The aim of this study is to investigate whether inhibition of serum prolactin levels below normal range during cabergoline administration may reduce the recurrence rate after drug withdrawal in patients with prolactinomas.
Prolactinoma patients will be assigned to a experimental group that maintains serum prolactin levels below 5 ng/mL and a control group that maintains normal serum prolactin levels. After that, cabergoline will be maintained at a therapeutic dose for 130 weeks. After cabergoline is discontinued, patients will be followed up with serum prolactin measurement for 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Cabergoline tablet
Seoul National University Hospital
Seoul, South Korea
RECRUITINGRecurrence rate within 1 year after cabergoline withdrawal
Record of PRL levels on every 3 month follow-up visit
Time frame: From 4 year to 5 years after cabergoline administration
Time to normalization of serum prolactin level
Record of PRL levels on follow-up visit
Time frame: Up to 1 year
Change from baseline on tumor volume measured by pituitary MRI
Record of he tumor volume from pituitary MRI on every 12-month follow-up visit
Time frame: Up to 3 years
Change from baseline of visual field defect
Record the Visual field scale on every 6 month follow-up visit,
Time frame: Up to 3 years
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