RecruitingNCT06953076

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

MyomaS Aspect Transformation at Ultrasound During Relugolix Estradiol Noretisterone Treatment: MySaturn Study


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

111 participants

Start Date

May 2, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses ultrasound imaging to track how uterine fibroids (non-cancerous muscle growths in the uterus) change in size and appearance during treatment with a hormone-based drug called relugolix combined with estradiol and norethisterone. Researchers want to understand how the drug transforms fibroid tissue over time. **You may be eligible if...** - You are 18 or older and have not yet gone through menopause - You have been diagnosed with uterine fibroids confirmed by ultrasound - You are experiencing heavy or irregular menstrual bleeding caused by the fibroids - Ultrasound images in digital format are available for review **You may NOT be eligible if...** - You are postmenopausal - Your fibroids are very small (10 mm or less) - There is any suspicion that the growth may be cancerous - You have no symptoms from the fibroids - You have a history of uterine, cervical, or endometrial cancer - You have ovarian cysts or other ovarian conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRelugolix/estradiol/norethisterone acetate

Oral therapy administered to patients with symptomatic uterine fibroids presenting with abnormal uterine bleeding


Locations(1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC GINECOLOGIA ONCOLOGICA

Roma, Italy

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NCT06953076


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