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.
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00547417
First received: October 18, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

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

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

ClinicalTrials.gov processed this record on August 28, 2014