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Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire

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ClinicalTrials.gov Identifier: NCT00147628
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Pfizer

Brief Summary:
To evaluate the effectiveness of sildenafil on erectile function and intercourse satisfaction in men with ED as well as to validate the new Sexual Experience Questionnaire which incorporates functional and emotional elements of a man's sexual experience into one comprehensive questionnaire.

Condition or disease Intervention/treatment Phase
Impotence Drug: sildenafil citrate Drug: placebo for sildenafil citrate Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind Placebo Controlled, Flexible-Dose Study With An Open-Label Phase To Assess The Efficacy Of Sildenafil Citrate On Erectile Function And Intercourse Satisfaction As Well As To Validate The Sexual Experience Questionnaire And Its Treatment Responsiveness In Men With Erectile Dysfunction
Study Start Date : November 2005
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The primary endpoints are: The changes from baseline to Visit 5 (Week 10) of the Erectile Function (Questions 1-5, 15) Intercourse Satisfaction domains (Questions 6-8) of the International Index of Erectile Function (IIEF).

Secondary Outcome Measures :
  1. The change from baseline to Visit 4 (Week 6), Visit 5 (Week 10) and Visit 7 (Week 16) in the domains and total score as well as the individual questions of the Sexual Experience Questionnaire (SEX-Q)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented clinical diagnosis of erectile dysfunction, defined by a score of less than or equal to 25 on the Erectile Dysfunction domain of the International Index of Erectile Function

Exclusion Criteria:

  • Subjects who have been treated with more than 6 doses of sildenafil or any other phosphodiesterase type 5 inhibitor

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 ClinicalTrials.gov identifier (NCT number): NCT00147628


Locations
United States, Alabama
Pfizer Investigational Site
Huntsville, Alabama, United States
United States, California
Pfizer Investigational Site
San Diego, California, United States
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Ocala, Florida, United States
Pfizer Investigational Site
Tallahassee, Florida, United States
United States, Indiana
Pfizer Investigational Site
Jeffersonville, Indiana, United States
United States, Iowa
Pfizer Investigational Site
Des Moines, Iowa, United States
United States, Louisiana
Pfizer Investigational Site
Shreveport, Louisiana, United States
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States
United States, New York
Pfizer Investigational Site
Garden City, New York, United States
Pfizer Investigational Site
Kingston, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Poughkeepsie, New York, United States
United States, North Dakota
Pfizer Investigational Site
Fargo, North Dakota, United States
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States
Pfizer Investigational Site
Spokane, Washington, United States
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00147628     History of Changes
Other Study ID Numbers: A1481236
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011

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