A Phase III clinical study evaluating the efficacy and safety of cabergoline tablets versus bromocriptine mesylate tablets in patients with hyperprolactinemia
A randomized, double-blind, double-dummy, active controlled, multicenter Phase III clinical study to evaluate the efficacy and safety of Cabergoline tablets compared with Bromocriptine mesylate tablets in female patients with hyperprolactinemia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
382
Cabergoline tablets will be administered for 14 weeks.The allowed dose range is from 0.25 mg (1 tablet) QW to 1mg (4 tablets) QW. Dosage adjustments are made based on the serum PRL level.
Bromocriptine mesylate tablets was administered for 14 weeks.The dose is 1.25 mg (0.5 tablet) QD to 7.5mg 3 tablets) QD. Dosage adjustments are made based on the serum PRL level.
Peking Union Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGThe percentage of subjects whose serum PRL levels returned to normal
Time frame: 14 weeks
The percentage of subjects whose ovulatory cycles resumed
Time frame: 14 weeks
The percentage of subjects whose galactorrhea disappeared
Time frame: 14 weeks
The percentage of subjects with pituitary PRL tumor shrinkage
Time frame: 14 weeks
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