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Levitra® - Real Life Safety and Efficacy of Levitra

NCT ID: NCT00663598

Last Updated: 2014-12-19

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

30825 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2004-09-30

Brief Summary

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Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily life conditions in a large number of subjects with erectile dysfunction (ED)

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

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Levitra (Vardenafil, BAY38-9456)

Intervention Type DRUG

Treatment according to US PI

Interventions

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Levitra (Vardenafil, BAY38-9456)

Treatment according to US PI

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male outpatients \>/= 18 years of age with a diagnosis of ED according to the 1992 US National Institutes of Health (NIH) Consensus Statement (the inability to achieve and maintain penile erection sufficient to complete satisfactory intercourse), and independent of any previous ED treatment

Exclusion Criteria

* Exclusion according to US PI
Minimum Eligible Age

18 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

Other Identifiers

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100477

Identifier Type: -

Identifier Source: org_study_id