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NCT00266864 · ClinicalTrials.gov registry record · Phase 2
Testosterone Replacement Therapy in Chronic Spinal Cord Injury
A Phase 2 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT00266864: Completed Phase 2 study, sponsored by VA Office of Research and Development.
NCT00266864 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00266864, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
It has long been recognized that co-morbidity associated with multiple metabolic syndrome, such as adverse body composition, insulin resistance and autonomic nervous system impairment, may lead to significant increase in cardiovascular morbidity and mortality. It is unclear whether the co-morbidity evident in this population are due directly to their immobility or are the result of unfavorable changes in their underlying hormonal milieu. The purpose of this study is to determine the effect of testosterone replacement therapy in hypogonadal males on: body composition, i.e. lean tissue and fat mass, glucose tolerance, resting energy expenditure, autonomic-cardiovascular integrity, muscular strength, psychological assessment
Primary Outcome
Dual energy X-ray absorptiometry assessment of lean tissue mass (LTM) at 12 months. Total body scans were performed and the energy level used for each total body scan was based on subject thickness (e. g., thin, standard, or thick). To analyze the results of each total body scan, proprietary software algorithms were used to segment the body into trunk, pelvis, and upper and lower extremities using the standard regions of interest. In accordance with International Society for Clinical Densitometr
Interventions
- DRUG Testosterone Transdermal System (Androderm 5 mg patch)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2003-08 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
What the finished NCT00266864 record still lists
NCT00266864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Testosterone Transdermal System (Androderm 5 mg patch) is the first listed.
NCT00266864 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00266864 about?
NCT00266864 is a clinical study titled "Testosterone Replacement Therapy in Chronic Spinal Cord Injury". It has long been recognized that co-morbidity associated with multiple metabolic syndrome, such as adverse body composition, insulin resistance and autonomic nervous system impairment, may lead to significant increase in cardiovascular morbidity and mortality. It is unclear whether the co-morbidity ...
What is the current status of trial NCT00266864?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2003-08. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00266864?
The interventions under investigation include: Testosterone Transdermal System (Androderm 5 mg patch) (DRUG).
Who is sponsoring clinical trial NCT00266864?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00266864's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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