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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00421083

Enrollment

180

Registered

2007-01-11

Start date

2004-09-30

Completion date

2005-06-30

Last updated

2007-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction, Spinal Cord Injuries

Keywords

Erectile dysfunction as a result of traumatic spinal cord injury

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.

Interventions

DRUGtadalafil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Safe and effective as shown by improvement on erectile function IIEF scores and SEP scores.	—

Secondary

Measure	Time frame
Additional efficacy variables including GAQ, SEP, and IIEF subdomains. Quality of life.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026