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
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456)

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: 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 Vardenafil dihydrochloride

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 ]

Enrollment:	7293
Study Start Date:	March 2007
Study Completion Date:	April 2010
Primary Completion Date:	April 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:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00874679 History of Changes
Other 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:	November 9, 2011
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

Additional relevant MeSH terms:

Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Vasodilator Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2012