Evaluation of the Safety and Efficacy of Vardenafil in Subjects With Erectile Dysfunction

Bayer333 enrolled

Overview

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

333

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

5mg, 10mg or 20mg taken 1 hours before sexual intercourse

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men \>/= 18 years of age, * ED 6 months or longer * Stable sexual relationship for \> 6 month. 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

Outcomes

Primary Outcomes

International Index of Erectile Function - Erectile Function Domain

Time frame: 12 weeks

Secondary Outcomes

Sexual Encounter Profile Question 2 and 3

Time frame: 12 weeks

Global Assessment Question

Time frame: 12 weeks

Other diary based variables

Time frame: 12 weeks

Safety and tolerability

Time frame: 12 weeks

Data from ClinicalTrials.gov

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