Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks

October 10, 2013 updated by: Bayer

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Duration of Efficacy and Safety of Vardenafil Administered for 10 Weeks in a Flexible-Dose Regimen Compared to Placebo in Subjects With Erectile Dysfunction

The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

383

Phase

  • Phase 3

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
  • History of unresponsiveness to sildenafil
  • Stable sexual relationship for > 6 month.

Exclusion Criteria:

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Levitra (Vardenafil, BAY38-9456)
5mg, 10mg or 20mg taken 8 hours before sexual intercourse
Placebo Comparator: Arm 2
Drug: Placebo
matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Per-patient success rates based on Sexual Encounter Profile, Question 3
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Per-subject success rates based on Sexual Encounter Profile, Question 2
Time Frame: 10 weeks
10 weeks
International Index of Erectile Function- Erectile Function domain score
Time Frame: 10 weeks
10 weeks
Global Assessment Question (GAQ)
Time Frame: 10 weeks
10 weeks
Safety and tolerability
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

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

Sponsor

Bayer

Collaborators

GlaxoSmithKline

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

December 1, 2003

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

May 20, 2008

First Posted (Estimate)

May 21, 2008

Study Record Updates

Last Update Posted (Estimate)

October 14, 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

  • 100493

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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