Status:
COMPLETED
Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
ICOS Corporation
Conditions:
Impotence
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexu...
Eligibility Criteria
Inclusion
- Male
- 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
- May not participate in the study if you have taken tadalafil previously.
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT00422734
Start Date
November 1 2006
End Date
January 1 2008
Last Update
June 10 2009
Active Locations (19)
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1
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, 35801
2
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, 72211
3
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, 92660
4
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.
Stuart, Florida, United States, 34996