The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial
Recruiting · NCT06439524 · Interventional (participants receive a specific treatment) · Lead sponsor: Main Line Health
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed across 1 US state.
- Main Line Health - Wynnewood, Pennsylvania, United States