RecruitingPhase 3NCT07124221

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

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Enrollment

382 participants

Start Date

Sep 12, 2025

Study Type

INTERVENTIONAL

Conditions

Hyperprolactinemia

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bromocriptine mesylate tablets and a drug called Cabergoline tablets for people with hyperprolactinemia. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCabergoline 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.

DRUGBromocriptine 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

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NCT07124221