Phase 4
Completed N=5
Intranasal Delivery of Testosterone and Its Effect on Doping Markers
Abuse of Anabolic Steroids
Source: ClinicalTrials.gov NCT02611154 ↗
Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Steroid Levels in Urine Steroid Profile — 69.5773456; 138.0291641; 163.117081; 107.7160658 ng/mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Steroid Levels in Urine Steroid Profile |
69.5773456; 138.0291641; 163.117081; 107.7160658; 14.15587072; 21.42280994 | — |
| SECONDARY Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Testosterone Level in Blood as Measured for Safety |
408.4; 373.4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02611154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.