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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Testosterone injection; Drug: Testosterone gel; Drug: Testosterone Oral

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • South Jordan, Utah, United States, 84095
      • Sports Medicine Research and Testing Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Testosterone injection; A single injection of testosterone; Other Names: testosterone cipionate, enanthate,or propionate; Drug: Testosterone gel; A daily dose of testosterone gel; Other Names: testosterone transdermal
Active Comparator: 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.	Drug: Testosterone injection; A single injection of testosterone; Other Names: testosterone cipionate, enanthate,or propionate; Drug: Testosterone Oral; A twice-daily pill of testosterone pill to swallow; Other Names: testosterone undecanoate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes in serum concentration of testosterone	Changes in serum concentrations of testosterone in injection, oral and cream administration of testosterone	12 weeks
Changes in serum concentration of androstenedione	Changes in serum concentrations of androstenedione in injection, oral and cream administration of testosterone	12 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Direct detection of testosterone esters	Direct detection of testosterone esters	12 weeks

Collaborators and Investigators

• Sponsor: Sports Medicine Research and Testing Laboratory
• Investigators: Study Director: Geoff Miller, PhD, Sports Medicine Research and Testing Laboratory

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2024
• Primary Completion (Actual): November 27, 2024
• Study Completion (Actual): November 27, 2024

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anabolic Agents; Androgens; Methyltestosterone; Testosterone 17 beta-cypionate; Testosterone; Testosterone undecanoate; Testosterone enanthate
• Other Study ID Numbers: SMRTL.2024.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No