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NCT00147628 Clinical Trial

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

Impotence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00147628
Other study ID # A1481236
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 2005
Est. completion date September 2006

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 209
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• sildenafil citrate

• placebo for sildenafil citrate

Locations
Country Name City State
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Des Moines Iowa
United States Pfizer Investigational Site Fargo North Dakota
United States Pfizer Investigational Site Garden City New York
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Huntsville Alabama
United States Pfizer Investigational Site Jeffersonville Indiana
United States Pfizer Investigational Site Kingston New York
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Ocala Florida
United States Pfizer Investigational Site Poughkeepsie New York
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Shreveport Louisiana
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Tallahassee Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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)
See also
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Completed NCT00654082 - A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction Phase 4
Withdrawn NCT00382161 - Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors Phase 3
Completed NCT00882934 - The Management of Erectile Dysfunction With Placebo Only N/A
Recruiting NCT00297544 - Effect of Sildenafil on Endothelial Function N/A
Completed NCT00245596 - Evaluation of the Index of Sexual Life Questionnaire Phase 4
Completed NCT00249730 - Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function. Phase 4
Completed NCT00547183 - Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection Phase 3
Completed NCT00422578 - Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction Phase 4
Completed NCT00547092 - Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection Phase 4
Completed NCT00547508 - To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking Phase 3
Completed NCT00422734 - Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life Phase 3
Completed NCT00301262 - Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied Phase 4
Completed NCT00245258 - Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction Phase 4
Completed NCT00547287 - Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations Phase 3
Completed NCT03830164 - Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer Phase 2
Recruiting NCT00498680 - Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i Phase 4
Completed NCT00150358 - To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension . Phase 4
Completed NCT00547495 - Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection Phase 3
Completed NCT00143221 - Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH) Phase 4

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