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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00874679
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : November 11, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment
Erectile Dysfunction Drug: Levitra (Vardenafil, BAY38-9456)

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Study Type : Observational
Actual Enrollment : 7293 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: REal-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra® Therapy
Study Start Date : March 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

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

Primary Outcome Measures :
  1. Physician's assessment of safety (incidence of adverse events) [ Time Frame: During observation period ]

Secondary Outcome Measures :
  1. Severity of ED symptoms [ Time Frame: End of study ]
  2. General quality of partnership as assessed by patient [ Time Frame: Initial visit and after 3, 6, 9 and 12 months ]
  3. General quality of partnership as assessed by partner [ Time Frame: Initial visit and after 3, 6, 9 and 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00874679

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Many Locations, China
Many Locations, Croatia
Many Locations, France
Many Locations, Germany
Many Locations, Hungary
Many Locations, Indonesia
Korea, Republic of
Many Locations, Korea, Republic of
Many Locations, Malaysia
Many Locations, Poland
Saudi Arabia
Many Locations, Saudi Arabia
Many Locations, Singapore
South Africa
Many Locations, South Africa
Many Locations, Spain
Many Locations, Sweden
Many Locations, Thailand
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer Healthcare AG Identifier: NCT00874679    
Other Study ID Numbers: 12805
REPEAT ( Other Identifier: 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 )
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: November 11, 2011
Last Verified: November 2011
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents