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

To determine if men with problems getting and keeping an erection prefer treatment with tadalafil or sildenafil.

Study Type: Interventional

Study Design: Other, Open Label, Uncontrolled, Crossover Assignment, Bio-equivalence Study

Intervention(s) in this Clinical Trial

• Drug: tadalafil
  • 20 mg tadalafil tablets taken by mouth, as needed, no more than once a day for 8 weeks.
• Drug: sildenafil
  • Current users of sildenafil citrate for a minimum of 6 weeks prior to visit 1 will continue with an individual dosage to be taken no more than once a day for an additional 4 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • sildenafil treatment for at least 10 weeks prior to a 1 week wash out
• Active Comparator: 2
  • Tadalafil treatment for 8 weeks following the 1 week washout period.

Primary Measures

• Patient choice of drug at visit 5
  • Time Frame: 14-15 weeks
    

Secondary Measures

• PAIRS self-administered scale scores
  • Time Frame: 14-15 weeks
    

Inclusion Criteria:

• History of erection problems
• Anticipate a monogamous female sexual relationship
• Abstain from other erection treatments throughout the study
• Currently use sildenafil

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/NCT00547352

Study ID Number: 9152

ClinicalTrials.gov Identifier: NCT00547352

Health Authority: Korea: Food and Drug Administration

Lilly Clinical Trial Registry