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Hormone Therapy

Hormone Therapy for Musculoskeletal Health (ARMOR Trial)

Phase 4
Waitlist Available
Led By Bradley C Nindl, PhD
Research Sponsored by Bradley Nindl
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
In men, total testosterone concentration within normal physiological range (300-1000 ng/dL)
Currently free of upper or lower body/extremity injury or impairment
Must not have
Any metabolic or endocrine disease
History of deep vein thrombosis, pulmonary embolism, or clotting disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 8 weeks
Awards & highlights

Summary

This trial aims to study how hormonal interventions can improve muscle, tendon, and bone function, as well as physical and psychological performance in military personnel. By examining hormone levels, muscle and bone images, blood

Who is the study for?
This trial is for military personnel who may be at risk of musculoskeletal injuries and have low testosterone levels. Participants should be in good health, able to undergo physical and mental stress tests, and willing to use hormonal treatments like patches or gels.Check my eligibility
What is being tested?
The study is testing the effects of hormone treatments (testosterone gel, estradiol/levonorgestrel patch) versus a placebo on muscle, tendon, bone function, and stress resilience. It includes multi-stressor training sessions and monitoring changes in body composition.See study design
What are the potential side effects?
Possible side effects include skin irritation from patches or gels, mood swings due to hormone fluctuations, potential increase in red blood cell count with testosterone treatment which can lead to complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My testosterone levels are within the normal range.
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I do not have any injuries or impairments in my arms or legs.
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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition related to my hormones or metabolism.
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I have a history of blood clots or clotting disorders.
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I have a history of endometriosis.
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I have a history of heart conditions or high blood pressure.
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I have a condition that stops me from exercising.
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I haven't been stopped from being active for over a month due to an injury in the last 2 years.
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I have been diagnosed with an eating disorder.
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I have a history of hereditary angioedema.
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I do not have conditions like thyroid issues, diabetes, or kidney problems that affect bone health.
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I have had a bone break in the past 6 months.
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I have been diagnosed with an eating disorder.
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I have had a stroke or heart attack in the past.
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I am being treated for or have a history of mental health issues.
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I or my close family member had breast cancer.
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I have not had a fracture in the last 6 months.
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I have a current diagnosis related to reproductive health issues like ovarian cysts or PCOS.
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I have experienced vaginal bleeding that has not been diagnosed.
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I have experienced chest pain, whether at rest or during any physical activity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biochemical: Bone turnover markers (CTx + P1NP), change from baseline, mean
Biochemical: Sex steroid hormones (Testosterone, Sex Hormone Binding Globulin, Estradiol), change from baseline and throughout training, mean
Biomechanical: Quadriceps Muscle Cross-sectional Area, change from baseline and throughout training, mean
+8 more
Secondary outcome measures
Biochemical: Cell culture, extracellular vesicles, micro- RNAs, change from baseline and throughout study, mean
Biochemical: Measures of anabolism (Growth Hormone, Insulin-like growth factor-1), change from baseline and throughout study, mean
Biochemical: Measures of inflammation (IL6, IL-1B, TNFa, CRP), change from baseline and throughout study, mean
+1 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: SUPPRESS (women): Multi-stressor training + Zoladex + Placebo patchExperimental Treatment3 Interventions
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.
Group II: SUPPRESS (men): Multi-Stressor Training + Zoladex + AndroGel 1.25gExperimental Treatment3 Interventions
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.
Group III: REPLACE (women): Multi-Stressor Training + Zoladex + Climara Pro PatchExperimental Treatment3 Interventions
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
Group IV: REPLACE (men): Multi-Stressor Training + Zoladex + AndroGel 5gExperimental Treatment3 Interventions
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.
Group V: CONTROL (men + women)Active Control1 Intervention
The control group will maintain their habitual exercise, diet, and sleep patterns, all of which will be monitored throughout the study.
Group VI: STRESS (men + women): Multi-Stressor TrainingActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Goserelin 3.6 MG
2017
Completed Phase 3
~360
Placebo Patch
2011
Completed Phase 4
~4500

Find a Location

Who is running the clinical trial?

U.S. Army Medical Research and Development CommandFED
288 Previous Clinical Trials
245,909 Total Patients Enrolled
Bradley NindlLead Sponsor
Bradley C Nindl, PhDPrincipal InvestigatorUniversity of Pittsburgh
~80 spots leftby Aug 2026