NCT07124221招募中3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 382
- 试验地点
- 1
- 主要终点
- The percentage of subjects whose serum PRL levels returned to normal
研究概览
简要总结
A Phase III clinical study evaluating the efficacy and safety of cabergoline tablets versus bromocriptine mesylate tablets in patients with hyperprolactinemia
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cabergoline tablets
Experimental
191subjects
干预措施: Cabergoline tablets (Drug)
Bromocriptine mesylate tablets
Active Comparator
191subjects
干预措施: Bromocriptine mesylate tablets (Drug)
结局指标
主要结局
The percentage of subjects whose serum PRL levels returned to normal
时间窗: 14 weeks
次要结局
- The percentage of subjects with pituitary PRL tumor shrinkage(14 weeks)
- The percentage of subjects whose ovulatory cycles resumed(14 weeks)
- The percentage of subjects whose galactorrhea disappeared(14 weeks)
研究者
研究点 (1)
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