Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Impotence
Intervention: tadalafil (Drug); tadalafil (Drug); placebo (Drug)
Phase: Phase 3
Sponsored by: Eli Lilly and Company
Official(s) and/or principal investigator(s):
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, Affiliation: Eli Lilly and Company
Study to determine if tadalafil works better than placebo for Asian men having trouble
getting or keeping an erection.
Official title: A Multinational, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil Administered "On Demand" to Asian Men With Erectile Dysfunction
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: IIEF questions and scores, Global Assessment Questions,
Patient's SEP Diary
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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
Locations and Contacts
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
Lilly Clinical Trial Registry
Starting date: April 2003
Ending date: December 2003
Last updated: October 18, 2007