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

NCT07124221 | Recruiting Phase 3

• 1 other identifier: GenSci127-301
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperprolactinemia

Outcome Measures

Primary Outcomes (1)

• The percentage of subjects whose serum PRL levels returned to normal

  14 weeks

Secondary Outcomes (3)

• The percentage of subjects whose ovulatory cycles resumed

  14 weeks

• The percentage of subjects whose galactorrhea disappeared

  14 weeks

• The percentage of subjects with pituitary PRL tumor shrinkage

  14 weeks

Study Arms (2)

Cabergoline tablets

EXPERIMENTAL

191subjects

Drug: Cabergoline tablets

Bromocriptine mesylate tablets

ACTIVE COMPARATOR

191subjects

Drug: Bromocriptine mesylate tablets

Interventions

Cabergoline tablets DRUG

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.

Cabergoline tablets

Bromocriptine mesylate tablets DRUG

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.

Bromocriptine mesylate tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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;
• Those who are positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody and Treponema pallidum antibody;
• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking Union Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Hyperprolactinemia

Interventions

Cabergoline; Bromocriptine

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Ergotamines

Central Study Contacts

lingling Li

CONTACT

+86-18826108784; lilingling01@genscigroup.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cabergoline tablets compared with Bromocriptine mesylate tablets

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 15, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): November 21, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

CN (1)