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

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
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

Locations
Status
LocationsStatus

Trial Design