Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection

Impotence Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Tadalafil Administered "On Demand" to Patients With Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547495
• Other study ID #: 5139
• Secondary ID: H6D-MC-LVDI
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2007
• Last updated: October 18, 2007
• Start date: March 2004
• Est. completion date: November 2004

Study information

• Verified date: October 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 3 months history of erectile dysfunction (ED)

• Anticipate a monogamous relationship with a female sexual partner

• Be able to make minimum required sexual intercourse attempts

• Abstain from using any other ED treatment

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, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Impotence

Intervention

Drug:
• tadalafil
5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
• placebo
placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks
• tadalafil
10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
• tadalafil
20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks

Locations

Country	Name	City	State
Japan	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.	Sapporo	Hokkaido

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	ICOS Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in SEP diary		12 weeks
Secondary	Change from baseline to endpoint of various questions from the IIEF and SEP diary		12 weeks

External Links

•   Lilly Clinical Trial Registry