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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

Pivotal Trial

No Placebo-Only Group

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

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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.

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English or Spanish is not my first language.

Select...

My surgery did not show any signs of endometriosis.

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I have not had surgery more invasive than laparoscopic or robotic surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

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