Overview

This trial is active, not recruiting.

Condition erectile dysfunction
Treatment tadalafil
Phase phase 4
Sponsor Eli Lilly and Company
Start date October 2014
End date May 2016
Trial size 600 participants
Trial identifier NCT02224846, 15382, H6D-GH-B022

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
tadalafil LY450190
Administered orally
(Experimental)
5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
tadalafil LY450190
Administered orally

Primary Outcomes

Measure
Proportion of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)
time frame: Baseline through Month 12

Secondary Outcomes

Measure
Change from Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score of 2.5 Milligrams (mg) Tadalafil
time frame: Baseline, Month 1, Month 3
Change from Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil
time frame: Baseline, Month 1, Month 3
Change from Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments
time frame: Baseline, Month 6, Month 12, Month 18, Month 24
Proportion of Participants with "Yes" Responses to Sexual Encounter Profile (SEP) Diary of 2.5 mg Tadalafil
time frame: Month 1 and Month 3
Proportion of Participants with "Yes" Responses to SEP Diary of 5 mg Tadalafil
time frame: Month 1 and Month 3
Proportion of Participants Achieving Normal Erectile Functioning of 2.5 mg Tadalafil
time frame: Month 1 and Month 3
Proportion of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil
time frame: Month 1 and Month 3
Proportion of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments
time frame: Month 6, Month 12, Month 18 and Month 24
Proportion of Participants with "Yes" Responses to GAQ1 and GAQ2 of 5 mg Tadalafil
time frame: Month 3
Proportion of Participants with "Yes" Responses to GAQ1 and GAQ2 of 5 mg Tadalafil Treatments
time frame: Month 12 and Month 24

Eligibility Criteria

Male participants from 22 years up to 69 years old.

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.

Additional Information

Official title Postmarketing Surveillance Study: A Randomized, Open-Label, 3-Month Interventional Study of Tadalafil Effectiveness (2.5 mg and 5 mg) and Long-Term Safety Administered Once Daily in Chinese Men With Erectile Dysfunction
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.