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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00668057
• Collaborator: (none)
• Enrollment: 624
• Locations: 7
• Arms: 6
• Duration (Months): 9
• Patients Per Site: 89.1
• Patients Per Site Per Month: 9.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456); Drug: Levitra (Vardenafil, BAY38-9456); Drug: Levitra (Vardenafil, BAY38-9456); Drug: Placebo; Drug: Placebo; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 624 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Dec 1, 2002
• Actual Primary Completion Date: Sep 1, 2003
• Actual Study Completion Date: Sep 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456); 5 mg Vardenafil orally 1 hour prior to sexual intercourse
Experimental: Arm 2	Drug: Levitra (Vardenafil, BAY38-9456); 10 mg Vardenafil orally 1 hour prior to sexual intercourse
Experimental: Arm 3	Drug: Levitra (Vardenafil, BAY38-9456); 20 mg Vardenafil orally 1 hour prior to sexual intercourse
Placebo Comparator: Arm 4	Drug: Placebo; 5 mg matching placebo
Placebo Comparator: Arm 5	Drug: Placebo; 10 mg matching placebo
Placebo Comparator: Arm 6	Drug: Placebo; 20 mg matching placebo

Outcome Measures

Primary Outcome Measures

1. Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15 [12 weeks]

Secondary Outcome Measures

1. Global Assessment Questionnaire [12 weeks]

2. Erectile Function domain score of the International Index of Erectile Function [12 weeks]

3. Safety and tolerability [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Hangzhou	Zhejiang	China	310003
2		Beijing		China	100034
3		Beijing		China	100044
4		Beijing		China	100083
5		Beijing		China	100853
6		Shanghai		China	200040
7		Shanghai		China	200127

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: NCT00668057
• Other Study ID Numbers: 10690
• First Posted: Apr 28, 2008
• Last Update Posted: Mar 6, 2015
• Last Verified: Mar 1, 2015

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

Study Results

No Results Posted as of Mar 6, 2015