Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty (CPP) in Girls.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Estradiol
研究概览
简要总结
The aim of the study is to determine the specificity, sensitivity and diagnostic efficiency of the Triptorelin Test in the assessment of CPP compared to GnRH test as gold standard.
Hypothesis: Aqueous Triptorelin Acetate is so efficient as GnRH to CPP assessment.
Study population are girls with suspicious clinical features of precocious puberty
详细描述
GnRH stimulation is the gold standard to distinguish between isolated premature thelarche (PT) and CPP. However, intravenous GnRH for testing is not fully available in all countries. To evaluate the diagnostic accuracy of a novel Triptorelin-test in the assessment of CPP compared to the GnRH test, a validation study was performed. Girls who presented thelarche with accelerated growth and/or advanced bone age were included. All girls underwent the two tests in a randomized order. CPP was ascertained according to LH response under GnRH (gold standard test).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •premature thelarche and/or
- •accelerated growth velocity (above 90 percentile)
- •advanced bone age at least 1.5 year in relation to chronological age.
排除标准
- •contact with sources of exogenous estrogens in the last four months previous to evaluation,
- •suspicion of peripheral precocious puberty,
- •previous central nervous system illness or suspicion of organic central precocious puberty.
结局指标
主要结局
Estradiol
时间窗: 24 hs
Levels of Estradiol are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.
LH
时间窗: 3 hs
Levels of LH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.
次要结局
- FSH(3 hs)
研究者
Analía Freire
Pediatric Endocrinology, PhD
Hospital de Niños R. Gutierrez de Buenos Aires