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

NCT06953076RecruitingOBSERVATIONAL

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 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 Facts

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

111

Start Date

2025-05-02

Completion Date

2026-05-02

Study Type

OBSERVATIONAL

Official Title

MyomaS Aspect Transformation at Ultrasound During Relugolix Estradiol Noretisterone Treatment: MySaturn Study

Interventions

Relugolix/estradiol/norethisterone acetate

Conditions

Uterine BleedingUterine LeiomyomasUterine HemorrhageUterine Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

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

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

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

Time frame: at baseline, and after 3 months, 6 months, and 12 months from treatment initiation

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC GINECOLOGIA ONCOLOGICA, Roma, Italy

Linked Diseases

Uterine Neoplasms

Uterine Neoplasms — a type of gynecological cancer.

Linked Papers

2024-07-30

A clinical ultrasound algorithm to identify uterine sarcoma and smooth muscle tumors of uncertain malignant potential in patients with myometrial lesions: the MYometrial Lesion UltrasouNd And mRi study

Differential diagnosis between benign uterine smooth muscle tumors and malignant counterpart is challenging. To evaluate the accuracy of a clinical and ultrasound based algorithm in predicting mesenchymal uterine malignancies, including smooth muscle tumors of uncertain malignant potential. We report the 12-month follow-up of an observational, prospective, single-center study that included women with at least 1 myometrial lesion ≥3 cm on ultrasound examination. These patients were classified according to a 3-class diagnostic algorithm, using symptoms and ultrasound features. "White" patients underwent annual telephone follow-up for 2 years, "Green" patients underwent a clinical and ultrasound follow-up at 6, 12, and 24 months and "Orange" patients underwent surgery. We further developed a risk class system to stratify the malignancy risk. Two thousand two hundred sixty-eight women were included and target lesion was classified as benign in 2158 (95.1%), as other malignancies in 58 (2.6%) an as mesenchymal uterine malignancies in 52 (2.3%) patients. At multivariable analysis, age (odds ratio 1.05 [95% confidence interval 1.03-1.07]), tumor diameter >8 cm (odds ratio 5.92 [95% confidence interval 2.87-12.24]), irregular margins (odds ratio 2.34 [95% confidence interval 1.09-4.98]), color score=4 (odds ratio 2.73 [95% confidence interval 1.28-5.82]), were identified as independent risk factors for malignancies, whereas acoustic shadow resulted in an independent protective factor (odds ratio 0.39 [95% confidence interval 0.19-0.82[). The model, which included age as a continuous variable and lesion diameter as a dichotomized variable (cut-off 81 mm), provided the best area under the curve (0.87 [95% confidence interval 0.82-0.91]). A risk class system was developed, and patients were classified as low-risk (predictive model value <0.39%: 0/606 malignancies, risk 0%), intermediate risk (predictive model value 0.40%-2.2%: 9/1093 malignancies, risk 0.8%), high risk (predictive model value ≥2.3%: 43/566 malignancies, risk 7.6%). The preoperative 3-class diagnostic algorithm and risk class system can stratify women according to risk of malignancy. Our findings, if confirmed in a multicenter study, will permit differentiation between benign and mesenchymal uterine malignancies allowing a personalized clinical approach.