Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The MySaturn Study
Recruiting now
Conditions studied: Uterine Bleeding, Uterine Leiomyomas, Uterine Hemorrhage, Uterine Neoplasms
In brief
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.
Key facts
- Study ID
- NCT06953076
- Run by
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- People needed
- 111
- Starts
- 2025-05-02
- Expected to finish
- 2027-05-02
- Last updated by the study team
- 2025-08-17
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years.
- Pre-menopausal status.
- Ultrasound diagnosis of benign myometrial lesion.
- Symptomatic patients presenting with abnormal uterine bleeding (menorrhagia/metrorrhagia).
- Availability of ultrasound images in digital format.
You may not qualify if…
- Patient refusal.
- Age < 18 years.
- Postmenopausal women.
- Myometrial lesion ≤ 10 mm.
- Myometrial formation suspected of malignancy on ultrasound (e.g., STUMP - Uterine Leiomyosarcoma).
- Asymptomatic patients with uterine fibromatosis.
- Personal history of malignant or premalignant uterine neoplasia (e.g., STUMPs, leiomyosarcoma, atypical endometrial hyperplasia, endometrial carcinoma, cervical carcinoma).
- Patients with ovarian pathology.
- Patients currently undergoing treatment for another malignancy.
- Patients lacking available digital ultrasound images or whose image quality is insufficient to adequately characterize the target lesion's ultrasound features
Where it is running
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC GINECOLOGIA ONCOLOGICA — Roma, Italy (enrolling)
Full record on ClinicalTrials.gov
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