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Completed

NCT Number: NCT00421083

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tadalafil

Drug

Other names: LY450190, Cialis, IC351

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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • ICOS Corporation

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2005
First posted
Jan 11, 2007
Registry last updated
Oct 25, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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