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

This study has been completed.

First Received: May 7, 2007 Last Updated: November 26, 2008 History of Changes

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00470873

Purpose

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.

Condition	Intervention
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456)

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Non-Interventional, Post-Marketing Surveillance Phase IV Study to Obtain Data on Safety and Efficacy of Levitra® in Routine Treatment of Erectile Dysfunction in Depressive and Non-Depressive Men.

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil

U.S. FDA Resources

Further study details as provided by Bayer:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	3000
Study Start Date:	January 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1	Drug: Levitra (Vardenafil, BAY38-9456) Primary care erectile dysfunction patients for whom physician decided to start the treatment with vardenafil

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470873

Locations

Poland

Many locations, Poland

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Sp. z o.o ( Medical Director )
Study ID Numbers:	12842, LV0610PL, VALOR
Study First Received:	May 7, 2007
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00470873 History of Changes
Health Authority:	Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological
Molecular Mechanisms of Pharmacological Action
Mental Disorders

Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010