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Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life

This study has been completed.

Sponsors and Collaborators: Eli Lilly and Company
ICOS Corporation
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00422734
  Purpose

To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexual quality of life of the man and his female study partner


Condition Intervention Phase
Impotence
Drug: tadalafil
Drug: Placebo
Phase III

MedlinePlus related topics:   Erectile Dysfunction   

Drug Information available for:   Tadalafil   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction and Sexual Quality of Life

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline to endpoint in the IIEF Erectile Function domain score ( sum of questions 1-5 and 15) and percent of yes responses to questions 2 and 3 of SEP. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To evaluate improvement of sexual quality of life as measured by the Sexual Quality of Life domain of the Sexual Life Quality Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate tadalafil 5 mg once daily compared with placebo in improving intercourse satisfaction in the subject and his female study partner [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To evaluate tadalafil 5 mg once daily compared with placebo in improving sexual satisfaction in the subject and his female study partner [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To evaluate tadalafil 5 mg once daily compared with placebo in improving treatment satisfaction in the subject and his female study partner [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Assess safety by monitoring adverse events. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:   344
Study Start Date:   November 2006
Study Completion Date:   January 2008
Primary Completion Date:   January 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Placebo Comparator
Placebo
Drug: Placebo
placebo tablet taken by mouth once a day for 12 weeks
2: Active Comparator
5 mg tadalafil
Drug: tadalafil
5 mg tadalafil tablet taken by mouth once a day for 12 weeks

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

Male

  • History of ED for at least a 3 months duration
  • Anticipate having the same female partner willing to participate throughout the study
  • At least 18 years of age at Visit 1 and agree to make at least 4 sexual attempts during the early phase of the study
  • Adequate partner sexual function as determined by a Female Sexual Function Index
  • Willing to record responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in the study

Exclusion Criteria:

  • May not participate in the study if you have taken tadalafil previously.
  • History of cardiac conditions including angina requiring treatment with nitrates, heart disease of coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for specified time before starting the study.
  • Have sexual partner not willing to complete the scales.
  • Use of nitrates.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422734

Locations
United States, Alabama
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.    
      Huntsville, Alabama, United States, 35801
United States, Arkansas
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.    
      Little Rock, Arkansas, United States, 72211
United States, California
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.    
      Newport Beach, California, United States, 92660
United States, Florida
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.    
      Stuart, Florida, United States, 34996
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.    
      Tampa, Florida, United States, 33607
United States, Iowa
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.    
      Des Moines, Iowa, United States, 50309
United States, Ohio
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.    
      Cleveland, Ohio, United States, 44106
United States, Tennessee
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.    
      Knoxville, Tennessee, United States, 37920
United States, Texas
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.    
      San Antonio, Texas, United States, 78229
United States, Virginia
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.    
      Virginia Beach, Virginia, United States, 23454
Austria
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.    
      Salzburg, Austria, 5020
France
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.    
      Lille, France, 59000
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.    
      Marseille, France, 13009
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.    
      Rennes, France, 35 700
Germany
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.    
      Augsburg, Germany, D-86150
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.    
      Berlin, Germany, 13465
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.    
      Hamburg, Germany, D-20354
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.    
      Leverkusen, Germany, 51375
Mexico
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.    
      La Joya, Mexico, 14000

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    
  More Information


Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Eli Lilly ( Chief Medical Officer )
Study ID Numbers:   9501, H6D-MC-LVGH
First Received:   January 16, 2007
Last Updated:   February 7, 2008
ClinicalTrials.gov Identifier:   NCT00422734
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders
Tadalafil
Quality of Life
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Sexual and Gender Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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