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Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00547183
Collaborator
ICOS Corporation (Industry)
298
Enrollment
1
Location
3
Arms
7
Duration (Months)
42.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study to evaluate the safety and effectiveness of 2.5 mg and 5 mg tadalafil when taken by men with diabetes mellitus who have problems getting and maintaining an erection.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
298 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Parallel-Design, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5 mg and 5 mg) Administered Once Daily to Men With Diabetes Mellitus and Erectile Dysfunction
Study Start Date :
Oct 1, 2004
Actual Study Completion Date :
May 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 2

2.5 mg tadalafil

Drug: tadalafil
2.5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
Other Names:
  • LY450190
  • Cialis
  • IC351

    		•
    Active Comparator: 3

    5 mg tadalafil

    Drug: tadalafil
    5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
    Other Names:
  • LY450190
  • Cialis
  • IC351

    		•
    Placebo Comparator: 1

    Drug: placebo
    Placebo tablet taken by mouth once a day, no more than 1 dose per day, for 12 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in the SEP diary [12 weeks]

    Secondary Outcome Measures

    1. Change in the GAQ, SEP, IIEF, SEAR, and RSE scores. [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 erectile dysfunction for at least 3 months.

    • Currently have diabetes mellitus of at least 3 months duration.

    • Agree to not use any other ED treatment during the study.

    • Anticipate the same female sexual partner for the study.

    • Must be willing to make the required number of sexual attempts.

    Exclusion Criteria:

    • History of other primary sexual disorder

    • Treatment with nitrates or potent CYP3A4 inhibitors

    • Have a penile implant or clinically significant penile deformity

    • History of certain heart problems

    • Have kidney or liver 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. Genthin Germany

    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:
    NCT00547183
    Other Study ID Numbers:
    • 8702
    • H6D-MC-LVFZ
    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