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

Launched by CHANGCHUN GENESCIENCE PHARMACEUTICAL CO., LTD. · Aug 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different medications, cabergoline and bromocriptine, to see which one works better and is safer for treating a condition called hyperprolactinemia. This condition happens when there is too much of a hormone called prolactin in the blood, which can cause problems like irregular periods or difficulty getting pregnant. The study aims to compare these two drugs in women who have this condition.

Women between the ages of 18 and 45 who have been diagnosed with hyperprolactinemia may be eligible to join the study. Participants must agree to use effective birth control during the study and be able to follow all study requirements. Women who are pregnant, breastfeeding, or have certain other health issues will not be able to participate. If you join, you can expect regular check-ups and careful monitoring to see how well the medication works and if there are any side effects. This study is not yet enrolling participants but will focus only on women who meet these specific health criteria.

Gender

FEMALE

Eligibility criteria

• 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.