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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.