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Study on Cabergoline for Treating Non-Functioning Pituitary Adenomas in Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as non-functioning pituitary adenomas (NFPAs). These are tumors located in the pituitary gland, which do not produce excess hormones. The study is investigating the effects of a medication called cabergoline, which is a type of drug known as a dopamine agonist. Cabergoline is taken in the form of a tablet and is being tested to see if it can help reduce the size of these tumors.

The purpose of the study is to evaluate how effective cabergoline is in treating non-functioning pituitary adenomas. Participants in the study will be randomly assigned to receive either cabergoline or a placebo. The study will last for two years, during which time the size of the tumor will be monitored using MRI scans. The researchers will be looking for changes in the tumor's size, including any shrinkage or growth, and will also assess whether there is a need for additional treatments like surgery or radiation.

Throughout the study, the researchers will also monitor for any changes in pituitary function, which is the gland's ability to produce hormones, as well as any changes in vision or other nerve functions. The study aims to provide valuable information on whether cabergoline can be an effective treatment option for people with non-functioning pituitary adenomas.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed for individuals with a non-functioning pituitary adenoma. This includes those with a previously untreated macroadenoma or a residual adenoma after surgery.

  2. Step 2

    Medication administration

    The medication used in this study is cabergoline, administered in the form of Dostinex 0.5 mg tablets. The tablets are taken orally. The specific dosage and frequency will be determined by the study protocol and communicated to the participant.

  3. Step 3

    Treatment duration

    The main study period lasts for two years. During this time, the effect of cabergoline on the adenoma will be evaluated.

  4. Step 4

    Monitoring and evaluation

    Throughout the study, regular monitoring will occur to assess changes in the tumor volume. This includes measuring the percentage and absolute change in size, as well as identifying any significant shrinkage or growth.

    Additional evaluations will determine the need for surgical or radiation treatment, changes in pituitary function, and any new or altered visual field defects.

  5. Step 5

    Hormonal response assessment

    The study will also assess the response of certain hormones, such as gonadotropins (FSH, LH) and their subunits. The relationship between tumor size and hormone levels will be analyzed.

  6. Step 6

    Completion of study

    The study is estimated to conclude by December 13, 2024. At the end of the study, final assessments will be conducted to evaluate the overall impact of the treatment.

Who can join the trial?

8 criteria

  • The patient must have a **non-functioning pituitary adenoma**. This is a type of tumor in the pituitary gland that does not produce hormones.
  • The patient must have a **macroadenoma**, which means the tumor is large, with the largest part being **10 mm or more** in size.
  • The tumor must show growth on repeated **MRI scans**. An MRI is a type of scan that uses magnets and radio waves to create pictures of the inside of the body.
  • If the tumor is close to the **chiasma opticum** (a part of the brain near the eyes), it must be **2 mm or less** away.
  • If the patient has had surgery to remove the tumor, there must be a **residual tumor** left that is **5 mm or more** in size.
  • The remaining tumor after surgery must be **extrasellar**, meaning it extends beyond the pituitary gland, or it must show growth after the surgery.
  • The study is open to both **male and female** patients.
  • The study includes patients from certain age groups, specifically adults.

Who cannot join the trial?

4 criteria

  • Individuals who are not diagnosed with a non-functioning pituitary adenoma cannot participate. A non-functioning pituitary adenoma is a type of tumor in the pituitary gland that does not produce excess hormones.
  • Participants must be within the specified age range for the study. If you are outside this age range, you cannot participate.
  • Both males and females are eligible, but if you do not identify as either, you may not be able to participate.
  • If you belong to a vulnerable population, you may not be eligible. Vulnerable populations include groups that may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs

Cabergoline is a medication used in this trial to treat non-functioning pituitary adenomas. It works by acting as a dopamine agonist, which means it stimulates dopamine receptors in the brain. This action can help reduce the size of the adenomas and manage symptoms associated with these types of tumors. The trial aims to evaluate how effective cabergoline is in treating these adenomas.

What is already known about the treatment

Cabergoline – Cabergoline is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating non-functioning pituitary adenomas. The main therapeutic indication for cabergoline is to reduce the size of these adenomas and manage associated symptoms. At the molecular level, cabergoline works by stimulating dopamine receptors, which leads to a decrease in the production of certain hormones by the pituitary gland. It is classified pharmacologically as a dopamine agonist.

Investigated diseases

Non-functioning pituitary adenoma – This is a type of benign tumor located in the pituitary gland that does not produce excess hormones. These adenomas can grow in size and may press on nearby structures, such as the optic nerves, leading to vision problems. As they enlarge, they might also affect the normal function of the pituitary gland, potentially causing hormonal imbalances. Symptoms often arise from the pressure exerted by the tumor rather than hormone production. The progression of the disease is typically slow, and symptoms may develop gradually over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510039-12-00Estimated enrolment60 patientsSponsorSt. Olavs Hospital HF

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