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

Primary Purpose

Impotence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
sildenafil citrate
placebo for sildenafil citrate
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impotence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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)

Full Information

First Posted
September 4, 2005
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00147628
Brief Title
Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire
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 Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impotence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sildenafil citrate
Intervention Type
Drug
Intervention Name(s)
placebo for sildenafil citrate
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Tallahassee
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Jeffersonville
State/Province
Indiana
Country
United States
Facility Name
Pfizer Investigational Site
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
Pfizer Investigational Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Pfizer Investigational Site
City
Garden City
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Kingston
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Fargo
State/Province
North Dakota
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
City
Spokane
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28892218
Citation
Kaminetsky JC, Stecher V, Tseng LJ. Quality of erections by age group in men with erectile dysfunction. Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.12976. Epub 2017 Sep 11.
Results Reference
derived
PubMed Identifier
19143915
Citation
Cappelleri JC, Bushmakin AG, Symonds T, Schnetzler G. Scoring correspondence in outcomes related to erectile dysfunction treatment on a 4-point scale (SCORE-4). J Sex Med. 2009 Mar;6(3):809-19. doi: 10.1111/j.1743-6109.2008.01155.x. Epub 2009 Jan 7.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481236&StudyName=Assessment+Of+Sildenafil+On+Erectile+Function+And+Intercourse+Satisfaction+And+To+Validate+A+New+Subject+Questionnaire
Description
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Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire

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