Evaluation of Efficacy and Safety of Vardenafil in Patients With Erectile Dysfunction and Type 1 Diabetes

Phase 4CompletedNCT00660998

Bayer318 enrolled

Overview

Asses efficacy of Vardenafil in patients with type 1 diabetes and erectile dysfunction

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

318

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

5mg, 10mg or 20mg taken 1h 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, * Diabetes type 1 * 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

Sexual Encounter Profile Question 2

Time frame: 12 weeks

Sexual Encounter Profile Question 3

Time frame: 12 weeks

Secondary Outcomes

International Index of Erectile Function - Erectile Function Domain

Time frame: 12 weeks

Safety and Tolerability

Time frame: 12 weeks

Data from ClinicalTrials.gov

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