Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection
- Registration Number
- NCT00547573
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 367
Inclusion Criteria
- History of erection problems
- Anticipate a monogamous female sexual relationship
- Abstain from other erection treatments at least 4 weeks before first dose and throughout the study
- Must be able to make required sexual intercourse attempts
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 10 mg tadalafil tablet 3 tadalafil 20 mg tadalafil tablet
- Primary Outcome Measures
Name Time Method IIEF Erectile Function Domain score from Questions 1-5 and 15. SEP Diary responses to Questions 2-3 and the entire Diary for baseline and endpoint scores. 4, 8, and 12 weeks
- Secondary Outcome Measures
Name Time Method IIEF questions and scores, Global Assessment Questions, Patient's 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 to your personal physician.
🇨🇳Beijing, China