A Study Of The Safety and Efficacy Of Viagra In Men With Erectile Dysfunction Who Do Not Self Identify.
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00343200
First received: June 20, 2006
Last updated: September 9, 2008
Last verified: September 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To compare the efficacy and safety of Viagra (sildenafil citrate) vs. placebo for the treatment of men with ED and at least 1 prespecified risk factor who do not self identify as having ED.
| Condition | Intervention | Phase |
|---|---|---|
|
Impotence |
Drug: Placebo Drug: Viagra (sildenafil citrate) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Flexible-Dose Study To Assess The Efficacy And Safety Of Viagra (Sildenafil Citrate) In Men With Erectile Dysfunction (ED) Who Do Not Self Identify. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF). [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Other questionnaires and variables such as IIEF, SEAR, GEAQ, SEX-Q, QEQ, EDITS, SEP, Event Log, Erection Hardness Grading Score, and Morisky Compliance. [ Time Frame: Weeks 8 and 12 ] [ Designated as safety issue: No ]
- Safety and Tolerability [ Time Frame: up to 12 Weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 371 |
| Study Start Date: | July 2006 |
| Study Completion Date: | September 2007 |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo tablet orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 8 weeks (DB phase). In 4-week OL phase, subjects received sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period.
|
|
Experimental: Sildenafil
Not Specified
|
Drug: Viagra (sildenafil citrate)
Sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 12 weeks (8-week DB phase and 4-week OL phase).
|
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men who do not identify as having ED with documented ED
- Men 30 years of age and older
- At least one prespecified risk factor for ED
Exclusion Criteria:
- Subjects currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis
- Subjects with a known history of retinitis pigmentosa.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343200
Hide Study Locations
Hide Study LocationsLocations
| United States, Alabama | |
| Pfizer Investigational Site | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Pfizer Investigational Site | |
| Mesa, Arizona, United States, 85213 | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85023 | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85051 | |
| United States, California | |
| Pfizer Investigational Site | |
| Anaheim, California, United States, 92801 | |
| Pfizer Investigational Site | |
| Beverly Hills, California, United States, 90211 | |
| Pfizer Investigational Site | |
| Huntington Beach, California, United States, 92648 | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92123 | |
| Pfizer Investigational Site | |
| Santa Rosa, California, United States, 95405 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Aurora, Colorado, United States, 80012 | |
| Pfizer Investigational Site | |
| Colorado Springs, Colorado, United States, 80904 | |
| Pfizer Investigational Site | |
| Denver, Colorado, United States, 80212 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| Avon, Connecticut, United States, 06001 | |
| Pfizer Investigational Site | |
| Manchester, Connecticut, United States, 06040 | |
| United States, Delaware | |
| Pfizer Investigational Site | |
| Wilmington, Delaware, United States, 19801 | |
| United States, District of Columbia | |
| Pfizer Investigational Site | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Hollywood, Florida, United States, 33021 | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32216 | |
| Pfizer Investigational Site | |
| Ocala, Florida, United States, 34474 | |
| Pfizer Investigational Site | |
| Pembroke Pines, Florida, United States, 33024 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33607 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Peoria, Illinois, United States, 61602 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Fort Wayne, Indiana, United States, 46825 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Arkansas City, Kansas, United States, 67005 | |
| Pfizer Investigational Site | |
| Newton, Kansas, United States, 67114 | |
| Pfizer Investigational Site | |
| Overland Park, Kansas, United States, 66215 | |
| Pfizer Investigational Site | |
| Wichita, Kansas, United States, 67207 | |
| Pfizer Investigational Site | |
| Wichita, Kansas, United States, 67205 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Livonia, Michigan, United States, 48152 | |
| United States, Minnesota | |
| Pfizer Investigational Site | |
| Edina, Minnesota, United States, 55435 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89146 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Binghamton, New York, United States, 13901 | |
| Pfizer Investigational Site | |
| Endwell, New York, United States, 13760 | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10016 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45236 | |
| Pfizer Investigational Site | |
| Mogadore, Ohio, United States, 44260 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73116 | |
| Pfizer Investigational Site | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Greer, South Carolina, United States, 29651 | |
| Pfizer Investigational Site | |
| Simpsonville, South Carolina, United States, 29681 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84121 | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84109 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Richmond, Virginia, United States, 23294 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Spokane, Washington, United States, 99207 | |
| Pfizer Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Oregon, Wisconsin, United States, 53575 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
| ClinicalTrials.gov Identifier: | NCT00343200 History of Changes |
| Other Study ID Numbers: | A1481247 |
| Study First Received: | June 20, 2006 |
| Last Updated: | September 9, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Erectile Dysfunction Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders Sildenafil Vasodilator Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013