Comparing quality of life after surgery for endometriosis with and without medication

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

This study is testing if a new combination therapy after surgery for endometriosis can improve the quality of life for women who have had the surgery.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Main Line Health (other)
• Locations: 1 site (Wynnewood, Pennsylvania)
• Trial ID: NCT06439524 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the impact of Relugolix combination therapy (Rel-CT) on the quality of life of women who have undergone excisional surgery for endometriosis. Participants will be randomly assigned to receive either Rel-CT or no hormonal suppression after their surgery. The primary outcome will be measured using the Endometriosis Health Profile 30 (EHP-30) scores, which assess health-related quality of life. The study will involve women over the age of 18 who are scheduled for laparoscopic surgery for endometriosis, with careful screening and exclusion criteria to ensure participant safety.

Who should consider this trial

Good fit: Ideal candidates are women over the age of 18 planning to undergo elective laparoscopic surgery for known or suspected endometriosis.

Not a fit: Patients with contraindications to Rel-CT or those interested in pregnancy within the next 12 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the quality of life for women recovering from endometriosis surgery by demonstrating the benefits of immediate post-operative medication.

How similar studies have performed: Other studies have explored hormonal treatments for endometriosis, but this specific approach of immediate post-operative Rel-CT is novel.

Eligibility criteria

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.

Where this trial is running

Wynnewood, Pennsylvania

• Main Line Health — Wynnewood, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Jordan Klebanoff, MD — Main Line Health
• Study coordinator: Jordan Klebanoff, MD

Conditions: Endometriosis