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LEVITRA® 20mg Special Drug Use Investigation (Long-term)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00909233
First received: May 8, 2009
Last updated: January 19, 2010
Last verified: January 2010
History of Changes
  Purpose

This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: LEVITRA® 20mg Special Drug Use Investigation (Long-term)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Efficacy of patients with LEVITRA treatment [ Time Frame: After 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • LEVITRA treatment improved the patient's erection [ Time Frame: After 6 months ] [ Designated as safety issue: No ]
  • LEVITRA improved the patient's erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourse [ Time Frame: After 6 months ] [ Designated as safety issue: No ]
  • Reporting a second successful intercourse within 24 hours of dosing [ Time Frame: After 6 months ] [ Designated as safety issue: No ]
  • Patients prefer LEVITRA over last Erectile Dysfunction treatment [ Time Frame: After 6 months ] [ Designated as safety issue: No ]
  • Tolerability of patients with LEVITRA treatment [ Time Frame: After 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 1221
Study Start Date: July 2007
Study Completion Date: December 2009
Primary Completion Date: December 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 to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909233

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 Ltd
ClinicalTrials.gov Identifier: NCT00909233     History of Changes
Other Study ID Numbers: 13930, LV0701JP
Study First Received: May 8, 2009
Last Updated: January 19, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Erectile dysfunction,
Phosphodiesterase Inhibitors

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Phosphodiesterase Inhibitors
Vardenafil
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Phosphodiesterase 5 Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013