Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection
NCT ID: NCT00547183
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
298 participants
INTERVENTIONAL
2004-10-31
2005-05-31
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
2.5 mg tadalafil
tadalafil
2.5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
3
5 mg tadalafil
tadalafil
5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
1
placebo
Placebo tablet taken by mouth once a day, no more than 1 dose per day, for 12 weeks
Interventions
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tadalafil
2.5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
tadalafil
5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
placebo
Placebo tablet taken by mouth once a day, 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
* Currently have diabetes mellitus of at least 3 months duration.
* Agree to not use any other ED treatment during the study.
* Anticipate the same female sexual partner for the study.
* Must be willing to make the required number of sexual attempts.
Exclusion Criteria
* Treatment with nitrates or potent CYP3A4 inhibitors
* Have a penile implant or clinically significant penile deformity
* History of certain heart problems
* Have kidney or liver 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 with your personal physician.
Genthin, , Germany
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-LVFZ
Identifier Type: -
Identifier Source: secondary_id
8702
Identifier Type: -
Identifier Source: org_study_id