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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00665340

Collaborator

(none)

219

Enrollment

Locations

Arms

Duration (Months)

18.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Jul 1, 2004

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Jan 1, 2005

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Erection Quality Scale [Week 8]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	City	State	Country	Postal Code
1	Phoenix	Arizona	United States	85023
2	Beverly Hills	California	United States	90212
3	Laguna Hills	California	United States	92653
4	Newport Beach	California	United States	92660
5	Aurora	Colorado	United States	80012
6	Trumbull	Connecticut	United States	06611
7	Aventura	Florida	United States	33180
8	Lawrenceville	New Jersey	United States	08648
9	Poughkeepsie	New York	United States	12601
10	Statesville	North Carolina	United States	28677
11	Wilmington	North Carolina	United States	28401
12	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT00665340

Other Study ID Numbers:

11561

First Posted:

Apr 23, 2008

Last Update Posted:

Oct 11, 2013

Last Verified:

Oct 1, 2013

Keywords provided by Bayer

Erectile Dysfunction

Vardenafil

Additional relevant MeSH terms:

Erectile Dysfunction

Vardenafil Dihydrochloride

Study Results

No Results Posted as of Oct 11, 2013