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...
Date First Received: October 18, 2007
Last Updated: October 18, 2007
Verified by: Eli Lilly and Company, October 2007
Clinical Trial Phase: Phase 3 | Start Date: July 2003
Overall Status: Completed
Estimated Enrollment: 1933
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: tadalafil
- 20 mg tadalafil tablet taken by mouth, as needed, no more than once a day, for 12 weeks.
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- tadalafil
Outcome Measures for this Clinical Trial
Primary Measures
- Change in the scores of the IIEF scale's Erectile Function domain, questions 1-5 and 15
- Time Frame: 12 weeks
- Time Frame: 12 weeks
Secondary Measures
- Percentage of Yes answers to questions 2 and 3 of the Sexual Encounter Profile
- Time Frame: 12 weeks
- Time Frame: 12 weeks
- Evaluation of score changes for selected GAQ, PAIRS, and IIEF questions.
- Time Frame: 12 weeks
- Time Frame: 12 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Eli Lilly and Company
Overall Clinical Trial Officials and Contacts
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) Study Director Eli Lilly and Company
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00547417
Study ID Number: 7006
ClinicalTrials.gov Identifier: NCT00547417
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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