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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00147628

Collaborator

(none)

209

Enrollment

Locations

Duration (Months)

10.5

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Impotence	Drug: sildenafil citrate Drug: placebo for sildenafil citrate	Phase 4

Study Design

Study Type:

Interventional

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 :

Nov 1, 2005

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country
1	Pfizer Investigational Site	Huntsville	Alabama	United States
2	Pfizer Investigational Site	San Diego	California	United States
3	Pfizer Investigational Site	Aurora	Colorado	United States
4	Pfizer Investigational Site	Miami	Florida	United States
5	Pfizer Investigational Site	Ocala	Florida	United States
6	Pfizer Investigational Site	Tallahassee	Florida	United States
7	Pfizer Investigational Site	Jeffersonville	Indiana	United States
8	Pfizer Investigational Site	Des Moines	Iowa	United States
9	Pfizer Investigational Site	Shreveport	Louisiana	United States
10	Pfizer Investigational Site	Las Vegas	Nevada	United States
11	Pfizer Investigational Site	Garden City	New York	United States
12	Pfizer Investigational Site	Kingston	New York	United States
13	Pfizer Investigational Site	New York	New York	United States
14	Pfizer Investigational Site	Poughkeepsie	New York	United States
15	Pfizer Investigational Site	Fargo	North Dakota	United States
16	Pfizer Investigational Site	Cincinnati	Ohio	United States
17	Pfizer Investigational Site	Houston	Texas	United States
18	Pfizer Investigational Site	San Antonio	Texas	United States
19	Pfizer Investigational Site	Seattle	Washington	United States
20	Pfizer Investigational Site	Spokane	Washington	United States