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

November 26, 2014 updated by: Bayer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2471

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Many locations, Poland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
At the patients control visit (approx. 3 months from the initial)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
At the patients control visit (approx. 3 months from the initial)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion (ACTUAL)

February 1, 2008

Study Registration Dates

First Submitted

May 7, 2007

First Submitted That Met QC Criteria

May 7, 2007

First Posted (ESTIMATE)

May 8, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 26, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12842
  • LV0610PL
  • VALOR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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