Trial Condition(s):
Erectile Dysfunction
Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in subjects with erectile dysfunction
Study Completed
Trial Purpose
This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.
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
463
Trial Dates
Phase
2/3
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No
Where to Participate
Locations
Status
| Locations | Status |
|---|
Trial Design
A Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Erectile Function domain of the International Index of Erectile FunctionTimeframe: 12 weeks
- Sexual Encounter Profile Question 2Timeframe: 12 weeks
- Sexual Encounter Profile Question 3Timeframe: 12 weeks
Secondary Outcome
- Erectile Function domain scores > 26Timeframe: 12 weeks
- Sexual Encounter Profile 2Timeframe: 12 weeks
- Global Assessment QuestionTimeframe: 12 weeks
- Reliability of insertionTimeframe: 12 weeks
- Reliability of maintenanceTimeframe: 12 weeks
- Other subject diary based variablesTimeframe: 12 weeks
- Safety and tolerabilityTimeframe: 12 weeks
Additional Information
Copyright © Bayer
Powered by
