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Testosterone abuse is extremely prevalent in athletes globally and especially in the United States professional sporting leagues
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone group one | Active Comparator | The participant will receive a single injection of one of three types of testosterone in phase one. In phase two the participant will receive two weeks of either a daily skin cream or a twice-daily pill to swallow. |
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| Testosterone group two | Active Comparator | The participant will receive a single injection of one of three types of testosterone in phase one. In phase two the participant will receive two weeks of either a daily skin cream or a twice-daily pill to swallow. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone injection | Drug | A single injection of testosterone |
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| Measure | Description | Time Frame |
|---|---|---|
| Detection windows of testosterone administered via injection, oral and skin cream. | Changes in urinary testosterone/epitestosterone ratio after administration of testosterone in injection, oral and cream | 12 weeks |
| Changes in serum concentration of testosterone | Changes in serum concentrations of testosterone in injection, oral and cream administration of testosterone | 12 weeks |
| Changes in serum concentration of androstenedione | Changes in serum concentrations of androstenedione in injection, oral and cream administration of testosterone | 12 weeks |
| Changes in serum concentration of luteinizing hormone | Changes in serum concentrations of luteinizing hormone after injection, oral and cream administration of testosterone | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Direct detection of testosterone esters | Direct detection of testosterone esters | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoff Miller, PhD | Sports Medicine Research and Testing Laboratory | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sports Medicine Research and Testing Laboratory | South Jordan | Utah | 84095 | United States |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| D043343 | Testosterone Propionate |
| C010792 | testosterone undecanoate |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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Three groups in phase one and two groups in phase two, randomized by a computer.
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| Testosterone gel | Drug | A daily dose of testosterone gel |
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| Testosterone Oral | Drug | A twice-daily pill of testosterone pill to swallow |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |