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

Recruitingn/aAges 18 Years - anyFemaleFondazione Policlinico Universitario Agostino Gem…
NCT06953076 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 e

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥ 18 years. 2. Pre-menopausal status. 3. Ultrasound diagnosis of benign myometrial lesion. 4. Symptomatic patients presenting with abnormal uterine bleeding (menorrhagia/metrorrhagia). 5. Availability of ultrasound images in digital format. Exclusion Criteria: 1. Patient refusal. 2. Age \< 18 years. 3. Postmenopausal women. 4. Myometrial lesion ≤ 10 mm. 5. Myometrial formation suspected of malignancy on ultrasound (e.g., STUMP - Uterine Leiomyosarcoma). 6. Asymptomatic patients with uterine fibromatosis. 7. Personal history of malignant or premalignant uterine neoplasia (e.g., STUMPs, leiomyosarcoma, atypical endometrial hyperplasia, endometrial carcinoma, cervical carcinoma). 8. Patients with ovarian pathology. 9. Patients currently undergoing treatment for another malignancy. 10. Patients lacking available digital ultrasound images or whose image quality is insufficient to adequately characterize the target lesion's ultrasound features
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What it tests

  • Relugolix/estradiol/norethisterone acetate
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Where

1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC GINECOLOGIA ONCOLOGICA
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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