Clinical trial NCT02611154: Intranasal Delivery of Testosterone and Its Effect on Doping Markers
Official title: Intranasal Delivery of Testosterone and Its Effect on Doping Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abuse of Anabolic Steroids
Keywords: Healthy Volunteers
Sports Medicine
Men's Health
Athletes
Anti-Doping
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Sports Medicine Research and Testing Laboratory
name: Partnership for Clean Competition
First posted: 2015-11-20
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Steroid Levels in Urine Steroid Profile
timeFrame: 4 weeks of dosing for each participant
Secondary outcomes:
measure: Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline
timeFrame: Day 1, Day 3, Day 5
measure: Testosterone Level in Blood as Measured for Safety
timeFrame: Day 0 and Day 19
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
Study officials:
affiliation: University of Utah
name: Stuart Willick, MD
role: PRINCIPAL_INVESTIGATOR
References:
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(Suppl 1):i21-4. doi: 10.1136/bjsm.2006.027482.
citation: 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.
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.
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.
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.
citation: 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.