Assessment of Duration of Erection With Vardenafil 10 mg
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...
Brief Summary
Official Title: “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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Levitra (Vardenafil, BAY38-9456)
- 10mg Vardenafil taken orally 1 hour prior to sexual intercourse
- Drug: Placebo
- Matching placebo
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Arm 1
- Placebo Comparator: Arm 2
Outcome Measures for this Clinical Trial
Primary Measures
- Effect of vardenafil on the duration of erection
- Time Frame: 4 weeks
Safety Issue?: No
- Time Frame: 4 weeks
Secondary Measures
- Perception of erection to be hard enough for penetration
- Time Frame: 4 weeks
Safety Issue?: No
- Time Frame: 4 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 64 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Bayer Industry
Overall Clinical Trial Officials and Contacts
Bayer Study Direct Study Director Bayer
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00663728
Study ID Number: 11575
ClinicalTrials.gov Identifier: NCT00663728
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00663728
