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Relugolix Combination Therapy for Endometriosis

Phase 3
Recruiting
Led By Jordan Klebanoff, MD
Research Sponsored by Main Line Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women over the age of 18 planning to undergo an elective laparoscopic/ robotic procedure for known or suspected endometriosis.
Be older than 18 years old
Must not have
Patients with known contraindications to Rel-CT
Primary language other than English/Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This trial aims to see if taking Relugolix combination therapy (Rel-CT) after surgery for endometriosis improves the quality of life compared to not taking Rel-CT after the same

Who is the study for?
This trial is for individuals who have undergone excisional surgery for endometriosis. It's designed to determine if taking Relugolix combination therapy (Rel-CT) post-surgery improves their quality of life compared to just having the surgery alone.
What is being tested?
The study compares two groups: one receiving Relugolix combination therapy after endometriosis surgery, and another undergoing only the surgery. The main focus is on whether Rel-CT leads to better health-related quality of life as measured by EHP-30 scores over time.
What are the potential side effects?
While specific side effects are not listed here, typical reactions to hormone treatments like relugolix may include hot flashes, headache, fatigue, and potential mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman over 18 planning surgery for endometriosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot take Rel-CT due to health reasons.
Select...
English or Spanish is not my first language.
Select...
My surgery did not show any signs of endometriosis.
Select...
I have not had surgery more invasive than laparoscopic or robotic surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
Change in EHP-30 scores between groups stratified by endometriosis stage
Comparison of EHP-30 by superficial vs deep infiltrating types
Comparison of EHP-30 subscales
+3 more

Trial Design

2Treatment groups
Active Control
Group I: Rel-CTActive Control1 Intervention
40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate, one tablet daily for 6 months
Group II: no study drugActive Control1 Intervention
no study drug

Find a Location

Who is running the clinical trial?

Main Line HealthLead Sponsor
21 Previous Clinical Trials
6,779 Total Patients Enrolled
PfizerIndustry Sponsor
4,625 Previous Clinical Trials
14,304,688 Total Patients Enrolled
4 Trials studying Endometriosis
472 Patients Enrolled for Endometriosis
Sumitomo Pharma America, Inc.Industry Sponsor
242 Previous Clinical Trials
53,026 Total Patients Enrolled
~73 spots leftby Feb 2026
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