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

Endometriosis

Tagged with

endometriosis

Interventions

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

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