Observing Changes in Uterine Fibroids by Ultrasound During Treatment with Relugolix, Estradiol, and Norethisterone in Premenopausal Women

What this Trial Is About

Uterine fibroids are common benign tumors that develop from the muscle of the uterus and affect many women by their 40s and 50s. Symptoms such as heavy menstrual bleeding, pelvic pain, and pressure can occur in about 25-50% of affected women. Distinguishing benign fibroids from rare malignant tumors before surgery is challenging, and ultrasound guided by MUSA criteria is the main tool for this evaluation. The study focuses on understanding how treatment with relugolix, estradiol, and norethisterone affects fibroid characteristics on ultrasound imaging. The treatment being studied is an oral combination of relugolix, estradiol, and norethisterone, given to premenopausal women with symptomatic uterine fibroids and abnormal uterine bleeding. The study collects data over 12 months, tracking changes in fibroid volume and ultrasound features at the start, and after 3, 6, and 12 months of treatment. It is an observational study combining retrospective and prospective data from 111 women over a 3-year period including 2 years of enrollment and 1 year of follow-up. Participants will have routine clinical evaluations, laboratory tests, and ultrasound imaging to monitor fibroid changes and symptoms. Ultrasound images in digital format are required for analysis. Researchers will observe fibroid volume and ultrasound appearance during treatment, as well as clinical characteristics and any adverse events. Safety will be monitored according to national pharmacovigilance regulations, and the study will provide valuable information about the impact of this treatment on fibroid morphology.

Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The MySaturn Study