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

NCT00663845 | Completed Phase 4

• 1 other identifier: 12165
• Study Type: interventional
• Target: 395
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Erectile Dysfunction

Keywords

Male Erectile Dysfunction; Dyslipidemia; Vardenafil

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (3)

• Duration of erection leading to positive Sexual Encounter Profile Question 3

  12 weeks

• Safety and tolerability

  12 weeks

• Other patient diary based variables

  12 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Levitra (Vardenafil, BAY38-9456) DRUG

10mg Vardenafil taken orally 1h prior to sexual intercourse

Arm 1

Placebo DRUG

Matching placebo

Arm 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Primary hypoactive sexual desire
• History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
• Nitrate therapy

Sponsors & Collaborators

• Bayer: lead
• GlaxoSmithKline: collaborator

MeSH Terms

Conditions

Erectile Dysfunction; Dyslipidemias

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2008
• First Posted: April 22, 2008
• Study Start: May 1, 2006
• Study Completion: April 1, 2007
• Last Updated: October 11, 2013

Record last verified: 2013-10