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LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01207947
First received: September 20, 2010
Last updated: September 22, 2010
Last verified: September 2010
History of Changes
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Safety of Levitra treatment, namely incidence of Adverse Events or Adverse Drug Reactions are evaluated [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 491
Study Start Date: October 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Vardenafil (Levitra, BAY38-9456)
Patients under daily life treatment receiving Levitra according to local drug information.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207947

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Yakuhin Co.LTD.
ClinicalTrials.gov Identifier: NCT01207947     History of Changes
Other Study ID Numbers: 13931, LV0702JP
Study First Received: September 20, 2010
Last Updated: September 22, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Sexual and Gender Disorders
Mental Disorders
Adrenergic alpha-Antagonists
Phosphodiesterase Inhibitors
Vardenafil
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Enzyme Inhibitors
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Phosphodiesterase 5 Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013