Conditions: Abuse of Anabolic Steroids
Keywords: Healthy Volunteers Sports Medicine Men's Health Athletes Anti-Doping
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 5
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: All participants will be receiving intranasal testosterone and will follow the same study procedures.

Interventions: intervention 1: Testosterone
Intervention descriptions: intervention 1: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks.

Protocol document: