Vardenafil Treatment of Erectile Dysfunction in Depressive and Non-Depressive Men (VALOR)
Information source: Bayer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Male Erectile Dysfunction; Impotence
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Manager, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Summary
The primary aim of this open, uncontrolled, prospective, non-interventional post-marketing
surveillance study is to obtain data on safety and efficacy of Levitra® in routine treatment
of erectile dysfunction. The secondary aim of this study is to assess the influence of the
treatment with Levitra® on self-esteem (depressive symptomology) in men with ED.
Clinical Details
Official title: A Non-Interventional, Post-Marketing Surveillance Phase IV Study to Obtain Data on Safety and Efficacy of Levitra® in Routine Treatment of Erectile Dysfunction in Depressive and Non-Depressive Men.
Study design: Screening, Cross-Sectional, Defined Population, Prospective Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Age over 18
- Erectile dysfunction untreated or ineffectively treated with other than vardenafil
PDE5 inhibitors
Exclusion Criteria:
- Treatment with nitrates
- Allergy to vardenafil or other tablets ingredients
- Treatment with CYP3A4 inhibitors (e. g. indinavir, ritonavir, ketoconazole,
itraconazole, erythromycin)
- Cardiovascular status excluding any sexual activity
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Bayer Clinical Research Center, ask Contact, Poland; Recruiting
Additional Information
Starting date: January 2007
Last updated: May 7, 2007
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