Clinical trial NCT02134470: Diagnostic Relevance of Salivary Testosterone Concentrations in Doping Control.
Official title: Diagnostic Relevance of Salivary Testosterone Concentrations After Exogene Low-dose Hormone Application as a Screening Method for in Doping Control.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Circadian
Exercise
Testosterone
Keywords: saliva
blood
urine
Lead sponsor: Paracelsus Medical University
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
First posted: 2014-05-09
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Salivary testosterone concentration
timeFrame: 2 weeks
Secondary outcomes:
measure: Serum testosterone
timeFrame: 2 weeks
measure: Circulating microRNA in blood plasma
timeFrame: 2 weeks
Other outcomes:
measure: Testosterone in hairs
timeFrame: 4 weeks
Locations:
city: Munich
country: Germany
facility: Technische Universität München
state: Bavaria
Study officials:
affiliation: Paracelsus Medical Private University Salzburg, AUT
name: Martin Schönfelder, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Technische Universität München, GER
name: Hande Hofmann, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Doping Analysis und Sports Biochemistry Dresden in Kreischa, GER
name: Detlef Thieme, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schonfelder 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.
citation: 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.