Completed

NCT Number: NCT02611154

Intranasal Delivery of Testosterone and Its Effect on Doping Markers

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.

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Key information

Conditions

Abuse of Anabolic Steroids

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Individuals below the age of 18 or greater than the age of 35 on the day of enrollment
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.
Unwilling to provide blood or urine samples
Not actively exercising
Individuals with any history of cancer, cardiovascular disease, endocrine abnormalities, renal disease, hepatic disease, neurologic disease or any psychiatric history
Individuals with a history of nasal disorders, nasal surgeries, sinus surgeries, or sinus disease
Individuals that have a baseline hematocrit value above the normal range
Individuals that are diabetic or are currently taking a diabetic medication
Individuals that are currently using any WADA prohibited substances
Individuals that have recently used or currently using anabolic androgenic steroids

Treatment and study plan

Testosterone

Drug

Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks.

Other names: Natesto

Primary outcomes

Steroid Levels in Urine Steroid Profile

Time frame: 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 outcomes

Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

Partnership for Clean Competition
Sports Medicine Research and Testing Laboratory

Registry information

Acronym: Intranasal

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Nov 20, 2015
Registry last updated: Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.