NCT00055302已完成2 期
An Open-label Study Evaluating the Safety and Efficacy of Anastrozole™ (ARIMIDEX) in the Treatment of Precocious Puberty in Girls With McCune-Albright Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The efficacy of study treatment will be assessed based on the change from baseline measurements relating to vaginal bleeding, bone age, and growth velocity
研究概览
简要总结
The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with McCune-Albright Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 10 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •informed written consent of parent/legal guardian and subject assent (as needed by local requirements)
- •females less than or equal to 10 years of age
- •diagnosed with McCune-Albright Syndrome
- •have progressive precocious puberty
排除标准
- •Any one of the following is regarded as a criterion for exclusion from the study:
- •any prior treatment of MAS associated with progressive precocious puberty with a third generation aromatase inhibitor (anastrozole, letrozole, exemestane) in which no clinical response was seen
- •concomitant treatment of precocious puberty associated with MAS, with the exception of bisphosphonates for polyostotic fibrous dysplasia and LHRH analogues in the case of central precocious puberty
- •liver function tests at screening visit (AST, ALT) > or = 3x the upper limit of the reference range for age
- •known hypersensitivity to any component of study medication
研究组 & 干预措施
1
Experimental
干预措施: Arimidex 1 mg (Drug)
结局指标
主要结局
The efficacy of study treatment will be assessed based on the change from baseline measurements relating to vaginal bleeding, bone age, and growth velocity
时间窗: 12 months or until the subject demonstrates the lack of efficacy bases upon progression of primary endpoints or experiences serious drug-related toxicity requiring withdrawal
次要结局
未报告次要终点
研究者
研究点 (1)
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