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OG-6219 for Endometriosis (ELENA Trial)

Verified Trial
Phase 2
Recruiting
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 first treatment cycle through completion of follow-up, an average of 20 weeks (each cycle is approximately 28 days).
Awards & highlights

ELENA Trial Summary

This trial will study the effects of a drug on pre-menopausal women's endometriosis-related 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.Check my eligibility
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).See study design
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.

ELENA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 18-49 and have not gone through menopause.
Select...
My endometriosis was confirmed through surgery.

ELENA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first treatment cycle through completion of follow-up, an average of 20 weeks (each cycle is approximately 28 days).
This trial's timeline: 3 weeks for screening, Varies for treatment, and first treatment cycle through completion of follow-up, an average of 20 weeks (each cycle is approximately 28 days). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Safety and tolerability of OG-6219
Secondary outcome measures
Therapeutic procedure
Therapeutic procedure
Electrocardiogram
+12 more

ELENA Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: OG-6219 Dose 3Experimental Treatment1 Intervention
OG-6219 Dose 3 BID
Group II: OG-6219 Dose 2Experimental Treatment1 Intervention
OG-6219 Dose 2 BID
Group III: OG-6219 Dose 1Experimental Treatment1 Intervention
OG-6219 Dose 1 BID
Group IV: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Iqvia Pty LtdIndustry Sponsor
107 Previous Clinical Trials
169,688 Total Patients Enrolled
Organon and CoLead Sponsor
491 Previous Clinical Trials
1,732,516 Total Patients Enrolled

Media Library

OG-6219 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05560646 — Phase 2
Endometriosis Research Study Groups: Placebo, OG-6219 Dose 1, OG-6219 Dose 2, OG-6219 Dose 3
Endometriosis Clinical Trial 2023: OG-6219 Highlights & Side Effects. Trial Name: NCT05560646 — Phase 2
OG-6219 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05560646 — Phase 2
Endometriosis Patient Testimony for trial: Trial Name: NCT05560646 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this trial extended to geriatric individuals?

"This clinical trial is searching for participants aged 18 to 49."

Answered by AI

How many centers are actively managing this research endeavor?

"Wasatch Clinical Research in Salt Lake City, Northeast Clinical Research of San Antonio in San Antonio, and Paramount Research Solutions in College Park are some of the 13 sites currently signing on participants for this trial."

Answered by AI

Has the FDA accepted OG-6219 Dose 2 for use in clinical practice?

"For OG-6219 Dose 2, our team at Power estimates its safety to be a 2 as there is some evidence of security but no proof that it provides the desired therapeutic effect."

Answered by AI

Are there any current opportunities to participate in this clinical investigation?

"Indeed, the clinical trial is recruiting as per information on clinicaltrials.gov. This medical study was first advertised on October 25th 2022 and updated December 9th 2022; its goal being to enrol 380 patients across 13 sites."

Answered by AI

What are the intake criteria for enrollment in this trial?

"Yes, the details published on clinicaltrials.gov affirm that this trial is currently admitting patients which it first advertised on October 25th 2022 and later updated on December 9th 2022. Altogether, 380 participants will be accepted across 13 medical sites."

Answered by AI

To whom does this investigation offer the chance for participation?

"This medical trial is looking to recruit 380 pre-menopausal females aged 18 - 49 who have been surgically diagnosed with endometrioma and display moderate to severe symptoms. In addition, the candidate must be willing to forgo any other interventional studies while participating in this one, agree not to become pregnant by using two forms of non-hormonal contraception throughout the study, submit a signed informed consent form prior to enrolment, and be compliant with all necessary procedures as outlined by researchers."

Answered by AI

Who else is applying?

What state do they live in?
Texas
New Jersey
Pennsylvania
What site did they apply to?
Other
Clinical Trials Management - Southshore
Clinical Trial Network LLC
Clinical Research of Philadelphia, LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0

Why did patients apply to this trial?

To better understand how to manage my type 2 diabetics. I have tried multiple birth controls and diet changes and my blood pressure prevents me in being in.
PatientReceived 1 prior treatment
Over a 1year. I have fiber 2 working to lose more waste I’m taking 1pill a day was taking insulin stop taking it my sugar was to low.
PatientReceived no prior treatments
I have tried multiple birth controls and diet changes and my blood pressure prevents me in being on anymore. My doctor believes he has tried all avenues.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Clinical Trials Management - Southshore: < 24 hours
Average response time
  • < 2 Days
~106 spots leftby Dec 2024