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

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.”

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.

Intervention(s) in this Clinical Trial

• Drug: Levitra (Vardenafil, BAY38-9456)
  • 10mg Vardenafil taken orally 1h prior to sexual intercourse
• Drug: Placebo
  • Matching placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Placebo Comparator: Arm 2

Primary Measures

• Sexual Encounter Profile Question 2 and 3 and International Index of Erectile Function - Erectile Function domain
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Duration of erection leading to positive Sexual Encounter Profile Question 3
  • Time Frame: 12 weeks
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Other patient diary based variables
  • Time Frame: 12 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00663845

Study ID Number: 12165

ClinicalTrials.gov Identifier: NCT00663845

Health Authority: United States: Food and Drug Administration

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