BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.
NCT ID: NCT00668057
Last Updated: 2015-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
624 participants
INTERVENTIONAL
2002-12-31
2003-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Levitra (Vardenafil, BAY38-9456)
5 mg Vardenafil orally 1 hour prior to sexual intercourse
Arm 2
Levitra (Vardenafil, BAY38-9456)
10 mg Vardenafil orally 1 hour prior to sexual intercourse
Arm 3
Levitra (Vardenafil, BAY38-9456)
20 mg Vardenafil orally 1 hour prior to sexual intercourse
Arm 4
Placebo
5 mg matching placebo
Arm 5
Placebo
10 mg matching placebo
Arm 6
Placebo
20 mg matching placebo
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Stable heterosexual relationship
Exclusion Criteria
* Nitrate use
22 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Hangzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Shanghai, , China
Shanghai, , China
Countries
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Other Identifiers
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10690
Identifier Type: -
Identifier Source: org_study_id
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