LH Response to GnRH Test in Prepubescent Girls Under 6 Years
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- LH response
研究概览
简要总结
The project aims to establish the normal LH and FSH response to a standardized GnRH dose in healthy girls below 6 years of age, and compares the normal GnRH response to the GnRH response in girls with early puberty development.
The novel data may help to determine whether the girl is in early puberty or not.
Healthy girls under 6 years of age attending routine examinations including an i.v. line for other causes are included in this study. Our examinations also include bone age determination, Tanner stage determination, and anthropometric measures (height and weight). 10 healthy girls in each of the following age groups: 7-12 months, 12-24 months, 24-36 months, 36-48 months, 48-60 months and 60-72 months are included.
详细描述
Please refer to the brief summary which covers the study aim, methods and outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 7 Months 至 6 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Endocrinologically healthy girls in the age from 7 months to 6 years
- •Obtained oral and written informed consent from participants parents
排除标准
- •Anamnestic, clinical or laboratory findings that indicate that the subject is suffering from other diseases (eg poorly controlled asthma) or is in a condition which might affect the subject's ability to complete the study or which is likely to affect the parameters under investigation.
- •Current medical treatment apart from prophylactic antibiotics or weak analgesics.
- •GFR <50 ml/min/1,73m2 or if absence of previous GFR study: serum creatinine above normal upper age-specific normal range.
- •Clinical signs of precocious puberty
研究组 & 干预措施
GnRH intervention
All participating subjects are assigned to receive an intravenous GnRH agonist injection.
干预措施: GnRH agonist (Drug)
结局指标
主要结局
LH response
时间窗: 30 minutes
次要结局
- FSH response(30 minutes)