drugset / Trial / NCT07463235

Safety and Potency of a High Cabergoline Dosage in Microprolactinomas

NCT07463235

Phase 3 Recruiting 70 enrolled University of Sao Paulo General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-03-04
Primary completion
2027-08-20
Completion
2029-12-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cabergoline Small molecule 0.5 mg Oral
Comparator Cabergoline Small molecule 1 mg Oral
Comparator Cabergoline Small molecule 2 mg Oral
Comparator Cabergoline Small molecule 3.5 mg Oral