Status:
COMPLETED
A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction
Lead Sponsor:
Eli Lilly and Company
Conditions:
Erectile Dysfunction
Eligibility:
MALE
22-69 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the study drug, taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED). The study will las...
Eligibility Criteria
Inclusion
- Have a history of erectile dysfunction for at least 3 months.
- Are sexually active and willing to remain sexually active with the same female partner during the study.
- Are willing to have 4 or more attempts of sexual intercourse with female partner between screening and first treatment start day.
- Are willing to stay away from any other medicines that the participants were already taking for erectile dysfunction during this study period.
Exclusion
- Have erectile dysfunction, which is caused by any other primary sexual disorder.
- Have certain problems with kidneys, liver, heart, blood sugar levels, eyes, or central nervous system (study doctor will discuss with participants).
- Have a penis deformity or penile implant that in the opinion of the participants' doctor is significant.
- Have human immunodeficiency virus (HIV) infection.
- Are using certain kinds of medicines, which are not allowed in this study.
- Are allergic to tadalafil.
- Are planning to father a baby or are in a relationship with a pregnant partner.
- Are participating or discontinued participation in the past 30 days from any another clinical trial, which is not compatible with this trial.
- Have participated or discontinued from any other tadalafil clinical trial.
- Have a history of drug, alcohol, or substance abuse within the past 6 months.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
635 Patients enrolled
Trial Details
Trial ID
NCT02224846
Start Date
October 1 2014
End Date
May 1 2017
Last Update
September 23 2019
Active Locations (17)
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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.
Beijing, China, 100020
2
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.
Changchun, China, 130021
3
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.
Changsha, China, 410011
4
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.
Chengdu, China, 610083