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

This study has been completed.
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00421083
First received: January 9, 2007
Last updated: October 23, 2007
Last verified: October 2007
  Purpose

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 Intervention Phase
Erectile Dysfunction
Spinal Cord Injuries
Drug: tadalafil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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.

Estimated Enrollment: 180
Study Start Date: September 2004
Study Completion Date: June 2005
Intervention Details:
    Drug: tadalafil
    Other Names:
    • LY450190
    • Cialis
    • IC351
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421083

Locations
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
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00421083     History of Changes
Other Study ID Numbers: 9108, H6D-MC-LVFY
Study First Received: January 9, 2007
Last Updated: October 23, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Erectile dysfunction as a result of traumatic spinal cord injury

Additional relevant MeSH terms:
Spinal Cord Injuries
Erectile Dysfunction
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Tadalafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014