Vardenafil Treatment Of Erectile Dysfunction In Depressive And Non-Depressive Men

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00470873
• Collaborator: (none)
• Enrollment: 2,471
• Location: 1
• Duration (Months): 13
• Patients Per Site Per Month: 189.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456)

Study Design

• Study Type: Observational
• Actual Enrollment: 2471 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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 Start Date: Jan 1, 2007
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Group 1	Drug: Levitra (Vardenafil, BAY38-9456); Primary care erectile dysfunction patients for whom physician decided to start the treatment with vardenafil

Outcome Measures

Primary Outcome Measures

1. Efficacy, safety, tolerance of the treatment with Vardenafil reported by the physician [At the patients control visit (approx. 3 months from the initial)]

Secondary Outcome Measures

1. Influence of vardenafil on depressive symptoms and self-esteem measured with CES-D and Rosenberg scale [At the patients control visit (approx. 3 months from the initial)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Many locations		Poland

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00470873
• Other Study ID Numbers: 12842; LV0610PL; VALOR; NCT00459394
• First Posted: May 8, 2007
• Last Update Posted: Dec 2, 2014
• Last Verified: Nov 1, 2014

• Additional relevant MeSH terms: Erectile Dysfunction; Vardenafil Dihydrochloride

Study Results

No Results Posted as of Dec 2, 2014