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Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00547573
Collaborator
ICOS Corporation (Industry)
367
Enrollment
1
Location
3
Arms
8
Duration (Months)
45.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
367 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multinational, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil Administered "On Demand" to Asian Men With Erectile Dysfunction
Study Start Date :
Apr 1, 2003
Actual Study Completion Date :
Dec 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 2

10 mg tadalafil tablet

Drug: tadalafil
10 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
Other Names:
  • LY450190
  • Cialis
  • IC351

    		•
    Active Comparator: 3

    20 mg tadalafil tablet

    Drug: tadalafil
    20 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
    Other Names:
  • LY450190
  • Cialis
  • IC351

    		•
    Placebo Comparator: 1

    placebo tablet

    Drug: placebo
    placebo tablet taken by mouth as needed for 12 weeks not more than once a day

    Outcome Measures

    Primary Outcome Measures

    1. IIEF Erectile Function Domain score from Questions 1-5 and 15. SEP Diary responses to Questions 2-3 and the entire Diary for baseline and endpoint scores. [4, 8, and 12 weeks]

    Secondary Outcome Measures

    1. IIEF questions and scores, Global Assessment Questions, Patient's SEP Diary [12 weeks]

    Eligibility Criteria

    Criteria

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

    • History of erection problems

    • Anticipate a monogamous female sexual relationship

    • Abstain from other erection treatments at least 4 weeks before first dose and throughout the study

    • Must be able to make required sexual intercourse attempts

    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

    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 to your personal physician. Beijing China

    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:
    NCT00547573
    Other Study ID Numbers:
    • 5874
    • H6D-MC-LVDY
    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