Trial Condition(s):

Erectile Dysfunction

A randomised study of Levitra to treat men with erections problems and previously untreated with similar therapy. (FINDER)

Bayer Identifier:

11334

ClinicalTrials.gov Identifier:

NCT00668096

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.

Inclusion Criteria
- Males with erectile dysfunction according to the National Institute of Health (NIH) Consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance
 - Heterosexual relationship for more than 6 months 
 - Partner willing to complete the TSS
Exclusion Criteria
- Primary hypoactive sexual desire
 - History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
 - Nitrate use
 - Other exclusion criteria apply according to the Summary of Product Characteristics

Trial Summary

Enrollment Goal
260
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1000

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 22299

Status
Completed
 
Locations

Investigative Site

Oulu, Finland, 90100

Status
Completed
 
Locations

Investigative Site

DRIESLINTER, Belgium, 3350

Status
Completed
 
Locations

Investigative Site

MARSEILLE, France, 13009

Status
Completed
 
Locations

Investigative Site

Westbury, United Kingdom, BA13 3FQ

Status
Completed
 
Locations

Investigative Site

GENK, Belgium, 3600

Status
Completed
 
Locations

Investigative Site

Naestved, Denmark, 4700

Status
Completed
 
Locations

Investigative Site

Tampere, Finland, 33100

Status
Completed
 
Locations

Investigative Site

Crowborough, United Kingdom, TN6 1DL

Status
Completed
 
Locations

Investigative Site

Kerava, Finland, 04250

Status
Completed
 
Locations

Investigative Site

LYON, France, 69000

Status
Completed
 
Locations

Investigative Site

Harrislee, Germany, 24955

Status
Completed
 
Locations

Investigative Site

Meißen, Germany, 01662

Status
Completed
 
Locations

Investigative Site

Leisnig, Germany, 04703

Status
Completed
 
Locations

Investigative Site

Altenburg, Germany, 04600

Status
Completed
 
Locations

Investigative Site

Leipzig, Germany, 04105

Status
Completed
 
Locations

Investigative Site

Gentofte, Denmark, DK-2820

Status
Completed
 
Locations

Investigative Site

Chipping Norton, United Kingdom, OX7 5AL

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 22303

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 22177

Status
Completed
 
Locations

Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Investigative Site

Wahlstedt, Germany, 23812

Status
Completed
 
Locations

Investigative Site

Hamilton, United Kingdom, ML3 ODR

Status
Completed
 
Locations

Investigative Site

Leipzig, Germany, 04249

Status
Completed
 
Locations

Investigative Site

MARSEILLE, France, 13015

Status
Completed
 
Locations

Investigative Site

Dresden, Germany, 01099

Status
Completed
 
Locations

Investigative Site

LILLE, France, 59000

Status
Completed
 

Trial Design