The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial
- Conditions
- Endometriosis
- Registration Number
- NCT06439524
- Lead Sponsor
- Main Line Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 110
Inclusion criteria<br><br> - Age = 18 years<br><br> - Planning to undergo an elective laparoscopic or robotic procedure for known or<br> suspected endometriosis<br><br>Exclusion criteria<br><br> - A known contraindication to REL-CT. Contraindications include:<br><br> - High risk of arterial, venous thrombotic, or thromboembolic disorder<br><br> - Pregnancy Known osteoporosis<br><br> - Current or history of breast cancer or other hormone-sensitive malignancies<br><br> - Known hepatic impairment or disease<br><br> - Undiagnosed abnormal uterine bleeding<br><br> - Known hypersensitivity to components of Rel-CT<br><br> - Any form of hormonal suppression of endometriosis within 4 weeks of the index<br> surgical procedure<br><br> - Primary language other than English/Spanish<br><br> - Interested in pregnancy within the 6 months following the surgical procedure. If<br> pregnancy test performed during pre-surgical work up is positive, the patient will<br> no longer be a candidate for endometriosis surgery and will therefore not be<br> eligible for the study.<br><br>Patients without histologic evidence of endometriosis following their surgical procedure<br>will be removed from the study prior to receiving the study intervention.<br><br>Patients who undergo a surgical intervention more invasive than the planned laparoscopic<br>or robotic excisional surgery, such as open abdominal surgical repair, will be removed<br>from the study prior to receiving the study intervention.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in EHP-30 scores between groups stratified by endometriosis stage;Comparison of EHP-30 subscales;Comparison of EHP-30 by superficial vs deep infiltrating types;Reintervention rates between groups;Compliance rates for the study drug and office visits following surgery;Rates of concomitant adenomyosis