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

June 10, 2026 updated by: Main Line Health

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The design of this study will be an unblinded randomized controlled trial of medical suppression with once daily Relugolix combination therapy (Rel-CT) following excisional surgery for endometriosis performed by high volume minimally invasive gynecologic surgeons. Women over the age of 18 scheduled to undergo a laparoscopic surgery for endometriosis will be screened and if agree and consented to participate will be randomized to either Rel-CT following surgery or no post-operative hormonal suppression using a block randomization with blocks 2 and 4. The surgeon will not have access to the randomization schedule to reduce selection bias. Inclusion criteria will include: 1) Patients over the age of 18 planning to undergo an elective laparoscopic/robotic procedure for known or suspected endometriosis. Exclusion criteria will include: 1) Patients with known contraindications to REL-CT; 2) Any form of hormonal suppression of endometriosis within the protocol guidelines; 3) Primary language other than English/Spanish; 4) Patients without histologic evidence of endometriosis following their surgical procedure; 5) Patients interested in pregnancy within the 12 months following their surgical procedure.

The primary outcome will be change in Endometriosis Health Profile 30 (EHP-30) score. A preoperative EHP-30 will be completed by all patients enrolled in the study within 4 weeks of their scheduled surgical procedure and then again postoperatively at 1 month, 3 months, and 6 months. Investigators expect that postoperative use of REL-CT will lead to a clinically meaningful improvement in EHP-30 scores compared to surgery alone. In addition, investigators will gather data on our secondary outcomes: These data could be very helpful in informing providers and patients of the utility of medical suppression of endometriosis using REL-CT following surgery.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Main Line Health
        • Contact:
          • Jordan Klebanoff, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • Age ≥ 18 years
  • Planning to undergo an elective laparoscopic or robotic procedure for known or suspected endometriosis

Exclusion criteria

-A known contraindication to REL-CT. Contraindications include:

  • High risk of arterial, venous thrombotic, or thromboembolic disorder
  • Pregnancy Known osteoporosis
  • Current or history of breast cancer or other hormone-sensitive malignancies
  • Known hepatic impairment or disease
  • Undiagnosed abnormal uterine bleeding
  • Known hypersensitivity to components of Rel-CT
  • The patient did not discontinue hormonal suppression within the required timeline:

Trans-Dermal, Oral Medication, Patch, or Vaginal Ring: day before surgery

Intrauterine Device or Sub-Dermal Implant: removed at surgery

Injectable Medication: at least 12 weeks before surgery

  • Primary language other than English/Spanish
  • Interested in pregnancy within the 6 months following the surgical procedure.
  • If pregnancy test performed during pre-surgical work up is positive, the patient will no longer be a candidate for endometriosis surgery and will therefore not be eligible for the study.
  • Patients without histologic evidence of endometriosis following their surgical procedure will be removed from the study prior to receiving the study intervention.
  • Patients who undergo a surgical intervention more invasive than the planned laparoscopic or robotic excisional surgery, such as open abdominal surgical repair, will be removed from the study prior to receiving the study intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rel-CT
40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate, one tablet daily for 6 months
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
Other Names:
  • Myfembree
  • Relugolix Combination Therapy (Rel-CT)
No Intervention: no study drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
This study aims to determine if immediate postoperative medical suppression with Regugolix combination therapy (Rel-CT) following excisional surgery for endometriosis is superior to surgery alone.
Time Frame: 6 months
The study will assess quality of life via change in total Endometriosis Health Profile 30 (EHP-30) scores following excisional surgery for endometriosis from baseline to 6 months postoperatively.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in EHP-30 scores between groups stratified by endometriosis stage
Time Frame: 6 months
Comparison of EHP-30 scores according to endometriosis stage of the participant of Rel-CT group to non Rel-Ct treatment group
6 months
Comparison of EHP-30 subscales
Time Frame: 6 months
Comparison of EHP-30 survey subscales in treatment groups.
6 months
Reintervention rates between groups
Time Frame: 6 months
Need for surgical reintervention will be assessed between treatment groups.
6 months
Compliance rates for the study drug and office visits following surgery
Time Frame: 6 months
Study drug adherence will be monitored and reported.
6 months
Rates of concomitant adenomyosis
Time Frame: 6 months
Rate of concomitant adenomyosis will be collected and compared between two treatment groups.
6 months
Comparison of EHP-30 by superficial vs deep infiltrating types
Time Frame: 6 months
Comparison of EHP-30 scores according to the participant having superficial or deep infiltrating endometriosis post-surgery.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Main Line Health

Collaborators

Pfizer
Sumitomo Pharma Switzerland GmbH

Investigators

  • Principal Investigator: Jordan Klebanoff, MD, Main Line Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2024

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1111 (Other Grant/Funding Number: Prima Psychiatry internal research fund)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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