drugset / Trial / NCT06455969

Adaptions and Resiliency to Multi-Stressor OpeRations

NCT06455969

RandomizedParallel-groupSingle-blindBasic science

Summary

Non-combat-related muscle, tendon and bone injuries are the most common injuries suffered by military personnel, particularly in new recruits. These injuries impact military readiness and are responsible for roughly 60% of limited duty days, 65% of soldiers who are unable to deploy, and nearly $500 million in medical cost to the government annually in the Army alone. Drug interventions must be studied and developed to prevent these negative outcomes and prepare military personnel for the demands of military service. At the current time, military leadership has identified critical gaps in understanding how to minimize these injuries and train soldiers with drug intervention serving among those gaps. The goal of this study is to determine how a hormonal intervention can change muscle, tendon, and bone function as well as physical and psychological performance in response to mental and physical stress. To do so, we will examine sex hormone (testosterone, estrogen) levels, muscle, tendon, and bone images, blood samples, and physical and mental performance. We will look at things like changes in hormone levels, chemicals released from active skeletal muscles, and your body composition. The results from this study will be used to improve physical readiness training in the military with the goal of reducing injuries.

Timeline

Start
2024-07-15
Primary completion
2026-08-01
Completion
2026-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Estradiol Other / unclassified 0.045 mg Other
Subject Goserelin Other / unclassified 3.6 mg
Subject Levonorgestrel Small molecule 0.015 mg Other
Subject Testosterone Small molecule 1.25 g Topical
Subject Testosterone Small molecule 5 g Topical