NCT07124221

A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 382 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

A Phase III clinical study evaluating the efficacy and safety of cabergoline tablets versus bromocriptine mesylate tablets in patients with hyperprolactinemia

Detailed description

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

Conditions

• Hyperprolactinemia

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2025-09-12
• Primary completion: 2026-11-21
• Completion: 2026-12-30
• First posted: 2025-08-15
• Last updated: 2025-10-02

Locations

1 site across 1 country: China