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

Primary Purpose

Erectile Dysfunction, Spinal Cord Injuries

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
tadalafil
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction as a result of traumatic spinal cord injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2007
Last Updated
October 23, 2007
Sponsor
Eli Lilly and Company
Collaborators
ICOS Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00421083
Brief Title
Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company
Collaborators
ICOS Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Spinal Cord Injuries
Keywords
Erectile dysfunction as a result of traumatic spinal cord injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tadalafil
Other Intervention Name(s)
LY450190, Cialis, IC351
Primary Outcome Measure Information:
Title
Safe and effective as shown by improvement on erectile function IIEF scores and SEP scores.
Secondary Outcome Measure Information:
Title
Additional efficacy variables including GAQ, SEP, and IIEF subdomains. Quality of life.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Indianapolis
State/Province
Indiana
Country
United States

12. IPD Sharing Statement

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

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