Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations

NCT04120363 | Completed Phase 4 Results DMC FDA Drug

• 3 other identifiers: PBRC 2019-017W81XWH19C0162W81XWH19D0010
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Caloric Restriction; Exercise; Sleep

Keywords

testosterone; anabolism; muscle mass; military operational stress

Outcome Measures

Primary Outcomes (5)

• Load Carriage Time

  A load carriage time trial (a militarily relevant aerobic performance assessment) was conducted near the end of each study phase to assess aerobic performance.

  Day 5 (Phase 1), Day 26 (Phase 2), Day 47 (Phase 3)

• Vertical Jump Height

  Lower-body peak power was assessed near the end of each phase using a vertical jump test.

  Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)

• Total Mass Lifted

  A 3-repetition maximum deadlift assessed muscular strength, endurance, and explosive power near the end of each study phase.

  Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)

• Wingate Peak Power

  Anaerobic capacity was assessed using a Wingate anaerobic cycle test near the end of each study phase.

  Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)

• Peak Aerobic Capacity

  Peak aerobic capacity was measured via treadmill VO2peak near the end of each study phase.

  Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)

Secondary Outcomes (1)

• Body Composition

  Day 7 (Phase 1), Day 28 (Phase 2), Day 49 (Phase 3)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

single intramuscular injection of 750 mg sesame oil solution on Day 8

Drug: Sesame Oil

Testosterone

EXPERIMENTAL

single intramuscular injection of 750 mg testosterone undecanoate on Day 8

Drug: Testosterone Undecanoate

Interventions

Testosterone Undecanoate DRUG

single intramuscular injection of 750 mg testosterone undecanoate

Also known as: Aveed

Testosterone

Sesame Oil DRUG

single intramuscular injection of 750 mg sesame oil solution

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• United States Army Research Institute of Environmental Medicine: collaborator
• United States Department of Defense: collaborator
• University of Arkansas: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (4)

• Lowe AC, Niclou A, Varanoske AN, Harris MN, Hebert C, Johannsen NM, Heymsfield SB, Greenway FL, Margolis LM, Lieberman HR, Beyl RA, Ferrando AA, Pasiakos SM, Rood JC. Exercise Heart Rate Variability Suggests Parasympathetic Hyperactivity during Simulated Military Operations Irrespective of Testosterone Administration. Med Sci Sports Exerc. 2025 Sep 1;57(9):1979-1987. doi: 10.1249/MSS.0000000000003743. Epub 2025 Apr 25.

  PMID: 40279652 DERIVED

• Varanoske AN, Harris MN, Hebert C, Johannsen NM, Heymsfield SB, Greenway FL, Ferrando AA, Rood JC, Pasiakos SM. Bioelectrical impedance phase angle is associated with physical performance before but not after simulated multi-stressor military operations. Physiol Rep. 2023 Mar;11(6):e15649. doi: 10.14814/phy2.15649.

  PMID: 36949577 DERIVED

• Wong MC, Bennett JP, Leong LT, Tian IY, Liu YE, Kelly NN, McCarthy C, Wong JMW, Ebbeling CB, Ludwig DS, Irving BA, Scott MC, Stampley J, Davis B, Johannsen N, Matthews R, Vincellette C, Garber AK, Maskarinec G, Weiss E, Rood J, Varanoske AN, Pasiakos SM, Heymsfield SB, Shepherd JA. Monitoring body composition change for intervention studies with advancing 3D optical imaging technology in comparison to dual-energy X-ray absorptiometry. Am J Clin Nutr. 2023 Apr;117(4):802-813. doi: 10.1016/j.ajcnut.2023.02.006. Epub 2023 Feb 14.

  PMID: 36796647 DERIVED

• Varanoske AN, Harris MN, Hebert C, Howard EE, Johannsen NM, Heymsfield SB, Greenway FL, Margolis LM, Lieberman HR, Church DD, Ferrando AA, Rood JC, Pasiakos SM. Effects of testosterone undecanoate on performance during multi-stressor military operations: A trial protocol for the Optimizing Performance for Soldiers II study. Contemp Clin Trials Commun. 2021 Jul 3;23:100819. doi: 10.1016/j.conctc.2021.100819. eCollection 2021 Sep.

  PMID: 34278044 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

testosterone undecanoate; Testosterone Propionate; Sesame Oil

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Testosterone; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Jennifer C Rood, PhD
• Organization: Pennington Biomedical Research Center

jennifer.rood@pbrc.edu

225-763-2524

Study Officials

• Jennifer C Rood, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 9, 2019
• Study Start: September 23, 2019
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: October 7, 2022
• Results First Posted: October 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)