RecruitingPhase 4NCT06455969

Adaptions and Resiliency to Multi-Stressor OpeRations

Musculoskeletal Resiliency and Adaptation to Sex Steroid Suppression and Replacement During Multi-Stressor Training


Sponsor

Bradley Nindl

Enrollment

120 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Estradiol / Levonorgestrel Transdermal System [Climara Pro], a drug called Goserelin 3.6 MG, and others for people with hypogonadism and musculoskeletal injury. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGoserelin 3.6 MG

Goserelin acetate (Zoladex) is a gonadotropin-releasing hormone agonist (GnRH). GnRH agonists induce a transient increase in sex hormone concentrations, but subsequently inhibit gonadotropin secretion and the production of testosterone in men and estrogen in women. An equilibration period will occur to allow steroid concentrations to reduce.

OTHERMulti-Stressor Training

A 4-week physical training program that mimics military training.

DRUGTestosterone gel (AndroGel 5g)

Male subjects will be randomly assigned to receive a topical testosterone gel (5g dose).

DRUGTestosterone gel (AndroGel 1.25g)

Male subjects will be randomly assigned to receive a topical testosterone gel (1.25g dose).


Locations(1)

Neuromuscular Research Laboratory

Pittsburgh, Pennsylvania, United States

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NCT06455969


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