Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)

Official Title: “A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Responsiveness of the Erectile Quality Scale (EQS) to Vardenafil HCl Flexible Dose Versus Placebo in Males With Erectile Dysfunction.”

This study was conducted to evaluate in adult men with erectile dysfunction (often called impotence), the effect of vardenafil HCl on the quality of their erections. Many men experience occasional erectile problems during their lives. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to study the responsiveness of the erection quality scale (EQS) to vardenafil HCl.

In this study, vardenafil HCl will be compared to placebo. Placebo is a pill which looks like the real drug but it is not. It contains no active ingredients.

Intervention(s) in this Clinical Trial

• Drug: Placebo
  • Matching placebo
• Drug: Levitra (Vardenafil, BAY38-9456)
  • 5m, 10 mg and 20 mg 1 h prior to sexual intercourse

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Arm 1
• Experimental: Arm 2

Primary Measures

• Erection Quality Scale
  • Time Frame: Week 8
    Safety Issue?: No

Secondary Measures

• Erection Quality Scale
  • Time Frame: Week 4 and 8
    Safety Issue?: No
• International Index of Erectile Function- Erectile Function domain score
  • Time Frame: Week 4 and 8
    Safety Issue?: No
• Per-subject success rates based on Sexual Encounter Profile, Question 2
  • Time Frame: Week 4, 8 Week 8
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: Week 8
    Safety Issue?: Yes
• Patient Diary Questions
  • Time Frame: Weeks 4, 8 Week 8
    Safety Issue?: No
• Global Assessment Question (GAQ)
  • Time Frame: Weeks 4, 8 of treatment and Week 8
    Safety Issue?: No
• Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25)
  • Time Frame: Week 8-LOCF
    Safety Issue?: No
• Penetration (SEP2) and Maintenance (SEP3) reliability
  • Time Frame: Week 8-LOCF
    Safety Issue?: No

Inclusion Criteria:

• Males who have had ED for at least six months
• Heterosexual relationship.
• Males 18 and older.

Exclusion Criteria:

• Primary hypoactive sexual desire.
• History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.
• Stable heterosexual relationship for > 6 month
• 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: 64 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/NCT00665340

Study ID Number: 11561

ClinicalTrials.gov Identifier: NCT00665340

Health Authority: United States: Food and Drug Administration

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