Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)

October 10, 2013 updated by: Bayer

A Randomized, Double Blind, Placebo-controlled, Parallel Group, Multi-center Study to Investigate the Responsiveness of the Erectile Quality Scale (EQS) to Vardenafil HCl Flexible Dose Versus Placebo in Males With Erectile Dysfunction.

This study was conducted to evaluate in adult men with erectile dysfunction (often called impotence), the effect of vardenafil HCl on the quality of their erections. Many men experience occasional erectile problems during their lives. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to study the responsiveness of the erection quality scale (EQS) to vardenafil HCl. In this study, vardenafil HCl will be compared to placebo. Placebo is a pill which looks like the real drug but it is not. It contains no active ingredients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

219

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
    • California
      • Beverly Hills, California, United States, 90212
      • Laguna Hills, California, United States, 92653
      • Newport Beach, California, United States, 92660
    • Colorado
      • Aurora, Colorado, United States, 80012
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
    • Florida
      • Aventura, Florida, United States, 33180
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
    • New York
      • Poughkeepsie, New York, United States, 12601
    • North Carolina
      • Statesville, North Carolina, United States, 28677
      • Wilmington, North Carolina, United States, 28401
    • Tennessee
      • Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:- Males who have had ED for at least six months- Heterosexual relationship.- Males 18 and older. Exclusion Criteria:- Primary hypoactive sexual desire.- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.- Stable heterosexual relationship for > 6 month- Other exclusion criteria apply according to the US Product Information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 2
Drug: Levitra (Vardenafil, BAY38-9456)
5m, 10 mg and 20 mg 1 h prior to sexual intercourse
Placebo Comparator: Arm 1
Drug: Placebo
Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Erection Quality Scale
Time Frame: Week 8
Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Erection Quality Scale
Time Frame: Week 4 and 8
Week 4 and 8
International Index of Erectile Function- Erectile Function domain score
Time Frame: Week 4 and 8
Week 4 and 8
Per-subject success rates based on Sexual Encounter Profile, Question 2
Time Frame: Week 4, 8 Week 8
Week 4, 8 Week 8
Safety and tolerability
Time Frame: Week 8
Week 8
Patient Diary Questions
Time Frame: Weeks 4, 8 Week 8
Weeks 4, 8 Week 8
Global Assessment Question (GAQ)
Time Frame: Weeks 4, 8 of treatment and Week 8
Weeks 4, 8 of treatment and Week 8
Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25)
Time Frame: Week 8-LOCF
Week 8-LOCF
Penetration (SEP2) and Maintenance (SEP3) reliability
Time Frame: Week 8-LOCF
Week 8-LOCF

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 22, 2008

First Posted (Estimate)

April 23, 2008

Study Record Updates

Last Update Posted (Estimate)

October 11, 2013

Last Update Submitted That Met QC Criteria

October 10, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11561

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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