Actively Recruiting
Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The MySaturn Study
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-17
111
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The MySaturn Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63; 18 years
- Pre-menopausal status
- Ultrasound diagnosis of benign myometrial lesion
- Symptomatic patients with abnormal uterine bleeding (menorrhagia or metrorrhagia)
- Availability of ultrasound images in digital format
You will not qualify if you...
- Patient refusal
- Age < 18 years
- Postmenopausal women
- Myometrial lesion 10 mm or smaller
- Myometrial lesion suspected of malignancy on ultrasound (e.g., STUMP, Uterine Leiomyosarcoma)
- Asymptomatic patients with uterine fibromatosis
- Personal history of malignant or premalignant uterine tumors
- Patients with ovarian pathology
- Patients currently receiving treatment for another malignancy
- Lack of available or adequate quality digital ultrasound images
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC GINECOLOGIA ONCOLOGICA
Roma, Italy, 00168
Actively Recruiting
Research Team
D
DANIELA ROMUALDI, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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