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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00874679
First Posted: April 2, 2009
Last Update Posted: November 11, 2011
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.
Information provided by:
Bayer
  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:


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

  Eligibility

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.


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
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
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 ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov 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 )
First Submitted: April 1, 2009
First Posted: April 2, 2009
Last Update Posted: November 11, 2011
Last Verified: November 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