Overview

A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction

Status:
Completed
Trial end date:
2017-05-01
Target enrollment:
0
Participant gender:
Male
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 last about up to 25 months for each participant.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Tadalafil
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.