Recruiting
Phase 3

Medical Management

Sponsor:

Main Line Health

Code:

NCT06439524

Conditions

Endometriosis

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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

Study ID

NCT06439524

Start date

Aug 15, 2024

Status verified date

Jun, 2025

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jordan Klebanoff, MD

610-896-4380Klebanoffj@mlhs.org

Sara Burke, MPH

484-476-2620BurkeSa@mlhs.org

Locations

Main Line Health

Recruiting

Wynnewood, Pennsylvania, United States, 19096

More Information

Sponsor

Main Line Health

Last update posted

Jun 12, 2026

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Main Line Health on 2026-06-12.