Trial Condition(s):
Erectile Dysfunction
Study Evaluation the Efficacy and Safety of Vardenafil in subjects with erectile dysfunction for 10 weeks
Bayer Identifier:
100493
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations |
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Trial Design
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Duration of Efficacy and Safety of Vardenafil Administered for 10 Weeks in a Flexible-Dose Regimen 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
- Per-patient success rates based on Sexual Encounter Profile, Question 3Timeframe: 10 weeks
Secondary Outcome
- Per-subject success rates based on Sexual Encounter Profile, Question 2Timeframe: 10 weeks
- International Index of Erectile Function- Erectile Function domain scoreTimeframe: 10 weeks
- Global Assessment Question (GAQ)Timeframe: 10 weeks
- Safety and tolerabilityTimeframe: 10 weeks
Additional Information
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