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

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00665340

Purpose

Assess the responsiveness of the Erection Quality Scale (EQS) to vardenafil HCl flexible dose therapy versus placebo in men with Erectile Dysfunction

Condition	Intervention	Phase
Erectile Dysfunction	Drug: Placebo Drug: Levitra (Vardenafil, BAY38-9456)	Phase IV

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by Bayer:

Primary Outcome Measures:

Erection Quality Scale [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Enrollment:	219
Study Start Date:	July 2004
Study Completion Date:	January 2005

Arms	Assigned Interventions
Arm 1: Placebo Comparator n/a	Drug: Placebo Matching placebo
Arm 2: Experimental n/a	Drug: Levitra (Vardenafil, BAY38-9456) 5m, 10 mg and 20 mg 1 h prior to sexual intercourse

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665340

Locations

United States, Arizona

Phoenix, Arizona, United States, 85023
United States, California

Newport Beach, California, United States, 92660

Beverly Hills, California, United States, 90212

Laguna Hills, California, United States, 92653
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

Wilmington, North Carolina, United States, 28412

Statesville, North Carolina, United States, 28677

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	( Bayer Healthcare Pharmaceuticals Inc., Therapeutic Area Head )
Study ID Numbers:	11561
Study First Received:	April 18, 2008
Last Updated:	April 22, 2008
ClinicalTrials.gov Identifier:	NCT00665340
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Erectile Dysfunction
Vardenafil

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Vardenafil
Sexual Dysfunction, Physiological

Mental Disorders
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Sexual and Gender Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009