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Completed

NCT Number: NCT06393634

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

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

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Sports Medicine Research and Testing Laboratory

South Jordan, Utah, 84095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • HEALTHY MALE ADULTS, AGED 18-60 YEARS

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

Treatment and study plan

Testosterone injection

Drug

A single injection of testosterone

Other names: testosterone cipionate, enanthate,or propionate

Testosterone gel

Drug

A daily dose of testosterone gel

Other names: testosterone transdermal

Testosterone Oral

Drug

A twice-daily pill of testosterone pill to swallow

Other names: testosterone undecanoate

Primary outcomes

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

    Time frame: 12 weeks

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

  2. Changes in serum concentration of testosterone

    Time frame: 12 weeks

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

  3. Changes in serum concentration of androstenedione

    Time frame: 12 weeks

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

  4. Changes in serum concentration of luteinizing hormone

    Time frame: 12 weeks

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

Secondary outcomes

  1. Direct detection of testosterone esters

    Time frame: 12 weeks

    Direct detection of testosterone esters

Sponsors and collaborators

Lead sponsor

Sports Medicine Research and Testing Laboratory

Industry

Registry information

Official study title

Comparing Direct and Indirect Detection Methods Following Multiple Routes of Testosterone administration-an Anti-doping Perspective

Acronym: T esters

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 1, 2024
Registry last updated
Dec 3, 2024

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.

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