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A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Summary
A Phase III clinical study evaluating the efficacy and safety of cabergoline tablets versus bromocriptine mesylate tablets in patients with hyperprolactinemia
Official title: A Randomized, Double-blind, Double-dummy, Positive Controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets in Female Patients With Hyperprolactinemia
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
382
Start Date
2025-09-12
Completion Date
2026-12-30
Last Updated
2025-10-02
Healthy Volunteers
No
Conditions
Interventions
Cabergoline tablets
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
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.
Locations (1)
Peking Union Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China