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OG-6219 for Endometriosis (ELENA Trial)
ELENA Trial Summary
This trial will study the effects of a drug on pre-menopausal women's endometriosis-related pain.
ELENA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowELENA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ELENA Trial Design
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Who is running the clinical trial?
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- I have long-term pelvic or body pain not due to endometriosis, needing regular pain treatment.My endometriosis was confirmed through surgery.I have had unexplained vaginal bleeding in the last 6 months.My family has a history of blood conditions that could lead to methemoglobinemia.I have a condition that causes my red blood cells to break down.I am a woman aged 18-49 and have not gone through menopause.
- Group 1: Placebo
- Group 2: OG-6219 Dose 1
- Group 3: OG-6219 Dose 2
- Group 4: OG-6219 Dose 3
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is eligibility for this trial extended to geriatric individuals?
"This clinical trial is searching for participants aged 18 to 49."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Clinical Trials Management - Southshore: < 24 hours
Average response time
- < 2 Days
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