Mild To Moderate Erectile Dysfunction Study

NCT ID: NCT00137072

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-02-28

Brief Summary

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

Detailed Description

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Conditions

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Impotence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Viagra (Sildenafil Citrate) 100 mg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

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Homewood, Alabama, United States

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Hoover, Alabama, United States

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Huntsville, Alabama, United States

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Phoenix, Arizona, United States

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Beverly Hills, California, United States

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La Mesa, California, United States

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Newport Beach, California, United States

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San Diego, California, United States

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Aurora, Colorado, United States

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Middlebury, Connecticut, United States

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Waterbury, Connecticut, United States

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Gainesville, Florida, United States

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New Port Richey, Florida, United States

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South Miami, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Fort Wayne, Indiana, United States

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Jeffersonville, Indiana, United States

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Des Moines, Iowa, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Hattiesburg, Mississippi, United States

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Las Vegas, Nevada, United States

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Bay Shore, New York, United States

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Kingston, New York, United States

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New York, New York, United States

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Poughkeepsie, New York, United States

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Cincinnati, Ohio, United States

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Nashville, Tennessee, United States

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San Antonio, Texas, United States

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Lacey, Washington, United States

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Spokane, Washington, United States

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Countries

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United States

Related Links

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Other Identifiers

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A1481230

Identifier Type: -

Identifier Source: org_study_id

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