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Real Life Safety and Efficacy of Vardenafil

This study has been terminated.
(Slow recruitment)
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01215409
First received: September 28, 2010
Last updated: May 14, 2013
Last verified: May 2013
History of Changes

September 28, 2010
May 14, 2013
February 2008
November 2008   (final data collection date for primary outcome measure)
General assessment of patients concerning efficacy and tolerability of vardenafil treatment [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01215409 on ClinicalTrials.gov Archive Site
  • Time to first intercourse after intake of vardenafil [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Percentage of successful second intercourse within 24 hours [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Percentage of participants who are willing to continue treatment [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Real Life Safety and Efficacy of Vardenafil
Vardenafil in Routine Treatment of Erectile Dysfunction

In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study, data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile dysfunction. The general objectives are to evaluate the product safety (primarily by recording adverse events), efficacy and patient acceptance.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Primary care clinics
Erectile Dysfunction
Drug: Vardenafil (Levitra, BAY38-9456)
5 mg or 10 mg or 20 mg of Vardenafil, orally when necessary for 2 months
Group 1
Intervention: Drug: Vardenafil (Levitra, BAY38-9456)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
377
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any adult patient (>/=18 years) with erectile dysfunction treated with LEVITRA®.
  • Patients must be able to give written informed consent for participation in the study after receiving detailed written and oral information prior to the study.

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the product information (Package Insert).
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01215409
14328, LV0611TW
No
Medical Director, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
May 2013

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