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

Lilly

Status and phase

Completed

Phase 4

Conditions

Erectile Dysfunction

Treatments

Drug: Tadalafil

Study type

Interventional

Funder types

Industry

Identifiers

NCT02224846

H6D-GH-B022 (Other Identifier)

15382

Details and patient eligibility

About

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.

Enrollment

635 patients

Sex

Male

Ages

22 to 69 years old

Volunteers

No Healthy Volunteers

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.