The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial

Launched by MAIN LINE HEALTH · May 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a medication called Relugolix combination therapy (Rel-CT) can affect the quality of life for women who have had surgery for endometriosis. The trial will compare two groups of participants: one group will take Rel-CT after their surgery, while the other group will not take this medication. Researchers want to find out if taking Rel-CT after surgery helps improve overall health and well-being, as measured by a survey that asks about pain, emotional health, and social support.

To participate in this study, women must be at least 18 years old and planning to have surgery for endometriosis. However, there are certain conditions that would exclude someone from joining, such as having certain health risks or if they are currently pregnant. Participants will complete the survey before surgery and then again at one month, three months, and six months after to track any changes in their health. This trial is currently recruiting participants, and it aims to provide valuable information about the benefits of starting Rel-CT after surgery for endometriosis.

Gender

FEMALE

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
• • Any form of hormonal suppression of endometriosis within 4 weeks of the index surgical procedure
• • 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.

Trial Officials