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NCT06455969 · ClinicalTrials.gov registry record · Phase 4
Adaptions and Resiliency to Multi-Stressor OpeRations
A Phase 4 study of Hypogonadism and Musculoskeletal Injury, sponsored by Bradley Nindl.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT06455969 is a Phase 4 study of Hypogonadism and Musculoskeletal Injury that is actively recruiting participants, run by Bradley Nindl. The registered enrollment target is 120 participants, roughly in line with the 115-participant average among 21 other Hypogonadism trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT06455969, a Phase 4 study of Hypogonadism and Musculoskeletal Injury, is actively recruiting participants, sponsored by Bradley Nindl.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Goserelin 3.6 MG
- OTHER Multi-Stressor Training
- DRUG Testosterone gel (AndroGel 5g)
- DRUG Testosterone gel (AndroGel 1.25g)
- DRUG Estradiol / Levonorgestrel Transdermal System [Climara Pro]
Study Locations (1)
Pennsylvania
- Neuromuscular Research Laboratory - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-07-15 |
| Est. Completion | 2026-08-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06455969
The ClinicalTrials.gov registry entry for NCT06455969 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 115-participant average among 21 other Hypogonadism trials with a reported enrollment target. The listed sponsor is Bradley Nindl, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hypogonadism appearing as the primary indexed condition, and to 5 interventions - of which Goserelin 3.6 MG is the first listed.
NCT06455969 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06455969 about?
NCT06455969 is a clinical study titled "Adaptions and Resiliency to Multi-Stressor OpeRations". 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 ...
What is the current status of trial NCT06455969?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2024-07-15. Estimated completion is 2026-08-01.
What conditions does trial NCT06455969 study?
This clinical trial studies the following conditions: Hypogonadism, Musculoskeletal Injury.
What interventions are being tested in trial NCT06455969?
The interventions under investigation include: Goserelin 3.6 MG (DRUG), Multi-Stressor Training (OTHER), Testosterone gel (AndroGel 5g) (DRUG), Testosterone gel (AndroGel 1.25g) (DRUG), Estradiol / Levonorgestrel Transdermal System [Climara Pro] (DRUG).
Who is sponsoring clinical trial NCT06455969?
This trial is sponsored by Bradley Nindl, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06455969 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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