Intranasal Delivery of Testosterone and Its Effect on Doping Markers
| Status: | Completed |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 3/11/2017 |
| Start Date: | November 18, 2015 |
| End Date: | January 19, 2016 |
Hypothesis: Intranasal administration of exogenous testosterone results in a characteristic
profile during anti-doping testing, which is different than the profile seen when
testosterone is administered into muscle, on skin or under the tongue.
Objective: The investigators aim to characterize the unique steroid doping profile following
administration of intranasal testosterone to healthy, active volunteer subjects.
profile during anti-doping testing, which is different than the profile seen when
testosterone is administered into muscle, on skin or under the tongue.
Objective: The investigators aim to characterize the unique steroid doping profile following
administration of intranasal testosterone to healthy, active volunteer subjects.
Testosterone is a substance commonly abused in the sporting world despite being banned by
all American sports leagues, international federations, and the World Anti-Doping Agency.
Current methods employed to detect exogenously administered testosterone include direct
detection using isotope ratio mass spectrometry (IRMS) and indirect detection using the
athlete biological passport (ABP). However, different formulations of testosterone (oral,
transdermal, sublingual, etc) are expected to result in characteristic IRMS profiles, affect
the ABP readings in unique ways, and differ in their windows of detection. In 2014, a new
formulation of testosterone, Natesto, which is administered intranasally, was FDA approved.
Though only approved for medical use, it is expected athletes may use this product, and its
effect on steroid doping markers has yet to be determined. Characterization of this
detection profile is necessary for confirmation of the exact product being administered in
an anti-doping setting. In this study, the investigators aim to understand the effects on
the steroid doping profile following a single administration of Natesto to healthy, active
volunteers. Windows of detection will be determined for the standard dosing of Natesto, and
the effects on ABP markers and IRMS profiles will also be established.
all American sports leagues, international federations, and the World Anti-Doping Agency.
Current methods employed to detect exogenously administered testosterone include direct
detection using isotope ratio mass spectrometry (IRMS) and indirect detection using the
athlete biological passport (ABP). However, different formulations of testosterone (oral,
transdermal, sublingual, etc) are expected to result in characteristic IRMS profiles, affect
the ABP readings in unique ways, and differ in their windows of detection. In 2014, a new
formulation of testosterone, Natesto, which is administered intranasally, was FDA approved.
Though only approved for medical use, it is expected athletes may use this product, and its
effect on steroid doping markers has yet to be determined. Characterization of this
detection profile is necessary for confirmation of the exact product being administered in
an anti-doping setting. In this study, the investigators aim to understand the effects on
the steroid doping profile following a single administration of Natesto to healthy, active
volunteers. Windows of detection will be determined for the standard dosing of Natesto, and
the effects on ABP markers and IRMS profiles will also be established.
Inclusion Criteria:
1. Males between the ages of 18 and 35 years-old who participate in regular, moderate to
high intensity physical activity will be recruited for the study.
Exclusion Criteria:
1. Individuals below the age of 18 or greater than the age of 35 on the day of
enrollment
2. Individuals who are in a Registered Testing Pool for anti-doping purposes, or
individuals who for any reason could be subject to doping control testing.
3. Unwilling to provide blood or urine samples
4. Not actively exercising
5. Individuals with any history of cancer, cardiovascular disease, endocrine
abnormalities, renal disease, hepatic disease, neurologic disease or any psychiatric
history
6. Individuals with a history of nasal disorders, nasal surgeries, sinus surgeries, or
sinus disease
7. Individuals that have a baseline hematocrit value above the normal range
8. Individuals that are diabetic or are currently taking a diabetic medication
9. Individuals that are currently using any WADA prohibited substances
10. Individuals that have recently used or currently using anabolic androgenic steroids
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