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

Sponsored by:	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:	December 2009
Estimated Primary Completion Date:	December 2009 (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

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

China
	Active, not recruiting
Many Locations, China
Croatia
	Active, not recruiting
Many Locations, Croatia
France
	Recruiting
Many Locations, France
Germany
	Active, not recruiting
Many Locations, Germany
	Recruiting
Many Locations, Germany
Hungary
	Recruiting
Many Locations, Hungary
Indonesia
	Recruiting
Many Locations, Indonesia
Korea, Republic of
	Recruiting
Many Locations, Korea, Republic of
Malaysia
	Recruiting
Many Locations, Malaysia
Poland
	Not yet recruiting
Many Locations, Poland
Saudi Arabia
	Recruiting
Many Locations, Saudi Arabia
Singapore
	Recruiting
Many Locations, Singapore
South Africa
	Not yet recruiting
Many Locations, South Africa
Spain
	Recruiting
Many Locations, Spain
Sweden
	Recruiting
Many Locations, Sweden
Thailand
	Not yet recruiting
Many Locations, Thailand

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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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:	Bayer Healthcare AG ( Global Medical Affairs Therapeutic Area Head )
Study ID Numbers:	12805, LV0602, 12842, 12942, 12975, 12976, 12977, 13047, 13048, 13067, 13093, 13112, 13208, 13416, 13417, 13600, 13930, 13931, 14328
Study First Received:	April 1, 2009
Last Updated:	September 8, 2009
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

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological

Mental Disorders
Genital Diseases, Male
Erectile Dysfunction

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 September 11, 2009