Ultrasound changes in fibroids during relugolix‑estradiol‑norethisterone treatment.
MyomaS Aspect Transformation at Ultrasound During Relugolix Estradiol Noretisterone Treatment: MySaturn Study
This project will see if relugolix‑estradiol‑norethisterone changes the ultrasound appearance of fibroids in premenopausal women with heavy menstrual bleeding.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 111 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06953076 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women aged 18 or older with symptomatic fibroids causing abnormal uterine bleeding, a myometrial lesion >10 mm on ultrasound, and available digital ultrasound images.
Not a fit: Patients unlikely to benefit include postmenopausal women, asymptomatic individuals, those with lesions ≤10 mm or ultrasound features suggesting malignancy, and people without usable digital ultrasound images.
Why it matters
Potential benefit: If successful, this could help clinicians use ultrasound changes to monitor response to relugolix combination therapy and improve noninvasive risk stratification of uterine lesions.
How similar studies have performed: Previous clinical trials have shown relugolix‑estradiol‑norethisterone reduces bleeding and pain in fibroid patients, but its specific effects on ultrasound morphology have not been well characterized prospectively.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Roma
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.