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To Determine Effect and Safety of Tadalafil Taken by Men of Different Races and With Different Diseases When Needed for Erections

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00547417
Collaborator
ICOS Corporation (Industry)
1,933
Enrollment
1
Location
1
Arm
8
Duration (Months)
241.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare men of different races and those with diabetes or depression to white men that do not have diabetes or depression but also suffer from the inability to get or keep an erection.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1933 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Study to Evaluate the Efficacy and Safety of Tadalafil Administered "On Demand" to Men of Various Populations With Erectile Dysfunction
Study Start Date :
Jul 1, 2003
Actual Study Completion Date :
Mar 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

tadalafil

Drug: tadalafil
20 mg tadalafil tablet taken by mouth, as needed, no more than once a day, for 12 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in the scores of the IIEF scale's Erectile Function domain, questions 1-5 and 15 [12 weeks]

    Secondary Outcome Measures

    1. Percentage of Yes answers to questions 2 and 3 of the Sexual Encounter Profile [12 weeks]

    2. Evaluation of score changes for selected GAQ, PAIRS, and IIEF questions. [12 weeks]

    Eligibility Criteria

    Criteria

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

    • At least 3 months history of erectile dysfunction (ED)

    • Anticipate a monogamous relationship with a female sexual partner

    • Be able to make minimum required sexual intercourse attempts

    • Abstain from using any other ED treatment

    Exclusion Criteria:

    • Other primary sexual disorders

    • History of penile implant or clinically significant penile deformity

    • History or current nitrate use

    • History of certain heart problems

    • History of certain kidney problems

    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. Dallas Texas United States

    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:
    NCT00547417
    Other Study ID Numbers:
    • 7006
    • H6D-MC-LVFN
    First Posted:
    Oct 22, 2007
    Last Update Posted:
    Oct 22, 2007
    Last Verified:
    Oct 1, 2007
    Additional relevant MeSH terms:
    Erectile Dysfunction
    Tadalafil

    Study Results

    No Results Posted as of Oct 22, 2007