Menu
Recruiting NCT07124221

A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets

Phase III Interventional Hyperprolactinemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cabergoline tablets, Bromocriptine mesylate tablets.
Who it may be relevant to
Registry conditions: Hyperprolactinemia. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

A Phase III clinical study evaluating the efficacy and safety of cabergoline tablets versus bromocriptine mesylate tablets in patients with hyperprolactinemia

Detailed description

A randomized, double-blind, double-dummy, active controlled, multicenter Phase III clinical study to evaluate the efficacy and safety of Cabergoline tablets compared with Bromocriptine mesylate tablets in female patients with hyperprolactinemia

Interventions

  • Drug Cabergoline tablets
    Cabergoline tablets will be administered for 14 weeks.The allowed dose range is from 0.25 mg (1 tablet) QW to 1mg (4 tablets) QW. Dosage adjustments are made based on the serum PRL level.
  • Drug Bromocriptine mesylate tablets
    Bromocriptine mesylate tablets was administered for 14 weeks.The dose is 1.25 mg (0.5 tablet) QD to 7.5mg 3 tablets) QD. Dosage adjustments are made based on the serum PRL level.

Primary outcome measures

  • The percentage of subjects whose serum PRL levels returned to normal [Time frame: 14 weeks]
Secondary outcome measures (3)
  • The percentage of subjects whose ovulatory cycles resumed [Time frame: 14 weeks]
  • The percentage of subjects whose galactorrhea disappeared [Time frame: 14 weeks]
  • The percentage of subjects with pituitary PRL tumor shrinkage [Time frame: 14 weeks]

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:
  • 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;
  • Those who are positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody and Treponema pallidum antibody;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Hospital, Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT07124221 · GenSci127-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