Official Title: “A Multinational, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil Administered "On Demand" to Asian Men With Erectile Dysfunction”

Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection.

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
  • 10 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
• Drug: tadalafil
  • 20 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
• Drug: placebo
  • placebo tablet taken by mouth as needed for 12 weeks not more than once a day

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 2
  • 10 mg tadalafil tablet
• Active Comparator: 3
  • 20 mg tadalafil tablet
• Placebo Comparator: 1
  • placebo tablet

Primary Measures

• IIEF Erectile Function Domain score from Questions 1-5 and 15. SEP Diary responses to Questions 2-3 and the entire Diary for baseline and endpoint scores.
  • Time Frame: 4, 8, and 12 weeks
    

Secondary Measures

• IIEF questions and scores, Global Assessment Questions, Patient's SEP Diary
  • Time Frame: 12 weeks
    

Inclusion Criteria:

• History of erection problems
• Anticipate a monogamous female sexual relationship
• Abstain from other erection treatments at least 4 weeks before first dose and throughout the study
• Must be able to make required sexual intercourse attempts

Exclusion Criteria:

• Other primary sexual disorders
• History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
• History of penile implant or clinically significant penile deformity
• Nitrate use
• Certain heart problems

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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00547573

Study ID Number: 5874

ClinicalTrials.gov Identifier: NCT00547573

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry