Case Control Study Regarding the Role of Follicle Stimulating Hormone in Chemically Castrated Young Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- PSA-concentration
研究概览
简要总结
In order to elucidate if FSH can have testosterone like effects, samples from young, non-smoking healthy volunteers, with normal body mass index, and with pharmacologically induced gonadotropin deficiency will be studied regarding their capacity to induce prostate specific antigen (PSA), which normally is regulated by testosterone.
详细描述
Normally, prostate specific antigen (PSA), which is a marker for prostate disease and progression, is exclusively produced in response to testosterone. In order to elucidate if follicle stimulating hormone (FSH) can have testosterone like effects, samples from n=30 non-smoking healthy volunteers, 20-30 years of age and with normal body mass index (20-25) with pharmacologically induced gonadotropin deficiency will be studied. The men are currently recruited and during 5 weeks undergoing:
- Pharmacologically induced gonadotropin deficiency w 1-3;
- FSH-treatment of 50% (group A), w 1-5;
- Testosterone (T) treatment of all (group A and B) w 4-5;
- End and follow up after 5 weeks.
A subcutaneous injection with the GnRH antagonist degarelix (240 mg¸ Ferring GmbH Wittland, Kiel, Germany) results in drop of both FSH and LH-induced testosterone. Half of the men will get recombinant FSH (300 IU; Gonal-f, Merck Serrono S.A. Aubonne, Schweiz) back, whereas 50% will not. Three weeks thereafter, the full spectrum of FSH dependent changes occur and are reflected in blood. From this occasion testosterone (Nebido, Ferring GmbH Wittland, Kiel, Germany) will be given to all participants to diminish the side-effects of the castration. Blood samples are collected at start, after 3 wks and after 5 wks. At that point also a follow up is undertaken. This experimental design will provide samples from each individual during normal conditions, during castration, and after a standardised dose of FSH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, non-smoking, body mass index 20-25,
排除标准
- •Medication or drug abuse
研究组 & 干预措施
GnRH antagonist + FSH + testosterone
At the start of the study: 240 mg of the gonadotropin releasing hormone antagonist Degarelix (Ferring GmbH, Wittland, Kiel, Germany) + recombinant FSH (Gonal-f, Merck Serrono S.A. Aubonne, Schweiz), 300 IU every second day for 5 weeks.
After 3 weeks: 1000 mg testosterone once.
干预措施: Degarelix 120 MG [Firmagon] (Drug)
GnRH antagonist + FSH + testosterone
At the start of the study: 240 mg of the gonadotropin releasing hormone antagonist Degarelix (Ferring GmbH, Wittland, Kiel, Germany) + recombinant FSH (Gonal-f, Merck Serrono S.A. Aubonne, Schweiz), 300 IU every second day for 5 weeks.
After 3 weeks: 1000 mg testosterone once.
干预措施: Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector (Drug)
GnRH antagonist + FSH + testosterone
At the start of the study: 240 mg of the gonadotropin releasing hormone antagonist Degarelix (Ferring GmbH, Wittland, Kiel, Germany) + recombinant FSH (Gonal-f, Merck Serrono S.A. Aubonne, Schweiz), 300 IU every second day for 5 weeks.
After 3 weeks: 1000 mg testosterone once.
干预措施: Testosterone Undecanoate (Drug)
GnRH antagonist + testosterone
At the start of the study: 240 mg of the gonadotropin releasing hormone antagonist Degarelix (Ferring GmbH, Wittland, Kiel, Germany).
After 3 weeks: 1000 mg testosterone (Nebido, Bayer AB, Solna, Sweden) once.
干预措施: Degarelix 120 MG [Firmagon] (Drug)
GnRH antagonist + testosterone
At the start of the study: 240 mg of the gonadotropin releasing hormone antagonist Degarelix (Ferring GmbH, Wittland, Kiel, Germany).
After 3 weeks: 1000 mg testosterone (Nebido, Bayer AB, Solna, Sweden) once.
干预措施: Testosterone Undecanoate (Drug)
结局指标
主要结局
PSA-concentration
时间窗: 5 weeks
Prostate marker
次要结局
- FSH dependent proteins(5 weeks)