NCT00667979CompletedPhase 4
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 264
- Primary Endpoint
- Sexual encounter profile Question 3
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm 1
Experimental
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug)
Arm 2
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Sexual encounter profile Question 3
Time Frame: 6 weeks
Secondary Outcomes
- Safety and Tolerability(6 weeks)
Investigators
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