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Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection

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: Impotence

Intervention: tadalafil (Drug); tadalafil (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

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

Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection.

Clinical Details

Official title: A Multinational, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil Administered "On Demand" to Asian Men With Erectile Dysfunction

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: IIEF Erectile Function Domain score from Questions 1-5 and 15. SEP Diary responses to Questions 2-3 and the entire Diary for baseline and endpoint scores.

Secondary outcome: IIEF questions and scores, Global Assessment Questions, Patient's SEP Diary

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- History of erection problems

- Anticipate a monogamous female sexual relationship

- Abstain from other erection treatments at least 4 weeks before first dose and

throughout the study

- Must be able to make required sexual intercourse attempts

Exclusion Criteria:

- Other primary sexual disorders

- History of radical prostatectomy or other pelvic surgery that affected being able to

have an erection

- History of penile implant or clinically significant penile deformity

- Nitrate use

- Certain heart problems

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 to your personal physician., Beijing, China
Additional Information

Lilly Clinical Trial Registry

Starting date: April 2003
Last updated: October 18, 2007

Page last updated: August 23, 2015

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