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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 17, 2008
Last updated: December 18, 2014
Last verified: December 2014
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:

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: 30825
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00663598

Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00663598     History of Changes
Other Study ID Numbers: 100477 
Study First Received: April 17, 2008
Last Updated: December 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents processed this record on October 27, 2016