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

NCT ID: NCT06393634

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-27

Study Completion Date

2024-11-27

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three groups in phase one and two groups in phase two, randomized by a computer.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Testosterone injection

Intervention Type DRUG

A single injection of testosterone

Testosterone gel

Intervention Type DRUG

A daily dose of testosterone gel

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.

Group Type ACTIVE_COMPARATOR

Testosterone injection

Intervention Type DRUG

A single injection of testosterone

Testosterone Oral

Intervention Type DRUG

A twice-daily pill of testosterone pill to swallow

Interventions

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Testosterone injection

A single injection of testosterone

Intervention Type DRUG

Testosterone gel

A daily dose of testosterone gel

Intervention Type DRUG

Testosterone Oral

A twice-daily pill of testosterone pill to swallow

Intervention Type DRUG

Other Intervention Names

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testosterone cipionate, enanthate,or propionate testosterone transdermal testosterone undecanoate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sports Medicine Research and Testing Laboratory

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geoff Miller, PhD

Role: STUDY_DIRECTOR

Sports Medicine Research and Testing Laboratory

Locations

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Sports Medicine Research and Testing Laboratory

South Jordan, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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SMRTL.2024.01

Identifier Type: -

Identifier Source: org_study_id