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

Impotence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547573
• Other study ID #: 5874
• Secondary ID: H6D-MC-LVDY
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2007
• Last updated: October 18, 2007
• Start date: April 2003
• Est. completion date: December 2003

Study information

• Verified date: October 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Impotence

Intervention

Drug:
• tadalafil
10 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
• tadalafil
20 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
• placebo
placebo tablet taken by mouth as needed for 12 weeks not more than once a day

Locations

Country	Name	City	State
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 to your personal physician.	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	ICOS Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		4, 8, and 12 weeks
Secondary	IIEF questions and scores, Global Assessment Questions, Patient's SEP Diary		12 weeks

External Links

•   Lilly Clinical Trial Registry