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

This study has been completed.
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00547287
First received: October 18, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted

October 18, 2007
October 18, 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
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Impotence
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2760
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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00547287
7925, H6D-VI-LVFH
No
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