Status:
COMPLETED
Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
ICOS Corporation
Conditions:
Erectile Dysfunction
Spinal Cord Injuries
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
This is a study of the efficacy and safety of on-demand dosing of tadalafil or placebo administered for 12 weeks to men with erectile dysfunction caused by spinal cord injury.
Eligibility Criteria
Inclusion
- males who developed erectile dysfunction as a result of spinal cord injury. Injury must have occurred 6 months before the start of the study.
- at least 4 sexual intercourse attempts during the first 4 weeks of the study without medication assistance
- no use of other erectile dysfunction treatment for at least 4 weeks before receiving the first dose of study drug. Also cannot use any other erectile dysfunction treatment during the study.
Exclusion
- Impotence caused by other primary sexual disorders including premature ejaculation or untreated endocrine diseases such as diabetes, hypopituitarism, hypothyroidism, or hypogonadism
- History of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection and history of penile implant.
- History of cardiac conditions including angina requiring certain treatment with nitrates; heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
- Significant renal problems within 6 months before starting the study. Also, active liver disease including jaundice at beginning of study.
- History of other central nervous system injuries, other than spinal cord injury, 6 months before starting the study.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00421083
Start Date
September 1 2004
End Date
June 1 2005
Last Update
October 25 2007
Active Locations (1)
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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.
Indianapolis, Indiana, United States