Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations

• Status: Completed
• Trial end date: 2021-07-08
• Target enrollment: 0
• Participant gender: Male

Summary

The objective of this study is to determine the effects of a single dose of testosterone undecanoate during and in recovery from simulated operational stress.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pennington Biomedical Research Center
• Collaborators: United States Army Research Institute of Environmental Medicine; United States Department of Defense; University of Arkansas
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Men aged 18-35 years

• Ability to understand verbal or written instructions/testing materials in English

• Physically active (as determined by accelerometry and review of a physical activity log)

• Not taking any prescription medications and/or willing to refrain from all medication use prior to and throughout the entire study period, unless provided/approved by the study physician

• Willing to refrain from alcohol, smoking, e-cigarettes or use of any nicotine product, caffeine, and dietary supplement use throughout the entire study period

• Willing to live on the Pennington Biomedical Research Center inpatient unit for 20 consecutive days

• Meets age-specific US Army body composition standards according to Army Regulation 600-9, which includes estimates of percent body fat based on height, weight, and circumference measures (neck and waist)

• Total testosterone concentration is within the normal physiological range (300-1,000 ng/dL)

Exclusion Criteria:

• Musculoskeletal injuries that compromise exercise capability

• Diagnosed cardiometabolic disorders (i.e., hypertension, hyperlipidemia, kidney disease, diabetes, etc.)

• Allergies or intolerance to foods, vegetarian practices, or history of complications with lidocaine

• Anabolic steroid, human growth hormone, or nutritional testosterone precursor-like supplement use within the past 6 months

• Will not refrain from smoking (any nicotine product), alcohol, caffeine, or any other dietary supplement during the study

• Adults unable to consent

• Women

• Prisoners

• Sedentary or engages in insufficient quantities of physical activity per week (aerobic and/or resistance training as determined by accelerometry and review of a physical activity log)

• Exceeds age-specific US Army body composition standards according to Army Regulation 600-9

• Previous history of kidney stones unless otherwise approved by the medical investigator

• Systolic blood pressure > 150 or diastolic blood pressure > 95 mmHg

• Previous history of breast or prostate cancer

• Previous history of Chronic Obstructive Pulmonary Disease or Obstructive Sleep Apnea

• Prostate-Specific Antigen (PSA) > 3ng/ml, Hematocrit > 50%, or positive urine drug screening

• Based on the investigative team's clinical judgment, a subject may not be appropriate for participation in the study