The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Planning to undergo an elective laparoscopic or robotic procedure for known or suspected endometriosis

Locations
United States
Pennsylvania
Main Line Health
RECRUITING
Wynnewood
Contact Information
Primary
Jordan Klebanoff, MD
Klebanoffj@mlhs.org
610-896-4380
Backup
Sara Burke, MPH
BurkeSa@mlhs.org
484-476-2620
Time Frame
Start Date: 2024-08-15
Estimated Completion Date: 2026-08-15
Participants
Target number of participants: 110
Treatments
Active_comparator: Rel-CT
40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate, one tablet daily for 6 months
No_intervention: no study drug
no study drug
Related Therapeutic Areas
Sponsors
Collaborators: Sumitomo Pharma Switzerland GmbH, Pfizer
Leads: Main Line Health

This content was sourced from clinicaltrials.gov