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Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse

NCT ID: NCT00667979

Last Updated: 2009-06-30

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

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2004-12-31

Brief Summary

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Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. However, there remains no prospectively obtained data on the maximal time of effectiveness of vardenafil. The goal of the current study was to determine if vardenafil will significantly increase the percentage of successful intercourse attempts from 12 to 24 hours following dosing. A total of three time points 12, 18, and 24 hours were assessed in this pilot study to better quantify the effect of vardenafil.

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

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Levitra (Vardenafil, BAY38-9456)

Intervention Type DRUG

10mg and 20mg to be taken 12, 18, 24 hours prior to sexual intercourse

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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Levitra (Vardenafil, BAY38-9456)

10mg and 20mg to be taken 12, 18, 24 hours prior to sexual intercourse

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men \>/= 18 years of age
* ED \>/= 6 months
* Stable sexual relationship for \> 6 months

Exclusion Criteria

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Healthcare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Other Identifiers

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11586

Identifier Type: -

Identifier Source: org_study_id