Safety and Potency of a High Cabergoline Dosage in Microprolactinomas

This will be a multicenter, prospective, randomized, open-label trial with women harboring microprolactinomas and treatment naïve. The sample will be added consecutively and randomized into 2 unblinded groups: the high dosage group will receive a high cabergoline (CAB) dose for a period of \~6 months vs the standard dosage group, which will use the lowest needed dose of CAB to achieve normoprolactinemia for 2 years. The primary outcome will be remission rate.

NCT Number	NCT07463235
Lead Sponsor	University of Sao Paulo General Hospital
Conditions	Prolactinoma, Prolactin Excess
Enrollment	70 participants
Start Date	2026-03-04
Primary Completion	2027-08-20 (estimated)
Study Completion	2029-12-20 (estimated)
Updated on ClinicalTrials.gov	2026-03-13