Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations

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:	NCT00547287

Purpose

Study to determine if men from around the world prefer sildenafil to tadalafil.

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

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Sildenafil Tadalafil Sildenafil citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title:	Switching From Sildenafil Citrate to Tadalafil in Treatment of Erectile Dysfunction: Multinational Assessment of Treatment Preference

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase [ Time Frame: 14 weeks ]

Secondary Outcome Measures:

Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains. [ Time Frame: 26 weeks ]

Enrollment:	2760
Study Start Date:	November 2002
Study Completion Date:	May 2004

Arms	Assigned Interventions
1: Active Comparator Currently prescribed dosage of sildenafil is continued until wash-out period.	Drug: sildenafil Current dosage of sildenafil is continued for 4 weeks (no more than once a day) of treatment assessment then the wash-out period will begin.
2: Active Comparator 20 mg tadalafil given after one week sildenafil wash-out period.	Drug: tadalafil 20 mg tadalafil as needed by mouth no more than once a day for a 4 week initiation period and a 4 weeks treatment period.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must be of legal age according to your country.
Must have had a history of erectile dysfunction for at least 3 months.
Must currently and have been using sildenafil for the last six weeks.
Agree to not use any other ED treatment during the study.
Anticipate the same female sexual partner for the study.

Exclusion Criteria:

History of other primary sexual disorder
Treatment with nitrates
Have a penile implant or clinically significant penile deformity
History of certain heart problems
Do not meet certain lab value reference ranges

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547287

Locations

Brazil
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.
Sao Paulo, Brazil

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:	7925, H6D-VI-LVFH
Study First Received:	October 18, 2007
Last Updated:	October 18, 2007
ClinicalTrials.gov Identifier:	NCT00547287 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Vasodilator Agents
Phosphodiesterase Inhibitors
Sexual Dysfunction, Physiological
Mental Disorders
Citric Acid

Tadalafil
Sildenafil
Cardiovascular Agents
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Sildenafil
Cardiovascular Agents
Genital Diseases, Male
Sexual and Gender Disorders

Pharmacologic Actions
Sexual Dysfunction, Physiological
Phosphodiesterase Inhibitors
Mental Disorders
Therapeutic Uses
Tadalafil
Erectile Dysfunction

ClinicalTrials.gov processed this record on May 07, 2009