Abuse of Anabolic Steroids
Conditions
Keywords
Healthy Volunteers, Sports Medicine, Men's Health, Athletes, Anti-Doping
Brief 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.
Detailed 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.
Interventions
DRUGTestosterone
Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks.
Sponsors
Sports Medicine Research and Testing Laboratory
Partnership for Clean Competition
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steroid Levels in Urine Steroid Profile | 4 weeks of dosing for each participant | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline | Day 1, Day 3, Day 5 | 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. |
| Testosterone Level in Blood as Measured for Safety | Day 0 and Day 19 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Intranasal Testosterone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Region of Enrollment United States | 5 participants |
| Sex/Gender, Customized Male Participants | 5 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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
Time frame: 4 weeks of dosing for each participant
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Urine Steroid Profile - Day 6 | Steroid Levels in Urine Steroid Profile | Epitestosterone | 14.54132527 ng/mL | Standard Deviation 7.954646945 |
| Urine Steroid Profile - Day 6 | Steroid Levels in Urine Steroid Profile | Etiocholanolone | 3420.811467 ng/mL | Standard Deviation 2957.358109 |
| Urine Steroid Profile - Day 6 | Steroid Levels in Urine Steroid Profile | 5αAdiol | 81.50246345 ng/mL | Standard Deviation 28.87216828 |
| Urine Steroid Profile - Day 6 | Steroid Levels in Urine Steroid Profile | 5βAdiol | 323.5235566 ng/mL | Standard Deviation 95.27658018 |
| Urine Steroid Profile - Day 6 | Steroid Levels in Urine Steroid Profile | Androsterone | 2780.422993 ng/mL | Standard Deviation 1545.144279 |
| Urine Steroid Profile - Day 6 | Steroid Levels in Urine Steroid Profile | Testosterone | 69.5773456 ng/mL | Standard Deviation 35.54601116 |
| Urine Steroid Profile - Day 13 | Steroid Levels in Urine Steroid Profile | 5βAdiol | 370.2752839 ng/mL | Standard Deviation 244.8399242 |
| Urine Steroid Profile - Day 13 | Steroid Levels in Urine Steroid Profile | Etiocholanolone | 2984.088377 ng/mL | Standard Deviation 2078.022714 |
| Urine Steroid Profile - Day 13 | Steroid Levels in Urine Steroid Profile | Testosterone | 138.0291641 ng/mL | Standard Deviation 141.9066157 |
| Urine Steroid Profile - Day 13 | Steroid Levels in Urine Steroid Profile | Epitestosterone | 16.23444899 ng/mL | Standard Deviation 11.98868156 |
| Urine Steroid Profile - Day 13 | Steroid Levels in Urine Steroid Profile | Androsterone | 3147.357191 ng/mL | Standard Deviation 2520.278196 |
| Urine Steroid Profile - Day 13 | Steroid Levels in Urine Steroid Profile | 5αAdiol | 70.09892435 ng/mL | Standard Deviation 31.91867777 |
| Urine Steroid Profile - Day 21 | Steroid Levels in Urine Steroid Profile | 5βAdiol | 386.6496467 ng/mL | Standard Deviation 178.3061711 |
| Urine Steroid Profile - Day 21 | Steroid Levels in Urine Steroid Profile | 5αAdiol | 79.92660959 ng/mL | Standard Deviation 19.82671546 |
| Urine Steroid Profile - Day 21 | Steroid Levels in Urine Steroid Profile | Etiocholanolone | 3168.249168 ng/mL | Standard Deviation 1630.873996 |
| Urine Steroid Profile - Day 21 | Steroid Levels in Urine Steroid Profile | Testosterone | 163.117081 ng/mL | Standard Deviation 109.276721 |
| Urine Steroid Profile - Day 21 | Steroid Levels in Urine Steroid Profile | Epitestosterone | 10.08654906 ng/mL | Standard Deviation 4.588211806 |
| Urine Steroid Profile - Day 21 | Steroid Levels in Urine Steroid Profile | Androsterone | 3377.718911 ng/mL | Standard Deviation 1511.306185 |
| Urine Steroid Profile - Day 28 | Steroid Levels in Urine Steroid Profile | Androsterone | 4014.439418 ng/mL | Standard Deviation 4846.667258 |
| Urine Steroid Profile - Day 28 | Steroid Levels in Urine Steroid Profile | Testosterone | 107.7160658 ng/mL | Standard Deviation 113.703136 |
| Urine Steroid Profile - Day 28 | Steroid Levels in Urine Steroid Profile | Epitestosterone | 9.736167767 ng/mL | Standard Deviation 4.015340993 |
| Urine Steroid Profile - Day 28 | Steroid Levels in Urine Steroid Profile | Etiocholanolone | 4614.568182 ng/mL | Standard Deviation 7192.193898 |
| Urine Steroid Profile - Day 28 | Steroid Levels in Urine Steroid Profile | 5αAdiol | 83.39693284 ng/mL | Standard Deviation 59.00306611 |
| Urine Steroid Profile - Day 28 | Steroid Levels in Urine Steroid Profile | 5βAdiol | 369.209311 ng/mL | Standard Deviation 243.4060107 |
