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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02134470
Other study ID # BISP-SALIVA-2014
Secondary ID
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


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
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