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Evaluation of the Safety and Efficacy of Vardenafil in Subjects With Erectile Dysfunction

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

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.

Clinical Details

Official title: Open-label, Multi-centre, Study to Investigate the Safety, Tolerability and Efficacy of Flexible Doses of Vardenafil Given on Demand in Males With Erectile Dysfunction

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

Primary outcome: International Index of Erectile Function - Erectile Function Domain

Secondary outcome:

Sexual Encounter Profile Question 2 and 3

Global Assessment Question

Other diary based variables

Safety and tolerability

Eligibility

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

Criteria:

Inclusion Criteria:

- Men >/= 18 years of age,

- ED 6 months or longer

- Stable sexual relationship for > 6 month.

Exclusion Criteria:

- Primary hypoactive sexual desire

- History of myocardial infarction, stroke or life-threatening arrhythmia within prior

6 month

- Nitrate therapy

- Other exclusion criteria apply according to the Summary of Product Characteristics

Locations and Contacts

Additional Information

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Starting date: March 2003
Last updated: December 10, 2014

Page last updated: August 23, 2015

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