NCT07045935Recruiting
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
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 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)
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Countries
- Switzerland
- Sponsor
- University Hospital, Basel, Switzerland(Other)
- Protocol no.
- 2025-00829; kt25Atila
- Conditions
- Prolactinoma
- Interventions
- Drug
Treatments studied
- Cabergoline (Dopamine Agonist)
Locations · 1
- Basel, SwitzerlandUniversity Hospital Basel, Dept. of Endocrinology, Metabolism & DiabetesRecruiting at this site
In total, worldwide, the only site listed in the registry is recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: September 23, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
Other identifiers
- 2025 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.