What side effects are associated with this type of intervention?

Common treatments for endometriosis that target pain and inflammation include combined estrogen-progestin contraceptives, progestins like dienogest, GnRH agonists and antagonists, and levonorgestrel IUDs. Estrogen-progestin contraceptives can cause nausea, weight gain, mood changes, and increased risk of blood clots. Progestins like dienogest may lead to weight gain, mood swings, and decreased bone density. GnRH agonists and antagonists often cause menopausal-like symptoms such as hot flashes, decreased libido, and bone loss. Levonorgestrel IUDs can cause irregular bleeding and hormonal side effects similar to those of oral contraceptives.

What prior FDA approvals exist?

The FDA has approved several treatments for endometriosis-related pain and inflammation. These include hormonal therapies such as GnRH agonists (e.g., leuprolide), GnRH antagonists (e.g., elagolix), and progestins (e.g., medroxyprogesterone acetate). Non-hormonal treatments like NSAIDs (e.g., ibuprofen) are also commonly used to manage pain. Additionally, combination oral contraceptives containing estrogen and progestin are frequently prescribed to reduce endometriosis symptoms. These treatments aim to alleviate pain and reduce inflammation, similar to the investigational drug OG-6219 being studied for its efficacy and safety in treating moderate to severe endometriosis-related pain.

What other types of research exist?

Promising novel alternatives to OG-6219 for endometriosis treatment include: 1) OSU-03012, a celecoxib-derivative that impairs endometriosis progression by blocking Y-box-binding protein 1 function. 2) BAY 86-5047, a CCR1 antagonist that has shown potential in reducing endometriosis-associated pelvic pain. 3) Selective inhibition of prostaglandin E2 receptors EP2 and EP4, which suppresses integrin-mediated mechanisms and may offer a nonsteroidal therapy option. 4) COX-2 specific inhibitors like rofecoxib, which have demonstrated effectiveness in managing endometriosis-related pain.

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OG-6219 for Endometriosis (ELENA Trial)

Verified Trial

Phase 2

Waitlist Available

Research Sponsored by Organon and Co

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 4 through v7, an average of 12 weeks (each cycle is approximately 28 days).

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

While specific side effects for OG-6219 aren't listed, common side effects in trials like this may include gastrointestinal issues, headaches, fatigue, potential allergic reactions, and hormonal changes due to the nature of treating endometriosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My endometriosis was confirmed through surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 4 through v7, an average of 12 weeks (each cycle is approximately 28 days).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 4 through v7, an average of 12 weeks (each cycle is approximately 28 days).

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 4 through v7, an average of 12 weeks (each cycle is approximately 28 days). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability of OG-6219

Secondary study objectives

Change from first treatment cycle to last planned treatment cycle in the Endometriosis Health Profile-30 (EHP-30) Domain Scores.

Change from first treatment cycle to last planned treatment cycle in the mean

Change from first treatment cycle to last planned treatment cycle in the mean dyspareunia score.

+1 more

Trial Design

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for endometriosis primarily aim to reduce pain and inflammation. Hormonal therapies, such as GnRH agonists/antagonists, work by suppressing ovarian hormone production, thereby reducing endometrial tissue growth and associated inflammation. Progestins and oral contraceptives help by thinning the endometrial lining and stabilizing hormone levels, which can alleviate pain. Non-hormonal treatments, including anti-inflammatory drugs, target the inflammatory pathways directly to reduce pain and swelling. Understanding these mechanisms is crucial for patients, as it helps them and their doctors choose the most appropriate treatment based on their specific symptoms and treatment goals.

Meta-Study of the Clinical Effect of Conservative Treatment in Uterine Fibroids.State of the art, new treatment strategies, and emerging drugs for non-hormonal treatment of endometriosis: a systematic review of randomized control trials.Endometriosis - insights into a multifaceted entity.