Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- testicular volume
研究概览
简要总结
Boys with constitutional delay of growth and puberty (CDGP) should be offered evidence-based effective and safe treatment option. This study compares the effects of low-dose testosterone and aromatase inhibitor letrozole on pubertal progression. The hypothesis is that, in boys CDGP showing earliest signs of puberty, peroral letrozole (2.5 mg/d for 6 mo) induces faster biochemical and clinical progression of puberty as compared to low-dose intramuscular testosterone Rx (~1mg/kg/mo for 6 mo). In addition, 10 or more boys who select watchful waiting instead of medication will provide background data on the natural progression of CDGP, and their data will not be used in primary statistical comparisons.
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
- 14 Years 至 17 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Constitutional delay of growth and puberty
- •Age 14 years or more
- •mean testicular volume 2.5 ml or more and less than 4 ml
- •serum testosterone level less than 5 nM OR
- •as above, but serum testosterone 1 nM or more with normal DHEAS level, even if the mean testicular volume is less than 2.5 ml OR
- •as above, but tanner stage G2 and testosterone level less than 3 nM
排除标准
- •Chronic diseases
- •Primary or secondary hypogonadism
- •Chromosomal anomalies
- •Chronic medication that potentially adversely affects bone mineralization (excluding inhaled corticosteroid treatment)
研究组 & 干预措施
Testosterone
~1mg/kg every 4 weeks for 6 months
干预措施: Testosterone (Drug)
Letrozole
2.5mg daily for 6 months
干预措施: Letrozole (Drug)
结局指标
主要结局
testicular volume
时间窗: one year
Testes will be measured with a ruler to the nearest millimeter and volume will be calculated at 0, 6, and 12 mo
clinical and biochemical measures of pubertal progression
时间窗: one year
Activity of the hypothalamic-pituitary-gonadal axis, evaluated by * genital and pubic hair stage of puberty according to Tanner; * growth velocity (cm/yr); * basal and gonadotropin-releasing hormone (GnRH)-stimulated gonadotropin levels; * urinary luteinizing hormone levels; * testosterone; * inhibin B; * anti-mullerian hormone (AMH)
次要结局
- Bone health(one year)
- Psychosocial well-being(one year)
- Puberty-related metabolical and clinical changes(one year)
研究者
Tero Varimo, MD, PhD
MD
Helsinki University Central Hospital