A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction
- Registration Number
- NCT00381732
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 280
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 placebo placebo tablet 3 tadalafil 5 mg tadalafil tablet 2 tadalafil 2.5 mg tadalafil tablet
- Primary Outcome Measures
Name Time Method 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. 24-128 weeks
- Secondary Outcome Measures
Name Time Method Changes in additional aspects of erectile function after 3 and 6 months of treatment; assessment of the pharmacokinetics of tadalafil 2.5mg and 5mg. 24 weeks
Trial Locations
- Locations (1)
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.
🇺🇸Bothell, Washington, United States