Status:
COMPLETED
Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations
Lead Sponsor:
Pennington Biomedical Research Center
Collaborating Sponsors:
United States Army Research Institute of Environmental Medicine
United States Department of Defense
Conditions:
Caloric Restriction
Exercise
Eligibility:
MALE
18-35 years
Phase:
PHASE4
Brief 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.
Detailed Description
This is a double-blind, randomized, placebo controlled trial in 32 physically active men exposed to 20 complete days (days 8-27) of simulated operational stress followed by 20 complete days of recover...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04120363
Start Date
September 23 2019
End Date
July 8 2021
Last Update
October 7 2022
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808