Adaptions and Resiliency to Multi-Stressor OpeRations

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-40
SponsorBradley Nindl

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

120 Participants
are divided into 6 treatment groups

6

Treatment groups

See 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