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

Uterine fibroids are benign tumors originating from the uterine muscle, affecting up to 70% of women by their 50s. Risk factors include African descent, nulliparity, obesity, and diabetes. While many fibroids are asymptomatic, 25-50% of affected women experience symptoms like heavy menstrual bleeding, pelvic pain, and pressure-related issues. Accurate diagnosis and differentiation from rare malignant tumors (e.g., uterine sarcomas) remain challenging, particularly before surgery. Ultrasound is the first-line tool for evaluating fibroids, with specific features (e.g., shape, vascularity) helping distinguish benign from suspicious lesions. The MUSA guidelines standardize ultrasound terminology for myometrial assessments. Current treatment options vary based on symptoms and malignancy risk. Among pharmacologic options, the combination of relugolix, estradiol, and norethisterone has shown efficacy in reducing bleeding and pain in symptomatic fibroids, with a favorable safety profile. However, its impact on fibroid morphology and ultrasound appearance is not yet well understood.

NCT Number	NCT06953076
Lead Sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions	Uterine Bleeding, Uterine Leiomyomas, Uterine Hemorrhage, Uterine Neoplasms
Enrollment	111 participants
Start Date	2025-05-02
Primary Completion	2026-05-02 (estimated)
Study Completion	2027-05-02 (estimated)
Updated on ClinicalTrials.gov	2025-08-17