Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT06439524

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Planning to undergo elective laparoscopic or robotic surgery for known or suspected endometriosis
Not Eligible

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

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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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