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

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Erectile Dysfunction

Intervention: Tadalafil (Drug)

Phase: Phase 4

Status: Active, not recruiting

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

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)

Secondary outcome:

Change from Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score of 2.5 Milligrams (mg) Tadalafil

Change from Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil

Change from Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments

Proportion of Participants with "Yes" Responses to Sexual Encounter Profile (SEP) Diary of 2.5 mg Tadalafil

Proportion of Participants with "Yes" Responses to SEP Diary of 5 mg Tadalafil

Proportion of Participants Achieving Normal Erectile Functioning of 2.5 mg Tadalafil

Proportion of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil

Proportion of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments

Proportion of Participants with "Yes" Responses to GAQ1 and GAQ2 of 5 mg Tadalafil

Proportion of Participants with "Yes" Responses to GAQ1 and GAQ2 of 5 mg Tadalafil Treatments

Eligibility

Minimum age: 22 Years. Maximum age: 69 Years. Gender(s): Male.

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.

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 with your personal physician., Beijing 100020, China

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 130021, China

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 410011, China

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 610083, China

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., Chongqing 400037, China

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., Fuzhou 350001, China

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., Guangzhou 510180, China

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., Hangzhou 310003, China

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., Hefei 230022, China

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., Nanjing 210008, China

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., Qingdao 266071, China

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., Shanghai 200092, China

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., Suzhou City 215004, China

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., Wenzhou 325035, China

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., Wu Han 430030, China

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., Wuhan 430022, China

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., Yinchuan 750004, China

Additional Information

Starting date: October 2014
Last updated: June 17, 2015

Page last updated: August 23, 2015

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