Official Title: “A Multicenter Open-Label Study to Determine Treatment Preference of Tadalafil (IC351, LY450190) or Sildenafil Citrate in the Oral Treatment of Erectile Dysfunction”

To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: tadalafil
  • 10 mg or 20 mg tadalafil tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)
• Drug: sildenafil
  • 25 mg, 50 mg, or 100 mg sildenafil citrate tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • tadalafil given the first 12 weeks and after a 4 week washout sildenafil is given for 12 weeks.
• Active Comparator: 2
  • sildenafil given the first 12 weeks and after a 4 week washout tadalafil is given for 12 weeks.

Primary Measures

• Preference Assessment measured by the Treatment Preference Question
  • Time Frame: 26 weeks
    

Secondary Measures

• Compare efficacies of the two drugs as measured by the Erectile Function domain of IIEF and Questions 2 and 3 of the SEP diary.
  • Time Frame: 0, 12, and 26 weeks
    
• Assess sexual encounters attributes measured by the PAIRS.
  • Time Frame: 0, 12, and 26 weeks
    
• Measure adverse events through the Side Effect Question.
  • Time Frame: 12 and 26 weeks
    

Inclusion Criteria:

• History of erection problems
• Never taken treatments known as PDE5 inhibitors for erection issues
• Abstain from using any other erection treatments during the study
• Anticipate a monogamous female sexual relationship
• Must be able to make required sexual intercourse attempts

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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00547092

Study ID Number: 7002

ClinicalTrials.gov Identifier: NCT00547092

Health Authority: European Union: European Medicines Agency

Lilly Clinical Trial Registry