Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00143260
Collaborator
(none)
250
25
9
10
1.1
Study Details
Study Description
Brief Summary
Safety/Efficacy of 100mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Multicenter Randomized Double-Blind, Placebo-Controlled, Fixed-Dose Parallel Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose - II
Study Start Date
:
Aug 1, 2005
Actual Primary Completion Date
:
May 1, 2006
Actual Study Completion Date
:
May 1, 2006
Outcome Measures
Primary Outcome Measures
- To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 8 hrs after a dose of Viagra. []
Secondary Outcome Measures
- Proportion (as above) of patients at various endpoints. Other questionnaires such as SEP, IIEF. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Men 18-70 years of age
-
Documented clinical diagnosis of erectile dysfunction of at least 3 months duration.
Exclusion Criteria:
-
Subjects with penile implants
-
Subjects with a known history of retinitis pigmentosa.
-
Subjects, due to the requirement of 100 mg dosage, who are receiving concomitant treatment with the potent CYP3A4 inhibitor ritonavir.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Pfizer Investigational Site | Birmingham | Alabama | United States | |
2 | Pfizer Investigational Site | Homewood | Alabama | United States | |
3 | Pfizer Investigational Site | Hoover | Alabama | United States | |
4 | Pfizer Investigational Site | Huntsville | Alabama | United States | |
5 | Pfizer Investigational Site | Phoenix | Arizona | United States | |
6 | Pfizer Investigational Site | La Mesa | California | United States | |
7 | Pfizer Investigational Site | Newport Beach | California | United States | |
8 | Pfizer Investigational Site | San Diego | California | United States | |
9 | Pfizer Investigational Site | Aurora | Colorado | United States | |
10 | Pfizer Investigational Site | Gainesville | Florida | United States | |
11 | Pfizer Investigational Site | South Miami | Florida | United States | |
12 | Pfizer Investigational Site | Tallahassee | Florida | United States | |
13 | Pfizer Investigational Site | Tampa | Florida | United States | |
14 | Pfizer Investigational Site | Fort Wayne | Indiana | United States | |
15 | Pfizer Investigational Site | Jeffersonville | Indiana | United States | |
16 | Pfizer Investigational Site | Des Moines | Iowa | United States | |
17 | Pfizer Investigational Site | Shreveport | Louisiana | United States | |
18 | Pfizer Investigational Site | Las Vegas | Nevada | United States | |
19 | Pfizer Investigational Site | Bay Shore | New York | United States | |
20 | Pfizer Investigational Site | Kingston | New York | United States | |
21 | Pfizer Investigational Site | New York | New York | United States | |
22 | Pfizer Investigational Site | Poughkeepsie | New York | United States | |
23 | Pfizer Investigational Site | Cincinnati | Ohio | United States | |
24 | Pfizer Investigational Site | San Antonio | Texas | United States | |
25 | Pfizer Investigational Site | Spokane | Washington | United States |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00143260
Other Study ID Numbers:
- A1481240
First Posted:
Sep 2, 2005
Last Update Posted:
Feb 1, 2021
Last Verified:
Jan 1, 2021