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

ConditionEndometriosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMain Line Health

About this trial

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 criteria

Qualifiers

Age ≥ 18 years

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Main Line Health

Lead sponsor

Pfizer

Collaborator

Sumitomo Pharma Switzerland GmbH

Collaborator