NCT01518062已完成4 期
Dose Response Trial of Biosynthetic Authentic Human Growth Hormone and Induction of Puberty With 17b Oestradiol in Girls With Turner's Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Final height
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to assess whether increasing doses of somatropin (Norditropin®) can maintain the initial increase in height velocity and improve final height. This trial has two trial periods, a main period of 4 years and an extension period until final height is reached.
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
- None
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Turner Syndrome
- •Well documented growth rate during the previous year
- •Height below the 50th percentile for the age in Dutch children
- •Normal thyroid function
排除标准
- •Any endocrine or metabolic disorder
- •Growth failure due to disorders of genitourinary, cardio-pulmonary, gastro-intestinal and nervous systems, nutritional/vitamins deficiencies and chondrodysplasias
- •Patients with hydrocephalus
研究组 & 干预措施
Low dose
Experimental
干预措施: somatropin (Drug)
Low dose
Experimental
干预措施: oestrogen (Drug)
Medium dose
Experimental
干预措施: somatropin (Drug)
Medium dose
Experimental
干预措施: oestrogen (Drug)
High dose
Experimental
干预措施: somatropin (Drug)
High dose
Experimental
干预措施: oestrogen (Drug)
结局指标
主要结局
Final height
次要结局
- Ratio between change in bone age and change in chronological age
- Age at onset of puberty
- Adverse events
- Height velocity (cm/year)
研究者
研究点 (1)
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