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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT06953076
Status
Recruiting
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Conditions

  • Uterine Bleeding
  • Uterine Hemorrhage
  • Uterine Leiomyomas
  • Uterine Neoplasms

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 2, 2025
Status verified
Aug 2025
Primary completion
May 2, 2026
Completion
May 2, 2027

Study Design

Enrollment
111 participants (estimated)

Arms

  • Arm: Uterine fibroids symptomatic for abnormal uterine bleeding
    Patients with ultrasound diagnosis of uterine fibroids, symptomatic for abnormal uterine bleeding, eligible for oral medical therapy with relugolix/estradiol/norethisterone

Primary Outcome Measure

To observe modifications in the volume of the myometrial lesion during treatment with relugolix/estradiol/norethisterone [ Time Frame: at baseline, and after 3 months, 6 months, and 12 months from treatment initiation ]

Central Contacts

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