Diagnostic Relevance of Salivary Testosterone Concentrations in Doping Control.

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02134470
• Other study ID #: BISP-SALIVA-2014
• Status: Active, not recruiting
• Phase: N/A
• First received: May 6, 2014
• Last updated: April 28, 2015
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: Paracelsus Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Circadian
• Exercise
• Testosterone

Intervention

Drug:
• Testosterone supplementation
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.

Locations

Country	Name	City	State
Germany	Technische Universität München	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Paracelsus Medical University	Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Testosterone in hairs	At onset, 2 weeks and 4 weeks after testosterone application steroid hormone concentration will be quantified in scalp hair.	4 weeks	No
Primary	Salivary testosterone concentration	Salivary testosterone concentration will be quantified in relation to circadian time, exercise, and external low-dose hormone application.	2 weeks	No
Secondary	Serum testosterone	Serum testosterone concentration (free/bound) will be quantified in relation to circadian time, exercise, and external low-dose hormone application.	2 weeks	No
Secondary	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	No

External Links

•   Institute of Preventive Pediatrics