Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life
NCT ID: NCT00422734
Last Updated: 2009-06-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
342 participants
INTERVENTIONAL
2006-11-30
2008-01-31
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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1
Placebo
Placebo
placebo tablet taken by mouth once a day for 12 weeks
2
5 mg tadalafil
tadalafil
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
Interventions
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tadalafil
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
Placebo
placebo tablet taken by mouth once a day for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of erectile dysfunction (ED) for at least 3 months duration
* Anticipate having the same female partner willing to participate throughout the study
* At least 18 years of age at Visit 1 and agree to make at least 4 sexual attempts during the early phase of the study
* Adequate partner sexual function as determined by a Female Sexual Function Index
* Willing to record responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in the study
Exclusion Criteria
* History of cardiac conditions including angina requiring treatment with nitrates, heart disease of coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for specified time before starting the study.
* Have sexual partner not willing to complete the scales.
* Use of nitrates.
18 Years
MALE
No
Sponsors
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ICOS Corporation
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
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.
Huntsville, Alabama, United States
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.
Little Rock, Arkansas, United States
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.
Newport Beach, California, United States
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Stuart, Florida, United States
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Tampa, Florida, United States
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Des Moines, Iowa, United States
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Cleveland, Ohio, United States
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Knoxville, Tennessee, United States
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San Antonio, Texas, United States
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Virginia Beach, Virginia, United States
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Salzburg, , Austria
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Lille, , France
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Marseille, , France
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Rennes, , France
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Augsburg, , Germany
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Berlin, , Germany
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Hamburg, , Germany
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Leverkusen, , Germany
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.
La Joya, , Mexico
Countries
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References
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Porst H, Gacci M, Buttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.
Shabsigh R, Seftel AD, Kim ED, Ni X, Burns PR. Efficacy and safety of once-daily tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline. J Sex Med. 2013 Mar;10(3):844-56. doi: 10.1111/j.1743-6109.2012.02898.x. Epub 2012 Oct 4.
Other Identifiers
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H6D-MC-LVGH
Identifier Type: -
Identifier Source: secondary_id
9501
Identifier Type: -
Identifier Source: org_study_id
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