| Urine Steroid Profile - Day 29 | Steroid Levels in Urine Steroid Profile | Testosterone | 14.15587072 ng/mL | Standard Deviation 4.228012086 |
| Urine Steroid Profile - Day 29 | Steroid Levels in Urine Steroid Profile | Etiocholanolone | 1154.779419 ng/mL | Standard Deviation 460.2075499 |
| Urine Steroid Profile - Day 29 | Steroid Levels in Urine Steroid Profile | 5βAdiol | 145.5896139 ng/mL | Standard Deviation 54.18663296 |
| Urine Steroid Profile - Day 29 | Steroid Levels in Urine Steroid Profile | 5αAdiol | 37.53345262 ng/mL | Standard Deviation 7.673138406 |
| Urine Steroid Profile - Day 29 | Steroid Levels in Urine Steroid Profile | Epitestosterone | 12.22899541 ng/mL | Standard Deviation 4.434891082 |
| Urine Steroid Profile - Day 29 | Steroid Levels in Urine Steroid Profile | Androsterone | 1098.544542 ng/mL | Standard Deviation 430.6835869 |
| Urine Steroid Profile - Day 30 | Steroid Levels in Urine Steroid Profile | Epitestosterone | 16.38534782 ng/mL | Standard Deviation 4.918171284 |
| Urine Steroid Profile - Day 30 | Steroid Levels in Urine Steroid Profile | Androsterone | 1689.228939 ng/mL | Standard Deviation 968.2213645 |
| Urine Steroid Profile - Day 30 | Steroid Levels in Urine Steroid Profile | Testosterone | 21.42280994 ng/mL | Standard Deviation 14.29364856 |
| Urine Steroid Profile - Day 30 | Steroid Levels in Urine Steroid Profile | 5βAdiol | 158.5303528 ng/mL | Standard Deviation 90.57253904 |
| Urine Steroid Profile - Day 30 | Steroid Levels in Urine Steroid Profile | Etiocholanolone | 1810.282342 ng/mL | Standard Deviation 1552.137347 |
| Urine Steroid Profile - Day 30 | Steroid Levels in Urine Steroid Profile | 5αAdiol | 51.7003489 ng/mL | Standard Deviation 22.77519196 |
| Urine Steroid Profile - Day 35 | Steroid Levels in Urine Steroid Profile | Etiocholanolone | 2612.685992 ng/mL | Standard Deviation 2105.416619 |
| Urine Steroid Profile - Day 35 | Steroid Levels in Urine Steroid Profile | Testosterone | 32.9077285 ng/mL | Standard Deviation 13.76180063 |
| Urine Steroid Profile - Day 35 | Steroid Levels in Urine Steroid Profile | Androsterone | 2292.971167 ng/mL | Standard Deviation 853.7596469 |
| Urine Steroid Profile - Day 35 | Steroid Levels in Urine Steroid Profile | 5αAdiol | 60.19484767 ng/mL | Standard Deviation 21.91151504 |
| Urine Steroid Profile - Day 35 | Steroid Levels in Urine Steroid Profile | 5βAdiol | 166.0185686 ng/mL | Standard Deviation 97.42880397 |
| Urine Steroid Profile - Day 35 | Steroid Levels in Urine Steroid Profile | Epitestosterone | 27.76476978 ng/mL | Standard Deviation 16.66310752 |
| Urine Steroid Profile - Day 42 | Steroid Levels in Urine Steroid Profile | 5αAdiol | 56.94343765 ng/mL | Standard Deviation 30.25653073 |
| Urine Steroid Profile - Day 42 | Steroid Levels in Urine Steroid Profile | Testosterone | 28.14492389 ng/mL | Standard Deviation 6.661553442 |
| Urine Steroid Profile - Day 42 | Steroid Levels in Urine Steroid Profile | Androsterone | 1561.824479 ng/mL | Standard Deviation 663.1827091 |
| Urine Steroid Profile - Day 42 | Steroid Levels in Urine Steroid Profile | 5βAdiol | 85.54384971 ng/mL | Standard Deviation 17.46215146 |
| Urine Steroid Profile - Day 42 | Steroid Levels in Urine Steroid Profile | Epitestosterone | 32.56796986 ng/mL | Standard Deviation 10.94213563 |
| Urine Steroid Profile - Day 42 | Steroid Levels in Urine Steroid Profile | Etiocholanolone | 1281.752255 ng/mL | Standard Deviation 372.3518874 |
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.
Time frame: Day 1, Day 3, Day 5
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Urine Steroid Profile - Day 6 | Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline | 0 Participants |
| Urine Steroid Profile - Day 13 | Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline | 0 Participants |
| Urine Steroid Profile - Day 21 | Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline | 0 Participants |
| Urine Steroid Profile - Day 28 | Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline | 0 Participants |
| Urine Steroid Profile - Day 29 | Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline | 0 Participants |
| Urine Steroid Profile - Day 30 | Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline | 0 Participants |
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.
Time frame: Day 0 and Day 19
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Urine Steroid Profile - Day 6 | Testosterone Level in Blood as Measured for Safety | 408.4 ng/mL |
| Urine Steroid Profile - Day 13 | Testosterone Level in Blood as Measured for Safety | 373.4 ng/mL |