Mild To Moderate Erectile Dysfunction Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00137072 |
Recruitment Status :
Completed
First Posted : August 29, 2005
Last Update Posted : February 1, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Impotence | Drug: Viagra (Sildenafil Citrate) 100 mg | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 355 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
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 |
Study Start Date : | April 2005 |
Actual Study Completion Date : | February 2006 |

- To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 8 hrs after a dose of Viagra.
- To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 12 hrs after a dose of Viagra. Other questionnaires such as SEP, IIEF.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137072
United States, Alabama | |
Pfizer Investigational Site | |
Birmingham, Alabama, United States | |
Pfizer Investigational Site | |
Homewood, Alabama, United States | |
Pfizer Investigational Site | |
Hoover, Alabama, United States | |
Pfizer Investigational Site | |
Huntsville, Alabama, United States | |
United States, Arizona | |
Pfizer Investigational Site | |
Phoenix, Arizona, United States | |
United States, California | |
Pfizer Investigational Site | |
Beverly Hills, California, United States | |
Pfizer Investigational Site | |
La Mesa, California, United States | |
Pfizer Investigational Site | |
Newport Beach, California, United States | |
Pfizer Investigational Site | |
San Diego, California, United States | |
United States, Colorado | |
Pfizer Investigational Site | |
Aurora, Colorado, United States | |
United States, Connecticut | |
Pfizer Investigational Site | |
Middlebury, Connecticut, United States | |
Pfizer Investigational Site | |
Waterbury, Connecticut, United States | |
United States, Florida | |
Pfizer Investigational Site | |
Gainesville, Florida, United States | |
Pfizer Investigational Site | |
New Port Richey, Florida, United States | |
Pfizer Investigational Site | |
South Miami, Florida, United States | |
Pfizer Investigational Site | |
Tallahassee, Florida, United States | |
Pfizer Investigational Site | |
Tampa, Florida, United States | |
United States, Indiana | |
Pfizer Investigational Site | |
Fort Wayne, Indiana, United States | |
Pfizer Investigational Site | |
Jeffersonville, Indiana, United States | |
United States, Iowa | |
Pfizer Investigational Site | |
Des Moines, Iowa, United States | |
United States, Louisiana | |
Pfizer Investigational Site | |
New Orleans, Louisiana, United States | |
Pfizer Investigational Site | |
Shreveport, Louisiana, United States | |
United States, Mississippi | |
Pfizer Investigational Site | |
Hattiesburg, Mississippi, United States | |
United States, Nevada | |
Pfizer Investigational Site | |
Las Vegas, Nevada, United States | |
United States, New York | |
Pfizer Investigational Site | |
Bay Shore, New York, United States | |
Pfizer Investigational Site | |
Kingston, New York, United States | |
Pfizer Investigational Site | |
New York, New York, United States | |
Pfizer Investigational Site | |
Poughkeepsie, New York, United States | |
United States, Ohio | |
Pfizer Investigational Site | |
Cincinnati, Ohio, United States | |
United States, Tennessee | |
Pfizer Investigational Site | |
Nashville, Tennessee, United States | |
United States, Texas | |
Pfizer Investigational Site | |
San Antonio, Texas, United States | |
United States, Washington | |
Pfizer Investigational Site | |
Lacey, Washington, United States | |
Pfizer Investigational Site | |
Spokane, Washington, United States |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
ClinicalTrials.gov Identifier: | NCT00137072 |
Other Study ID Numbers: |
A1481230 |
First Posted: | August 29, 2005 Key Record Dates |
Last Update Posted: | February 1, 2021 |
Last Verified: | January 2021 |
Erectile Dysfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders Sildenafil Citrate Molecular Mechanisms of Pharmacological Action |
Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Urological Agents |