Trial Condition(s):

Erectile Dysfunction

Evaluating the Efficacy of Vardenafil in subjects with Erectile Dysfunction (ED) administered 12, 18 or 24 hours prior to intercourse

Bayer Identifier:

11586

ClinicalTrials.gov Identifier:

NCT00667979

EudraCT Number:

2004-001549-13

Study Completed

Trial Purpose

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. However, there remains no prospectively obtained data on the maximal time of effectiveness of vardenafil. The goal of the current study was to determine if vardenafil will significantly increase the percentage of successful intercourse attempts from 12 to 24 hours following dosing. A total of three time points 12, 18, and 24 hours were assessed in this pilot study to better quantify the effect of vardenafil.

Inclusion Criteria
- Men >/= 18 years of age- ED >/= 6 months - Stable sexual relationship for > 6 months
Exclusion Criteria
- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month- Nitrate therapy- Other exclusion criteria apply according to the Summary of Product Characteristics

Trial Summary

Enrollment Goal
264
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

Many locations, Germany

Status
Completed
 

Trial Design