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CompletedNCT06393634T estersUpdated Dec 3, 2024

Comparing Direct and Indirect Detection Methods of Multiple Routes of Testosterone Administration

An Early Phase 1 interventional study of Testosterone injection and Testosterone gel in Healthy, sponsored by Sports Medicine Research and Testing Laboratory. Completed at 1 site in United States. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-03.

Sponsored by Sports Medicine Research and Testing Laboratory · Early Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Nov 2024, 1 year 10 months ago, and no results have been posted to the registry.
Phase
Early Phase 1
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study summary

Testosterone abuse is extremely prevalent in athletes globally and especially in the United States professional sporting leagues

Read the detailed description

Because human bodies make testosterone naturally, it can be difficult to determine whether the testosterone in your body is natural or if it came from administering testosterone. Currently, testosterone abuse by athletes is detected by anti-doping laboratories in urine samples and use can also be inferred by testing blood samples. As a pharmaceutical preparation, testosterone is available to administer to your body in different ways. However, due to lack of controlled data on the various preparations of testosterone administrations related to the anti-doping field, this study id designed to look at five different testosterone preparations delivered three different ways and how they compare to each other in terms of anti-doping detection and how long they will be in circulation in your body.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Sports Medicine Research and Testing Laboratory is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • HEALTHY MALE ADULTS, AGED 18-60 YEARS

Exclusion criteria

Exclusion Criteria:

  • Individuals currently enrolled in a registered testing pool for anti-doping purposes
  • Unwilling to provide urine or blood samples
  • Individuals who are not actively exercising
  • Individuals who show a high risk of heart attack or cardiovascular disease as defined by a physician
  • Individuals that have an elevated baseline hematocrit as determined by the PI
  • Individuals who are diabetic or are currently taking diabetic medications.
  • Individuals that have donated blood (approximately 500 mL) in the past 8 weeks
  • Individuals with severe acne
  • Individuals with a history of cancer, cardiac, renal or hepatic disease
05

Study design

Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Active comparator
    Testosterone group one

    The participant will receive a single injection of one of three types of testosterone in phase one. In phase two the participant will receive two weeks of either a daily skin cream or a twice-daily pill to swallow.

    Drug: Testosterone injection · Drug: Testosterone gel

  • Active comparator
    Testosterone group two

    The participant will receive a single injection of one of three types of testosterone in phase one. In phase two the participant will receive two weeks of either a daily skin cream or a twice-daily pill to swallow.

    Drug: Testosterone injection · Drug: Testosterone Oral

Interventions

  • DrugTestosterone injection

    A single injection of testosterone

    Also known as: testosterone cipionate, enanthate,or propionate

  • DrugTestosterone gel

    A daily dose of testosterone gel

    Also known as: testosterone transdermal

  • DrugTestosterone Oral

    A twice-daily pill of testosterone pill to swallow

    Also known as: testosterone undecanoate

06

What researchers measure

Primary outcomes

  1. Detection windows of testosterone administered via injection, oral and skin cream.

    Changes in urinary testosterone/epitestosterone ratio after administration of testosterone in injection, oral and cream

    Time frame: 12 weeks

  2. Changes in serum concentration of testosterone

    Changes in serum concentrations of testosterone in injection, oral and cream administration of testosterone

    Time frame: 12 weeks

  3. Changes in serum concentration of androstenedione

    Changes in serum concentrations of androstenedione in injection, oral and cream administration of testosterone

    Time frame: 12 weeks

  4. Changes in serum concentration of luteinizing hormone

    Changes in serum concentrations of luteinizing hormone after injection, oral and cream administration of testosterone

    Time frame: 12 weeks

Secondary outcomes

  1. Direct detection of testosterone esters

    Direct detection of testosterone esters

    Time frame: 12 weeks

07

Study locations

1 site
  • Sports Medicine Research and Testing Laboratory
    South Jordan, Utah 84095, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06393634
Lead sponsor
Sports Medicine Research and Testing Laboratory
Responsible party
Sponsor
First posted
May 1, 2024
Start date
Nov 27, 2024
Primary completion
Nov 27, 2024
Completion
Nov 27, 2024
Last update
Dec 3, 2024

Study contacts

Geoff Miller, PhD
study director · Sports Medicine Research and Testing Laboratory

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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