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

Not Applicable

Not yet recruiting

• Conditions: Hyperprolactinemia
• Interventions: Drug: Cabergoline tablets; Drug: Bromocriptine mesylate tablets

• Registration Number: NCT07124221
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief 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

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-08-03
• Study First Submitted QC: 2025-08-12
• Study First Posted: 2025-08-15
• Last Update Submitted: 2025-08-15
• Last Update Posted: 2025-08-20
• Study Start: 2025-08-30
• Primary Completion: 2025-09-20
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 382

Inclusion Criteria

• Women aged 18 to 45 at the time of signing the ICF;
• Clinically diagnosed hyperprolactinemia, with or without pituitary PRL tumor;
• Agree to and abide by the adoption of effective contraceptive measures during the study period (from signing the ICF to 4 weeks after the last administration of the investigational drug);
• voluntarily signed the ICF, could understand and abide by the requirements of this research protocol, and were followed up regularly and on time.

Exclusion Criteria

• Women who are pregnant or breastfeeding;

• Those who have previously received carbergoline treatment or radiotherapy, or have a history of allergy to ergol preparations or their derivatives;

• The presence of other types or mixed pituitary tumors；

• hyperprolactinemia syndrome caused by hypothalamic or other intracranial lesions；

• hyperprolactinemia syndrome caused by other systemic diseases;

• Laboratory tests during the screening period meet any of the following conditions:

  1. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times ULN, or total bilirubin (TBIL) > 1.5 times ULN, or serum creatinine (Cr) or UREA (UREA)/urea nitrogen (BUN) > 2 times ULN;
  2. Those who are positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody and Treponema pallidum antibody;
  3. Hyperprolactinemia: Screening tests show that the PRL recovery rate is less than 40%;

• Those who have received ovulation-inducing agents, drugs that may cause an increase in PRL or other prohibited combination drugs within 4 weeks prior to screening;

• The patients not suitable for participating in this clinical study due to other reasons.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cabergoline tablets	Cabergoline tablets	191subjects
Bromocriptine mesylate tablets	Bromocriptine mesylate tablets	191subjects

Primary Outcome Measures

Name	Time	Method
The percentage of subjects whose serum PRL levels returned to normal	14 weeks

Secondary Outcome Measures

Name	Time	Method
The percentage of subjects with pituitary PRL tumor shrinkage	14 weeks
The percentage of subjects whose ovulatory cycles resumed	14 weeks
The percentage of subjects whose galactorrhea disappeared	14 weeks

Trial Locations

Locations (1)

Peking Union Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China