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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00147628
First received: September 4, 2005
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Impotence
Drug: sildenafil citrate
Drug: placebo for sildenafil citrate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • 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)

Enrollment: 209
Study Start Date: November 2005
Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00147628     History of Changes
Other Study ID Numbers: A1481236
Study First Received: September 4, 2005
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Citric Acid
Sildenafil
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents

ClinicalTrials.gov processed this record on September 16, 2014