NCT01710696已完成3 期
Induction of Puberty With 17-Beta Estradiol in Girls With Turner Syndrome. An Open Randomized Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pubertal stage assesed by Tanner score
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to induce normal pubertal development in girls with Turner Syndrome in accordance with that of their peers and their individual state psychosocial maturation.
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
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Turner Syndrome
- •Treatment with growth hormone
- •Bone age minimum 12 years and maximum 14 years
- •Clear signs of ovarian insufficiency
- •Well documented growth rate during the last 12 months
排除标准
- •Signs of spontaneous puberty
- •Known or suspected hypersensitivity to trial product
- •Acute or chronic liver disease
- •Previous treatment with estrogen
- •Undiagnosed abnormal genital bleeding
- •Known thyroid diseases not adeadequately treated
- •Porphyria
研究组 & 干预措施
Individual dose
Experimental
干预措施: 17-beta estradiol (Drug)
Fixed dose
Experimental
干预措施: 17-beta estradiol (Drug)
结局指标
主要结局
Pubertal stage assesed by Tanner score
FSH (Follicle Stimulating Hormone) levels
次要结局
- Height velocity
- Pubertal stage assessed by Tanner score: Breast, pubic hair, axillary hair
- Adverse events
研究者
研究点 (1)
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