Diagnostic Relevance of Salivary Testosterone Concentrations in Doping Control.

Study Overview
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Brief Summary
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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.

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

Conditions
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Circadian, Exercise, Testosterone

Intervention / Treatment
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* Drug: Testosterone supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male healthy informed consent Exclusion Criteria: any metabolic, cardiovascular, pulmonary disorder neoplastic or hormonal disorders active sports competitor disorders which hinder cycling ergometry

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testosterone<br>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. | Drug: Testosterone supplementation<br>* Low-dose testosterone supplementation will be facilitated by using hormone patches. For pharmacokinetic aspects circadian profiles of saliva/blood/urine will be measured under native conditions and under exogene hormone application. In addition, cross-reactivity of a standardized exercise bout and hormone application will be of further interest.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary testosterone concentration | Salivary testosterone concentration will be quantified in relation to circadian time, exercise, and external low-dose hormone application. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum testosterone | Serum testosterone concentration (free/bound) will be quantified in relation to circadian time, exercise, and external low-dose hormone application. | 2 weeks | 
| Circulating microRNA in blood plasma | Circulating microRNA in blood plasma will be screened in relation to circadian time, exercise, and external low-dose hormone application. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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saliva, blood, urine