Actively Recruiting
The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial
Led by Main Line Health · Updated on 2025-06-15
110
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
Main Line Health
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this investigator-initiated single-site clinical trial is to compare the overall quality of life of participants taking Relugolix combination therapy (Rel-CT) following excisional surgery for endometriosis to participants that do not take Rel-CT following the same surgery. Rel-CT is an FDA approved form of medical treatment for endometriosis. It is known to work in treating endometriosis pain. However, investigators do not know whether or not there is a benefit to beginning Rel-CT immediately following surgery. This study will test if patients who take Rel-CT after surgery have better quality of life and less chance the endometriosis comes back, requiring additional surgery. The main question it aims to answer is: \- Does taking Rel-CT following excisional surgery for endometriosis result in higher Endometriosis Health Profile 30 (EHP-30) scores, indicating a positive impact on overall health-related quality of life and well-being? Participants will: * Be randomly assigned to one of two treatment groups. One treatment group will take study drug Rel-CT after having excisional surgery, and the other treatment group will just have the surgery alone. * Be asked to complete questionnaires, called the Endometriosis Health Profile 30 (EHP-30) at 4 timepoints. The first time is before surgery, then at follow-up visits at 1 month, 3 months, and 6 months. The survey has 30 questions that ask about pain, control, powerlessness, emotional well-being, social support, and self-image. Researchers will compare the two treatment groups (Rel-CT and non Rel-CT) to see if there is a change in EHP-30 scores.
CONDITIONS
Official Title
The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Planning to undergo elective laparoscopic or robotic surgery for known or suspected endometriosis
You will not qualify if you...
- Known contraindication to Relugolix combination therapy including high risk of blood clots, pregnancy, known osteoporosis, history of breast cancer or other hormone-sensitive cancers, liver disease, or hypersensitivity to Rel-CT components
- Use of hormonal suppression for endometriosis not discontinued within required timelines before surgery
- Primary language other than English or Spanish
- Interested in pregnancy within 6 months after surgery
- Positive pregnancy test during pre-surgical workup
- No histologic evidence of endometriosis after surgery
- Undergoing more invasive surgery than planned laparoscopic or robotic excisional surgery
AI-Screening
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Trial Site Locations
Total: 1 location
1
Main Line Health
Wynnewood, Pennsylvania, United States, 19096
Actively Recruiting
Research Team
J
Jordan Klebanoff, MD
CONTACT
S
Sara Burke, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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