Adaptions and Resiliency to Multi-Stressor OpeRations
NCT Number: NCT06455969
Acronym: ARMOR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Musculoskeletal Injury|Hypogonadism
Interventions: DRUG: Goserelin 3.6 MG|OTHER: Multi-Stressor Training|DRUG: Testosterone gel (AndroGel 5g)|DRUG: Testosterone gel (AndroGel 1.25g)|DRUG: Estradiol / Levonorgestrel Transdermal System [Climara Pro]|DRUG: Placebo Patch
Sponsor: Bradley Nindl
Collaborators: U.S. Army Medical Research and Development Command
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-15
Completion Date: 2026-08-01
Locations: Neuromuscular Research Laboratory, Pittsburgh, Pennsylvania, 15203, United States

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.

Primary Outcome Measures: Biomechanical: Tendon Cross-Sectional Area, change from baseline and throughout training, mean, Through study completion, an average of 8 weeks|Biomechanical: Tendon Shear Wave Elastography, change from baseline and throughout training, mean, Through study completion, an average of 8 weeks|Biomechanical: Tendon Thickness, change from baseline and throughout training, mean, Through study completion, an average of 8 weeks|Biomechanical: Quadriceps Muscle Cross-sectional Area, change from baseline and throughout training, mean, Through study completion, an average of 8 weeks|Biomechanical: Quadriceps Muscle Echointensity, change from baseline and throughout training, mean, Through study completion, an average of 8 weeks|Body composition: Lean mass, change from baseline, mean, Through study completion, an average of 8 weeks|Body Composition: Fat mass, change from baseline, mean, Through study completion, an average of 8 weeks|Body Composition: Body mass, change from baseline and throughout training, mean, Through study completion, an average of 8 weeks|Body Composition: Body Fat Percentage, change from baseline, mean, Through study completion, an average of 8 weeks|Biochemical: Bone turnover markers (CTx + P1NP), change from baseline, mean, Through study completion, an average of 8 weeks|Biochemical: Sex steroid hormones (Testosterone, Sex Hormone Binding Globulin, Estradiol), change from baseline and throughout training, mean, Through study completion, an average of 8 weeks
Secondary Outcome Measures: Bone microarchitecture: High Resolution- peripheral Computed Tomography, change from baseline, mean, Through study completion, an average of 8 weeks|Biochemical: Cell culture, extracellular vesicles, micro- RNAs, change from baseline and throughout study, mean, Through study completion, an average of 8 weeks|Biochemical: Measures of inflammation (IL6, IL-1B, TNFa, CRP), change from baseline and throughout study, mean, Through study completion, an average of 8 weeks|Biochemical: Measures of anabolism (Growth Hormone, Insulin-like growth factor-1), change from baseline and throughout study, mean, Through study completion, an average of 8 weeks