Clinical trial NCT06393634: Comparing Direct and Indirect Detection Methods of Multiple Routes of Testosterone Administration
Official title: Comparing Direct and Indirect Detection Methods Following Multiple Routes of Testosterone administration-an Anti-doping Perspective
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Sports Medicine Research and Testing Laboratory
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups in phase one and two groups in phase two, randomized by a computer.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection windows of testosterone administered via injection, oral and skin cream.
timeFrame: 12 weeks
measure: Changes in serum concentration of testosterone
timeFrame: 12 weeks
measure: Changes in serum concentration of androstenedione
timeFrame: 12 weeks
measure: Changes in serum concentration of luteinizing hormone
timeFrame: 12 weeks
Secondary outcomes:
measure: Direct detection of testosterone esters
timeFrame: 12 weeks
Other outcomes:
Locations:
city: South Jordan
country: United States
facility: Sports Medicine Research and Testing Laboratory
state: Utah
Study officials:
affiliation: Sports Medicine Research and Testing Laboratory
name: Geoff Miller, PhD
role: STUDY_DIRECTOR
References: