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NCT00957528 · ClinicalTrials.gov registry record · Phase 1
Cycled Testosterone Replacement Study
A Phase 1 study, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00957528: Completed Phase 1 study, sponsored by The University of Texas Medical Branch, Galveston.
NCT00957528 is a Phase 1 study that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00957528, a Phase 1 study, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether testosterone (male hormone) therapy is effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing in men aged 60 to 85 years. Effectiveness will be determined based on improvements in body composition, muscle metabolism, muscle strength, and bone metabolism.
Primary Outcome
The fractional synthetic rate (FSR) of mixed muscle is calculated by directly measuring the incorporation of L-\[ring-13C6\]-phenylalanine into protein (%/hr),, using the precursor-product model: FSR = \[(EP2 - EP1)/(EM•t)\]•60•100, where EP1 and EP2 are the enrichments of bound L-\[ring-13C6\]-phenylalanine in the first and second muscle biopsies, t is the time interval (min) between biopsies, and EM is the mean L-\[ring-13C6\]-phenylalanine enrichment in the muscle intracellular pool.
Interventions
- DRUG Placebo
- DRUG Testosterone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2006-01 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
What the finished NCT00957528 record still lists
NCT00957528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00957528 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00957528 about?
NCT00957528 is a clinical study titled "Cycled Testosterone Replacement Study". The purpose of this study is to determine whether testosterone (male hormone) therapy is effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing in men aged 60 to 85 years. Effectiveness will be determined based on improvements in body composition, muscle metabo...
What is the current status of trial NCT00957528?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2006-01. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00957528?
The interventions under investigation include: Placebo (DRUG), Testosterone (DRUG).
Who is sponsoring clinical trial NCT00957528?
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 NCT00957528's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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