MyomaS Aspect Transformation at Ultrasound During Relugolix Estradiol Noretisterone Treatment: MySaturn Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- To observe modifications in the volume of the myometrial lesion during treatment with relugolix/estradiol/norethisterone
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: Relugolix/estradiol/norethisterone acetate (Drug)
结局指标
主要结局
To observe modifications in the volume of the myometrial lesion during treatment with relugolix/estradiol/norethisterone
时间窗: at baseline, and after 3 months, 6 months, and 12 months from treatment initiation
Modifications in the volume of the myometrial lesion
To observe the ultrasound features of myometrial lesions during treatment with relugolix/estradiol/norethisterone
时间窗: at baseline, and after 3 months, 6 months, and 12 months from treatment initiation
* 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
次要结局
- Description of the clinical characteristics of the study population during treatment with relugolix/estradiol/norethisterone.(at baseline, and after 3 months, 6 months, and 12 months from treatment initiation)
研究者
ROMUALDI DANIELA
Medical Doctor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS