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

NCT06439524 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-06-15

No results posted yet for this study

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.

Conditions

  • Endometriosis

Interventions

DRUG

40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate

if randomized to study drug, participants will take one tablet Rel-CT daily following excisional surgery for endometriosis

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Sumitomo Pharma Switzerland GmbH

    collaborator INDUSTRY

  • Main Line Health

    lead OTHER

Principal Investigators

  • Jordan Klebanoff, MD · Main Line Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2026-02-15
Completion
2026-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06439524 on ClinicalTrials.gov