Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse
Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. However, there remains no prospectively obtained data on the maximal time of effectiveness of vardenafil. The goal of the current study was to determine if vardenafil will significantly increase the percentage of successful intercourse attempts from 12 to 24...
Brief Summary
Official Title: “A Pilot, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Vardenafil Versus Placebo Administered 12, 18 and 24 Hours Prior to Initiation of Sexual Intercourse in Subjects With ED”
Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. However, there remains no prospectively obtained data on the maximal time of effectiveness of vardenafil. The goal of the current study was to determine if vardenafil will significantly increase the percentage of successful intercourse attempts from 12 to 24 hours following dosing. A total of three time points 12, 18, and 24 hours were assessed in this pilot study to better quantify the effect of vardenafil.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Levitra (Vardenafil, BAY38-9456)
- 10mg and 20mg to be taken 12, 18, 24 hours 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
- Sexual encounter profile Question 3
- Time Frame: 6 weeks
Safety Issue?: No
- Time Frame: 6 weeks
Secondary Measures
- Safety and Tolerability
- Time Frame: 6 weeks
Safety Issue?: Yes
- Time Frame: 6 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Men >/= 18 years of age
- ED >/= 6 months
- Stable sexual relationship for > 6 months
Exclusion Criteria:
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
- Nitrate therapy
- Other exclusion criteria apply according to the Summary of Product Characteristics
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 Director 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/NCT00667979
Study ID Number: 11586
ClinicalTrials.gov Identifier: NCT00667979
Health Authority: Australia: Human Research Ethics Committee
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