CARESS Study: Cabergoline for the Reduction of Endometriosis Symptoms and Lesion Size

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital Clinico San Carlos

Participant type

Patients

Age range

18-64 years

Gender

Male

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Decision date (initial)

2025-09-17

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Secondary objectives 4

1. Analyse the impact on serum prolactin levels and angiogenic markers such as VEGF, determining their relationship with the progression of endometriotic lesions.
2. Compare the efficacy of conventional hormonal treatments in terms of reducing lesion size and improving clinical symptoms.
3. Determine whether the treatment improves other symptoms associated with endometriosis, such as irregular bleeding and infertility, by analysing specific clinical parameters.
4. Establish evidence-based recommendations for incorporating cabergoline as a non-hormonal therapeutic option in clinical guidelines for the comprehensive management of endometriosis.

Conditions and MedDRA coding

Endometriosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

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

Exclusion criteria 7

1. Documented allergy to dopamine agonists or previous serious side effects with cabergoline
2. Severe uncontrolled comorbidities (ASA> III).
3. Active thromboembolic disease.
4. Pregnancy or breastfeeding at the start of the study.
5. History of heart valve disorders, history of fibrotic disorders, or impaired liver function.
6. Breast Cancer
7. Patient unwillingness to participate in the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Reduction in the size of endometriotic lesions assessed by transvaginal ultrasound/magnetic resonance imaging (MRI)/laparoscopy.
2. Relief of pelvic pain measured by visual analogue scale (VAS) before and after treatment.

Secondary endpoints 6

1. Demographic and clinical characteristics: Age, BMI, ethnicity, comorbidities (diabetes, hypertension, immunosuppression, smoking)
2. 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.
3. Changes in serum prolactin and VEGF levels as pre- and post-treatment angiogenic markers.
4. Impact on other symptoms associated with endometriosis, such as irregular bleeding and infertility, assessed clinically and through hormonal analysis (FSH, LH, estradiol, AMH).
5. Safety profile: frequency and type of adverse effects related to cabergoline (nausea, vomiting, dizziness).
6. Quality of life measured using specific questionnaires such as the Endometriosis Health Profile (EHP-30).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Clinico San Carlos

Sponsor organisation

Hospital Clinico San Carlos

Address

Calle Del Profesor Martin Lagos Sn

City

Madrid

Postcode

28040

Country

Spain

Scientific contact point

Organisation

Hospital Clinico San Carlos

Contact name

CEIm HCSC

Public contact point

Organisation

Hospital Clinico San Carlos

Contact name

CEIm HCSC

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications