About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Pre-menopausal status.
Ultrasound diagnosis of benign myometrial lesion.
Symptomatic patients presenting with abnormal uterine bleeding (menorrhagia/metrorrhagia).
Disqualifiers
Patient refusal.
Age < 18 years.
Postmenopausal women.
Myometrial lesion ≤ 10 mm.
Trial population
Patients with ultrasound diagnosis of uterine fibroids, symptomatic for abnormal uterine bleeding, eligible for oral medical therapy with relugolix/estradiol/norethisterone
Trial design
Case-only
Other
Treatments tested in this trial
Relugolix/estradiol/norethisterone acetate
DrugOral therapy administered to patients with symptomatic uterine fibroids presenting with abnormal uterine bleeding
Treatment groups
Trial outcomes
Primary outcomes
To observe modifications in the volume of the myometrial lesion during treatment with relugolix/estradiol/norethisterone
Modifications in the volume of the myometrial lesion
To observe the ultrasound features of myometrial lesions during treatment with relugolix/estradiol/norethisterone
* Uterine volume * Outer contour: regular or irregular; * Echogenicity of the myometrial formation: mixed or homogeneous; * Presence of cystic areas; * Presence of acoustic shadows; * Vascularization of the lesions, expressed on a 1 to 4 ordinal scale; * "Cooked aspect" , if present
Secondary outcomes
Description of the clinical characteristics of the study population during treatment with relugolix/estradiol/norethisterone.
* Effect on abnormal uterine bleeding, measured as the number of sanitary pads used during the cycle in patients who do not develop amenorrhea; * Hemoglobin, serum iron, and ferritin levels * Dyspareunia, assessed using NRS or VAS scales; * Chronic pelvic pain, assessed using NRS or VAS scales; * Compression-related symptoms; * Pollakiuria and dyschezia; * Dyspareunia
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