Adaptions and Resiliency to Multi-Stressor OpeRations

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Bradley Nindl
Study ID
NCT06455969
Phase
PHASE4
Status
Recruiting
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Conditions

  • Hypogonadism
  • Musculoskeletal Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Goserelin 3.6 MG — DRUG
    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.
  • Multi-Stressor Training — OTHER
    A 4-week physical training program that mimics military training.
  • Testosterone gel (AndroGel 5g) — DRUG
    Male subjects will be randomly assigned to receive a topical testosterone gel (5g dose).
  • Testosterone gel (AndroGel 1.25g) — DRUG
    Male subjects will be randomly assigned to receive a topical testosterone gel (1.25g dose).
  • Estradiol / Levonorgestrel Transdermal System [Climara Pro] — DRUG
    Female subjects will be randomly assigned to receive a estrogen/ progesterone patch.
  • Placebo Patch — DRUG
    Female subjects will be randomly assigned to receive a placebo patch identical to the Climara Pro patch.

Study Details

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.

Key Dates

Start date
Jul 15, 2024
Status verified
Aug 2025
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • No Intervention: CONTROL (men + women)
    The control group will maintain their habitual exercise, diet, and sleep patterns, all of which will be monitored throughout the study.
  • Active Comparator: STRESS (men + women): Multi-Stressor Training
    Research volunteers will be randomized into the stress exposure group (STRESS) will undergo a 4-week exercise training program consisting of 5 consecutive days of strenuous physical training followed by 2 days of recovery (energy balance, no structured exercise). The exercise training program will consist of military-relevant physical training exercises (e.g., load carriage, aerobic and resistance exercises) that progressively increase in duration and intensity to increase exercise energy expenditure. Participants will perform multiple exercises per day using a variety of endurance and muscle loading modalities designed to mimic movements typically observed during real-life military operations.
  • Experimental: SUPPRESS (men): Multi-Stressor Training + Zoladex + AndroGel 1.25g
    In addition to participating in the multi-stressor training program, male participants randomized to the GnRH suppressed (SUPPRESS) group will be administered a long-acting GnRH agonist (Zoladex) by trained medical professionals to suppress endogenous gonadal steroids. Following GnRH agonist administration, men will be administered 1.25g/day (SUPPRESS) of topical 1% testosterone gel (AndroGel, Abbvie, North Chicago, IL) to be applied to the shoulders, upper arms, and/or stomach area daily.
  • Experimental: SUPPRESS (women): Multi-stressor training + Zoladex + Placebo patch
    In addition to participating in the multi-stressor training program, male participants randomized to the GnRH suppressed (SUPPRESS) group will be administered a long-acting GnRH agonist (Zoladex) by trained medical professionals to suppress endogenous gonadal steroids. Following GnRH agonist administration, women in the SUPRESS group will receive a placebo transdermal patch.
  • Experimental: REPLACE (men): Multi-Stressor Training + Zoladex + AndroGel 5g
    Following GnRH agonist administration, men will be administered 5g/day (REPLACE) of topical 1% testosterone gel (AndroGel, Abbvie, North Chicago, IL) to be applied to the shoulders, upper arms, and/or stomach area daily.
  • Experimental: REPLACE (women): Multi-Stressor Training + Zoladex + Climara Pro Patch
    Following GnRH agonist administration, women, the REPLACE group will receive a transdermal estradiol (0.045 mg/day) + levonorgestrel (0.015 mg/day) patch (Climara Pro, Bayer, NJ) to be placed on a clean, dry area of the skin on the lower

Primary Outcome Measure

Biomechanical: Tendon Cross-Sectional Area, change from baseline and throughout training, mean [ Time Frame: Through study completion, an average of 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Neuromuscular Research LaboratoryPittsburghPennsylvania15203
Brian J Martin, PhD
[email protected]
412-246-0460

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