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

Erectile Dysfunction Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663845
• Other study ID #: 12165
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2008
• Last updated: October 10, 2013
• Start date: May 2006
• Est. completion date: April 2007

Study information

• Verified date: October 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Encounter Profile Question 2 and 3 and International Index of Erectile Function - Erectile Function domain		12 weeks	No
Secondary	Duration of erection leading to positive Sexual Encounter Profile Question 3		12 weeks	No
Secondary	Safety and tolerability		12 weeks	Yes
Secondary	Other patient diary based variables		12 weeks	No

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