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Levitra� - Real Life Safety and Efficacy of Levitra

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Erectile Dysfunction

Intervention: Levitra (Vardenafil, BAY38-9456) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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)

Clinical Details

Official title: REALISE Levitra® - Real Life Safety and Efficacy of Levitra

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Improvement of Erectile Disfunction

Onset of Drug Effect

Second successful intercourse

Secondary outcome: General Safety Parameters

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

Additional Information

Click here and search for drug information provided by the FDA.

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Starting date: October 2003
Last updated: December 18, 2014

Page last updated: August 23, 2015

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