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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 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 628 participants.

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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

Sponsor

Bayer

591 total trials

What the Registry Record Tells You About NCT00492635

The ClinicalTrials.gov registry entry for NCT00492635 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 628 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

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

NCT00492635 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.