Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours

Phase 3CompletedNCT00668018

Bayer887 enrolled

Overview

Assess efficacy of vardenafil within 6 hours after intake

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

887

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

Vardenafil 10mg orally on demand prior to intercourse

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age: 18 years and older * Males with erectile dysfunction * Stable heterosexual relationship Exclusion Criteria: * Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months * Nitrate use

Outcomes

Primary Outcomes

Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake

Time frame: 12 weeks

Secondary Outcomes

International Index of Erectile Function

Time frame: 12 weeks

Global Assessment Question (GAQ)

Time frame: 12 weeks

Other diary responses

Time frame: 12 weeks

General Safety

Time frame: 12 weeks

Data from ClinicalTrials.gov

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