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

This study has been completed.
Information provided by:
Bayer Identifier:
First received: April 1, 2009
Last updated: November 9, 2011
Last verified: November 2011
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:

Further study details as provided by Bayer:

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

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

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00874679

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
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer Healthcare AG Identifier: NCT00874679     History of Changes
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 )
Study First Received: April 1, 2009
Last Updated: November 9, 2011

Additional relevant MeSH terms:
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 processed this record on August 17, 2017