Status:
RECRUITING
Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The MySaturn Study
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Uterine Bleeding
Uterine Leiomyomas
Eligibility:
FEMALE
18+ years
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 ...
Detailed Description
Uterine fibroids are the most common benign tumors in women of reproductive age, affecting up to 70% of women in their 40s and 50s. While often asymptomatic, around 25-50% experience symptoms such as ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Pre-menopausal status.
- Ultrasound diagnosis of benign myometrial lesion.
- Symptomatic patients presenting with abnormal uterine bleeding (menorrhagia/metrorrhagia).
- Availability of ultrasound images in digital format.
Exclusion
- Patient refusal.
- Age \< 18 years.
- Postmenopausal women.
- Myometrial lesion ≤ 10 mm.
- Myometrial formation suspected of malignancy on ultrasound (e.g., STUMP - Uterine Leiomyosarcoma).
- Asymptomatic patients with uterine fibromatosis.
- Personal history of malignant or premalignant uterine neoplasia (e.g., STUMPs, leiomyosarcoma, atypical endometrial hyperplasia, endometrial carcinoma, cervical carcinoma).
- Patients with ovarian pathology.
- Patients currently undergoing treatment for another malignancy.
- Patients lacking available digital ultrasound images or whose image quality is insufficient to adequately characterize the target lesion's ultrasound features
Key Trial Info
Start Date :
May 2 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 2 2027
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT06953076
Start Date
May 2 2025
End Date
May 2 2027
Last Update
August 17 2025
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC GINECOLOGIA ONCOLOGICA
Roma, Italy, 00168