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

Spinal Cord Injuries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421083
• Other study ID #: 9108
• Secondary ID: H6D-MC-LVFY
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2007
• Last updated: October 23, 2007
• Start date: September 2004
• Est. completion date: June 2005

Study information

• Verified date: October 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Spinal Cord Injuries

Intervention

Drug:
• tadalafil

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	ICOS Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safe and effective as shown by improvement on erectile function IIEF scores and SEP scores.
Secondary	Additional efficacy variables including GAQ, SEP, and IIEF subdomains. Quality of life.

External Links

•   Lilly Clinical Trial Registry