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

NCT ID: NCT00874679

Last Updated: 2011-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7293 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Levitra (Vardenafil, BAY38-9456)

Intervention Type DRUG

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

Interventions

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Levitra (Vardenafil, BAY38-9456)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients with diagnosis of erectile dysfunction, decision taken by the investigator to prescribe Vardenafil.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Healthcare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , China

Site Status

Many Locations, , Croatia

Site Status

Many Locations, , France

Site Status

Many Locations, , Germany

Site Status

Many Locations, , Hungary

Site Status

Many Locations, , Indonesia

Site Status

Many Locations, , Malaysia

Site Status

Many Locations, , Poland

Site Status

Many Locations, , Saudi Arabia

Site Status

Many Locations, , Singapore

Site Status

Many Locations, , South Africa

Site Status

Many Locations, , South Korea

Site Status

Many Locations, , Spain

Site Status

Many Locations, , Sweden

Site Status

Many Locations, , Thailand

Site Status

Countries

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China Croatia France Germany Hungary Indonesia Malaysia Poland Saudi Arabia Singapore South Africa South Korea Spain Sweden Thailand

Other Identifiers

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REPEAT

Identifier Type: OTHER

Identifier Source: secondary_id

LV0602

Identifier Type: OTHER

Identifier Source: secondary_id

12942 - LV0602KR

Identifier Type: OTHER

Identifier Source: secondary_id

12975 - LV0602HR

Identifier Type: OTHER

Identifier Source: secondary_id

12976 - LV0602CN

Identifier Type: OTHER

Identifier Source: secondary_id

12977 - LV0602SG

Identifier Type: OTHER

Identifier Source: secondary_id

13047 - LV0602SE

Identifier Type: OTHER

Identifier Source: secondary_id

13048 - LV0602ZA

Identifier Type: OTHER

Identifier Source: secondary_id

13067 - LV0602HU

Identifier Type: OTHER

Identifier Source: secondary_id

13093 - LV0602MY

Identifier Type: OTHER

Identifier Source: secondary_id

13112 - LV0602ID

Identifier Type: OTHER

Identifier Source: secondary_id

13208 - LV0602TH

Identifier Type: OTHER

Identifier Source: secondary_id

13416 - LV0602ES

Identifier Type: OTHER

Identifier Source: secondary_id

13417 - LV0602SA

Identifier Type: OTHER

Identifier Source: secondary_id

13600 - LV0602PL

Identifier Type: OTHER

Identifier Source: secondary_id

14525 - LV0602FR

Identifier Type: OTHER

Identifier Source: secondary_id

12805

Identifier Type: -

Identifier Source: org_study_id