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NCT04460872 · ClinicalTrials.gov registry record · Phase 2
Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury
A Phase 2 study of Spinal Cord Injuries and Spinal Cord Injury, sponsored by North Florida Foundation for Research and Education.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 2
- Study locations
NCT04460872 is a Phase 2 study of Spinal Cord Injuries and Spinal Cord Injury that is actively recruiting participants, run by North Florida Foundation for Research and Education. The registered enrollment target is 21 participants, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (66% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT04460872, a Phase 2 study of Spinal Cord Injuries and Spinal Cord Injury, is actively recruiting participants, sponsored by North Florida Foundation for Research and Education.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 2
- Study locations
Study Summary
This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.
Conditions Studied
Interventions
- DRUG Testosterone Enanthate
- BEHAVIORAL Locomotor Training
Study Locations (2)
Florida
- North Florida/South Georgia Veterans Health System - Gainesville
- Brooks Rehabilitation - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2021-01-31 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04460872
The ClinicalTrials.gov registry entry for NCT04460872 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (66% lower). The listed sponsor is North Florida Foundation for Research and Education, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Spinal Cord Injuries appearing as the primary indexed condition, and to 2 interventions - of which Testosterone Enanthate is the first listed.
NCT04460872 reports 2 study locations spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT04460872 about?
NCT04460872 is a clinical study titled "Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury". This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfuncti...
What is the current status of trial NCT04460872?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2021-01-31. Estimated completion is 2026-06-30.
What conditions does trial NCT04460872 study?
This clinical trial studies the following conditions: Spinal Cord Injuries, Spinal Cord Injury, Hypogonadism, Central Nervous System Diseases, Endocrine System Diseases.
What interventions are being tested in trial NCT04460872?
The interventions under investigation include: Testosterone Enanthate (DRUG), Locomotor Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT04460872?
This trial is sponsored by North Florida Foundation for Research and Education, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04460872 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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