Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment - A Randomized, Single-Blind Active- Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Switzerland
University Hospital Basel, Dept. of Endocrinology, Metabolism & Diabetes
RECRUITING
Basel
Contact Information
Primary
Cihan Atila, Dr.
cihan.atila@usb.ch
+41 61 328 4579
Time Frame
Start Date: 2025-09-16
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 60
Treatments
Active_comparator: Experimental intervention arm (Cabergoline)
The experimental intervention arm aims to treat patients (with hyperprolactinemia) with Cabergoline (Dopamine Agonist) by targeting the suppression of prolactin levels (below the normal plasma prolactin range).
Active_comparator: Control intervention arm (Cabergoline)
The control intervention arm aims to treat patients (with hyperprolactinemia ) with Cabergoline (Dopamine Agonist) by targeting the normalisation of prolactin levels (within the normal plasma prolactin range).
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Basel, Switzerland