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Hormone Therapy

Hormone Therapy for Musculoskeletal Health (ARMOR Trial)

Phase 4

Recruiting

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 up to 5 years

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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