Cabergoline vs Bromocriptine for Hyperprolactinemia
A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets
Recruiting
Phase 3Interventional Study
Hyperprolactinemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 45
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
382 (estimated)
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
Who this trial is looking for
This trial is looking for women aged 18 to 45 who have been diagnosed with hyperprolactinemia. Participants will take either cabergoline or bromocriptine for treatment and need to follow specific guidelines during the study.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman aged 18 to 45.
I have been diagnosed with hyperprolactinemia.
I agree to use effective birth control during the study.
I can understand and follow the study requirements.
You may not be able to join if
I am pregnant or breastfeeding.
I have been treated with cabergoline before.
I have other types of pituitary tumors.
I have hyperprolactinemia caused by other diseases.
I have liver or kidney problems according to lab tests.
I have tested positive for certain infections.
I took medications that could affect my condition in the last 4 weeks.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
A Phase III clinical study evaluating the efficacy and safety of cabergoline tablets versus bromocriptine mesylate tablets in patients with hyperprolactinemia
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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 …
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.
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