Early access
Sign in
Taking peoplePhase 4

Cabergoline and blood sugar handling in adults with prolactinoma

Compares cabergoline treatment strategies for effects on blood sugar in adults with prolactinoma.

Key facts

Who runs it
University Hospital, Basel, Switzerland
Where
Switzerland1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
Status
Recruiting
Phase
Phase 4
People taking part
60 people, planned
Started
16 Sept 2025
Expected to end
31 Dec 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Cabergoline (Dopamine Agonist)
Record updated
23 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a prolactinoma, a pituitary tumour that makes too much of the hormone prolactin. It compares two cabergoline treatment goals and their effect on blood sugar.

Age
18 years and older
Sex
All sexes
Disease stage
High prolactin caused by a prolactinoma, diagnosed by current guidelines. People who have not been treated yet can join. People already on cabergoline can also join.
Earlier treatment
One group has had no treatment yet. The other group is already treated with cabergoline and has normal prolactin levels.
Biomarker or test result
For untreated people: prolactin level at least two times the local laboratory maximum, plus imaging findings.

Main reasons for not taking part

  • Another cause of high prolactin
  • Pregnancy or breastfeeding within the last 8 weeks
  • Current or past psychotic disorder, or active substance use disorder within the last six months
  • Severe liver disease or severe kidney disease (eGFR < 30 ml/min)
  • Tumour problems that need surgery, or a clear wish for surgery

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Diagnosed adult patients (at least 18 years of age) with prolactinoma-induced hyperprolactinemia, defined as a prolactin level ≥ two times the local laboratory maximum and radiographic criteria, based on current guidelines
  • Diagnosed adult patients (at least 18 years of age) with prolactinoma-induced hyperprolactinaemia based on current guidelines
  • Patients treated with cabergoline as DA therapy and prolactin levels within the normal range

Who cannot take part

  • Current or previous psychotic disorder
  • Concomitant treatment with strong or moderate CYP3A4 inhibitors
  • Local complications on morphological imaging, related to signs or clinical symptoms which make surgical intervention necessary or a clear patient's preference for surgical treatment
  • Gastrointestinal disease or previous surgery: chronic active inflammatory bowel disease, active gastrointestinal ulcer disease, or surgery on the gastrointestinal tract (e.g. sleeve stomach, gastric band)
  • Active substance use disorder within the last six months
  • History of pulmonary, pericardial, and/or retroperitoneal fibrotic disorders
  • Patient incapable of giving informed consent due to cognitive impairment or other reasons (e.g., legal incapacity)
  • Severe hepatic insufficiency or cholestasis; Child Pugh C or; AST/ ALT > 3 x the upper limit of normal ULN or; Cholestasis (total bilirubin > 2x ULN)
  • Severe renal impairment (eGFR < 30 ml/min)
  • alternative explanation for hyperprolactinaemia
  • Pregnancy or breastfeeding within the last 8 weeks

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

This randomized, active-controlled, parallel-arm, single-blind trial is to compare the effects of Dopamine agonists (DA) therapy targeting different established treatment strategies on glucose metabolism assessed by an oral glucose tolerance test.

The 2 groups in the trial

  • Experimental intervention arm (Cabergoline)Existing treatment, for comparison

    The experimental intervention arm aims to treat patients (with hyperprolactinemia) with Cabergoline (Dopamine Agonist) by targeting the suppression of prolactin levels (below the normal plasma prolactin range).

    Treatment: Cabergoline (Dopamine Agonist)

  • Control intervention arm (Cabergoline)Existing treatment, for comparison

    The control intervention arm aims to treat patients (with hyperprolactinemia ) with Cabergoline (Dopamine Agonist) by targeting the normalisation of prolactin levels (within the normal plasma prolactin range).

    Treatment: Cabergoline (Dopamine Agonist)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment - A Randomized, Single-Blind Active- Controlled Trial
Plain-language title
Cabergoline and blood sugar handling in adults with prolactinomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
23 September 2025