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Vardenafil Treatment Of Erectile Dysfunction In Depressive And Non-Depressive Men

NCT ID: NCT00470873

Last Updated: 2014-12-02

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

Total Enrollment

2471 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-02-29

Brief Summary

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The primary aim of this open, uncontrolled, prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. The secondary aim of this study is to assess the influence of the treatment with Levitra on self-esteem (depressive symptomology) in men with ED.

Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Levitra (Vardenafil, BAY38-9456)

Intervention Type DRUG

Primary care erectile dysfunction patients for whom physician decided to start the treatment with vardenafil

Interventions

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Levitra (Vardenafil, BAY38-9456)

Primary care erectile dysfunction patients for whom physician decided to start the treatment with vardenafil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age over 18
* Erectile dysfunction untreated or ineffectively treated with other than vardenafil PDE5 inhibitors

Exclusion Criteria

* Treatment with nitrates
* Allergy to vardenafil or other tablets ingredients
* Treatment with CYP3A4 inhibitors (e.g. indinavir, ritonavir, ketoconazole, itraconazole, erythromycin)
* Cardiovascular status excluding any sexual activity
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

Locations

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Many Locations, , Poland

Site Status

Countries

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Poland

Other Identifiers

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LV0610PL

Identifier Type: -

Identifier Source: secondary_id

VALOR

Identifier Type: -

Identifier Source: secondary_id

12842

Identifier Type: -

Identifier Source: org_study_id

NCT00459394

Identifier Type: -

Identifier Source: nct_alias