Abuse of Anabolic SteroidsPhase 4IntranasalNCT02611154
Intranasal Delivery of Testosterone and Its Effect on Doping Markers
A Phase 4 study testing Testosterone in people with Abuse of Anabolic Steroids, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Abuse of Anabolic Steroids
- What is being tested?
- Testosterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2015to 19 Jan 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
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.
Read the 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.
- Conditions
- Abuse of Anabolic Steroids
- Being tested
- Testosterone
- Keywords
- Healthy Volunteers, Sports Medicine, Men's Health, Athletes, Anti-Doping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Also called Natesto
Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Testosterone | Experimental | All participants will be receiving intranasal testosterone and will follow the same study procedures. Receives: Drug: Testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks of dosing for each participant
Secondary outcomes (2)
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.
Measured: Day 1, Day 3, Day 5
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.
Measured: Day 0 and Day 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start18 Nov 2015
- Primary completion19 Jan 2016
- Study completion19 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Abuse of Anabolic SteroidsStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Sports Medicine Research and Testing Laboratory, Partnership for Clean Competition
- Responsible party
- Principal investigator, Stuart Willick, University of Utah
- Investigators
- Stuart Willick, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611154
- Sponsor's protocol ID
- 84225
- Acronym
- Intranasal
- Status last verified
- Jan 2020
- First submitted
- 11 Nov 2015
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will be published in scientific literature without Patient Health Information (PHI) identifying any participant data.
Publications
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.
PubMed 16799097Geyer 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.
PubMed 24632537Sottas 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.
PubMed 20122450Vernec 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.
PubMed 24659508Jia 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.
PubMed 25879005Bassil 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.
PubMed 19707253
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Delivery of Testosterone and Its Effect on Doping Markers
- ClinicalTrials.gov ID
- NCT02611154
- Acronym / sponsor ID
- Intranasal / 84225
- Conditions
- Abuse of Anabolic Steroids
- Keywords
- Healthy Volunteers, Sports Medicine, Men's Health, Athletes, Anti-Doping
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Sports Medicine Research and Testing Laboratory, Partnership for Clean Competition
- Study start
- 18 Nov 2015 (actual)
- Primary completion
- 19 Jan 2016 (actual)
- Study completion
- 19 Jan 2016 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Posted 10 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intranasal Testosterone | Experimental | Drug: TestosteroneAll participants will be receiving intranasal testosterone and will follow the same study procedures. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TestosteroneAlso: NatestoParticipants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks. | Drug | Intranasal Testosterone |
Primary outcome
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
2 secondary outcomes
Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline
Time frame: Day 1, Day 3, Day 5
Testosterone Level in Blood as Measured for Safety
Time frame: Day 0 and Day 19
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16799097Saudan 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.
- Background: PubMed 24632537Geyer 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.
- Background: PubMed 20122450Sottas 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.
- Background: PubMed 24659508Vernec 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.
- Background: PubMed 25879005Jia 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.
- Background: PubMed 19707253Bassil 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.
- Individual participant dataSharing planned: No. Data will be published in scientific literature without Patient Health Information (PHI) identifying any participant data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Willick, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone in people with Abuse of Anabolic Steroids, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steroid Levels in Urine Steroid Profile (time frame: 4 weeks of dosing for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02611154, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.