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Prolactinoma drug doses face off: which is better for your metabolism?

NCT ID NCT07045935

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • University Hospital Basel, Dept. of Endocrinology, Metabolism & Diabetes

    RECRUITING

    Basel, 4031, Switzerland

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