Evaluating High Versus Standard Dose Cabergoline Treatment in Women with Microprolactinomas for Remission Outcomes

What this Trial Is About

Researchers are conducting a multicenter, randomized, open-label trial to study women with microprolactinomas who have not previously been treated. The study compares two dosing regimens of cabergoline CAB, a dopamine agonist used to treat prolactinomas. The goal is to evaluate remission rates and potentially improve future treatments for this condition by testing a higher dose against the current standard dose over different time periods. Participants will be randomly assigned to one of two groups. The high-dose group will receive escalating doses of oral CAB over 7 weeks to reach 3.5 mg per week, maintain this dose for about 6 months, and then gradually reduce the dose over 1 month. The standard-dose group will take a lower dose of CAB sufficient to normalize prolactin levels, adjusted as needed, for 2 years. After treatment, CAB will be withdrawn for all patients regardless of tumor size or hormone levels. During the study, participants will be closely monitored with clinical evaluations and laboratory tests to assess remission at 3, 6, and 12 months after treatment starts. Researchers will track hormone levels, tumor size, and any side effects. The total duration of involvement varies by treatment group, ranging from about 6 months to 2 years, followed by dose discontinuation. This approach aims to provide detailed information on the safety and effectiveness of the different dosing strategies.

Safety and Potency of a High Cabergoline Dosage in Microprolactinomas