Clinical trial NCT00147628: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impotence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 209
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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 outcomes:
measure: 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)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jeffersonville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Des Moines
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Garden City
country: United States
facility: Pfizer Investigational Site
state: New York
city: Kingston
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Pfizer Investigational Site
state: New York
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.
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.