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

Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• The percentage of subjects whose serum PRL levels returned to normal [Срок оценки: 14 weeks]

Вторичные конечные точки (3)

• The percentage of subjects whose ovulatory cycles resumed [Срок оценки: 14 weeks]
• The percentage of subjects whose galactorrhea disappeared [Срок оценки: 14 weeks]
• The percentage of subjects with pituitary PRL tumor shrinkage [Срок оценки: 14 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking Union Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT07124221 · GenSci127-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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