Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection
NCT ID: NCT00547495
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
343 participants
INTERVENTIONAL
2004-03-31
2004-11-30
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
TRIPLE
Study Groups
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1
Placebo tablet
placebo
placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks
2
5 mg tadalafil
tadalafil
5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
3
10 mg tadalafil
tadalafil
10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
4
20 mg tadalafil
tadalafil
20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Interventions
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tadalafil
5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
placebo
placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks
tadalafil
10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
tadalafil
20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Anticipate a monogamous relationship with a female sexual partner
* Be able to make minimum required sexual intercourse attempts
* Abstain from using any other ED treatment
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
20 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 with your personal physician.
Sapporo, Hokkaido, Japan
Countries
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Other Identifiers
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H6D-MC-LVDI
Identifier Type: -
Identifier Source: secondary_id
5139
Identifier Type: -
Identifier Source: org_study_id