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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 Phase
Erectile Dysfunction Drug: Vardenafil (Levitra, BAY38-9456) Phase 4

Study Design

Study Type : Observational
Actual Enrollment : 491 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers
Study Start Date : October 2007
Primary Completion Date : June 2009
Study Completion Date : March 2010


Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1 Drug: Vardenafil (Levitra, BAY38-9456)
Patients under daily life treatment receiving Levitra according to local drug information.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Safety of Levitra treatment, namely incidence of Adverse Events or Adverse Drug Reactions are evaluated [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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
Erectile dysfunction patients of 18 years-old or older and also the patients with combination use of alpha-blockers.
Criteria

Inclusion Criteria:

  • Patients >/= 18 years
  • Enrollment within 7 days after initiation of combination use of Levitra and alpha-blockers

Exclusion Criteria:

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): NCT01207947


Locations
Japan
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01207947     History of Changes
Other Study ID Numbers: 13931
LV0702JP ( Other Identifier: Company internal )
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Keywords provided by Bayer:
Vardenafil
Erectile dysfunction
Phosphodiesterase Inhibitors
Combination use with alpha-blockers

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Adrenergic alpha-Antagonists
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs