Cabergoline versus bromocriptine for treating hyperprolactinemia in women
Official title: A Randomized, Double-blind, Double-dummy, Positive Controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets in Female Patients With Hyperprolactinemia
Run by Changchun GeneScience Pharmaceutical Co., Ltd. · NCT07124221 · Data updated 2026-11-12
This trial tests whether cabergoline tablets work better and are as safe as bromocriptine tablets for women aged 18–45 with hyperprolactinemia.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 382 (estimated) |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | September 12, 2025 |
| Main results expected | November 21, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | October 2, 2025 |
| Trial ID | NCT07124221 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–45 with clinically diagnosed hyperprolactinemia (with or without a pituitary PRL tumor) who can use effective contraception and consent to study procedures are the intended participants.
✕Probably not a fit
Women who are pregnant or breastfeeding, have other pituitary or intracranial causes of hyperprolactinemia, systemic diseases causing high prolactin, prior cabergoline treatment or allergy to ergol derivatives, or disqualifying laboratory results are unlikely to benefit from joining this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, double-dummy, active-controlled Phase III trial comparing cabergoline tablets with bromocriptine mesylate tablets in female patients with hyperprolactinemia. Eligible participants are women 18–45 years old, with or without a prolactin-secreting pituitary tumor, who agree to use effective contraception and attend regular follow-up. The study will measure efficacy endpoints such as normalization of prolactin levels and clinical symptom improvement, along with safety and tolerability. It is sponsored by Changchun GeneScience and conducted at centers including Peking Union Hospital in Beijing.
Why it matters
Potential benefit: If successful, cabergoline could provide better control of prolactin levels and fewer side effects than bromocriptine for affected women.
How similar studies have gone: Previous clinical work has generally shown cabergoline to be more effective and better tolerated than bromocriptine for lowering prolactin, so this trial builds on established evidence.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Peking Union Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: lingling Li
- Email: lilingling01@genscigroup.com
- Phone: +86-18826108784
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.