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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Main Line Health
  Wynnewood, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Jordan Klebanoff, MD — Main Line Health
• Study coordinator: Jordan Klebanoff, MD
• Email: Klebanoffj@mlhs.org
• Phone: 610-896-4380

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing different techniques to treat endometriosis

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• Postoperative Pain Trajectories After Endometriosis Surgery

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• Imaging endometriosis with a special PET tracer in adult women

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  Recruiting Universitaire Ziekenhuizen KU Leuven · Leuven · NCT07876648

• Fiber supplement for digestive symptoms in endometriosis

  A fiber-based supplement is being tested to see if it is safe and helps with gut and vaginal microbiomes and digestive symptoms in women with endometriosis.

  Recruiting LOAM Science · San Francisco, California · NCT07875062

• Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy

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• Atypical Endometriosis: Histology, Immunophenotype and Molecular Features

  Researchers will look at how endometriotic tissue that looks atypical under the microscope relates to clinical features and ultrasound findings to better separate benign from potentially atypical lesions.

  Recruiting Casa di Cura Dott. Pederzoli · Peschiera del Garda, Verona · NCT07816133

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.