Trial Condition(s):
Erectile Dysfunction
Study evaluating the efficacy, safety, and reliability of Vardenafil
Bayer Identifier:
100536
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
Study to investigate the efficacy and safety of Vardenafil
Inclusion Criteria
- Heterosexual males - >/= 18 years old with ED for more than six months - Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation
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
523
Trial Dates
Phase
3
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No
Where to Participate
Locations
| Locations |
|---|
Trial Design
A randomised, double-blind, parallel-group, placebo-controlled study evaluating the efficacy, safety, and reliability of 10mg vardenafil administered for 12 weeks 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:
2
Primary Outcome
- Sexual Encounter Profile question 2 (SEP 2)Timeframe: 12 weeks
Secondary Outcome
- Sexual Encounter Profile question 3 (SEP 3)Timeframe: 12 weeks
- International Index of Erectile Function (IIEF) - EF (Erectile Function) domainTimeframe: 12 weeks
- Safety and TolerabilityTimeframe: 12 weeks
Additional Information
Copyright © Bayer
Powered by
