AuthorisedPhase III and phase IV (Integrated)Interventional

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

The CARESS study is researching a new way to treat endometriosis, a condition where tissue similar to the lining of the womb grows elsewhere in the body. This often causes pain and other problems. Researchers are testing a medicine called cabergoline to see if it can help by making endometriosis growths smaller and lessening pelvic pain. They will measure growth size using scans and also ask about pain levels. This important study is in its Phase III and Phase IV, meaning it’s being thoroughly tested in a larger group of people to confirm its benefits and safety before it could potentially be made widely available. It aims to find better ways to manage endometriosis symptoms and improve quality of life for those affected.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Hospital Clinico San Carlos

Enrolment target

120

Start

17 Sep 2025

Endometriosis

What is this study about?

Endometriosis is a common condition where tissue similar to the lining of the womb grows outside of the womb, such as on the ovaries, fallopian tubes, or bowel. This can cause severe pain, heavy periods, and sometimes difficulty getting pregnant. We understand that living with endometriosis can be very challenging, and researchers are always looking for new and better ways to manage its symptoms.

This study, called CARESS, is investigating a medicine called cabergoline. Cabergoline is already used for other health conditions, and doctors want to see if it could also be helpful for endometriosis. The main goals are to find out if this medicine can make the endometriosis growths (called lesions) smaller and reduce the pelvic pain that many people with endometriosis experience. They will use scans like transvaginal ultrasound or MRI, or sometimes a keyhole surgery called a laparoscopy, to check the size of these growths. They will also ask participants to rate their pain before and after taking the medicine.

Beyond checking growth size and pain, the study will also look at other important things. This includes how cabergoline affects other symptoms like irregular bleeding or problems with fertility, and how it impacts a person's overall quality of life. The study will also carefully monitor any side effects to make sure the treatment is safe. Understanding these different aspects will help doctors decide if cabergoline could be a good treatment option for endometriosis in the future.

Key takeaways

The CARESS study is testing if cabergoline can treat endometriosis.
It aims to reduce endometriosis growths and relieve pelvic pain.
The study is in its final phases (Phase III and IV), common stages for new medicines.
Participation involves taking medication, having scans, and completing questionnaires.
Potential benefits include symptom relief, but side effects are possible and monitored.
You can withdraw from the study at any time.

Who may be eligible?

To be able to take part in this study, participants must be at least 18 years old. This study is specifically looking for male participants.

If you are a male aged 18 or older and have been diagnosed with endometriosis, you might be suitable for this study. The research team will need to check your medical history to make sure you meet all the specific requirements for participation and that the study is safe for you.

Quick self-check

Are you 18 years old or older?
Are you male?
Have you been diagnosed with endometriosis?
Are you happy to take study medication?
Are you able to attend clinic appointments for assessments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in the CARESS study, you will be given the study medication, which includes either Sibilla diario or Dostinex tablets, to take regularly. You will have several visits to the study clinic where various assessments will be carried out. These assessments will involve having scans, such as transvaginal ultrasound or MRI, to measure the size of any endometriosis growths. You might also have blood tests taken to check different levels in your body.

Throughout the study, you will be asked to complete questionnaires, including one called the Endometriosis Health Profile (EHP-30), to help us understand how the treatment is affecting your pain, other symptoms, and overall quality of life. The research team will also monitor you closely for any side effects or changes in your health. The total duration of your participation in the study, including all treatments and follow-up appointments, will be explained fully by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as a reduction in endometriosis lesion size and relief from pelvic pain, which could improve your quality of life. However, like all medicines, cabergoline can have side effects. These could include feeling sick (nausea), being sick (vomiting), or feeling dizzy. These will be carefully monitored by the study team. It's important to remember that taking part is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Spain

Common questions

What is endometriosis?

Endometriosis is a condition where tissue similar to the lining of the womb grows in other parts of the body, often causing pain and other symptoms.

What is the aim of the CARESS study?

The study aims to see if a medicine called cabergoline can shrink endometriosis growths and reduce pelvic pain.

What kind of medicine is being tested?

The study is testing two medicines: Sibilla diario and Dostinex (which contains cabergoline).

Will I need scans if I join?

Yes, you will likely have scans like ultrasound or MRI to measure the size of any endometriosis growths.

Can I leave the study if I change my mind?

Yes, you have the right to leave the study at any time without needing to give a reason.