Trial Condition(s):
Erectile Dysfunction
Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in subjects with erectile dysfunction
Bayer Identifier:
10898
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
| Locations |
|---|
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
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