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

Tracking Information

First Received Date ^ICMJE

October 18, 2007

Last Updated Date

October 18, 2007

Start Date ^ICMJE

March 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 [ Time Frame: 12 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Change from baseline to endpoint of various questions from the IIEF and SEP diary [ Time Frame: 12 weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Impotence

Intervention ^ICMJE

Drug: tadalafil
Drug: placebo

Study Arms / Comparison Groups

Placebo Comparator: Placebo tablet
Active Comparator: 5 mg tadalafil
Active Comparator: 10 mg tadalafil
Active Comparator: 20 mg tadalafil

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

343

Completion Date

November 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00547495

Responsible Party

Study ID Numbers ^ICMJE

5139, H6D-MC-LVDI

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

ICOS Corporation

Investigators ^ICMJE

Study Director:

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)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP