Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00547287
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : October 22, 2007
ICOS Corporation
Information provided by:
Eli Lilly and Company

October 18, 2007
October 22, 2007
October 22, 2007
November 2002
Not Provided
Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase [ Time Frame: 14 weeks ]
Same as current
No Changes Posted
Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains. [ Time Frame: 26 weeks ]
Same as current
Not Provided
Not Provided
Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations
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.
Not Provided
Phase 3
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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.
    Other Names:
    • LY450190
    • Cialis
    • IC351
  • 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.
  • Active Comparator: 1
    Currently prescribed dosage of sildenafil is continued until wash-out period.
    Intervention: Drug: sildenafil
  • Active Comparator: 2
    20 mg tadalafil given after one week sildenafil wash-out period.
    Intervention: Drug: tadalafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2004
Not Provided

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Eli Lilly and Company
ICOS Corporation
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP