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

NCT ID: NCT00665340

Last Updated: 2013-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Erectile Dysfunction

Keywords

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Erectile Dysfunction Vardenafil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Arm 2

Group Type EXPERIMENTAL

Levitra (Vardenafil, BAY38-9456)

Intervention Type DRUG

5m, 10 mg and 20 mg 1 h prior to sexual intercourse

Interventions

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Placebo

Matching placebo

Intervention Type DRUG

Levitra (Vardenafil, BAY38-9456)

5m, 10 mg and 20 mg 1 h prior to sexual intercourse

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:- Males who have had ED for at least six months- Heterosexual relationship.- Males 18 and older.

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Phoenix, Arizona, United States

Site Status

Beverly Hills, California, United States

Site Status

Laguna Hills, California, United States

Site Status

Newport Beach, California, United States

Site Status

Aurora, Colorado, United States

Site Status

Trumbull, Connecticut, United States

Site Status

Aventura, Florida, United States

Site Status

Lawrenceville, New Jersey, United States

Site Status

Poughkeepsie, New York, United States

Site Status

Statesville, North Carolina, United States

Site Status

Wilmington, North Carolina, United States

Site Status

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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11561

Identifier Type: -

Identifier Source: org_study_id