Vardenafil Treatment Of Erectile Dysfunction In Depressive And Non-Depressive Men - Full Text View

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:	Observational Model: Cohort Time Perspective: 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 Vardenafil dihydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Efficacy, safety, tolerance of the treatment with Vardenafil reported by the physician [ Time Frame: At the patients control visit (approx. 3 months from the initial) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Influence of vardenafil on depressive symptoms and self-esteem measured with CES-D and Rosenberg scale [ Time Frame: At the patients control visit (approx. 3 months from the initial) ] [ Designated as safety issue: No ]

Enrollment:	3000
Study Start Date:	January 2007
Study Completion Date:	February 2008

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

No publications provided

Responsible Party:	Medical Director, Bayer Sp. z o.o
ClinicalTrials.gov Identifier:	NCT00470873 History of Changes
Obsolete Identifiers:	NCT00459394
Other Study ID Numbers:	12842, LV0610PL, VALOR
Study First Received:	May 7, 2007
Last Updated:	April 7, 2011
Health Authority:	Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:

Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Vasodilator Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012