Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection
NCT ID: NCT00547573
Last Updated: 2007-10-22
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
367 participants
INTERVENTIONAL
2003-04-30
2003-12-31
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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2
10 mg tadalafil tablet
tadalafil
10 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
3
20 mg tadalafil tablet
tadalafil
20 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
1
placebo tablet
placebo
placebo tablet taken by mouth as needed for 12 weeks not more than once a day
Interventions
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tadalafil
10 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
tadalafil
20 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
placebo
placebo tablet taken by mouth as needed for 12 weeks not more than once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Anticipate a monogamous female sexual relationship
* Abstain from other erection treatments at least 4 weeks before first dose and throughout the study
* Must be able to make required sexual intercourse attempts
Exclusion Criteria
* History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
* History of penile implant or clinically significant penile deformity
* Nitrate use
* Certain heart problems
18 Years
MALE
No
Sponsors
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ICOS Corporation
INDUSTRY
Eli Lilly and Company
INDUSTRY
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, ESt)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak to your personal physician.
Beijing, , China
Countries
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Other Identifiers
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H6D-MC-LVDY
Identifier Type: -
Identifier Source: secondary_id
5874
Identifier Type: -
Identifier Source: org_study_id