Overview

Intranasal Delivery of Testosterone and Its Effect on Doping Markers

Status:
Completed
Trial end date:
2016-01-19
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Utah
Collaborators:
Partnership for Clean Competition
Sports Medicine Research and Testing Laboratory
Treatments:
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Criteria
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