Prolactinoma drug doses face off: which is better for your metabolism?
NCT ID NCT07045935
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study looks at how different doses of the drug cabergoline affect blood sugar control in people with prolactinoma, a type of pituitary tumor. Researchers will randomly assign 60 adults to different treatment strategies and measure their glucose levels after a sugar drink. The goal is to find the best dose to manage the tumor while keeping metabolism healthy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cabergoline (a dopamine agonist drug)
- What this could lead to
- If successful, this trial could help doctors choose the best cabergoline dose to manage prolactinoma while minimizing negative effects on blood sugar.
- What could go wrong
- This is a small, early-phase trial (60 people) comparing different doses of an existing drug, not testing a new cure. Results may not apply to all patients, and cabergoline can cause side effects like nausea or dizziness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria (treatment-naïve patients): * 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. Inclusion Criteria (treatment-naïve patients): * 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 Exclusion Criteria: * alternative explanation for hyperprolactinaemia * Active substance use disorder within the last six months * Current or previous psychotic disorder * Pregnancy or breastfeeding within the last 8 weeks * 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) * History of pulmonary, pericardial, and/or retroperitoneal fibrotic disorders * 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) * Patient incapable of giving informed consent due to cognitive impairment or other reasons (e.g., legal incapacity)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospital Basel, Dept. of Endocrinology, Metabolism & Diabetes
RECRUITINGBasel, 4031, Switzerland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Scientists hunt for hidden genes behind pituitary tumors
- Could a short, High-Dose drug course cure small pituitary tumors?
- New scan could spot invisible brain tumors
- New hope for patients with hard-to-treat pituitary tumors
- New survey aims to better measure life quality in pituitary tumor patients
- What do patients and doctors really think about prolactinoma care?