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

Prolactinoma

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

Inclusion Criteria3

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.
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 Criteria14

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)

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.