Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

Bayer463 enrolled

Overview

This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

463

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

Vardenafil 5mg or 10mg or 20mg taken orally on demand 1 hour prior to sexual intercourse

PlaceboDRUG

Matching placebo

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement, * History of unresponsiveness to sildenafil * 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

Outcomes

Primary Outcomes

Erectile Function domain of the International Index of Erectile Function

Time frame: 12 weeks

Sexual Encounter Profile Question 2

Time frame: 12 weeks

Sexual Encounter Profile Question 3

Time frame: 12 weeks

Secondary Outcomes

Erectile Function domain scores > 26

Time frame: 12 weeks

Sexual Encounter Profile 2

Time frame: 12 weeks

Global Assessment Question

Time frame: 12 weeks

Reliability of insertion

Time frame: 12 weeks

Reliability of maintenance

Time frame: 12 weeks

Other subject diary based variables

Time frame: 12 weeks

Safety and tolerability

Time frame: 12 weeks

Data from ClinicalTrials.gov

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