Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury

Completed · Phase 3

Conditions studied: Erectile Dysfunction, Spinal Cord Injuries

In brief

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.

Key facts

Study ID

NCT00421083

Run by

Eli Lilly and Company

People needed

180

Starts

2004-09-01

Expected to finish

2005-06-01

Last updated by the study team

2007-10-25

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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