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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00547287
Collaborator
ICOS Corporation (Industry)
2,760
Enrollment
1
Location
2
Arms
18
Duration (Months)
153.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
2760 participants
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Switching From Sildenafil Citrate to Tadalafil in Treatment of Erectile Dysfunction: Multinational Assessment of Treatment Preference
Study Start Date :
Nov 1, 2002
Actual Study Completion Date :
May 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Currently prescribed dosage of sildenafil is continued until wash-out 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.
Active Comparator: 2

20 mg tadalafil given after one week sildenafil wash-out period.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase [14 weeks]

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sao Paulo Brazil

    Sponsors and Collaborators

    • Eli Lilly and Company
    • ICOS Corporation

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00547287
    Other Study ID Numbers:
    • 7925
    • H6D-VI-LVFH
    First Posted:
    Oct 22, 2007
    Last Update Posted:
    Oct 22, 2007
    Last Verified:
    Oct 1, 2007
    Additional relevant MeSH terms:
    Erectile Dysfunction
    Sildenafil Citrate
    Tadalafil

    Study Results

    No Results Posted as of Oct 22, 2007