Study of cabergoline compared to dienogest and ethinylestradiol for reducing endometriosis symptoms and lesion size in women with confirmed endometriosis

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What is this study about?

This study focuses on endometriosis, a condition where tissue similar to the uterus lining grows outside the uterus, causing pain and other symptoms. The research aims to test whether cabergoline tablets can help reduce the size of endometriosis growths and relieve pelvic pain compared to standard treatments.

The study will compare two different treatments. One group will receive cabergoline (0.5 mg taken twice per week), while the other group will receive standard treatment with either dienogest or combined birth control pills. The treatment period will last for 6 months.

During the study, doctors will monitor changes in the endometriosis growths using various imaging techniques such as ultrasound and magnetic resonance imaging. They will also track how well the treatment helps with pain and other symptoms. The study will also look at how the medications affect hormone levels in the body and overall quality of life for people with endometriosis.

1 Initial evaluation

A detailed assessment will be performed to confirm your endometriosis diagnosis using imaging methods (ultrasound or magnetic resonance imaging).

Your pain levels will be measured using a special scale called Visual Analogue Scale (VAS).

Basic health measurements will be taken, including height and weight to calculate your Body Mass Index (BMI).

2 Treatment assignment

You will be assigned to receive either:

– Cabergoline tablets (0.5 mg twice per week)

– Standard treatment: Sibilla diario (dienogest/ethinylestradiol) tablets taken daily

3 Treatment period

You will take the assigned medication as prescribed throughout the study period.

Regular check-ups will be scheduled to monitor your progress.

Your pain levels will be regularly assessed using the pain scale.

Blood tests will be performed to check hormone levels.

4 Health monitoring

Your endometriosis lesions will be measured using imaging methods to track changes in size.

You will be asked to complete quality of life questionnaires.

Any side effects will be recorded, particularly focusing on nausea, vomiting, or dizziness.

Additional symptoms such as irregular bleeding will be monitored.

5 Final evaluation

A final assessment of your endometriosis lesions will be performed using imaging methods.

Final pain level measurements will be taken.

A complete evaluation of your symptoms and overall health status will be conducted.

Final blood tests will be performed to assess hormone levels.

Who Can Join the Study?

Must be female aged between 18 and 40 years old and still having menstrual periods (premenopausal)
Must have a confirmed diagnosis of endometriosis through one of these tests:
- Ultrasound scan
- MRI (magnetic resonance imaging)
- Laparoscopy (a minor surgery where a camera is inserted through a small cut)
Must have experienced pelvic pain for at least 1 month with a pain score of 3 or higher on a pain scale
Must not have used the medication cabergoline in the past 3 months
Must have a body mass index (BMI) between 18 and 35 (BMI is a measure of body weight in relation to height)
Must not have any allergies to the study medications
Must be willing to participate in the study and sign a consent form
Must be able to communicate effectively with the study team and understand instructions

Who Cannot Join the Study?

History of hypersensitivity (severe allergic reactions) to cabergoline or similar medications
Pregnant women or those planning pregnancy during the study period
Currently breastfeeding mothers
History of heart valve disease (problems with heart valves)
Severe liver problems or abnormal liver function tests
Uncontrolled high blood pressure (hypertension)
Current use of other medications that might interact with cabergoline
History of fibrotic disorders (excessive tissue scarring) in any organ
Presence of other gynecological conditions that could interfere with the study results
Mental health conditions that could affect ability to follow study procedures
Any medical condition that the study doctor determines could make participation unsafe
Participation in another clinical trial within the past 30 days
Unable to provide informed consent
History of drug or alcohol abuse within the past year

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.09.2025

Trial locations

Investigated drugs:

Cabergoline is a medication that affects hormone levels in the body. In this trial, it’s being tested to see if it can help reduce endometriosis symptoms and shrink endometriotic lesions. It belongs to a group of drugs called dopamine agonists, which are commonly used to treat various hormone-related conditions.

Dienogest is a hormone medication commonly used as a standard treatment for endometriosis. It helps reduce pain and other symptoms associated with endometriosis by suppressing the growth of endometrial tissue.

Combined hormonal contraceptives (also known as birth control pills) are standard medications used to treat endometriosis. They contain a combination of estrogen and progestin hormones that help control the menstrual cycle and reduce endometriosis symptoms.

Investigated diseases:

Endometriosis

Endometriosis – A chronic condition where tissue similar to the lining of the uterus grows outside the uterine cavity. This tissue can be found on the ovaries, fallopian tubes, and the tissue lining the pelvis. During each menstrual cycle, this misplaced tissue responds to hormonal changes, leading to inflammation and the formation of scar tissue. The condition typically develops several years after the onset of menstruation and can cause pain during menstruation, intercourse, and other pelvic activities. The displaced endometrial tissue can also affect fertility and cause irregular bleeding patterns.

Trial ID:

2025-522812-18-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of cabergoline compared to dienogest and ethinylestradiol for reducing endometriosis symptoms and lesion size in women with confirmed endometriosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?