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

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Testosterone injection; Drug: Testosterone Oral; Drug: Testosterone gel

• Registration Number: NCT06393634
• Lead Sponsor: Sports Medicine Research and Testing Laboratory

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-01
• Status Verified: 2024-11
• Study Start: 2024-11-27
• Primary Completion: 2024-11-27
• Study Completion: 2024-11-27
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testosterone group two	Testosterone Oral	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.
Testosterone group one	Testosterone injection	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.
Testosterone group two	Testosterone injection	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.
Testosterone group one	Testosterone gel	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.

Primary Outcome Measures

Name	Time	Method
Detection windows of testosterone administered via injection, oral and skin cream.	12 weeks	Changes in urinary testosterone/epitestosterone ratio after administration of testosterone in injection, oral and cream
Changes in serum concentration of testosterone	12 weeks	Changes in serum concentrations of testosterone in injection, oral and cream administration of testosterone
Changes in serum concentration of androstenedione	12 weeks	Changes in serum concentrations of androstenedione in injection, oral and cream administration of testosterone
Changes in serum concentration of luteinizing hormone	12 weeks	Changes in serum concentrations of luteinizing hormone after injection, oral and cream administration of testosterone

Secondary Outcome Measures

Name	Time	Method
Direct detection of testosterone esters	12 weeks	Direct detection of testosterone esters

Trial Locations

Locations (1)

Sports Medicine Research and Testing Laboratory; 🇺🇸 South Jordan, Utah, United States