CARESS Study: Cabergoline for the Reduction of Endometriosis Symptoms and Lesion Size
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Reduction in the size of endometriotic lesions assessed by transvaginal ultrasound/magnetic resonance imaging (MRI)/laparoscopy.
研究概览
简要总结
To evaluate the efficacy of cabergoline (0.5 mg twice weekly) in reducing the size of endometriotic lesions and alleviating pelvic pain in women with confirmed endometriosis, compared with a control group receiving standard treatment (dienogest or combined contraceptives) for endometriosis.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 40 years old, and premenopausal.
- •Confirmed diagnosis of endometriosis by ultrasound/magnetic resonance imaging/laparoscopy.
- •Pelvic pain (≥1 month) assessed using a VAS scale ≥3 points.
- •No treatment with cabergoline in the three months prior to the start of the study.
- •BMI between 18 and 35 kg/m².
- •No allergy to the treatments.
- •Consent to participate in the study.
- •Ability to speak and understand the message.
排除标准
- •Documented allergy to dopamine agonists or previous serious side effects with cabergoline
- •Severe uncontrolled comorbidities (ASA> III).
- •Active thromboembolic disease.
- •Pregnancy or breastfeeding at the start of the study.
- •History of heart valve disorders, history of fibrotic disorders, or impaired liver function.
- •Breast Cancer
- •Patient unwillingness to participate in the study
结局指标
主要结局
Reduction in the size of endometriotic lesions assessed by transvaginal ultrasound/magnetic resonance imaging (MRI)/laparoscopy.
Reduction in the size of endometriotic lesions assessed by transvaginal ultrasound/magnetic resonance imaging (MRI)/laparoscopy.
Relief of pelvic pain measured by visual analogue scale (VAS) before and after treatment.
Relief of pelvic pain measured by visual analogue scale (VAS) before and after treatment.
次要结局
- Demographic and clinical characteristics: Age, BMI, ethnicity, comorbidities (diabetes, hypertension, immunosuppression, smoking)
- Eznian classification (a system designed to describe deep infiltrating endometriosis (DIE) in a detailed and topographical manner, complementing the limitations of other classifications such as ASRM.
- Changes in serum prolactin and VEGF levels as pre- and post-treatment angiogenic markers.
- Impact on other symptoms associated with endometriosis, such as irregular bleeding and infertility, assessed clinically and through hormonal analysis (FSH, LH, estradiol, AMH).
- Safety profile: frequency and type of adverse effects related to cabergoline (nausea, vomiting, dizziness).
- Quality of life measured using specific questionnaires such as the Endometriosis Health Profile (EHP-30).
研究者
CEIm HCSC
Scientific
Hospital Clinico San Carlos