Trial Condition(s):

Erectile Dysfunction

Assessment of efficacy of vardenafil, influence on self-esteem and self-confidence in subjects with erectile dysfunction

Bayer Identifier:

11139

ClinicalTrials.gov Identifier:

NCT00661596

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.

Inclusion Criteria
- Age: 18 years and older
 - Males with erectile dysfunction
 - Stable heterosexual relationship
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 acc. to Summary of Product Characteristics

Trial Summary

Enrollment Goal
129
Trial Dates
black-arrow
Phase
3
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

Málaga, Spain, 29010

Status
Completed
 
Locations

Investigative Site

Valladolid, Spain, 47011

Status
Completed
 
Locations

Investigative Site

Móstoles, Spain, 28935

Status
Completed
 
Locations

Investigative Site

Alicante, Spain, 03010

Status
Completed
 
Locations

Investigative Site

Oviedo, Spain, 33006

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08025

Status
Completed
 
Locations

Investigative Site

Sevilla, Spain, 41071

Status
Completed
 
Locations

Investigative Site

Valencia, Spain, 46014

Status
Completed
 
Locations

Investigative Site

Sabadell, Spain, 08208

Status
Completed
 
Locations

Investigative Site

Vigo, Spain, 36211

Status
Completed
 
Locations

Investigative Site

Hondarribia, Spain, 28280

Status
Completed
 
Locations

Investigative Site

Granada, Spain, 18003

Status
Completed
 

Trial Design