A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets
NCT ID: NCT07124221
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
382 participants
INTERVENTIONAL
2025-09-12
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cabergoline tablets
191subjects
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
191subjects
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking Union Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GenSci127-301
Identifier Type: -
Identifier Source: org_study_id
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