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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00874679

Purpose

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.

Condition	Intervention	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456)	Phase IV

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	REal-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra® Therapy

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Physician's assessment of safety (incidence of adverse events) [ Time Frame: During observation period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Severity of ED symptoms [ Time Frame: End of study ] [ Designated as safety issue: No ]
General quality of partnership as assessed by patient [ Time Frame: Initial visit and after 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
General quality of partnership as assessed by partner [ Time Frame: Initial visit and after 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

n.a.

Estimated Enrollment:	5000
Study Start Date:	April 2007
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1	Drug: Levitra (Vardenafil, BAY38-9456) Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874679

Locations

China

Many Locations, China
Croatia

Many Locations, Croatia
France

Many Locations, France
Germany

Many Locations, Germany
Hungary

Many Locations, Hungary
Indonesia

Many Locations, Indonesia
Korea, Republic of

Many Locations, Korea, Republic of
Malaysia

Many Locations, Malaysia
Poland

Many Locations, Poland
Saudi Arabia

Many Locations, Saudi Arabia
Singapore

Many Locations, Singapore
South Africa

Many Locations, South Africa
Spain

Many Locations, Spain
Sweden

Many Locations, Sweden
Thailand

Many Locations, Thailand

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Healthcare AG ( Global Medical Affairs Therapeutic Area Head )
Study ID Numbers:	12805, REPEAT, LV0602, 12942 - LV0602KR, 12975 - LV0602HR, 12976 - LV0602CN, 12977 - LV0602SG, 13047 - LV0602SE, 13048 - LV0602ZA, 13067 - LV0602HU, 13093 - LV0602MY, 13112 - LV0602ID, 13208 - LV0602TH, 13416 - LV0602ES, 13417 - LV0602SA, 13600 - LV0602PL, 14525 - LV0602FR
Study First Received:	April 1, 2009
Last Updated:	February 1, 2010
ClinicalTrials.gov Identifier:	NCT00874679 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; China: Ethics Committee; Spain: Ministry of Health; France: French Data Protection Authority; Croatia: Agency for Medicinal Product and Medical Devices; Croatia: Ethics Committee; Hungary: National Institute of Pharmacy; Indonesia: National Agency of Drug and Food Control; South Korea: Institutional Review Board; Malaysia: Medical Research Ethics Committee (MREC); Malaysia: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Sweden: Regional Ethical Review Board; Singapore: Domain Specific Review Boards; Singapore: Health Sciences Authority; Thailand: Ethical Committee; South Africa: Human Research Ethics Committee; South Africa: Department of Health; South Africa: Medicines Control Council; South Africa: National Health Research Ethics Council; United States: Food and Drug Administration

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological
Molecular Mechanisms of Pharmacological Action
Mental Disorders

Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010