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

Healthy Clinical Trial

— T esters  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06393634
• Other study ID #: SMRTL.2024.01
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: May 8, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: April 2024
• Source: Sports Medicine Research and Testing Laboratory
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Testosterone injection
A single injection of testosterone
• Testosterone gel
A daily dose of testosterone gel
• Testosterone Oral
A twice-daily pill of testosterone pill to swallow

Locations

Country	Name	City	State
United States	Sports Medicine Research and Testing Laboratory	South Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Sports Medicine Research and Testing Laboratory

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks
Primary	Changes in serum concentration of testosterone	Changes in serum concentrations of testosterone in injection, oral and cream administration of testosterone	12 weeks
Primary	Changes in serum concentration of androstenedione	Changes in serum concentrations of androstenedione in injection, oral and cream administration of testosterone	12 weeks
Primary	Changes in serum concentration of luteinizing hormone	Changes in serum concentrations of luteinizing hormone after injection, oral and cream administration of testosterone	12 weeks
Secondary	Direct detection of testosterone esters	Direct detection of testosterone esters	12 weeks