Not Signed In -
Erectile Dysfunction |
ED; Erectile Disorder; Erectile Disorder (Impotence) |
Clinical Trial: Mild ED I
This study is currently recruiting patients.
Verified by Pfizer August 2005
|
Purpose
Safety/Efficacy of 100-mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction
| Condition | Intervention | Phase |
|---|---|---|
| Erectile Dysfunction | Drug: Viagra (Sildenafil Citrate) 100 mg | Phase IV |
MedlinePlus related topics: Erectile Dysfunction
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Further Study Details:
Primary Outcomes: 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 Outcomes: Secondarily to determine the proportion of sexual intercourses that are successful 12 hours after dosing. Additionally, to determine the proportion of men with mild to moderate ED who can successfully have and keep an erection sufficient for successful
Expected Total Enrollment: 350
Secondary Outcomes: Secondarily to determine the proportion of sexual intercourses that are successful 12 hours after dosing. Additionally, to determine the proportion of men with mild to moderate ED who can successfully have and keep an erection sufficient for successful
Expected Total Enrollment: 350
Study start: April 2005
Eligibility
Ages Eligible for Study: 18 Years - 70 Years, Genders Eligible for Study: Male
Criteria
Inclusion Criteria:
- Men 18-70 years of age
- Documented clinical diagnosis of erectile dysfunction of at least 3 months duration. Erectile dysfunction
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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00137072
Pfizer CT.gov Call Center 1-800-718-1021
Alabama
Pfizer Investigational Site, Hoover, Alabama, 35216, United States; Recruiting
Pfizer Investigational Site, Huntsville, Alabama, 35801, United States; Recruiting
Pfizer Investigational Site, Birmingham, Alabama, 35205, United States; Recruiting
Pfizer Investigational Site, Homewood, Alabama, 35209, United States; Recruiting
Arizona
Pfizer Investigational Site, Phoenix, Arizona, 85032, United States; Recruiting
California
Pfizer Investigational Site, Newport Beach, California, 92660, United States; Recruiting
Pfizer Investigational Site, La Mesa, California, 91942, United States; Recruiting
Pfizer Investigational Site, Beverly Hills, California, 90212, United States; Recruiting
Pfizer Investigational Site, San Diego, California, 92101, United States; Recruiting
Colorado
Pfizer Investigational Site, Aurora, Colorado, 80012, United States; Recruiting
Connecticut
Pfizer Investigational Site, Middlebury, Connecticut, 06762, United States; Recruiting
Pfizer Investigational Site, Waterbury, Connecticut, 06708, United States; Recruiting
Florida
Pfizer Investigational Site, Tallahassee, Florida, 32308, United States; Recruiting
Pfizer Investigational Site, South Miami, Florida, 33143, United States; Recruiting
Pfizer Investigational Site, Gainesville, Florida, 32605, United States; Recruiting
Pfizer Investigational Site, New Port Richey, Florida, 34652, United States; Recruiting
Pfizer Investigational Site, Tampa, Florida, 33607, United States; Recruiting
Indiana
Pfizer Investigational Site, Jeffersonville, Indiana, 47130, United States; Recruiting
Pfizer Investigational Site, Fort Wayne, Indiana, 46825, United States; Recruiting
Iowa
Pfizer Investigational Site, Des Moines, Iowa, 50309, United States; Recruiting
Louisiana
Pfizer Investigational Site, Shreveport, Louisiana, 71106, United States; Recruiting
Pfizer Investigational Site, New Orleans, Louisiana, 70122, United States; Recruiting
Mississippi
Pfizer Investigational Site, Hattiesburg, Mississippi, 39401, United States; Recruiting
Nevada
Pfizer Investigational Site, Las Vegas, Nevada, 89109-6226, United States; Recruiting
New York
Pfizer Investigational Site, Poughkeepsie, New York, 12601, United States; Recruiting
Pfizer Investigational Site, New York, New York, 10016, United States; Recruiting
Pfizer Investigational Site, Bayshore, New York, 11706, United States; Recruiting
Pfizer Investigational Site, Kingston, New York, 12401, United States; Recruiting
Tennessee
Pfizer Investigational Site, Nashville, Tennessee, 37209, United States; Recruiting
Texas
Pfizer Investigational Site, San Antonio, Texas, 78229, United States; Recruiting
Washington
Pfizer Investigational Site, Lacey, Washington, 98516, United States; Recruiting
Pfizer Investigational Site, Lacey, Washington, 98516, United States; Recruiting
Pfizer Investigational Site, Spokane, Washington, 99207, United States; Recruiting
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A1481230
Last Updated: August 26, 2005
Record first received: August 26, 2005
ClinicalTrials.gov Identifier: NCT00137072
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30
Last Updated: August 26, 2005
Record first received: August 26, 2005
ClinicalTrials.gov Identifier: NCT00137072
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30
email this page
print this page
bookmark this page
feedback on this page
