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

Phase 3

Completed

• Conditions: Erectile Dysfunction; Spinal Cord Injuries

• Registration Number: NCT00421083
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study Completion: 2005-06
• Study First Submitted: 2007-01-09
• Study First Submitted QC: 2007-01-09
• Study First Posted: 2007-01-11
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-23
• Last Update Posted: 2007-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safe and effective as shown by improvement on erectile function IIEF scores and SEP scores.

Secondary Outcome Measures

Name	Time	Method
Additional efficacy variables including GAQ, SEP, and IIEF subdomains. Quality of life.

Trial Locations

Locations (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