Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
Study to investigate the efficacy and safety of Vardenafil taken 12, 18, or 24 hours prior
intercourse
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Sexual encounter profile Question 3
Secondary outcome: Safety and Tolerability
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Additional Information
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Starting date: September 2004
Ending date: December 2004
Last updated: April 27, 2008
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