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

Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: tadalafil
  • 5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
• Drug: placebo
  • placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks
• Drug: tadalafil
  • 10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
• Drug: tadalafil
  • 20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Placebo tablet
• Active Comparator: 2
  • 5 mg tadalafil
• Active Comparator: 3
  • 10 mg tadalafil
• Active Comparator: 4
  • 20 mg tadalafil

Primary Measures

• Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in SEP diary
  • Time Frame: 12 weeks
    

Secondary Measures

• Change from baseline to endpoint of various questions from the IIEF and SEP diary
  • Time Frame: 12 weeks
    

Inclusion Criteria:

• 3 months history of erectile dysfunction (ED)
• Anticipate a monogamous relationship with a female sexual partner
• Be able to make minimum required sexual intercourse attempts
• Abstain from using any other ED treatment

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: 20 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/NCT00547495

Study ID Number: 5139

ClinicalTrials.gov Identifier: NCT00547495

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Lilly Clinical Trial Registry