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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00547417
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : October 22, 2007
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company

Brief Summary:
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 or disease Intervention/treatment Phase
Impotence Drug: tadalafil Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1933 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2003
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
tadalafil
Drug: tadalafil
20 mg tadalafil tablet taken by mouth, as needed, no more than once a day, for 12 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00547417     History of Changes
Other Study ID Numbers: 7006
H6D-MC-LVFN
First Posted: October 22, 2007    Key Record Dates
Last Update Posted: October 22, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents