BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.

Erectile Dysfunction Clinical Trial

Official title:

Randomized, Double-blind, Multi-centre, Parallel-goup Study to Investigate the Efficacy and Safety of Three Doses of BAY38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients With Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668057
• Other study ID #: 10690
• Status: Completed
• Phase: Phase 3
• First received: April 24, 2008
• Last updated: March 5, 2015
• Start date: December 2002
• Est. completion date: September 2003

Study information

• Verified date: March 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 624
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.

• Stable heterosexual relationship

Exclusion Criteria:

• Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)

• Nitrate use

• Other exclusion criteria apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Levitra (Vardenafil, BAY38-9456)
5 mg Vardenafil orally 1 hour prior to sexual intercourse
• Levitra (Vardenafil, BAY38-9456)
10 mg Vardenafil orally 1 hour prior to sexual intercourse
• Levitra (Vardenafil, BAY38-9456)
20 mg Vardenafil orally 1 hour prior to sexual intercourse
• Placebo
5 mg matching placebo
• Placebo
10 mg matching placebo
• Placebo
20 mg matching placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15		12 weeks	No
Secondary	Global Assessment Questionnaire		12 weeks	No
Secondary	Erectile Function domain score of the International Index of Erectile Function		12 weeks	No
Secondary	Safety and tolerability		12 weeks	Yes

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