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Mild To Moderate Erectile Dysfunction Study

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
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description
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Brief Summary:
Safety/Efficacy of 100-mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction

Condition or disease Intervention/treatment Phase
Impotence Drug: Viagra (Sildenafil Citrate) 100 mg Phase 4

Study Design
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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

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

Eligibility Criteria
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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
Criteria

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
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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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
Additional relevant MeSH terms:
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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