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

GeneScience Pharmaceuticals (GenSci)

Status and phase: Enrolling; Phase 3

Conditions: Hyperprolactinemia

Treatments: Drug: Bromocriptine mesylate tablets; Drug: Cabergoline tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07124221

GenSci127-301

Details and patient eligibility

About

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

Full 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

Enrollment: 382 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

382 participants in 2 patient groups

Cabergoline tablets

Experimental group

Description:

191subjects

Treatment:

Drug: Cabergoline tablets

Bromocriptine mesylate tablets

Active Comparator group

Description:

191subjects

Treatment:

Drug: Bromocriptine mesylate tablets