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NCT00240981 · ClinicalTrials.gov registry record · Phase 4
TOM: Testosterone in Older Men With Sarcopenia
A Phase 4 study, sponsored by Boston Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 209
- Enrollment target
NCT00240981: Clinical Trial Phase 4 study, sponsored by Boston Medical Center.
NCT00240981 is a Phase 4 study that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 209 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00240981, a Phase 4 study, was terminated before completion, sponsored by Boston Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 209 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether testosterone replacement in older men with low testosterone levels will increase muscle strength, improve physical performance and overall sense of well being, and reduce fatigue.
Primary Outcome
Primary outcome was a change from baseline in leg-press strength at 6 months.
Interventions
- DRUG Topical testosterone gel 1% (active formulation)
- DRUG Topical gel (placebo formulation)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2005-01 |
| Est. Completion | 2009-12 |
| Phase | Phase 4 |
Why NCT00240981 stopped before completion
NCT00240981 is an interventional study that assigns participants to a tested intervention. The registered 209 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Topical testosterone gel 1% (active formulation) is the first listed.
NCT00240981 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00240981 about?
NCT00240981 is a clinical study titled "TOM: Testosterone in Older Men With Sarcopenia". The purpose of this study is to determine whether testosterone replacement in older men with low testosterone levels will increase muscle strength, improve physical performance and overall sense of well being, and reduce fatigue.
What is the current status of trial NCT00240981?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 209 participants. The study started on 2005-01. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00240981?
The interventions under investigation include: Topical testosterone gel 1% (active formulation) (DRUG), Topical gel (placebo formulation) (DRUG).
Who is sponsoring clinical trial NCT00240981?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00240981's enrollment target sits among peer trials
209 399th of 2000 higher than 1,602 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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