LEVITRA® 20mg Special Drug Use Investigation (Long-term)

December 12, 2014 updated by: Bayer
This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1221

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

  • Japan
      • Many locations, Japan

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 to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

  • This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.

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: Vardenafil, (Levitra, BAY38-9456)
Patients under daily life treatment receiving Levitra according to local drug information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of patients with LEVITRA treatment
Time Frame: After 6 months
After 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
LEVITRA treatment improved the patient's erection
Time Frame: After 6 months
After 6 months
LEVITRA improved the patient's erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourse
Time Frame: After 6 months
After 6 months
Reporting a second successful intercourse within 24 hours of dosing
Time Frame: After 6 months
After 6 months
Patients prefer LEVITRA over last Erectile Dysfunction treatment
Time Frame: After 6 months
After 6 months
Tolerability of patients with LEVITRA treatment
Time Frame: After 6 months
After 6 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

August 1, 2007

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

May 8, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (ESTIMATE)

May 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 15, 2014

Last Update Submitted That Met QC Criteria

December 12, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13930
  • LV0701JP

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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