Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection
- Registration Number
- NCT00547495
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 343
Inclusion Criteria
- 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 radical prostatectomy or other pelvic surgery that affected being able to have an erection
- History of penile implant or clinically significant penile deformity.
- Nitrate use
- Certain heart problems
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 placebo Placebo tablet 2 tadalafil 5 mg tadalafil 4 tadalafil 20 mg tadalafil 3 tadalafil 10 mg tadalafil
- Primary Outcome Measures
Name Time Method Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in SEP diary 12 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline to endpoint of various questions from the IIEF and SEP diary 12 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.
🇯🇵Sapporo, Hokkaido, Japan