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Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations

NCT04120363 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-10-07

Study results available
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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

Interventions

DRUG

Testosterone Undecanoate

single intramuscular injection of 750 mg testosterone undecanoate

DRUG

Sesame Oil

single intramuscular injection of 750 mg sesame oil solution

Sponsors & Collaborators

  • United States Army Research Institute of Environmental Medicine

    collaborator FED

  • United States Department of Defense

    collaborator FED

  • University of Arkansas

    collaborator OTHER

  • Pennington Biomedical Research Center

    lead OTHER

Principal Investigators

  • Jennifer C Rood, PhD · Pennington Biomedical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-23
Primary Completion
2021-07-08
Completion
2021-07-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04120363 on ClinicalTrials.gov