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Diagnostic Relevance of Salivary Testosterone Concentrations in Doping Control.

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02134470
Enrollment
12
Registered
2014-05-09
Start date
2014-04-30
Completion date
2015-12-31
Last updated
2015-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian, Exercise, Testosterone

Keywords

saliva, blood, urine

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.

Interventions

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.

Sponsors

Technical University of Munich
CollaboratorOTHER
Paracelsus Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Salivary testosterone concentration2 weeksSalivary testosterone concentration will be quantified in relation to circadian time, exercise, and external low-dose hormone application.

Secondary

MeasureTime frameDescription
Serum testosterone2 weeksSerum testosterone concentration (free/bound) will be quantified in relation to circadian time, exercise, and external low-dose hormone application.
Circulating microRNA in blood plasma2 weeksCirculating microRNA in blood plasma will be screened in relation to circadian time, exercise, and external low-dose hormone application.

Other

MeasureTime frameDescription
Testosterone in hairs4 weeksAt onset, 2 weeks and 4 weeks after testosterone application steroid hormone concentration will be quantified in scalp hair.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026