Official Title: “A Randomized, Double-Blind, Crossover Study to Evaluate the Duration of Erection Following Vardenafil (10mg) Administration for Four Weeks in a Fixed Dose Regimen Compared to Placebo in Males With ED”

Assessment of duration of erection with vardenafil 10 mg

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study

The main characteristics of ED are the inability to achieve and/or maintain an erection which would allow the patient to insert his penis into his partner's vagina and more importantly to maintain the erection long enough for a successful completion of the intercourse. This study assessed the effect of 10mg vardenafil, taken on demand in an 'at home' setting, as compared to placebo (dummy medication with no pharmacological activity), on the duration of erection from the moment when the patient perceived his erection to be hard enough for penetration until withdrawal from the partner's vagina leading to successful completion which may or may not have included ejaculation. The patient used the stopwatch for the above assessments. The efficacy of oral ED treatments is measured by questionnaires and patient diaries.

Intervention(s) in this Clinical Trial

• Drug: Levitra (Vardenafil, BAY38-9456)
  • 10mg Vardenafil taken orally 1 hour 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

• Effect of vardenafil on the duration of erection
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• Perception of erection to be hard enough for penetration
  • Time Frame: 4 weeks
    Safety Issue?: No

Inclusion Criteria:

• Age: 18 to 64 years
• Males with erectile dysfunction
• Stable heterosexual relationship

Exclusion Criteria:

• Primary hypoactive sexual desire
• History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months nitrate use

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Direct Study Director Bayer  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00663728

Study ID Number: 11575

ClinicalTrials.gov Identifier: NCT00663728

Health Authority: United States: Food and Drug Administration

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