Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment

Recruiting now · Phase 4

Conditions studied: Prolactinoma

In brief

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.

Key facts

Study ID: NCT07045935
Run by: University Hospital, Basel, Switzerland
People needed: 60
Starts: 2025-09-16
Expected to finish: 2029-12-31
Last updated by the study team: 2025-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

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 is running

University Hospital Basel, Dept. of Endocrinology, Metabolism & Diabetes — Basel, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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