Cabergoline versus bromocriptine for treating hyperprolactinemia in women

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

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
• Enrollment: 382 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07124221 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: lingling Li

Conditions Hyperprolactinemia