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NCT00665496 · ClinicalTrials.gov registry record · Phase 3

A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction

A Phase 3 study of Erectile Dysfunction, sponsored by Bayer.

Completed
Registry status
Phase 3
Development phase
732
Enrollment target
20
Study locations

NCT00665496 is a Phase 3 study of Erectile Dysfunction that has completed, run by Bayer. The registered enrollment target is 732 participants, above the 209-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (250% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT00665496, a Phase 3 study of Erectile Dysfunction, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 3
Development phase
732 participants
Enrollment target
20
Study locations

Study Summary

This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. Patients were asked to fill in questionnaires and a diary in which they filled in details about attempts at sexual activity during study period. Patients received also a stopwatch to record the time of onset of erection. Stopwatch should be started immediately prior to initiating sexual activity and stopped when an erection perceived to be adequate for penetration was obtained.

Conditions Studied

Erectile Dysfunction

Interventions

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

Study Locations (20)

Florida

  • - Aventura
  • - Jacksonville
  • - Pembroke Pines

California

  • - Beverly Hills
  • - San Bernardino

North Carolina

  • - Charlotte
  • - Wilmington

Ontario

  • - Barrie
  • - Toronto

Quebec

  • - Montreal
  • - Sherbrooke

Arizona

  • - Phoenix

Colorado

  • - Aurora

Connecticut

  • - Trumbull

Trial Details

FieldValue
Enrollment Target 732 participants
Start Date 2003-06
Est. Completion 2003-11
Phase Phase 3

Sponsor

Bayer

591 total trials

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What the Registry Record Tells You About NCT00665496

The ClinicalTrials.gov registry entry for NCT00665496 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 732 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 209-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (250% higher). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Erectile Dysfunction appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00665496 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Florida, California, North Carolina.

Frequently Asked Questions

What is clinical trial NCT00665496 about?

NCT00665496 is a clinical study titled "A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction". This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. Patients were asked to fill in questionnaires and a diary in which they filled in details about attempts...

What is the current status of trial NCT00665496?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 732 participants. The study started on 2003-06. Estimated completion is 2003-11.

What conditions does trial NCT00665496 study?

This clinical trial studies the following conditions: Erectile Dysfunction.

What interventions are being tested in trial NCT00665496?

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

Who is sponsoring clinical trial NCT00665496?

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

Where is trial NCT00665496 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.