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| Name | Class |
|---|---|
| Sports Medicine Research and Testing Laboratory | INDUSTRY |
| Partnership for Clean Competition | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Testosterone | Experimental | All participants will be receiving intranasal testosterone and will follow the same study procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone | Drug | Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Steroid Levels in Urine Steroid Profile | Participants were instructed to follow this dosing pattern: Begin taking Intranasal Testosterone at Day 1 for 5 consecutive days (Days 1-5), then to take 2 days off (Day 6 and 7) Urine sample at Day 6 Begin taking Intranasal Testosterone at Day 8 for 5 consecutive days (Days 8-12), then to take 3 days off (Day 13, Day 14, Day 15) Urine sample at Day 13 Begin taking Intranasal Testosterone at Day 16 for 5 consecutive days (Days 16-20), then to take 2 days off (Day 21 and 22) Urine sample at Day 21 Begin taking Intranasal Testosterone at Day 23 for 5 consecutive days (Days 23-27 ), then to take 2 days off (Day 28 and 29) Urine sample at Day 28 The first day of the dosing pattern is considered Day 1 and the last day of the pattern is considered Day 29. Samples 4-8 were analyzed between 0 and 24hours post-dose Sample 9 was analyzed 48 hours post-dose Sample 10 was analyzed 72 hours post-dose Sample 11 was analyzed one week post-dose | 4 weeks of dosing for each participant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline | Participants were asked to provide 3 urine samples at Day 1, Day 3, Day 5 to measure their baseline urinary steroid marker levels. To accommodate participant schedules, all baseline samples were collected within a two week timeframe. This outcome is measuring if any participants baseline urine samples resulted in a suspicious steroid profile. For this study, "suspicious" is defined as any urine sample resulting in testosterone steroid detection above 200ng/mL. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Willick, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Orthopaedic Center | Salt Lake City | Utah | 84108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16799097 | Background | Saudan C, Baume N, Robinson N, Avois L, Mangin P, Saugy M. Testosterone and doping control. Br J Sports Med. 2006 Jul;40 Suppl 1(Suppl 1):i21-4. doi: 10.1136/bjsm.2006.027482. | |
| 24632537 | Background | Geyer H, Schanzer W, Thevis M. Anabolic agents: recent strategies for their detection and protection from inadvertent doping. Br J Sports Med. 2014 May;48(10):820-6. doi: 10.1136/bjsports-2014-093526. Epub 2014 Mar 14. |
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Data will be published in scientific literature without Patient Health Information (PHI) identifying any participant data.
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Recruitment for this study began in November 2015 and ended December 2015. The final participant was enrolled on 03DEC2015 and completed the study on 19JAN2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intranasal Testosterone | All participants will be receiving intranasal testosterone and will follow the same study procedures. Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intranasal Testosterone | All participants will be receiving intranasal testosterone and will follow the same study procedures. Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Steroid Levels in Urine Steroid Profile | Participants were instructed to follow this dosing pattern: Begin taking Intranasal Testosterone at Day 1 for 5 consecutive days (Days 1-5), then to take 2 days off (Day 6 and 7) Urine sample at Day 6 Begin taking Intranasal Testosterone at Day 8 for 5 consecutive days (Days 8-12), then to take 3 days off (Day 13, Day 14, Day 15) Urine sample at Day 13 Begin taking Intranasal Testosterone at Day 16 for 5 consecutive days (Days 16-20), then to take 2 days off (Day 21 and 22) Urine sample at Day 21 Begin taking Intranasal Testosterone at Day 23 for 5 consecutive days (Days 23-27 ), then to take 2 days off (Day 28 and 29) Urine sample at Day 28 The first day of the dosing pattern is considered Day 1 and the last day of the pattern is considered Day 29. Samples 4-8 were analyzed between 0 and 24hours post-dose Sample 9 was analyzed 48 hours post-dose Sample 10 was analyzed 72 hours post-dose Sample 11 was analyzed one week post-dose | Posted | Mean | Standard Deviation | ng/mL | 4 weeks of dosing for each participant |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intranasal Testosterone | All participants will be receiving intranasal testosterone and will follow the same study procedures. Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Geoffry Miller | Sports Medicine Research & Testing Laboratory | 801-994-9519 | gmiller@smrtl.org |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| C000722508 | Natesto |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Day 1, Day 3, Day 5 |
| Testosterone Level in Blood as Measured for Safety | Testosterone level in blood to ensure safety levels of testosterone prior to (Day 0) and after the first two weeks of drug administration (Day 19). Steroid levels below the normal range were considered safe to continue study participation. | Day 0 and Day 19 |
| 20122450 | Background | Sottas PE, Saugy M, Saudan C. Endogenous steroid profiling in the athlete biological passport. Endocrinol Metab Clin North Am. 2010 Mar;39(1):59-73, viii-ix. doi: 10.1016/j.ecl.2009.11.003. |
| 24659508 | Background | Vernec AR. The Athlete Biological Passport: an integral element of innovative strategies in antidoping. Br J Sports Med. 2014 May;48(10):817-9. doi: 10.1136/bjsports-2014-093560. Epub 2014 Mar 21. |
| 25879005 | Background | Jia H, Sullivan CT, McCoy SC, Yarrow JF, Morrow M, Borst SE. Review of health risks of low testosterone and testosterone administration. World J Clin Cases. 2015 Apr 16;3(4):338-44. doi: 10.12998/wjcc.v3.i4.338. |
| 19707253 | Background | Bassil N, Alkaade S, Morley JE. The benefits and risks of testosterone replacement therapy: a review. Ther Clin Risk Manag. 2009 Jun;5(3):427-48. doi: 10.2147/tcrm.s3025. Epub 2009 Jun 22. |
| Participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Salt Lake City, Utah, USA | Number | participants |
|
| Urine Steroid Profile - Day 6 |
Day 6 steroid level in urine. Urine sample analyzed within 24 hours of dosing. |
| OG001 | Urine Steroid Profile - Day 13 | Day 13 steroid level in urine. Urine sample analyzed within 24 hours of dosing. |
| OG002 | Urine Steroid Profile - Day 21 | Day 21 steroid level in urine. Urine sample analyzed within 24 hours of dosing. |
| OG003 | Urine Steroid Profile - Day 28 | Day 28 steroid level in urine. Urine sample analyzed within 24 hours of dosing. |
| OG004 | Urine Steroid Profile - Day 29 | Day 29 steroid level in urine. Urine sample analyzed within the 24-48 hour window post-administration. |
| OG005 | Urine Steroid Profile - Day 30 | Day 30 steroid level in urine. Urine sample analyzed within the 48-72 hour window post-administration. |
| OG006 | Urine Steroid Profile - Day 35 | Urine was collected at Day 35 to identify any suppression of endogenous testosterone production following administration. |
| OG007 | Urine Steroid Profile - Day 42 | Urine was collected at Day 42 to identify any suppression of endogenous testosterone production following administration. |
|
|
| Secondary | Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline | Participants were asked to provide 3 urine samples at Day 1, Day 3, Day 5 to measure their baseline urinary steroid marker levels. To accommodate participant schedules, all baseline samples were collected within a two week timeframe. This outcome is measuring if any participants baseline urine samples resulted in a suspicious steroid profile. For this study, "suspicious" is defined as any urine sample resulting in testosterone steroid detection above 200ng/mL. | Posted | Count of Participants | Participants | Day 1, Day 3, Day 5 |
|
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| Secondary | Testosterone Level in Blood as Measured for Safety | Testosterone level in blood to ensure safety levels of testosterone prior to (Day 0) and after the first two weeks of drug administration (Day 19). Steroid levels below the normal range were considered safe to continue study participation. | Posted | Mean | Full Range | ng/mL | Day 0 and Day 19 |
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| 0 |
| 5 |
| 0 |
| 5 |
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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 |