Real Life Safety and Efficacy of Vardenafil

May 16, 2014 updated by: Bayer

Vardenafil in Routine Treatment of Erectile Dysfunction

In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study, data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile dysfunction. The general objectives are to evaluate the product safety (primarily by recording adverse events), efficacy and patient acceptance.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

372

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

  • Taiwan
      • Many Locations, Taiwan

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 clinics

Description

Inclusion Criteria:

  • Any adult patient (>/=18 years) with erectile dysfunction treated with LEVITRA®.
  • Patients must be able to give written informed consent for participation in the study after receiving detailed written and oral information prior to the study.

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the product information (Package Insert).

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Vardenafil (Levitra, BAY38-9456)
5 mg or 10 mg or 20 mg of Vardenafil, orally when necessary for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
General assessment of patients concerning efficacy and tolerability of vardenafil treatment
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to first intercourse after intake of vardenafil
Time Frame: 2 months
2 months
Percentage of successful second intercourse within 24 hours
Time Frame: 2 months
2 months
Percentage of participants who are willing to continue treatment
Time Frame: 2 months
2 months
Number of participants with adverse events
Time Frame: 2 months
2 months

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

February 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 28, 2010

First Submitted That Met QC Criteria

October 5, 2010

First Posted (Estimate)

October 6, 2010

Study Record Updates

Last Update Posted (Estimate)

May 19, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14328
  • LV0611TW (Other Identifier: Company internal)

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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