The Effect of Testosterone Supplementation on Rehabilitation Outcomes
Public ClinicalTrials.gov record NCT00037999. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 care team blinded as to whether the subject is receiving testosterone or placebo. At baseline, weekly, at discharge, and at 6 and 12 months after discharge, subjects will be assessed using validated measures (i.e., Functional Independence Measure - FIM). Our hypothesis is that testosterone supplementation, as an adjunct to traditional rehabilitation therapy, will improve rehabilitation outcomes.
Study identification
- NCT ID
- NCT00037999
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 65 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2001
- Primary completion
- Not listed
- Completion
- Feb 29, 2004
- Last update posted
- Jan 20, 2009
2001 – 2004
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| VA Medical Center | Richmond | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00037999, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 20, 2009 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00037999 live on ClinicalTrials.gov.