To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking
- Registration Number
- NCT00547508
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Study to see how effective different doses of tadalafil are for getting and keeping an erection when sex is attempted after a certain number of hours.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 485
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
- History of other primary sexual disorder
- Treatment with nitrates
- Have a penile implant or clinically significant penile deformity
- History of certain heart problems
- Do not meet certain lab value reference ranges
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 placebo Placebo 2 placebo Placebo 4 tadalafil tadalafil 3 tadalafil tadalafil 6 tadalafil tadalafil 5 tadalafil tadalafil
- Primary Outcome Measures
Name Time Method Prove superiority to placebo by measuring question 3 of the SEP diary 6-10 and 24 weeks
- Secondary Outcome Measures
Name Time Method Compare effectiveness when patient can freely choose time of sex versus when time of sex attempt is set by the score of question 3 in the SEP diary 6-10 and 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.
🇺🇸Knoxville, Tennessee, United States