A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5mg and 5mg) Administered Once Daily to Men With Erectile Dysfunction

Eli Lilly and Company1 site in 1 country280 target enrollmentOctober 2003

ConditionsErectile Dysfunction

Interventionsplacebo tadalafil

Drugstadalafil placebo

Overview

Phase: Phase 3
Intervention: placebo
Conditions: Erectile Dysfunction
Sponsor: Eli Lilly and Company
Enrollment: 280
Locations: 1
Primary Endpoint: Changes in erectile function measured at baseline and after 6 months of treatment with 2.5mg and 5mg tadalafil; assessment of safety after 1 and 2 years of therapy with 5mg tadalafil.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of 2.5mg and 5mg tadalafil taken once daily in men with erectile dysfunction.

Registry

clinicaltrials.gov

Start Date

October 2003

End Date

June 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•Men with erectile dysfunction
•At least 18 years of age

Exclusion Criteria

•Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
•A history of certain impotence disorders
•History of specified pelvic surgery
•Any significant genital abnormality identified at the start of the study

Arms & Interventions

1

placebo tablet

Intervention: placebo

2

2.5 mg tadalafil tablet

Intervention: tadalafil

3

5 mg tadalafil tablet

Intervention: tadalafil

Outcomes

Primary Outcomes

Changes in erectile function measured at baseline and after 6 months of treatment with 2.5mg and 5mg tadalafil; assessment of safety after 1 and 2 years of therapy with 5mg tadalafil.

Time Frame: 24-128 weeks

Secondary Outcomes

Changes in additional aspects of erectile function after 3 and 6 months of treatment; assessment of the pharmacokinetics of tadalafil 2.5mg and 5mg.(24 weeks)