Healthy
Conditions
Brief summary
Testosterone abuse is extremely prevalent in athletes globally and especially in the United States professional sporting leagues
Detailed description
Because human bodies make testosterone naturally, it can be difficult to determine whether the testosterone in your body is natural or if it came from administering testosterone. Currently, testosterone abuse by athletes is detected by anti-doping laboratories in urine samples and use can also be inferred by testing blood samples. As a pharmaceutical preparation, testosterone is available to administer to your body in different ways. However, due to lack of controlled data on the various preparations of testosterone administrations related to the anti-doping field, this study id designed to look at five different testosterone preparations delivered three different ways and how they compare to each other in terms of anti-doping detection and how long they will be in circulation in your body.
Interventions
A single injection of testosterone
DRUGTestosterone gel
A daily dose of testosterone gel
DRUGTestosterone Oral
A twice-daily pill of testosterone pill to swallow
Sponsors
Sports Medicine Research and Testing Laboratory
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Three groups in phase one and two groups in phase two, randomized by a computer.
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* HEALTHY MALE ADULTS, AGED 18-60 YEARS
Exclusion criteria
* Individuals currently enrolled in a registered testing pool for anti-doping purposes * Unwilling to provide urine or blood samples * Individuals who are not actively exercising * Individuals who show a high risk of heart attack or cardiovascular disease as defined by a physician * Individuals that have an elevated baseline hematocrit as determined by the PI * Individuals who are diabetic or are currently taking diabetic medications. * Individuals that have donated blood (approximately 500 mL) in the past 8 weeks * Individuals with severe acne * Individuals with a history of cancer, cardiac, renal or hepatic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection windows of testosterone administered via injection, oral and skin cream. | 12 weeks | Changes in urinary testosterone/epitestosterone ratio after administration of testosterone in injection, oral and cream |
| Changes in serum concentration of testosterone | 12 weeks | Changes in serum concentrations of testosterone in injection, oral and cream administration of testosterone |
| Changes in serum concentration of androstenedione | 12 weeks | Changes in serum concentrations of androstenedione in injection, oral and cream administration of testosterone |
| Changes in serum concentration of luteinizing hormone | 12 weeks | Changes in serum concentrations of luteinizing hormone after injection, oral and cream administration of testosterone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Direct detection of testosterone esters | 12 weeks | Direct detection of testosterone esters |
Countries
United States
Outcome results
None listed