Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks

Phase 3CompletedNCT00682019

Bayer383 enrolled

Overview

The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

383

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

5mg, 10mg or 20mg taken 8 hours before 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

Per-patient success rates based on Sexual Encounter Profile, Question 3

Time frame: 10 weeks

Secondary Outcomes

Per-subject success rates based on Sexual Encounter Profile, Question 2

Time frame: 10 weeks

International Index of Erectile Function- Erectile Function domain score

Time frame: 10 weeks

Global Assessment Question (GAQ)

Time frame: 10 weeks

Safety and tolerability

Time frame: 10 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.