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Safety and Potency of a High Cabergoline Dosage in Microprolactinomas

Study acronym: SPARAGMOS
StatusRecruiting
PhasePhase 3
Started2026-03-04
View on ClinicalTrials.gov ↗

Amendment history

2026-03-10
Study Status, Arms and Interventions v1
Re-verified, no change to tracked fields
2026-03-04
Original filing
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.
Trial Details
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