Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
623 participants
INTERVENTIONAL
2010-08-31
2012-01-31
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
TRIPLE
Study Groups
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2.5 milligram (mg) titrated to 5 mg Tadalafil
2.5 mg for 4 weeks, followed by 5 mg for 8 weeks with option to continue treatment at 5 mg for an additional 4 weeks
Tadalafil
Administer orally
5 mg Tadalafil
5.0 mg for 12 weeks with option to continue treatment for additional 4 weeks
Tadalafil
Administer orally
Placebo
for 12 weeks
Placebo
Administer orally
Interventions
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Tadalafil
Administer orally
Placebo
Administer orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are able to read, understand and provide signed informed consent.
* Have an International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is greater than or equal to 17 and less than 26 at screening.
* Have been taking a maximum dose of sildenafil citrate (100 milligram \[mg\]), vardenafil (20 mg), or tadalafil (20 mg) on as needed basis for at least one month prior to screening.
* Anticipate having the same female sexual partner during the study who is willing to participate in the required number of sexual intercourse attempts and complete study measures during the study.
* Agree to make at least four sexual intercourse attempts during both the 4-week as needed run-in period and the 4-week non-drug run-in period.
* Agree not to use any other erectile dysfunction (ED) treatment, including herbal therapy during the 4-week non-drug, run-in, the double-blind treatment period, the open label period and for 96 hours after the end of the study.
* Are female and at least 18 years of age at screening.
* Anticipate having the same male study subject as her sexual partner during the study.
* Able to read, understand and provide signed informed consent.
* Agree to make the required number of sexual intercourse attempts with the male sexual study partner during the study.
* Willing to participate in recording responses to the treatment satisfaction scale.
Exclusion Criteria
* Prior ineffective treatment with (or nonresponder to) any PDE5 Inhibitor
* Have previously used or are currently using any PDE5 inhibitor once daily.
* Present with ED caused by other primary disorders or ED caused by untreated/inadequately treated endocrine disease.
* Partner unwilling to complete all study requirements.
* History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator
* Exhibit evidence of clinically significant renal insufficiency or hepatobiliary disease, or significant cardiac history as determined by the investigator
* Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens
* Have previously completed or withdrawn from this study or any other study investigating tadalafil for once-daily use.
18 Years
MALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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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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Huntsville, Alabama, United States
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Lancaster, California, United States
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Newport Beach, California, United States
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San Diego, California, United States
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Spring Valley, California, United States
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Tarzana, California, United States
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New Britain, Connecticut, United States
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Aventura, Florida, United States
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Fort Lauderdale, Florida, United States
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Oviedo, Florida, United States
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Meridian, Idaho, United States
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Nampa, Idaho, United States
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Lansing, Kansas, United States
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Topeka, Kansas, United States
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Haverhill, Massachusetts, United States
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Troy, Michigan, United States
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Toms River, New Jersey, United States
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Garden City, New York, United States
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Poughkeepsie, New York, United States
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Concord, North Carolina, United States
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Wilmington, North Carolina, United States
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Fargo, North Dakota, United States
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Lyndhurst, Ohio, United States
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Bala-Cynwyd, Pennsylvania, United States
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Anderson, South Carolina, United States
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Greer, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Knoxville, Tennessee, United States
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Austin, Texas, United States
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San Antonio, Texas, United States
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Clinton, Utah, United States
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Bellevue, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Langley, British Columbia, Canada
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Victoria, British Columbia, Canada
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Burlington, Ontario, Canada
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North York, Ontario, Canada
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Montreal, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
Countries
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References
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Kim E, Seftel A, Goldfischer E, Baygani S, Burns P. Comparative efficacy of tadalafil once daily in men with erectile dysfunction who demonstrated previous partial responses to as-needed sildenafil, tadalafil, or vardenafil. Curr Med Res Opin. 2015 Feb;31(2):379-89. doi: 10.1185/03007995.2014.989317. Epub 2014 Dec 2.
Kim ED, Seftel AD, Goldfischer ER, Ni X, Burns PR. A return to normal erectile function with tadalafil once daily after an incomplete response to as-needed PDE5 inhibitor therapy. J Sex Med. 2014 Mar;11(3):820-30. doi: 10.1111/jsm.12253. Epub 2013 Jul 10.
Other Identifiers
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H6D-US-LVIP
Identifier Type: OTHER
Identifier Source: secondary_id
13461
Identifier Type: -
Identifier Source: org_study_id
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