Trial Condition(s):
Erectile Dysfunction
Evaluating the Efficacy of Vardenafil in subjects with Erectile Dysfunction (ED) administered 12, 18 or 24 hours prior to intercourse
Bayer Identifier:
11586
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Sexual encounter profile Question 3Timeframe: 6 weeks
Secondary Outcome
- Safety and TolerabilityTimeframe: 6 weeks
Additional Information
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