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A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction
This study has been completed.
Study NCT00381732   Information provided by Eli Lilly and Company
First Received: September 26, 2006   Last Updated: November 6, 2007   History of Changes

September 26, 2006
November 6, 2007
October 2003
 
Changes in erectile function measured at baseline and after 6 months of treatment with 2.5mg and 5mg tadalafil; assessment of safety after 1 and 2 years of therapy with 5mg tadalafil. [ Time Frame: 24-128 weeks ]
Changes in erectile function measured at baseline and after 6 months of treatment with 2.5mg and 5mg tadalafil; assessment of safety after 1 and 2 years of therapy with 5mg tadalafil.
Complete list of historical versions of study NCT00381732 on ClinicalTrials.gov Archive Site
Changes in additional aspects of erectile function after 3 and 6 months of treatment; assessment of the pharmacokinetics of tadalafil 2.5mg and 5mg. [ Time Frame: 24 weeks ]
Changes in additional aspects of erectile function after 3 and 6 months of treatment; assessment of the pharacokinetics of tadalafil 2.5mg and 5mg.
 
A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction
A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5mg and 5mg) Administered Once Daily to Men With Erectile Dysfunction

This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of 2.5mg and 5mg tadalafil taken once daily in men with erectile dysfunction.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Erectile Dysfunction
  • Drug: tadalafil
    2.5 mg or 5 mg tadalafil tablet taken by mouth once a day for 24 weeks. Followed by an open label extension where all patients receive 5 mg doses.
    Other Names:
    • LY450190
    • Cialis
    • IC351
  • Drug: placebo
    Placebo tablet taken by mouth once a day for 24 weeks. Placebo patient will receive 5 mg tadalafil tablet during the open label extension.
  • 1: Placebo Comparator
    placebo tablet
    Intervention: Drug: placebo
  • 2: Active Comparator
    2.5 mg tadalafil tablet
    Intervention: Drug: tadalafil
  • 3: Active Comparator
    5 mg tadalafil tablet
    Intervention: Drug: tadalafil
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
280
June 2006
 

Inclusion Criteria:

  • Men with erectile dysfunction
  • At least 18 years of age

Exclusion Criteria:

  • Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
  • A history of certain impotence disorders
  • History of specified pelvic surgery
  • Any significant genital abnormality identified at the start of the study
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00381732
 
7019, H6D-MC-LVFP
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
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP