Cabergoline treatment targets and glucose metabolism in people with prolactinomas
Official title: Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment - A Randomized, Single-Blind Active- Controlled Trial
Run by University Hospital, Basel, Switzerland · NCT07045935 · Data updated 2026-11-12
This trial will test whether different cabergoline treatment targets change blood sugar control in adults with prolactinomas.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Status | Recruiting |
| Started | September 16, 2025 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | September 23, 2025 |
| Trial ID | NCT07045935 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with prolactinoma-induced hyperprolactinemia who are eligible for cabergoline therapy according to current imaging and laboratory criteria are ideal candidates.
✕Probably not a fit
People with alternative causes of high prolactin, recent pregnancy or breastfeeding, active substance use or psychotic disorders, severe liver or kidney impairment, or who cannot attend visits in Basel are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, active-controlled, parallel-arm, single-blind Phase 4 trial comparing two established dopamine agonist (cabergoline) treatment strategies over 12 months. Participants will undergo oral glucose tolerance testing with insulin measurements to quantify glucose tolerance, insulin sensitivity, and beta-cell function. The trial compares targeting different prolactin levels during cabergoline therapy to see if metabolic outcomes differ. All treatment and testing are carried out at the University Hospital Basel with cabergoline given according to guideline-based dosing.
Why it matters
Potential benefit: If successful, results could clarify which cabergoline treatment target best preserves or improves glucose metabolism for people with prolactinomas.
How similar studies have gone: Dopamine agonists like cabergoline are well established for lowering prolactin and shrinking tumors, but randomized comparisons focusing on metabolic outcomes by different prolactin targets are limited and this approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
University Hospital Basel, Dept. of Endocrinology, Metabolism & Diabetes
Basel, Switzerland Recruiting
Study contacts
- Principal investigator: Cihan Atila, Dr. — University Hospital Basel, Dept. of Endocrinology, Metabolism & Diabetes
- Study coordinator: Cihan Atila, Dr.
- Email: cihan.atila@usb.ch
- Phone: +41 61 328 4579
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
High-dose cabergoline for microprolactinoma remission
This study will try whether a short course of higher-dose cabergoline leads to more remissions than the standard low-dose approach in treatment-naïve premenopausal women with microprolactinomas.
-
Investigation of pituitary tumors and related disorders in children
This study is trying to find out more about pituitary tumors in children by looking at their genes and how these tumors affect their health and emotions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.