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NCT00037999 · ClinicalTrials.gov registry record · Phase 2
The Effect of Testosterone Supplementation on Rehabilitation Outcomes
A Phase 2 study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00037999 is a Phase 2 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 60 participants.
The verdict
NCT00037999, a Phase 2 study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
The objective of this project is to determine the safety and efficacy of testosterone supplementation as an adjunct to traditional rehabilitation therapy in the care of deconditioned older men. Our long range goal is to determine whether other hormones (e.g., combined testosterone and growth hormone) are helpful as an adjunct to traditional rehabilitation therapy. This project is important to the VA health care system because 38% of American veterans are aged (age \> 65 years), bioavailable testosterone is diminished in older age men, low testosterone is associated with impaired muscle strength, and lack of muscle strength hinders rehabilitation. Older men who are not successfully rehabilitated often get admitted to nursing homes for long term care, at a cost of approximately $40,000/year. Payment for long term care is currently one of our most difficult health care problems. If testosterone supplementation improves rehabilitation outcomes, as our pilot data suggest it will, patients will be more satisfied and long-term care financial resources will be saved. We will conduct a randomized, placebo-controlled trial to test the hypothesis that supplementation with testosterone improves rehabilitation outcomes in deconditioned older men. Specifically, we will screen all hospitalized older men with delayed discharge from the hospital (\> 7 day hospital stay). Men who have at least one new impairment in their ability to perform activities of daily living (e.g., inability to walk), low serum testosterone concentration, and no contraindications (e.g., prostate or breast cancer) will be offered the opportunity to participate. Study participants will be randomized to receive either testosterone (5 mg transdermally each night) or placebo (matching transdermal patch) daily in a double-blind fashion for the duration of their hospital course (expected average duration of study is 29 days). Subjects will then receive their rehabilitation as usual, with all members of the health
Interventions
- PROCEDURE Testosterone supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2001-04 |
| Est. Completion | 2004-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00037999
The ClinicalTrials.gov registry entry for NCT00037999 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Testosterone supplement is the first listed.
NCT00037999 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00037999 about?
NCT00037999 is a clinical study titled "The Effect of Testosterone Supplementation on Rehabilitation Outcomes". The objective of this project is to determine the safety and efficacy of testosterone supplementation as an adjunct to traditional rehabilitation therapy in the care of deconditioned older men. Our long range goal is to determine whether other hormones (e.g., combined testosterone and growth hormone...
What is the current status of trial NCT00037999?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2001-04. Estimated completion is 2004-03.
What interventions are being tested in trial NCT00037999?
The interventions under investigation include: Testosterone supplement (PROCEDURE).
Who is sponsoring clinical trial NCT00037999?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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