Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied - Full Text View

Purpose

Men's quality of life (QoL) is potentially affected by mild erectile dysfunction (ED) to the same extent as it is by moderate and severe ED. This study will provide controlled clinical data measuring efficacy, QoL parameters and satisfaction changes in men with mild ED treated with Viagra versus those treated with a placebo. With an open-label extension, this study will also provide all study subjects the opportunity to receive the active drug treatment for 6 weeks.

Condition	Intervention	Phase
Impotence	Drug: Viagra (Sildenafil citrate)	Phase IV

MedlinePlus related topics:

Erectile Dysfunction

Drug Information available for:

Sildenafil citrate Sildenafil Citric acid Sodium Citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Multi-Center, Parallel Group, Flexible Dose Trial With A Double-Blind, Randomized, Placebo-Controlled Phase Followed By An Open-Label Phase To Assess The Impact Of Viagra On The Sexual Satisfaction Of Men With Mild Erectile Dysfunction

Further study details as provided by Pfizer:

Primary Outcome Measures:

Measure the impact of treatment with VIAGRA on the treatment satisfaction in ment with mild ED who are sexually dissatisfied, measured by ED Inventory of Treatment Satisfaction at the end of the double-blind treatment

Secondary Outcome Measures:

Measure Viagra's effect on the Patient Reported Erectile Function Assessment
measure Viagra's effect on the erectile function parameters
measure treatment's effect on degree of bother
examine correlation between degree of bother and International Index of Erectile Function & Quality of Life
report Viagra's safety in this patient population

Enrollment:	183
Study Start Date:	November 2005

Eligibility

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

Criteria

Inclusion Criteria:

Men above age of majority
Mild erectile dysfunction (IIEF-EF 22-25) and sexual dissatisfaction (IIEF-OS 7 or less)

Exclusion Criteria:

Use of more than 4 doses of any PDE5 inhibitor in the past 12 weeks and use of any PDE5 inhibitor in the past 4 weeks
Subjects currently taking any other commercially available drug or non-drug treatment for ED

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301262

Locations


Canada, Alberta
	Pfizer Investigational Site
	Calgary, Alberta, Canada, T2L 1K8
	Pfizer Investigational Site
	Calgary, Alberta, Canada, T2V 4R6
	Pfizer Investigational Site
	Edmonton, Alberta, Canada, T5H 4B9

Canada, British Columbia
	Pfizer Investigational Site
	Surrey, British Columbia, Canada, V3V 1N1
	Pfizer Investigational Site
	Vancouver, British Columbia, Canada, V6Z 2T1
	Pfizer Investigational Site
	Victoria, British Columbia, Canada, V8T 5G1
	Pfizer Investigational Site
	Langley, British Columbia, Canada, V3A 4H9
	Pfizer Investigational Site
	Vancouver, British Columbia, Canada, V5Z 1K3

Canada, Newfoundland and Labrador
	Pfizer Investigational Site
	Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0

Canada, Nova Scotia
	Pfizer Investigational Site
	Halifax, Nova Scotia, Canada, B3H 3A7

Canada, Ontario
	Pfizer Investigational Site
	Oakville, Ontario, Canada, L6H 3P1
	Pfizer Investigational Site
	London, Ontario, Canada, N6A 4V2
	Pfizer Investigational Site
	Toronto, Ontario, Canada, M6A 3B5
	Pfizer Investigational Site
	Kingston, Ontario, Canada, K7L 3J7
	Pfizer Investigational Site
	Toronto, Ontario, Canada, M5T 2S8
	Pfizer Investigational Site
	Corunna, Ontario, Canada, N0N 1G0
	Pfizer Investigational Site
	Sarnia, Ontario, Canada, N7T 4X3
	Pfizer Investigational Site
	Barrie, Ontario, Canada, L4M 7G1

Canada, Quebec
	Pfizer Investigational Site
	Montréal, Quebec, Canada, H2X 1N8
	Pfizer Investigational Site
	Montreal, Quebec, Canada, H2X 1N8
	Pfizer Investigational Site
	L'Ancienne-Lorette, Quebec, Canada, G2E 2X1
	Pfizer Investigational Site
	Montreal, Quebec, Canada, H2L 5B1
	Pfizer Investigational Site
	Pointe-Claire, Quebec, Canada, H9R 4S3
	Pfizer Investigational Site
	Chicoutimi, Quebec, Canada, G7H 4A3
	Pfizer Investigational Site
	St. Leonard, Quebec, Canada, H1S 3A9
	Pfizer Investigational Site
	Sherbrooke, Quebec, Canada, J1H 1Z1
	Pfizer Investigational Site
	Montreal, Quebec, Canada, H3S 1Z1

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	A1481238
First Received:	March 7, 2006
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00301262
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological

Sexual Dysfunction, Physiological

Mental Disorders

Citric Acid

Sildenafil

Genital Diseases, Male

Erectile Dysfunction

Additional relevant MeSH terms:

Vasodilator Agents

Phosphodiesterase Inhibitors

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Enzyme Inhibitors

Cardiovascular Agents

Sexual and Gender Disorders

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00301262