Ultrasound changes in fibroids during relugolix‑estradiol‑norethisterone treatment.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

MySaturn is a monocentric ambispective observational project enrolling 111 premenopausal women treated with relugolix‑estradiol‑norethisterone and followed for up to 12 months. The study compares retrospective and prospective digital ultrasound images using MUSA-standard terminology to track changes in lesion size, shape, and vascularity. Symptom scores for bleeding and pain and adverse events are recorded alongside imaging. The goal is to characterize whether medical therapy alters ultrasound features that help distinguish benign fibroids from lesions with suspicious characteristics.

Why it matters

Who can join: the full rules

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

Where it's running

• Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC GINECOLOGIA ONCOLOGICA
  Roma, Italy Recruiting

Study contacts

• Principal investigator: Daniela Romualdi, MD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Daniela Romualdi, Md
• Email: daniela.romualdi@policlinicogemelli.it
• Phone: +393392996830

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.