Abuse of Anabolic Steroids Clinical Trial
— IntranasalOfficial title:
Intranasal Delivery of Testosterone and Its Effect on Doping Markers
| Verified date | January 2020 |
| Source | University of Utah |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 5 |
| Est. completion date | January 19, 2016 |
| Est. primary completion date | January 19, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 35 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Utah Orthopaedic Center | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| University of Utah | Partnership for Clean Competition, Sports Medicine Research and Testing Laboratory |
United States,
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. Epub 2009 Jun 22. — View Citation
Geyer H, Schänzer 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. Review. — View Citation
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. Review. — View Citation
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:i21-4. Review. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 |
4 weeks of dosing for each participant | |
| 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. | Day 1, Day 3, Day 5 | |
| 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. | Day 0 and Day 19 |