Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00470873
First received: May 7, 2007
Last updated: April 7, 2011
Last verified: April 2011
History of Changes
  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:

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 June 18, 2013