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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681772
• Other study ID #: 100541
• Status: Completed
• Phase: Phase 4
• First received: April 18, 2008
• Last updated: December 10, 2014
• Start date: March 2003
• Est. completion date: November 2003

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Levitra (Vardenafil, BAY38-9456)
5mg, 10mg or 20mg taken 1 hours before sexual intercourse

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Index of Erectile Function - Erectile Function Domain		12 weeks	No
Secondary	Sexual Encounter Profile Question 2 and 3		12 weeks	No
Secondary	Global Assessment Question		12 weeks	No
Secondary	Other diary based variables		12 weeks	No
Secondary	Safety and tolerability		12 weeks	Yes

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