NCT02974270Unknown4 期
Analysis of Body Mass Index in Central Precocious Puberty(CPP) Patients Treated With Leuprolide Acetate
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months
研究概览
简要总结
Analysis of body mass index in Central Precocious Puberty patients treated with leuprolide acetate
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child diagnosed with CPP who has a peak-stimulated Lutenizing Hormone(LH) concentration over 5 IU/liter before initiation of therapy
- •Chronological age(CA) at the appearance of pubertal changes less than 8 years in girls and less than 9 years in boys.
- •Tanner stage ≥2
- •Advanced bone age (Bone Age/Chronological Age >1.1)
- •Able to have the signed written informed consent provided by the patients' parents or legal guardians prior to any study-related procedures
排除标准
- •Patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion
- •Patient with a cerebral tumor requiring a neurosurgery or cerebral irradiation known chronic disease of underlying medical condition
- •Currently on or planning growth hormone treatment
- •Previous Gonadotropin-Releasing Hormone agonist treatment
- •Any patient who in opinion of the investigator should not participate in the study
研究组 & 干预措施
Leuprolide acetate
Experimental
干预措施: Leuprolide (Drug)
结局指标
主要结局
Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months
时间窗: 6 months
次要结局
- Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 3 months(3 months)
研究者
Cheol Woo Ko
MD, PhD
Kyungpook National University Hospital
研究点 (1)
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