Quality of Erection Study - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00159900

Purpose

The study objective is to evaluate the effect that sildenafil citrate has on the hardness of erections in males with erectile dysfunction, based on subject responses to question 5 on the Event Log (hardness of erection) as measured at the end of double blind treatment (week 6).

Condition	Intervention	Phase
Erectile Dysfunction	Drug: 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, Efficacy Study
Official Title:	A Multicenter, Parallel Group Flexible Dose Study With A Double Blind, Randomized, Placebo Controlled Phase And An Open-Label Phase To Evaluate The Quality Of Erections In Men With Erectile Dysfunction Treated With Sildenafil Citrate

Further study details as provided by Pfizer:

Primary Outcome Measures:

Responses to Question 5 (erectile hardness) of the Event Log as measured from baseline to the end of double-blind treatment (week 6).

Secondary Outcome Measures:

Responses to the Quality of Erectile Questionnaire (QEQ) Responses to International Index of Erectile Function (IIEF) Domains (Erectile Function; Orgasmic Function; Sexual Desire; Intercourse Satisfaction; Overall Satisfaction)

Estimated Enrollment:	300
Study Start Date:	May 2005
Estimated Study Completion Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male subjects aged 18-55
Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.)

Exclusion Criteria:

Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction [Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening]

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159900

Locations

Brazil, mg
Pfizer Investigational Site
Belo Horizonte, mg, Brazil, 30130-008
Brazil, RJ
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 20551-030
Brazil, SP
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04262-000
Pfizer Investigational Site
Rio Claro, SP, Brazil, 13500-020
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04044-060
Germany
Pfizer Investigational Site
Marburg, Germany, 35039
Pfizer Investigational Site
Starnberg, Germany, 82319
Pfizer Investigational Site
Rosenheim, Germany, D 83022
Pfizer Investigational Site
Muenchen, Germany, 81925
Pfizer Investigational Site
Frankfurt, Germany, 65929
Pfizer Investigational Site
Muenchen, Germany, 81369
Italy
Pfizer Investigational Site
Catania, Italy, 95124
Pfizer Investigational Site
Roma, Italy, 00161
Pfizer Investigational Site
Firenze, Italy, 50139
Poland
Pfizer Investigational Site
Warszawa, Poland, 00-911
Pfizer Investigational Site
Lodz, Poland, 90-625
Pfizer Investigational Site
Lodz, Poland, 93-171
Pfizer Investigational Site
Lublin, Poland, 20-008
Pfizer Investigational Site
Szczecin, Poland, 71-240
Turkey
Pfizer Investigational Site
Istanbul, Turkey, 34900
Pfizer Investigational Site
Izmir, Turkey, 35100
Pfizer Investigational Site
Diyarbakir, Turkey, 21280
Pfizer Investigational Site
Bursa, Turkey, 16070

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Study ID Numbers:	A1481222
Study First Received:	September 8, 2005
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00159900
Health Authority:	Germany: Ethics Commission

Keywords provided by Pfizer:

Impotence

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 January 16, 2009