Head-to-Head: which drug tames high prolactin better?
NCT ID NCT07124221
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether cabergoline works better than bromocriptine for women with high prolactin levels. About 382 women aged 18-45 will take one of the two drugs for 14 weeks. The main goal is to see whose prolactin levels return to normal, along with checking ovulation, breast discharge, and tumor shrinkage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cabergoline tablets
- What this could lead to
- If cabergoline works better or has fewer side effects than bromocriptine, it could become a preferred treatment for women with high prolactin levels.
- What could go wrong
- This is a Phase 3 trial, but both drugs are already approved; the main question is which is better. Some women may not respond or may experience side effects like nausea or dizziness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 382 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Hospital, Chinese Academy of Medical Sciences
RECRUITINGBeijing, Beijing Municipality, 100730, China
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