Adaptions and Resiliency to Multi-Stressor OpeRations

Short name ARMOR

NCTNCT06455969Other idSTUDY23090134

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 120 participants (estimated)
Sponsor: Bradley Nindl · Other
Design: Randomized · Single masking
Countries: 1 country
United States
Start: 15 Jul 2024
Primary completion: Aug 2027 (estimated)
Completion: Aug 2027 (estimated)
First posted: 13 Jun 2024
Last update posted: 18 Aug 2026
Conditions: Musculoskeletal Injury · Hypogonadism · Hormonal Contraception

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20242025202620272028

Ph 4
ARMOR
NCT06455969
15 Jul 2024 to est. Aug 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Goserelin 3.6 MGDrug
Multi-Stressor TrainingOther
Testosterone gel (AndroGel 5g)Drug
Testosterone gel (AndroGel 1.25g)Drug

Arms5

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.
Active comparator
Hormonal Contraceptive Use (women): Multi-stressor training + Hormonal Contraceptive Use
Female participants who report that they are currently using hormonal contraception will undergo the multi-stressor training program.
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.

Primary outcomes11

Outcomes the sponsor listed as primary.

Biomechanical: Tendon Cross-Sectional Area, change from baseline and throughout training, mean
Time frame · Through study completion, an average of 8 weeks
Biomechanical: Tendon Shear Wave Elastography, change from baseline and throughout training, mean
Time frame · Through study completion, an average of 8 weeks
Biomechanical: Tendon Thickness, change from baseline and throughout training, mean
Time frame · Through study completion, an average of 8 weeks
Biomechanical: Quadriceps Muscle Cross-sectional Area, change from baseline and throughout training, mean
Time frame · Through study completion, an average of 8 weeks
Biomechanical: Quadriceps Muscle Echointensity, change from baseline and throughout training, mean
Time frame · Through study completion, an average of 8 weeks
Body composition: Lean mass, change from baseline, mean
Time frame · Through study completion, an average of 8 weeks
Body Composition: Fat mass, change from baseline, mean
Time frame · Through study completion, an average of 8 weeks
Body Composition: Body mass, change from baseline and throughout training, mean
Time frame · Through study completion, an average of 8 weeks
Body Composition: Body Fat Percentage, change from baseline, mean
Time frame · Through study completion, an average of 8 weeks
Biochemical: Bone turnover markers (CTx + P1NP), change from baseline, mean
Time frame · Through study completion, an average of 8 weeks
Biochemical: Sex steroid hormones (Testosterone, Sex Hormone Binding Globulin, Estradiol), change from baseline and throughout training, mean
Time frame · Through study completion, an average of 8 weeks

Secondary outcomes(4)

Bone microarchitecture: High Resolution- peripheral Computed Tomography, change from baseline, mean
Time frame · Through study completion, an average of 8 weeks
Biochemical: Cell culture, extracellular vesicles, micro- RNAs, change from baseline and throughout study, mean
Time frame · Through study completion, an average of 8 weeks
Biochemical: Measures of inflammation (IL6, IL-1B, TNFa, CRP), change from baseline and throughout study, mean
Time frame · Through study completion, an average of 8 weeks
Biochemical: Measures of anabolism (Growth Hormone, Insulin-like growth factor-1), change from baseline and throughout study, mean
Time frame · Through study completion, an average of 8 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 40 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Age 18-40 years 2. body mass index (BMI) 18-30 kg/m2 3. weight stable (±10 lbs) in past 2 months 4. takes part in moderate physical activity for at least 150 minutes/week 5. currently free of upper or lower body /extremity injury or impairment 6. able to commit to study duration 7. agrees to adhere to study requirements 8. not taking prescription medications or be willing to refrain from medication prior to and throughout the study period, unless approved by study physician 9. in women, eumenorrheic (cycles of 26-35 days) OR using monophasic oral contraceptive pills with norethindrone acetate (e.g., first generation progestin) for previous 3 months 1\) Current smoker 2) current clinical diagnosis of an eating disorder 3) use of medication incompatible with measurement of reproductive and metabolic hormones or which may interfere with any of the study outcomes; with the exception of approved contraceptives for the contraceptive STRESS \& CONTROL groups 4) current oligo/amenorrhea in women 5) any metabolic or endocrine disease 6) has been diagnosed with a medical condition, physical or psychological, that currently prevents potential subjects from exercising 7) currently pregnant or becomes pregnant during the study 8) history of heart condition OR high blood pressure 9) treating physician requires subject participates in medically supervised physical activity only 10) history of drug addiction, or regular use of recreational drugs 11) currently undergoing treatment for or have a history of mental health conditions 12) Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, Cushing's, diabetes mellitus or renal insufficiency 13) Current use of medications known to affect bone metabolism including estrogens, androgens, anti-estrogens, bisphosphonates (oral bisphosphonates within one year of the baseline visit or IV bisphosphonates within three years of the baseline visit), calcitonin, fluoride, oral or inhaled glucocorticoids, suppressive doses of thyroxine, lithium, pharmacological doses of vitamin D (greater than 2000 IU/day), anti-convulsants, depot medroxyprogesterone within 6 months; with the exception of approved contraceptives for the contraceptive STRESS \& CONTROL groups 14) History of deep vein thrombosis, pulmonary embolism, or clotting disorders. 15) History of stroke or myocardial infarction 16) Fracture within the last 6 months. 17) Systolic blood pressure \> 160 or diastolic blood pressure \> 95 18) Active substance abuse 19) History of hereditary angioedema 20) History of chest pain at rest, during daily activities of living, or when performing physical activity 21) Musculoskeletal injury removing subject from physical activity for more than a month within the past 2 years 22) Recreational drug use more than 2 times per month in each of the previous 6 months 23) Self-reported vision is worse than 20/20. 24) Personal history or history of a first-degree relative with breast cancer 25) Participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration 26) Diagnosed with eating disorder 27) Have food allergies, intolerance, restriction, or special diet needs 28) History of endometriosis 29) Current diagnosis of reproductive health issues, such as ovarian cysts, PCOS, pelvic lesions, undiagnosed ovarian enlargement 30) Have undiagnosed abnormal vaginal bleeding 31) Currently breastfeeding or within 2 months after stopping breastfeeding 32) Frequent headaches accompanied by vision changes (indicative of possible pituitary pathology) For SUPPRESS and REPLACE: 1-32 listed above 33) PSA \>3 ng/mL) 34) Serum 25-hydroxyvitamin D \< 20 ng/mL 35) Thyroid dysfunction 36) Serum creatinine \> 2 mg/dL 37) Personal history or history of a first-degree relative with breast cancer 38) Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2x the upper limit of normal 39) Serum bilirubin \> 2 mg/dL 40) Serum alkaline phosphatase \> 150 U/L 41) Plasma hemoglobin \< 10 gm/dL 42) Hematocrit \> 50 43) In men, Serum testosterone level \< 270 or \> 1070 ng/dL (\< 9 or \> 37 nmol/ L) 44) Triglycerides \> 150 fasting

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