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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00665340
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : October 11, 2013
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Placebo Drug: Levitra (Vardenafil, BAY38-9456) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : July 2004
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Arm Intervention/treatment
Placebo Comparator: Arm 1 Drug: Placebo
Matching placebo

Experimental: Arm 2 Drug: Levitra (Vardenafil, BAY38-9456)
5m, 10 mg and 20 mg 1 h prior to sexual intercourse

Primary Outcome Measures :
  1. Erection Quality Scale [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Erection Quality Scale [ Time Frame: Week 4 and 8 ]
  2. International Index of Erectile Function- Erectile Function domain score [ Time Frame: Week 4 and 8 ]
  3. Per-subject success rates based on Sexual Encounter Profile, Question 2 [ Time Frame: Week 4, 8 Week 8 ]
  4. Safety and tolerability [ Time Frame: Week 8 ]
  5. Patient Diary Questions [ Time Frame: Weeks 4, 8 Week 8 ]
  6. Global Assessment Question (GAQ) [ Time Frame: Weeks 4, 8 of treatment and Week 8 ]
  7. Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25) [ Time Frame: Week 8-LOCF ]
  8. Penetration (SEP2) and Maintenance (SEP3) reliability [ Time Frame: Week 8-LOCF ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00665340

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United States, Arizona
Phoenix, Arizona, United States, 85023
United States, California
Beverly Hills, California, United States, 90212
Laguna Hills, California, United States, 92653
Newport Beach, California, United States, 92660
United States, Colorado
Aurora, Colorado, United States, 80012
United States, Connecticut
Trumbull, Connecticut, United States, 06611
United States, Florida
Aventura, Florida, United States, 33180
United States, New Jersey
Lawrenceville, New Jersey, United States, 08648
United States, New York
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Statesville, North Carolina, United States, 28677
Wilmington, North Carolina, United States, 28401
United States, Tennessee
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer Identifier: NCT00665340    
Other Study ID Numbers: 11561
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: October 11, 2013
Last Verified: October 2013
Keywords provided by Bayer:
Erectile Dysfunction
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents