NCT02611154

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

November 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 10, 2017

Completed
Last Updated

February 11, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

November 11, 2015

Results QC Date

October 6, 2016

Last Update Submit

January 29, 2020

Conditions

Abuse of Anabolic Steroids

Keywords

Healthy VolunteersSports MedicineMen's HealthAthletesAnti-Doping

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    Day 1, Day 3, Day 5

  • Testosterone Level in Blood as Measured for Safety

    Day 0 and Day 19

Study Arms (1)

Intranasal Testosterone

EXPERIMENTAL

All participants will be receiving intranasal testosterone and will follow the same study procedures.

Drug: Testosterone

Interventions

TestosteroneDRUG

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

Also known as: Natesto
Intranasal Testosterone

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

Related Publications (6)

  • 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.

    PMID: 16799097BACKGROUND

  • 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.

    PMID: 24632537BACKGROUND

  • 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.

    PMID: 20122450BACKGROUND

  • 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.

    PMID: 24659508BACKGROUND

  • 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.

    PMID: 25879005BACKGROUND

  • 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.

    PMID: 19707253BACKGROUND

MeSH Terms

Interventions

TestosteroneNatesto

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Dr. Geoffry Miller
Organization
Sports Medicine Research & Testing Laboratory
gmiller@smrtl.org
801-994-9519

Study Officials

  • Stuart Willick, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

November 11, 2015

First Posted

November 20, 2015

Study Start

November 18, 2015

Primary Completion

January 19, 2016

Study Completion

January 19, 2016

Last Updated

February 11, 2020

Results First Posted

March 10, 2017

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Data will be published in scientific literature without Patient Health Information (PHI) identifying any participant data.

Locations

US(1)