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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Drug

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

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Rel-CTActive comparator 1 intervention
Group B: no study drugNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

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.

Time frame
6 months

Secondary outcomes

1

Change in EHP-30 scores between groups stratified by endometriosis stage

Comparison of EHP-30 scores according to endometriosis stage of the participant of Rel-CT group to non Rel-Ct treatment group

Time frame
6 months
2

Comparison of EHP-30 subscales

Comparison of EHP-30 survey subscales in treatment groups.

Time frame
6 months
3

Comparison of EHP-30 by superficial vs deep infiltrating types

Comparison of EHP-30 scores according to the participant having superficial or deep infiltrating endometriosis post-surgery.

Time frame
6 months
4

Reintervention rates between groups

Need for surgical reintervention will be assessed between treatment groups.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Main Line Health

Lead sponsor

Pfizer

Collaborator

Sumitomo Pharma Switzerland GmbH

Collaborator