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NCT00492635 · ClinicalTrials.gov registry record · Phase 3

Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving ED

A Phase 3 study, sponsored by Bayer.

Completed
Registry status
Phase 3
Development phase
628
Enrollment target

NCT00492635: Completed Phase 3 study, sponsored by Bayer.

NCT00492635 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 628 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00492635, a Phase 3 study, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 3
Development phase
628 participants
Enrollment target

Study Summary

A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed' (immediately before intended sexual activity) compared to placebo, to evaluate its tolerability and if it can help in recovery of erections after a nerve sparing radical prostatectomy.

Interventions

  • DRUG Placebo
  • DRUG Levitra (Vardenafil, BAY38-9456)

Trial Details

FieldValue
Enrollment Target 628 participants
Start Date 2004-12
Est. Completion 2007-09
Phase Phase 3
Bayer

591 total trials

What the finished NCT00492635 record still lists

NCT00492635 is an interventional study that assigns participants to a tested intervention. The registered 628 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower).

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

NCT00492635 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00492635 about?

NCT00492635 is a clinical study titled "Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving ED". A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed' (immediately before intended sexual activity) compared to placebo, to evaluate its tolerability and if it can help in recovery of erections after a nerve sparing radical prostatectomy.

What is the current status of trial NCT00492635?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 628 participants. The study started on 2004-12. Estimated completion is 2007-09.

What interventions are being tested in trial NCT00492635?

The interventions under investigation include: Placebo (DRUG), Levitra (Vardenafil, BAY38-9456) (DRUG).

Who is sponsoring clinical trial NCT00492635?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00492635's enrollment target sits among peer trials

628 586th of 2000 higher than 1,415 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 NCT00492635, the US trial registry maintained by the National Library of Medicine. NCT00492635 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.