Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: tadalafil
  • 2.5 mg or 5 mg tadalafil tablet taken by mouth once a day for 24 weeks. Followed by an open label extension where all patients receive 5 mg doses.
• Drug: placebo
  • Placebo tablet taken by mouth once a day for 24 weeks. Placebo patient will receive 5 mg tadalafil tablet during the open label extension.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • placebo tablet
• Active Comparator: 2
  • 2.5 mg tadalafil tablet
• Active Comparator: 3
  • 5 mg tadalafil tablet

Primary Measures

• 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 Measures

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

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

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) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00381732

Study ID Number: 7019

ClinicalTrials.gov Identifier: NCT00381732

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry