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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00874679
First received: April 1, 2009
Last updated: November 9, 2011
Last verified: November 2011
History of Changes

April 1, 2009
November 9, 2011
March 2007
April 2010   (final data collection date for primary outcome measure)
Physician's assessment of safety (incidence of adverse events) [ Time Frame: During observation period ] [ Designated as safety issue: Yes ]
Physician's assessment of safety (incidence of adverse events) [ Time Frame: During observation period ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00874679 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
REPEAT - Real-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra Therapy
REal-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra® Therapy

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment
Erectile Dysfunction
Drug: Levitra (Vardenafil, BAY38-9456)
Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment
Group 1
Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7293
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Croatia,   France,   Germany,   Hungary,   Indonesia,   Korea, Republic of,   Malaysia,   Poland,   Saudi Arabia,   Singapore,   South Africa,   Spain,   Sweden,   Thailand
 
NCT00874679
12805, REPEAT, LV0602, 12942 - LV0602KR, 12975 - LV0602HR, 12976 - LV0602CN, 12977 - LV0602SG, 13047 - LV0602SE, 13048 - LV0602ZA, 13067 - LV0602HU, 13093 - LV0602MY, 13112 - LV0602ID, 13208 - LV0602TH, 13416 - LV0602ES, 13417 - LV0602SA, 13600 - LV0602PL, 14525 - LV0602FR
No
Global Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP