NCT06953076 Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The MySaturn Study
| NCT ID | NCT06953076 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Uterine Bleeding |
| Study Type | OBSERVATIONAL |
| Enrollment | 111 participants |
| Start Date | 2025-05-02 |
| Primary Completion | 2026-05-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 111 participants in total. It began in 2025-05-02 with a primary completion date of 2026-05-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Daniela Romualdi, MD
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06953076 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Uterine Bleeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06953076 currently recruiting?
Yes, NCT06953076 is actively recruiting participants. Contact the research team at daniela.romualdi@policlinicogemelli.it for enrollment information.
Where is the NCT06953076 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06953076 clinical trial?
NCT06953076 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Daniela Romualdi, MD at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 111 participants.