Comparing Direct and Indirect Detection Methods of Multiple Routes of Testosterone Administration (T esters)

Sports Medicine Research and Testing Laboratory (SMRTL)

Status and phase: Completed; Early Phase 1

Conditions: Healthy

Treatments: Drug: Testosterone gel; Drug: Testosterone injection; Drug: Testosterone Oral

Study type: Interventional

Funder types: Industry

Identifiers

NCT06393634

SMRTL.2024.01

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Testosterone group one

Active Comparator group

Description:

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.

Treatment:

Drug: Testosterone injection

Drug: Testosterone gel

Testosterone group two

Active Comparator group

Description:

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.

Treatment:

Drug: Testosterone Oral

Drug: Testosterone injection