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

This study has been completed.

First Received: October 18, 2007 No Changes Posted

Sponsors and Collaborators:	Eli Lilly and Company ICOS Corporation
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00547495

Purpose

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

Condition	Intervention	Phase
Impotence	Drug: tadalafil Drug: placebo	Phase III

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Tadalafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Tadalafil Administered "On Demand" to Patients With Erectile Dysfunction

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Enrollment:	343
Study Start Date:	March 2004
Study Completion Date:	November 2004

Arms	Assigned Interventions
1: Placebo Comparator Placebo tablet	Drug: placebo placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks
2: Active Comparator 5 mg tadalafil	Drug: tadalafil 5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
3: Active Comparator 10 mg tadalafil	Drug: tadalafil 10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
4: Active Comparator 20 mg tadalafil	Drug: tadalafil 20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547495

Locations

Japan, Hokkaido
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, Japan

Sponsors and Collaborators

Eli Lilly and Company

ICOS Corporation

Investigators

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	5139, H6D-MC-LVDI
Study First Received:	October 18, 2007
Last Updated:	October 18, 2007
ClinicalTrials.gov Identifier:	NCT00547495 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Sexual Dysfunction, Physiological
Mental Disorders

Tadalafil
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Sexual Dysfunction, Physiological
Molecular Mechanisms of Pharmacological Action
Mental Disorders
Tadalafil

Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009