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NCT00957801 · ClinicalTrials.gov registry record · Phase 4
Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men
A Phase 4 study, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- Phase 4
- Development phase
- 29
- Enrollment target
NCT00957801: Completed Phase 4 study, sponsored by The University of Texas Medical Branch, Galveston.
NCT00957801 is a Phase 4 study that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 29 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00957801, a Phase 4 study, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 29 participants
- Enrollment target
Study Summary
Skeletal muscle loss is a common consequence of aging and in some individuals reaches a level that compromises health and quality of life. Age-associated increases in cytokine and inflammatory signaling may be important contributors to this process. The investigators will assess the practical question of whether testosterone injection and gel application elicit similar responses. Resistance exercise will be used as a means of stimulating both inflammatory and anabolic responses in skeletal muscle. In order to assess the effects of testosterone on these responses, subjects will perform resistance exercise on two occasions separated by 7 days. The first session will be performed prior to the initiation of testosterone and/or medrol therapy and the second session will be performed after receiving therapy for 7 days.
Primary Outcome
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Interventions
- DRUG Medrol
- DRUG Testosterone gel
- DRUG Testosterone injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2009-03 |
| Est. Completion | 2015-12 |
| Phase | Phase 4 |
What the finished NCT00957801 record still lists
NCT00957801 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Medrol is the first listed.
NCT00957801 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00957801 about?
NCT00957801 is a clinical study titled "Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men". Skeletal muscle loss is a common consequence of aging and in some individuals reaches a level that compromises health and quality of life. Age-associated increases in cytokine and inflammatory signaling may be important contributors to this process. The investigators will assess the practical quest...
What is the current status of trial NCT00957801?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 29 participants. The study started on 2009-03. Estimated completion is 2015-12.
What interventions are being tested in trial NCT00957801?
The interventions under investigation include: Medrol (DRUG), Testosterone gel (DRUG), Testosterone injection (DRUG).
Who is sponsoring clinical trial NCT00957801?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00957801's enrollment target sits among peer trials
29 1634th of 2000 higher than 366 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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