Adaptions and Resiliency to Multi-Stressor OpeRations

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.

Conditions

• Musculoskeletal Injury
• Hypogonadism

Interventions

DRUG

Goserelin 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.

OTHER

Multi-Stressor Training

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

DRUG

Testosterone gel (AndroGel 5g)

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

DRUG

Testosterone gel (AndroGel 1.25g)

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

DRUG

Estradiol / Levonorgestrel Transdermal System [Climara Pro]

Female subjects will be randomly assigned to receive a estrogen/ progesterone patch.

DRUG

Placebo Patch

Female subjects will be randomly assigned to receive a placebo patch identical to the Climara Pro patch.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command

  collaborator FED

• Bradley Nindl

  lead OTHER

Principal Investigators

• Bradley C Nindl, PhD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-15

Primary Completion

2026-08-01

Completion

2026-08-01

FDA Drug

Yes

Countries

• United States

Study Locations