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临床试验/NCT02134470
NCT02134470Unknown不适用

Diagnostic Relevance of Salivary Testosterone Concentrations After Exogene Low-dose Hormone Application as a Screening Method for in Doping Control.

Paracelsus Medical University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
12
试验地点
1
主要终点
Salivary testosterone concentration

研究概览

简要总结

It is generally accepted that chemical testing of biologic fluids is the most objective means of diagnosis of drug use. In recent years saliva has attracted much attention. The prime advantage of saliva is that it offers non-invasive, stress-free and real-time repeated sampling whereas blood collection is undesirable, difficult and expensive. In addition, it is known that androgens such as testosterone can be assayed in saliva, as these steroids pass the endothelial-epithelial barriers by passive diffusion. Nevertheless, the correlations of blood, urine and saliva concentrations are not well documented. In recent reviews, it is pointed out that salivary hormone analysis could be a promising method for sports medicine and doping control, but much work is needed before the use of saliva samples in this area receives the acceptance. According to recent studies the increase of testosterone concentration in saliva is significantly higher than alterations of steroid concentrations (or ratios) in blood or urine. Saliva concentration may therefore serve as screening parameter to select suspicious cases for further target evaluation (e.g. by IRMS). This may be beneficial to identify cases of transdermal administration of low steroid doses. It is therefore the aim of the present project to detect administered testosterone in saliva and compare these levels to those in blood and urine. The intention is not to detect high dosage but low dosage abuse of testosterone, as a single-dose by patch application. From the practical point of view saliva could offer a complementary specimen for a pre-screening of testosterone. So it could be assumed that salivary testosterone exceed upon plasma and/or urine levels. So the present study could be the base for a new method to preselect the suspicious samples for testosterone abuse.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • informed consent

排除标准

  • any metabolic, cardiovascular, pulmonary disorder
  • neoplastic or hormonal disorders
  • active sports competitor
  • disorders which hinder cycling ergometry

研究组 & 干预措施

Testosterone

Experimental

Chemical testing of saliva is an objective method to quantify steroid hormones. Recent studies indicate that salivary testosterone is significantly higher than in other body fluids. Therefore, saliva may serve as pre-screening parameter to select suspicious cases for further target evaluation. The aim of the present project is to detect administered testosterone in saliva and compare these levels to those in blood and urine. Therefore, each participant represents its own control.

干预措施: Testosterone supplementation (Drug)

结局指标

主要结局

Salivary testosterone concentration

时间窗: 2 weeks

Salivary testosterone concentration will be quantified in relation to circadian time, exercise, and external low-dose hormone application.

次要结局

  • Circulating microRNA in blood plasma(2 weeks)
  • Serum testosterone(2 weeks)

研究者

发起方
Paracelsus Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Martin Schoenfelder

Head of Institute, Research Institute of Molecular Sports Medicine and Rehabilitation

Paracelsus Medical University

研究点 (1)

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