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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00421083
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : October 25, 2007
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Spinal Cord Injuries Drug: tadalafil Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : September 2004
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

Arms and Interventions
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Intervention Details:
  • Drug: tadalafil
    Other Names:
    • LY450190
    • Cialis
    • IC351

Outcome Measures
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Primary Outcome Measures :
  1. Safe and effective as shown by improvement on erectile function IIEF scores and SEP scores.

Secondary Outcome Measures :
  1. Additional efficacy variables including GAQ, SEP, and IIEF subdomains. Quality of life.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421083


Locations
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United States, Indiana
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
Sponsors and Collaborators
Eli Lilly and Company
ICOS Corporation
Investigators
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Study Director: 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) Eli Lilly and Company
More Information
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ClinicalTrials.gov Identifier: NCT00421083    
Other Study ID Numbers: 9108
H6D-MC-LVFY
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: October 25, 2007
Last Verified: October 2007
Keywords provided by Eli Lilly and Company:
Erectile dysfunction as a result of traumatic spinal cord injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Erectile Dysfunction
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Sexual Dysfunction, Physiological
 Male Urogenital Diseases
Sexual Dysfunctions, Psychological
Mental Disorders
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents