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

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ClinicalTrials.gov Identifier: NCT00874679
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : November 11, 2011
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date April 1, 2009
First Posted Date April 2, 2009
Last Update Posted Date November 11, 2011
Study Start Date March 2007
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2009)
Physician's assessment of safety (incidence of adverse events) [ Time Frame: During observation period ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 1, 2009)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title REPEAT - Real-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra Therapy
Official Title REal-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra® Therapy
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment
Condition Erectile Dysfunction
Intervention Drug: Levitra (Vardenafil, BAY38-9456)
Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment
Study Groups/Cohorts Group 1
Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 8, 2011)
7293
Original Estimated Enrollment
 (submitted: April 1, 2009)
20000
Actual Study Completion Date April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China,   Croatia,   France,   Germany,   Hungary,   Indonesia,   Korea, Republic of,   Malaysia,   Poland,   Saudi Arabia,   Singapore,   South Africa,   Spain,   Sweden,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Global Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date November 2011