Trial Condition(s):

Erectile Dysfunction

Study Evaluation the Efficacy and Safety of Vardenafil in subjects with erectile dysfunction for 10 weeks

Bayer Identifier:

100493

ClinicalTrials.gov Identifier:

NCT00682019

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal

383

Trial Dates

December2003

August2004

Phase

Could I receive a placebo?

Yes

Products

Levitra (Vardenafil, BAY38-9456)

Accepts Healthy Volunteers

Where to Participate

Locations

Status

Locations	Status

Trial Design

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

Trial Type:

Interventional

Intervention Type:

Drug

Trial Purpose:

Treatment

Allocation:

Randomized

Blinding:

Double Blind

Assignment:

Parallel Assignment

Trial Arms:

Primary Outcome

Per-patient success rates based on Sexual Encounter Profile, Question 3
Timeframe: 10 weeks

Secondary Outcome

Per-subject success rates based on Sexual Encounter Profile, Question 2
Timeframe: 10 weeks

International Index of Erectile Function- Erectile Function domain score
Timeframe: 10 weeks

Global Assessment Question (GAQ)
Timeframe: 10 weeks

Safety and tolerability
Timeframe: 10 weeks

Erectile Dysfunction

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

EU CT Number:

Trial Purpose

Key Participation Requirements

sex

age

18 Years

No Limit

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information