Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury
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...
Brief Summary
Official Title: “A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Assess Efficacy and Safety of Tadalafil (LY450190) in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: tadalafil
Outcome Measures for this Clinical Trial
Primary Measures
- Safe and effective as shown by improvement on erectile function IIEF scores and SEP scores.
Secondary Measures
- Additional efficacy variables including GAQ, SEP, and IIEF subdomains. Quality of life.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 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 Criteria:
- 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.
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Eli Lilly and Company Industry
Overall Clinical Trial Officials and Contacts
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) Study Director Eli Lilly and Company
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00421083
Study ID Number: 9108
ClinicalTrials.gov Identifier: NCT00421083
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00421083
