Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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
- LY450190
- Cialis
- IC351
Other Names:
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
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 Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries 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 May 16, 2013