Trial Condition(s):
Erectile Dysfunction
Assessment of duration of erection with vardenafil 10 mg
Bayer Identifier:
11575
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This study assessed the effect of 10mg vardenafil, taken on demand in an 'at home' setting, as compared to placebo (dummy medication with no pharmacological activity), on the duration of erection from the moment when the patient perceived his erection to be hard enough for penetration until withdrawal from the partner's vagina leading to successful completion which may or may not have included ejaculation. The patient used the stopwatch for the above assessments. The efficacy of oral ED treatments is measured by questionnaires and patient diaries.
Inclusion Criteria
- Males with erectile dysfunction- Stable heterosexual relationship
Exclusion Criteria
- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months nitrate use
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations |
|---|
Trial Design
A randomized, double-blind, crossover study to evaluate the duration of erection following vardenafil (10mg) administration for four weeks in a fixed dose regimen compared to placebo in males with ED
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Effect of vardenafil on the duration of erectionTimeframe: 4 weeks
Secondary Outcome
- Perception of erection to be hard enough for penetrationTimeframe: 4 weeks
Additional Information
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