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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00663845

Enrollment

395

Registered

2008-04-22

Start date

2006-05-31

Completion date

2007-04-30

Last updated

2013-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Male Erectile Dysfunction, Dyslipidemia, Vardenafil

Brief summary

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.

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

10mg Vardenafil taken orally 1h prior to sexual intercourse

DRUGPlacebo

Matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Sexual Encounter Profile Question 2 and 3 and International Index of Erectile Function - Erectile Function domain	12 weeks

Secondary

Measure	Time frame
Safety and tolerability	12 weeks
Other patient diary based variables	12 weeks
Duration of erection leading to positive Sexual Encounter Profile Question 3	12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026