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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Apr 29, 2025

Keywords

ClinConnect Summary

The MySaturn Study is a clinical trial designed to investigate how a combination treatment of relugolix, estradiol, and norethisterone affects uterine fibroids, which are non-cancerous tumors that can cause heavy bleeding and pelvic discomfort in women. This study aims to understand if this treatment can change the size and appearance of fibroids as seen on ultrasound, which is the primary tool used for diagnosing and monitoring these growths. The study is particularly relevant for women who are experiencing symptoms related to their fibroids and have been diagnosed with benign myometrial lesions.

To participate in this trial, women must be at least 18 years old, pre-menopausal, and experiencing abnormal uterine bleeding due to fibroids. However, those who have had certain types of cancer or other related health issues, or who do not have clear ultrasound images of their fibroids, will not be eligible. If you qualify and choose to participate, you will receive the treatment and be monitored to see how your fibroids respond. This study is important as it seeks to improve treatment options for women suffering from fibroid-related symptoms, offering hope for better management of their condition.

Gender

FEMALE

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