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

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

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil Vardenafil dihydrochloride

U.S. FDA Resources

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
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

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
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

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

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Affairs Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00665340 History of Changes
Other Study ID Numbers:	11561
Study First Received:	April 18, 2008
Last Updated:	June 29, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Erectile Dysfunction
Vardenafil

Additional relevant MeSH terms:

Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Vasodilator Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012