The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial
NCT06439524
· ctgov
recruiting
phase phase-3
- Enrollment
- 110
- Start
- 2024-08-15
- Completion
- 2028-12-01
- Last updated
- 2026-06-12
- Has results
- False
- Countries
- United States
Conditions
Tagged with
Interventions
-
40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate
DRUG
if randomized to study drug, participants will take one tablet Rel-CT daily following excisional surgery for endometriosis
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.
License: public-domain-us
· commercial use OK
· attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine