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

NCT06393634 | Completed Early Phase 1 FDA Drug

• 1 other identifier: SMRTL.2024.01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Direct detection of testosterone esters

  12 weeks

Study Arms (2)

Testosterone group one

ACTIVE COMPARATOR

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; Drug: Testosterone gel

Testosterone group two

ACTIVE COMPARATOR

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; Drug: Testosterone Oral

Interventions

Testosterone injection DRUG

A single injection of testosterone

Also known as: testosterone cipionate, enanthate,or propionate

Testosterone group one; Testosterone group two

Testosterone gel DRUG

A daily dose of testosterone gel

Also known as: testosterone transdermal

Testosterone group one

Testosterone Oral DRUG

A twice-daily pill of testosterone pill to swallow

Also known as: testosterone undecanoate

Testosterone group two

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• HEALTHY MALE ADULTS, AGED 18-60 YEARS

You may not qualify if:

• 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

Sponsors & Collaborators

• Sports Medicine Research and Testing Laboratory: lead

Study Sites (1)

Sports Medicine Research and Testing Laboratory

South Jordan, Utah, 84095, United States

Location

MeSH Terms

Interventions

Testosterone; Testosterone Propionate; testosterone undecanoate

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Geoff Miller, PhD

  Sports Medicine Research and Testing Laboratory

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three groups in phase one and two groups in phase two, randomized by a computer.

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: November 27, 2024
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)