RecruitingPhase 4NCT07045935

Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment

Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment - A Randomized, Single-Blind Active- Controlled Trial


Sponsor

University Hospital, Basel, Switzerland

Enrollment

60 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how dopamine agonist medications (like cabergoline) used to treat prolactinomas (benign pituitary tumors that cause high prolactin levels) affect metabolism — including blood sugar, body weight, and cardiovascular risk markers. The aim is to better understand the metabolic effects of these commonly used medications. **You may be eligible if...** - You are an adult (18+) diagnosed with a prolactinoma (a pituitary tumor causing high prolactin) - You are either newly diagnosed and not yet on treatment, OR - You are already on cabergoline with prolactin levels now in the normal range **You may NOT be eligible if...** - Your high prolactin has a different cause - You have active substance use disorder, or a current or prior psychotic disorder - You are pregnant or breastfeeding - You have severe liver disease or severe kidney problems - You have a history of fibrosis affecting the lungs, heart lining, or abdomen - You need surgery for your tumor due to complications - You have a significant bowel condition or prior major gut surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCabergoline (Dopamine Agonist)

Cabergoline is available in tablet form, with doses of 0.5 mg per tablet. The standard dosing for hyperprolactinemia typically starts at 0.25 mg to 0.5 mg per week, which can be gradually increased based on the patient's response, with a usual range of 0.25 mg to 2 mg per week. The dose required to achieve the target prolactin levels (pre- defined for each intervention arm) may vary between patients, so a fixed dose is not specified. This allows for individualized treatment based on each patient's response.


Locations(1)

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

Basel, Switzerland

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NCT07045935


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