Assessing Efficacy and Safety of Flexible Dosing With Vardenafil in Subjects With Erectile Dysfunction and Hyperlipidemia

Bayer395 enrolled

Overview

This study is being conducted in US to obtain information on the efficacy, safety, and duration of erection of flexible-dose regime of vardenafil compared to placebo (dummy medication with no pharmacological activity), in patients with co-morbid factors associated with erectile dysfunction (also called impotence). The duration of erection endpoint will be assessed by patient utilized stopwatch timings during each attempt at sexual intercourse. Elevated levels of total cholesterol or low levels of HDL may result in atherosclerosis and induce erectile dysfunction. Vardenafil (Levitra) is approved by the Food and Drug Administration for the treatment of erectile dysfunction. While there is no intent to assess the effect vardenafil has on blood lipids, the study will provide prospective data on men diagnosed with both ED and dyslipidemia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

395

Conditions

Erectile Dysfunction

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males with ED for more than 6 months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance) * Stable heterosexual relationship for more than 6 months * Between 18 and \<65 years of age * Diagnosed dyslipidemia and treated with a stable dose of a statin (or generic equivalent) \>/=3 months at Screening. In addition, the subject must have remained on this stable dose of statin (or its generic equivalent) throughout the study and no additional therapy to treat dyslipidemia was initiated * InternationaI Index of Erectile Function - Erectile Function domain score of \<25, denoting mild to severe ED at Visit 2 Exclusion Criteria: * Primary hypoactive sexual desire * History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month * Nitrate therapy * Other exclusion criteria apply according to the US Product Information

Outcomes

Primary Outcomes

Sexual Encounter Profile Question 2 and 3 and International Index of Erectile Function - Erectile Function domain

Time frame: 12 weeks

Secondary Outcomes

Duration of erection leading to positive Sexual Encounter Profile Question 3

Time frame: 12 weeks

Safety and tolerability

Time frame: 12 weeks

Other patient diary based variables

Time frame: 12 weeks