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Diagnostic Relevance of Salivary Testosterone Concentrations in Doping Control.

Information source: Paracelsus Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Circadian; Exercise; Testosterone

Intervention: Testosterone supplementation (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Paracelsus Medical University

Official(s) and/or principal investigator(s):
Martin Schönfelder, Dr., Principal Investigator, Affiliation: Paracelsus Medical Private University Salzburg, AUT
Hande Hofmann, Dr., Principal Investigator, Affiliation: Technische Universität München, GER
Detlef Thieme, Dr., Principal Investigator, Affiliation: Institute of Doping Analysis und Sports Biochemistry Dresden in Kreischa, GER


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.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Salivary testosterone concentration

Secondary outcome:

Serum testosterone

Circulating microRNA in blood plasma


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.


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

Locations and Contacts

Technische Universität München, Munich, Bavaria 80809, Germany
Additional Information

Institute of Preventive Pediatrics

Related publications:

Schönfelder M, Hofmann H, Anielski P, Thieme D, Oberhoffer R, Michna H. Gene expression profiling in human whole blood samples after controlled testosterone application and exercise. Drug Test Anal. 2011 Oct;3(10):652-60. doi: 10.1002/dta.360.

Thieme D, Rautenberg C, Grosse J, Schoenfelder M. Significant increase of salivary testosterone levels after single therapeutic transdermal administration of testosterone: suitability as a potential screening parameter in doping control. Drug Test Anal. 2013 Nov-Dec;5(11-12):819-25. doi: 10.1002/dta.1536. Epub 2013 Oct 25.

Starting date: April 2014
Last updated: April 28, 2015

Page last updated: August 23, 2015

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