Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

Bayer348 enrolled

Overview

To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

348

Conditions

Erectile Dysfunction

Interventions

Vardenafil (Levitra, BAY38-9456)DRUG

Vardenafil 10 mg orally on demand prior to intercourse

PlaceboDRUG

Matching placebo

Eligibility

Sex: MALEMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age: 20 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 * Other exclusion criteria apply according to the Summary of Product Characteristics

Locations (13)

Unnamed facility

Hong Kong, Hong Kong

Unnamed facility

Jakarta, Jakarta Special Capital Region, Indonesia

Unnamed facility

Petlaing Jaya, Salangor, Malaysia

Unnamed facility

Kuching, Sarawak, Malaysia

Outcomes

Primary Outcomes

International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3)

Time frame: 12 weeks

Secondary Outcomes

Global Assessment Question

Time frame: 12 weeks

Other diary responses

Time frame: 12 weeks

Safety and tolerability

Time frame: 12 weeks

Data from ClinicalTrials.gov

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