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

Sponsor:	Eli Lilly and Company
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Tadalafil

U.S. FDA Resources

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
Placebo Comparator: 1 Placebo tablet	Drug: placebo placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks
Active Comparator: 2 5 mg tadalafil	Drug: tadalafil 5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks Other Names: LY450190 Cialis IC351
Active Comparator: 3 10 mg tadalafil	Drug: tadalafil 10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks Other Names: LY450190 Cialis IC351
Active Comparator: 4 20 mg tadalafil	Drug: tadalafil 20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks Other Names: LY450190 Cialis IC351

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
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

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

Additional relevant MeSH terms:

Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Tadalafil
Phosphodiesterase 5 Inhibitors

Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012