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

This study has been completed.

Sponsors and Collaborators:	Eli Lilly and Company ICOS Corporation
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00547417

Purpose

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	Intervention	Phase
Impotence	Drug: tadalafil	Phase III

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Tadalafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Percentage of Yes answers to questions 2 and 3 of the Sexual Encounter Profile [ Time Frame: 12 weeks ]
Evaluation of score changes for selected GAQ, PAIRS, and IIEF questions. [ Time Frame: 12 weeks ]

Enrollment:	1933
Study Start Date:	July 2003
Study Completion Date:	March 2004

Arms	Assigned Interventions
1: Active Comparator tadalafil	Drug: tadalafil 20 mg tadalafil tablet taken by mouth, as needed, no more than 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:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547417

Locations

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.
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

More Information

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

Study ID Numbers:	7006, H6D-MC-LVFN
Study First Received:	October 18, 2007
Last Updated:	October 18, 2007
ClinicalTrials.gov Identifier:	NCT00547417
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders

Tadalafil
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 January 16, 2009