drugset / Trial / NCT07463235
Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |