About this trial
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 criteria
Qualifiers
Age 18-40 years
body mass index (BMI) 18-30 kg/m2
weight stable (±10 lbs) in past 2 months
takes part in moderate physical activity for at least 150 minutes/week
Disqualifiers
Current smoker
current clinical diagnosis of an eating disorder
use of medication incompatible with measurement of reproductive and metabolic hormones or which may interfere with any of the study outcomes
current oligo/amenorrhea in women
Trial design
Treatments tested in this trial
- Goserelin 3.6 MG
- Multi-Stressor Training
- Testosterone gel (AndroGel 5g)
- Testosterone gel (AndroGel 1.25g)
- Estradiol / Levonorgestrel Transdermal System [Climara Pro]
- Placebo Patch
Treatment groups
6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Bradley Nindl
Lead sponsor
University of Pittsburgh
Sponsor institution
U.S. Army Medical Research and Development Command
Collaborator