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Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery

NCT02734238 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2019-01-16

Study results available
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Summary

The objective of this study is to determine whether maintaining a eugonadal state, during severe, sustained energy deficit, attenuates physiological decrements, particularly the loss of lean body mass.

Conditions

  • Caloric Restriction
  • Exercise

Interventions

DRUG

Sesame Oil

200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35

DRUG

testosterone enanthate

200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35

Sponsors & Collaborators

  • United States Army Research Institute of Environmental Medicine

    collaborator FED

  • MyoSyntax

    collaborator UNKNOWN

  • Defence Research and Development Canada

    collaborator INDUSTRY

  • United States Department of Defense

    collaborator FED

  • Pennington Biomedical Research Center

    lead OTHER

Principal Investigators

  • Jennifer C Rood, Ph.D. · Pennington Biomedical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-12-31
Completion
2017-12-31

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 NCT02734238 on ClinicalTrials.gov