Official Title: “Switching From Sildenafil Citrate to Tadalafil in Treatment of Erectile Dysfunction: Multinational Assessment of Treatment Preference”

Study to determine if men from around the world prefer sildenafil to tadalafil.

Study Type: Interventional

Study Design: Treatment, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: tadalafil
  • 20 mg tadalafil as needed by mouth no more than once a day for a 4 week initiation period and a 4 weeks treatment period.
• Drug: sildenafil
  • Current dosage of sildenafil is continued for 4 weeks (no more than once a day) of treatment assessment then the wash-out period will begin.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Currently prescribed dosage of sildenafil is continued until wash-out period.
• Active Comparator: 2
  • 20 mg tadalafil given after one week sildenafil wash-out period.

Primary Measures

• Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase
  • Time Frame: 14 weeks
    

Secondary Measures

• Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains.
  • Time Frame: 26 weeks
    

Inclusion Criteria:

• Must be of legal age according to your country.
• Must have had a history of erectile dysfunction for at least 3 months.
• Must currently and have been using sildenafil for the last six weeks.
• Agree to not use any other ED treatment during the study.
• Anticipate the same female sexual partner for the study.

Exclusion Criteria:

• History of other primary sexual disorder
• Treatment with nitrates
• Have a penile implant or clinically significant penile deformity
• History of certain heart problems
• Do not meet certain lab value reference ranges

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 January 09, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00547287

Study ID Number: 7925

ClinicalTrials.gov Identifier: NCT00547287

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry