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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00663598
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Levitra (Vardenafil, BAY38-9456) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30825 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: REALISE Levitra® - Real Life Safety and Efficacy of Levitra
Study Start Date : October 2003
Study Completion Date : September 2004


Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
Treatment according to US PI


Outcome Measures

Primary Outcome Measures :
  1. Improvement of Erectile Disfunction [ Time Frame: 8 weeks ]
  2. Onset of Drug Effect [ Time Frame: 8 weeks ]
  3. Second successful intercourse [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. General Safety Parameters [ Time Frame: 8 weeks ]

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
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

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): NCT00663598


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00663598     History of Changes
Other Study ID Numbers: 100477
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Erectile Dysfunction
Vardenafil

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