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

Lilly

Status and phase

Completed

Phase 3

Conditions

Spinal Cord Injuries

Erectile Dysfunction

Treatments

Drug: tadalafil

Study type

Interventional

Funder types

Industry

Identifiers

NCT00421083

H6D-MC-LVFY

9108

Details and patient eligibility

About

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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.