Actively Recruiting
A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2025-10-02
382
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase III clinical study evaluating the efficacy and safety of cabergoline tablets versus bromocriptine mesylate tablets in patients with hyperprolactinemia
CONDITIONS
Official Title
A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 45 at the time of signing the informed consent form
- Clinically diagnosed hyperprolactinemia, with or without pituitary prolactin tumor
- Agree to use effective contraceptive measures during the study and for 4 weeks after last drug administration
- Voluntarily signed informed consent, understand and agree to study requirements, and able to attend regular follow-ups on time
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Previous cabergoline treatment or radiotherapy, or history of allergy to ergol preparations or derivatives
- Presence of other types or mixed pituitary tumors
- Hyperprolactinemia caused by hypothalamic or other intracranial lesions
- Hyperprolactinemia caused by other systemic diseases
- Laboratory abnormalities during screening: AST or ALT > 2 times upper limit, total bilirubin > 1.5 times upper limit, creatinine or urea nitrogen > 2 times upper limit
- Positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or Treponema pallidum antibody
- PRL recovery rate less than 40% on screening tests
- Use of ovulation-inducing agents, drugs increasing prolactin, or prohibited combination drugs within 4 weeks before screening
- Any other conditions making participation unsuitable as determined by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
L
lingling Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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