Quality of Erection Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00159900
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : April 8, 2008
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Sildenafil Citrate Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : May 2005
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00159900

Pfizer Investigational Site
Belo Horizonte, MG, Brazil, 30130-008
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 20551-030
Pfizer Investigational Site
Rio Claro, SP, Brazil, 13500-020
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04044-060
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04262-000
Pfizer Investigational Site
Frankfurt, Germany, 65929
Pfizer Investigational Site
Marburg, Germany, 35039
Pfizer Investigational Site
Muenchen, Germany, 81369
Pfizer Investigational Site
Muenchen, Germany, 81925
Pfizer Investigational Site
Rosenheim, Germany, D 83022
Pfizer Investigational Site
Starnberg, Germany, 82319
Pfizer Investigational Site
Catania, Italy, 95124
Pfizer Investigational Site
Firenze, Italy, 50139
Pfizer Investigational Site
Roma, Italy, 00161
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
Pfizer Investigational Site
Warszawa, Poland, 00-911
Pfizer Investigational Site
Bursa, Turkey, 16070
Pfizer Investigational Site
Diyarbakir, Turkey, 21280
Pfizer Investigational Site
Istanbul, Turkey, 34900
Pfizer Investigational Site
Izmir, Turkey, 35100
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00159900     History of Changes
Other Study ID Numbers: A1481222
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: April 8, 2008
Last Verified: April 2008

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Citric Acid
Sildenafil Citrate
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents