A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction
This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of 2.5mg and 5mg tadalafil taken once daily in men with erectile dysfunction...
Brief Summary
Official Title: “A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5mg and 5mg) Administered Once Daily to Men With Erectile Dysfunction”
This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of 2.5mg and 5mg tadalafil taken once daily in men with erectile dysfunction.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: tadalafil
- 2.5 mg or 5 mg tadalafil tablet taken by mouth once a day for 24 weeks. Followed by an open label extension where all patients receive 5 mg doses.
- Drug: placebo
- Placebo tablet taken by mouth once a day for 24 weeks. Placebo patient will receive 5 mg tadalafil tablet during the open label extension.
Arms, Groups and Cohorts in this Clinical Trial
- Placebo Comparator: 1
- placebo tablet
- Active Comparator: 2
- 2.5 mg tadalafil tablet
- Active Comparator: 3
- 5 mg tadalafil tablet
Outcome Measures for this Clinical Trial
Primary Measures
- Changes in erectile function measured at baseline and after 6 months of treatment with 2.5mg and 5mg tadalafil; assessment of safety after 1 and 2 years of therapy with 5mg tadalafil.
- Time Frame: 24-128 weeks
- Time Frame: 24-128 weeks
Secondary Measures
- Changes in additional aspects of erectile function after 3 and 6 months of treatment; assessment of the pharmacokinetics of tadalafil 2.5mg and 5mg.
- Time Frame: 24 weeks
- Time Frame: 24 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Men with erectile dysfunction
- At least 18 years of age
Exclusion Criteria:
- Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
- A history of certain impotence disorders
- History of specified pelvic surgery
- Any significant genital abnormality identified at the start of the study
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 Investigator Information
Lead Investigator: Eli Lilly and Company Industry
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 February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00381732
Study ID Number: 7019
ClinicalTrials.gov Identifier: NCT00381732
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00381732
