officer

MD

Findings from Research

Depot medroxyprogesterone acetate (DMPA-SC 104) is as effective as leuprolide in reducing endometriosis-associated pain over an 18-month period, with significant improvements in multiple pain categories.

DMPA-SC 104 causes significantly less decline in bone mineral density compared to leuprolide, and BMD levels return to pre-treatment levels 12 months after stopping DMPA-SC 104, indicating a safer profile for bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous depot medroxyprogesterone acetate versus leuprolide acetate in the treatment of endometriosis-associated pain. Crosignani, PG., Luciano, A., Ray, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of endometriosis with a decreasing dosage of a gonadotropin-releasing hormone agonist (nafarelin): a pilot study with low-dose agonist therapy ("draw-back" therapy). [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic excision of endometriosis: a randomized, placebo-controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

"Medical oophorectomy" using a long-acting GNRH agonist--a possible new approach to the treatment of endometriosis. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Inflammatory status influences aromatase and steroid receptor expression in endometriosis. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Subcutaneous depot medroxyprogesterone acetate versus leuprolide acetate in the treatment of endometriosis-associated pain. [2022]