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

NCT00421083 | Completed Phase 3

• 2 other identifiers: 9108H6D-MC-LVFY
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction; Spinal Cord Injuries

Keywords

Erectile dysfunction as a result of traumatic spinal cord injury

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

tadalafil DRUG

Also known as: LY450190, Cialis, IC351

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• ICOS Corporation: collaborator

Study Sites (1)

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

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Erectile Dysfunction; Spinal Cord Injuries

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 9, 2007
• First Posted: January 11, 2007
• Study Start: September 1, 2004
• Study Completion: June 1, 2005
• Last Updated: October 25, 2007

Record last verified: 2007-10

Locations

US (1)