Study Completed

Erectile Dysfunction

Bayer Identifier:

11586

ClinicalTrials.gov Identifier:

NCT00667979

EudraCT Number:

2004-001549-13

EU CT Number:

Not Available

Evaluating the Efficacy of Vardenafil in subjects with Erectile Dysfunction (ED) administered 12, 18 or 24 hours prior to intercourse

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.

Key Participants Requirements

Sex

Male

Age

18 - 64 Years

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

264

Trial Dates

September 2004 - December 2004

Phase

Phase 4

Could I Receive a placebo

Yes

Products

Levitra (Vardenafil, BAY38-9456)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Germany

Primary Outcome

Sexual encounter profile Question 3
Time Frame:
6 weeks
Safety Issue:
no

Secondary Outcome

Safety and Tolerability
Time Frame:
6 weeks
Safety Issue:
yes

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

Additional Information

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