Cabergoline for Endometriosis

Inclusion criteria

• {"criterion_text":"- Aged between 18 and 40 years old, and premenopausal."}
• {"criterion_text":"- Confirmed diagnosis of endometriosis by ultrasound/magnetic resonance imaging/laparoscopy."}
• {"criterion_text":"- Pelvic pain (≥1 month) assessed using a VAS scale ≥3 points."}
• {"criterion_text":"- No treatment with cabergoline in the three months prior to the start of the study."}
• {"criterion_text":"- BMI between 18 and 35 kg/m²."}
• {"criterion_text":"- No allergy to the treatments."}
• {"criterion_text":"- Consent to participate in the study."}
• {"criterion_text":"- Ability to speak and understand the message."}

Exclusion criteria

• {"criterion_text":"- Documented allergy to dopamine agonists or previous serious side effects with cabergoline"}
• {"criterion_text":"- Severe uncontrolled comorbidities (ASA> III)."}
• {"criterion_text":"- Active thromboembolic disease."}
• {"criterion_text":"- Pregnancy or breastfeeding at the start of the study."}
• {"criterion_text":"- History of heart valve disorders, history of fibrotic disorders, or impaired liver function."}
• {"criterion_text":"- Breast Cancer"}
• {"criterion_text":"- Patient unwillingness to participate in the study"}

Primary endpoints

• {"endpoint_text":"- Reduction in the size of endometriotic lesions assessed by transvaginal ultrasound/magnetic resonance imaging (MRI)/laparoscopy.","definition_or_measurement_approach":"Size reduction assessed by transvaginal ultrasound, MRI, or laparoscopy."}
• {"endpoint_text":"- Relief of pelvic pain measured by visual analogue scale (VAS) before and after treatment.","definition_or_measurement_approach":"Pelvic pain measured using visual analogue scale (VAS) pre- and post-treatment."}

Secondary endpoints

• {"endpoint_text":"- Demographic and clinical characteristics: Age, BMI, ethnicity, comorbidities (diabetes, hypertension, immunosuppression, smoking)","definition_or_measurement_approach":"Collection of standard demographic and clinical variables (age, BMI, ethnicity, specified comorbidities)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Classification of lesions using the Eznian system for deep infiltrating endometriosis."}
• {"endpoint_text":"- Changes in serum prolactin and VEGF levels as pre- and post-treatment angiogenic markers.","definition_or_measurement_approach":"Measurement of serum prolactin and VEGF levels before and after treatment."}
• {"endpoint_text":"- Impact on other symptoms associated with endometriosis, such as irregular bleeding and infertility, assessed clinically and through hormonal analysis (FSH, LH, estradiol, AMH).","definition_or_measurement_approach":"Clinical assessment of symptoms and hormonal laboratory analyses (FSH, LH, estradiol, AMH)."}
• {"endpoint_text":"- Safety profile: frequency and type of adverse effects related to cabergoline (nausea, vomiting, dizziness).","definition_or_measurement_approach":"Recording frequency and type of adverse events attributed to cabergoline (e.g., nausea, vomiting, dizziness)."}
• {"endpoint_text":"- Quality of life measured using specific questionnaires such as the Endometriosis Health Profile (EHP-30).","definition_or_measurement_approach":"Quality of life assessed with validated questionnaires, e.g., EHP-30."}

Spain

Earliest CTIS Part Ii Submission Date

25-08-2025

Latest Decision Or Authorization Date

17-09-2025

Processing Time Days

23

Number Of Sites

1

Number Of Participants

120

Primary sponsor

Full Name

Hospital Clinico San Carlos

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain