LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers
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|ClinicalTrials.gov Identifier: NCT01207947|
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : January 21, 2015
Main object is to investigate the safety profile of Levitra in combination use with alpha-blockers in patients with erectile dysfunction used in clinical practice after launch.
In the initial combination date and the first and second observation after initial combination date, number of tablets prescribed, dose of tablets and number of tablets taken until follow-up visit will be investigated. The efficacy and tolerability will be evaluated at 2 months after initial combination date.
|Condition or disease||Intervention/treatment|
|Erectile Dysfunction||Drug: Vardenafil (Levitra, BAY38-9456)|
|Study Type :||Observational|
|Actual Enrollment :||491 participants|
|Official Title:||LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||March 2010|
Drug: Vardenafil (Levitra, BAY38-9456)
Patients under daily life treatment receiving Levitra according to local drug information.
- Efficacy of Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied [ Time Frame: 2 months ]
- Safety of Levitra treatment, namely incidence of Adverse Events or Adverse Drug Reactions are evaluated [ Time Frame: 2 months ]
- Tolerability of patients with Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied [ Time Frame: 2 months ]
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): NCT01207947
|Many Locations, Japan|
|Study Director:||Bayer Study Director||Bayer|