CircadianNCT02134470
Diagnostic Relevance of Salivary Testosterone Concentrations in Doping Control.
A study testing Testosterone supplementation in people with Circadian and Exercise, run by Paracelsus Medical University at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circadian, Exercise, Testosterone
- What is being tested?
- Testosterone supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male
- healthy
- informed consent
Who cannot join
- any metabolic, cardiovascular, pulmonary disorder
- neoplastic or hormonal disorders
- active sports competitor
- disorders which hinder cycling ergometry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Relevance of Salivary Testosterone Concentrations After Exogene Low-dose Hormone Application as a Screening Method for in Doping Control.
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.
- Conditions
- Circadian, Exercise, Testosterone
- Being tested
- Testosterone supplementation
- Keywords
- saliva, blood, urine
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone supplementationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone | Experimental | Chemical testing of saliva is an objective method to quantify steroid hormones. Recent studies indicate that salivary testosterone is significantly higher than in other body fluids. Therefore, saliva may serve as pre-screening parameter to select suspicious cases for further target evaluation. The aim of the present project is to detect administered testosterone in saliva and compare these levels to those in blood and urine. Therefore, each participant represents its own control. Receives: Drug: Testosterone supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary testosterone concentration
Salivary testosterone concentration will be quantified in relation to circadian time, exercise, and external low-dose hormone application.
Measured: 2 weeks
Secondary outcomes (2)
Serum testosterone
Serum testosterone concentration (free/bound) will be quantified in relation to circadian time, exercise, and external low-dose hormone application.
Measured: 2 weeks
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CircadianStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich
- Responsible party
- Principal investigator, Dr. Martin Schoenfelder, Paracelsus Medical University
- Investigators
- Martin Schönfelder, Dr., Principal investigator, Paracelsus Medical Private University Salzburg, AUTHande Hofmann, Dr., Principal investigator, Technische Universität München, GERDetlef Thieme, Dr., Principal investigator, Institute of Doping Analysis und Sports Biochemistry Dresden in Kreischa, GER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134470
- Sponsor's protocol ID
- BISP-SALIVA-2014
- Status last verified
- Apr 2015
- First submitted
- 6 May 2014
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22031502Thieme 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.
PubMed 24167110
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Relevance of Salivary Testosterone Concentrations After Exogene Low-dose Hormone Application as a Screening Method for in Doping Control.
- ClinicalTrials.gov ID
- NCT02134470
- Acronym / sponsor ID
- BISP-SALIVA-2014
- Conditions
- Circadian, Exercise, Testosterone
- Keywords
- saliva, blood, urine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Collaborators
- Technical University of Munich
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testosterone | Experimental | Drug: Testosterone supplementationChemical testing of saliva is an objective method to quantify steroid hormones. Recent studies indicate that salivary testosterone is significantly higher than in other body fluids. Therefore, saliva may serve as pre-screening parameter to select suspicious cases for further target evaluation. The aim of the present project is to detect administered testosterone in saliva and compare these levels to those in blood and urine. Therefore, each participant represents its own control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male
- healthy
- informed consent
Key exclusion criteria (4 listed)
- any metabolic, cardiovascular, pulmonary disorder
- neoplastic or hormonal disorders
- active sports competitor
- disorders which hinder cycling ergometry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone supplementationLow-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. | Drug | Testosterone |
Primary outcome
Salivary testosterone concentration
Time frame: 2 weeks
Salivary testosterone concentration will be quantified in relation to circadian time, exercise, and external low-dose hormone application.
2 secondary outcomes
Serum testosterone
Time frame: 2 weeks
Circulating microRNA in blood plasma
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Background: PubMed 22031502Schonfelder 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.
- Background: PubMed 24167110Thieme 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.
- Institute of Preventive PediatricsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Schönfelder, Dr. principal investigator
Paracelsus Medical Private University Salzburg, AUT
Hande Hofmann, Dr. principal investigator
Technische Universität München, GER
Detlef Thieme, Dr. principal investigator
Institute of Doping Analysis und Sports Biochemistry Dresden in Kreischa, GER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testosterone supplementation in people with Circadian and Exercise, run by Paracelsus Medical University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary testosterone concentration (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02134470, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.