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Levitra® - Real Life Safety and Efficacy of Levitra (REALISE)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00663598
First received: April 17, 2008
Last updated: June 5, 2009
Last verified: June 2009
History of Changes
  Purpose

Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily life conditions in a large number of subjects with erectile dysfunction (ED)


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: REALISE Levitra® - Real Life Safety and Efficacy of Levitra

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Improvement of Erectile Disfunction [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Onset of Drug Effect [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Second successful intercourse [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • General Safety Parameters [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 30000
Study Start Date: October 2003
Study Completion Date: September 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
Treatment according to US PI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Male outpatients >/= 18 years of age with a diagnosis of ED according to the 1992 US National Institutes of Health (NIH) Consensus Statement (the inability to achieve and maintain penile erection sufficient to complete satisfactory intercourse), and independent of any previous ED treatment

Exclusion Criteria:

- Exclusion according to US PI

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663598

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  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00663598     History of Changes
Other Study ID Numbers: 100477
Study First Received: April 17, 2008
Last Updated: June 5, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Erectile Dysfunction
Vardenafil

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

ClinicalTrials.gov processed this record on June 18, 2013