An observational study in Uterine Bleeding, Uterine Leiomyomas and Uterine Hemorrhage, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
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 heavy menstrual bleeding, pelvic pain, and pressure-related issues. The severity depends on the number, size, and location of the fibroids.
Though most fibroids are benign, a small risk exists for malignant uterine tumors (e.g., leiomyosarcomas, STUMPs). Diagnosing these malignancies preoperatively remains a challenge due to the lack of reliable imaging markers. Ultrasound is the first-line diagnostic tool, guided by MUSA criteria, but further prospective data are needed to improve risk stratification.
The combination of Relugolix, Estradiol, and Norethisterone (Ryeqo®) is an effective medical treatment for symptomatic fibroids, especially in premenopausal women. It reduces bleeding while minimizing side effects of estrogen deprivation. Over 70% of women in clinical trials have shown significant improvement within 24 weeks. However, its effect on fibroid morphology and ultrasound features remains unclear.
The MySaturn Study aims to assess whether this therapy modifies the ultrasound appearance of myometrial lesions over 12 months. The study also tracks symptom changes and adverse events. It involves 111 premenopausal women in a monocentric ambispective observational design, combining retrospective and prospective data from July 1, 2023. The study spans 3 years (2 years of enrollment + 1 year follow-up) and uses routine clinical, laboratory, and imaging data for analysis.
Adverse events will be monitored and reported in accordance with national pharmacovigilance regulations.
90 studies on the registry are indexed under Uterine Hemorrhage; 13 are open to participants now.
This study's planned enrollment of 111 is close to the median of 122 across 27 observational studies indexed under Uterine Hemorrhage.
Browse Uterine Hemorrhage studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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Patients with ultrasound diagnosis of uterine fibroids, symptomatic for abnormal uterine bleeding, eligible for oral medical therapy with relugolix/estradiol/norethisterone
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with ultrasound diagnosis of uterine fibroids, symptomatic for abnormal uterine bleeding, eligible for oral medical therapy with relugolix/estradiol/norethisterone
Drug: Relugolix/estradiol/norethisterone acetate
Drug pages: Relugolix · Estradiol · Norethindrone Acetate
Oral therapy administered to patients with symptomatic uterine fibroids presenting with abnormal uterine bleeding
Also known as: Ryeqo
To observe modifications in the volume of the myometrial lesion during treatment with relugolix/estradiol/norethisterone
Modifications in the volume of the myometrial lesion
Time frame: at baseline, and after 3 months, 6 months, and 12 months from treatment initiation
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
Time frame: at baseline, and after 3 months, 6 months, and 12 months from treatment initiation
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
Time frame: at baseline, and after 3 months, 6 months, and 12 months from treatment initiation
Plan to share: Undecided
Started May 2025 (actual). Primary completion is estimated for May 2026, 12 months after the start.
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