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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00681772
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 333
• Arm: 1
• Duration (Months): 8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 333 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Mar 1, 2003
• Actual Study Completion Date: Nov 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456); 5mg, 10mg or 20mg taken 1 hours before sexual intercourse

Outcome Measures

Primary Outcome Measures

1. International Index of Erectile Function - Erectile Function Domain [12 weeks]

Secondary Outcome Measures

1. Sexual Encounter Profile Question 2 and 3 [12 weeks]

2. Global Assessment Question [12 weeks]

3. Other diary based variables [12 weeks]

4. Safety and tolerability [12 weeks]

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bayer
• GlaxoSmithKline

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00681772
• Other Study ID Numbers: 100541
• First Posted: May 21, 2008
• Last Update Posted: Dec 11, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by , ,: Erectile Dysfunction; Vardenafil
• Additional relevant MeSH terms: Erectile Dysfunction; Vardenafil Dihydrochloride

Study Results

No Results Posted as of Dec 11, 2014