check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

12165

ClinicalTrials.gov Identifier:

NCT00663845

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assessing efficacy and safety of flexible dosing with Vardenafil in subjects with erectile dysfunction and hyperlipidemia

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - 65 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
395
Trial Dates
May 2006 - April 2007
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Primary Outcome

  • Sexual Encounter Profile Question 2 and 3 and International Index of Erectile Function - Erectile Function domain
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Duration of erection leading to positive Sexual Encounter Profile Question 3
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Safety and tolerability
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    yes
  • Other patient diary based variables
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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