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NCT00345969 · ClinicalTrials.gov registry record · Phase 3

Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

A Phase 3 study, sponsored by Washington University School of Medicine.

Completed
Registry status
Phase 3
Development phase
25
Enrollment target

NCT00345969: Completed Phase 3 study, sponsored by Washington University School of Medicine.

NCT00345969 is a Phase 3 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 25 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00345969, a Phase 3 study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
Phase 3
Development phase
25 participants
Enrollment target

Study Summary

The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether exercise training combined with testosterone replacement therapy can improve skeletal muscle strength, and lean mass, to a greater degree than exercise training alone.

Primary Outcome

Total Lean Mass measured by Dual X-ray Absorptiometry (DXA)

Interventions

  • BEHAVIORAL Supervised exercise training
  • DRUG Transdermal Testosterone gel (1%)

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2004-11
Est. Completion 2009-08
Phase Phase 3

What the finished NCT00345969 record still lists

NCT00345969 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Supervised exercise training is the first listed.

NCT00345969 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00345969 about?

NCT00345969 is a clinical study titled "Exercise and Testosterone Therapy in Elderly Men With Physical Frailty". The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether exercise training combined with testosterone replacement therapy can improve skeletal muscle strength, and lean mass, to a greater degree than exercise training alone.

What is the current status of trial NCT00345969?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2004-11. Estimated completion is 2009-08.

What interventions are being tested in trial NCT00345969?

The interventions under investigation include: Supervised exercise training (BEHAVIORAL), Transdermal Testosterone gel (1%) (DRUG).

Who is sponsoring clinical trial NCT00345969?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00345969's enrollment target sits among peer trials

25 1941st of 2000 higher than 58 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00345969, the US trial registry maintained by the National Library of Medicine. NCT00345969 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.