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Mild To Moderate Erectile Dysfunction Study

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00137072
First received: August 26, 2005
Last updated: September 3, 2011
Last verified: September 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Impotence
 Drug: Viagra (Sildenafil Citrate) 100 mg
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

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:
  • 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.

Enrollment: 355
Study Start Date: April 2005
Study Completion Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137072

  Hide Study Locations
Locations
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
Bayshore, 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
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00137072     History of Changes
Other Study ID Numbers: A1481230
Study First Received: August 26, 2005
Last Updated: September 3, 2011
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 June 18, 2013