About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Planning to undergo an elective laparoscopic or robotic procedure for known or suspected endometriosis
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate
Drugif randomized to study drug, participants will take one tablet Rel-CT daily following excisional surgery for endometriosis
Treatment groups
Trial outcomes
Primary outcomes
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.
The study will assess quality of life via change in total Endometriosis Health Profile 30 (EHP-30) scores following excisional surgery for endometriosis from baseline to 6 months postoperatively.
Secondary outcomes
Change in EHP-30 scores between groups stratified by endometriosis stage
Comparison of EHP-30 scores according to endometriosis stage of the participant of Rel-CT group to non Rel-Ct treatment group
Comparison of EHP-30 subscales
Comparison of EHP-30 survey subscales in treatment groups.
Comparison of EHP-30 by superficial vs deep infiltrating types
Comparison of EHP-30 scores according to the participant having superficial or deep infiltrating endometriosis post-surgery.
Reintervention rates between groups
Need for surgical reintervention will be assessed between treatment groups.
Sponsors and contacts
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