REPEAT - Real-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra Therapy

November 9, 2011 updated by: Bayer

REal-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra® Therapy

The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. Furthermore, the data collection particularly focuses on the experience of the patient and his satisfaction with the treatment. Treatment naive patients as well as pre-treated patients will be included in the study.The maximum observation period per patient is 12 months.Besides the physician's documentation, the patient should fill out a questionnaire at every visit. The questionnaires will be handed out and collected by the physician. Furthermore, an additional questionnaire for the patient's partner can be distributed at each visit in case the partner is willing to participate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7293

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

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

Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment

Description

Inclusion Criteria:

  • Outpatients with diagnosis of erectile dysfunction, decision taken by the investigator to prescribe Vardenafil.

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the local product information. All contraindications listed in the local product information are applicable.

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Levitra (Vardenafil, BAY38-9456)
Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physician's assessment of safety (incidence of adverse events)
Time Frame: During observation period
During observation period

Secondary Outcome Measures

Outcome Measure
Time Frame
Severity of ED symptoms
Time Frame: End of study
End of study
General quality of partnership as assessed by patient
Time Frame: Initial visit and after 3, 6, 9 and 12 months
Initial visit and after 3, 6, 9 and 12 months
General quality of partnership as assessed by partner
Time Frame: Initial visit and after 3, 6, 9 and 12 months
Initial visit and after 3, 6, 9 and 12 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

March 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

April 1, 2009

First Submitted That Met QC Criteria

April 1, 2009

First Posted (Estimate)

April 2, 2009

Study Record Updates

Last Update Posted (Estimate)

November 11, 2011

Last Update Submitted That Met QC Criteria

November 9, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12805
  • REPEAT (Company Internal)
  • LV0602 (Other Identifier: Company Internal)
  • 12942 - LV0602KR (Other Identifier: Company Internal)
  • 12975 - LV0602HR (Other Identifier: Company Internal)
  • 12976 - LV0602CN (Other Identifier: Company Internal)
  • 12977 - LV0602SG (Other Identifier: Company Internal)
  • 13047 - LV0602SE (Other Identifier: Company Internal)
  • 13048 - LV0602ZA (Other Identifier: Company Internal)
  • 13067 - LV0602HU (Other Identifier: Company Internal)
  • 13093 - LV0602MY (Other Identifier: Company Internal)
  • 13112 - LV0602ID (Other Identifier: Company Internal)
  • 13208 - LV0602TH (Other Identifier: Company Internal)
  • 13416 - LV0602ES (Other Identifier: Company Internal)
  • 13417 - LV0602SA (Other Identifier: Company Internal)
  • 13600 - LV0602PL (Other Identifier: Company Internal)
  • 14525 - LV0602FR (Other Identifier: Company Internal)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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