Intranasal Delivery of Testosterone and Its Effect on Doping Markers

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 4

Conditions: Abuse of Anabolic Steroids

Treatments: Drug: Testosterone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02611154

84225

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Intranasal Testosterone

Experimental group

Description:

All participants will be receiving intranasal testosterone and will follow the same study procedures.

Treatment:

Drug: Testosterone