Dehydroepiandrosterone(DHEA) Substitution in Adolescent and Young Women With Central Adrenal Insufficiency. A Multicenter, Randomised Double Blind Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Increase of pubes as measured by tanner stage
研究概览
简要总结
30 adolescent girls and young women between 13 and 26 years with central adrenal insufficiency and a grand shortage of DHEA are recruit. The clinical trial is double-blind to show that the substitution of the hormone DHEA stimulates secondary hair growth, enhances well being and mood of the patients. It should also normalize the serum content of DHEA, aldosterone and testosterone.
详细描述
30 adolescent girls and young women between 13 and 26 years with central adrenal insufficiency and a grand shortage of DHEA are recruit. After randomization they either get DHEA or placebo for 12 months daily. The clinical trial is double-blind to show that the substitution of the hormone DHEA stimulates secondary hair growth, enhances well being and mood of the patients. It should also normalize the serum content of DHEA, aldosterone and testosterone.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 13 Years 至 26 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female gender
- •age between 13 and 26 Years
- •breast developement minimal Tanner stage 3
- •serum content of DHEAS less than 400 ng/ml
- •central hypocortisolism
- •2 additional pituitary hormon deficiencies (growth hormone, TSH, FSH, LH, prolactin, ADH)
- •no scheduled change of the auxilliary medication during the clinical trial
排除标准
- •initial diagnosis of a cerebral tumor less than one year
- •constitution after cerebral exposure with over 30 gray
- •craniopharyngioma with hypothalamic defect syndrome or relapse
- •blindness
- •mental retardation or psychiatric disorder
- •systemic disorder, diabetes mellitus, cardiovascular disease, liver disease requiring treatment
- •elevated liver enzyme levels
- •pregnancy
- •in case of no hypogonadism: no secure contraception
研究组 & 干预措施
1
substitution of DHEA-hormone, oral, once daily
干预措施: Dehydroepiandrosterone (Drug)
2
substitution of placebo, oral, once daily
干预措施: placebo (Drug)
结局指标
主要结局
Increase of pubes as measured by tanner stage
时间窗: one year
次要结局
- enhancement in well being and mood by psychometric tests(one year)
- normalization of the serum content of DHEA, androstanedione and testosterone(one year)