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

Condition(s) targeted: Erectile Dysfunction

Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Assessment of efficacy of Vardenafil in patients with erectile dysfunction and high cholesterol.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Study Evaluating the Efficacy, Safety, and Duration of Erection of Flexible-Dose Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction and Dyslipidemia.

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

Duration of erection leading to positive Sexual Encounter Profile Question 3

Safety and tolerability

Other patient diary based variables

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Male.

Criteria:

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

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Starting date: May 2006
Ending date: April 2007
Last updated: April 17, 2008