2025-522812-18-00
Not yet recruiting
Phase III and phase IV (Integrated)
CARESS Study: Cabergoline for the Reduction of Endometriosis Symptoms and Lesion Size
Hospital Clinico San Carlos1 site in 1 country120 target enrollmentStarted: September 17, 2025Last updated:
Overview
- Phase
- Phase III and phase IV (Integrated)
- Status
- Not yet recruiting
- Sponsor
- Hospital Clinico San Carlos
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Reduction in the size of endometriotic lesions assessed by transvaginal ultrasound/magnetic resonance imaging (MRI)/laparoscopy.
Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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).
Investigators
CEIm HCSC
Scientific
Hospital Clinico San Carlos
Study Sites (1)
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