Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection

Verified by: Eli Lilly and Company, October 2007
First Received: October 18, 2007 | Last Updated: October 18, 2007 | Phase: Phase 3 | Start Date: April 2003
Overall Status: Completed | Estimated Enrollment: 367
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Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Eli Lilly and Company Industry

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  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00547573