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

• ClinicalTrials.gov Identifier: NCT00681772
• Recruitment Status: Completed
• First Posted: May 21, 2008
• Last Update Posted: December 11, 2014
• Sponsor: Bayer
• Collaborator: GlaxoSmithKline
• Information provided by: Bayer

Tracking Information

• First Submitted Date: April 18, 2008
• First Posted Date: May 21, 2008
• Last Update Posted Date: December 11, 2014
• Study Start Date: March 2003
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: May 20, 2008): International Index of Erectile Function - Erectile Function Domain [ Time Frame: 12 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 20, 2008)

• Sexual Encounter Profile Question 2 and 3 [ Time Frame: 12 weeks ]
• Global Assessment Question [ Time Frame: 12 weeks ]
• Other diary based variables [ Time Frame: 12 weeks ]
• Safety and tolerability [ Time Frame: 12 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of the Safety and Efficacy of Vardenafil in Subjects With Erectile Dysfunction
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Erectile Dysfunction

Intervention

Drug: Levitra (Vardenafil, BAY38-9456)

5mg, 10mg or 20mg taken 1 hours before sexual intercourse

Study Arms

Experimental: Arm 1

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 20, 2008): 333
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 2003
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00681772
• Other Study ID Numbers: 100541
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
• Original Responsible Party: Bayer Healthcare AG, Therapeutic Area Head
• Current Study Sponsor: Bayer
• Original Study Sponsor: Same as current
• Collaborators: GlaxoSmithKline

Investigators

• Study Director: Bayer Study Director; Bayer

• PRS Account: Bayer
• Verification Date: December 2014