Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire

NCT ID: NCT00147628

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

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-09-30

Brief Summary

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To evaluate the effectiveness of sildenafil on erectile function and intercourse satisfaction in men with ED as well as to validate the new Sexual Experience Questionnaire which incorporates functional and emotional elements of a man's sexual experience into one comprehensive questionnaire.

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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sildenafil citrate

Intervention Type DRUG

placebo for sildenafil citrate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented clinical diagnosis of erectile dysfunction, defined by a score of less than or equal to 25 on the Erectile Dysfunction domain of the International Index of Erectile Function

Exclusion Criteria

* Subjects who have been treated with more than 6 doses of sildenafil or any other phosphodiesterase type 5 inhibitor
Minimum Eligible Age

18 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

Huntsville, Alabama, United States

Site Status

Pfizer Investigational Site

San Diego, California, United States

Site Status

Pfizer Investigational Site

Aurora, Colorado, United States

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Pfizer Investigational Site

Miami, Florida, United States

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Pfizer Investigational Site

Ocala, Florida, United States

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Tallahassee, Florida, United States

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Pfizer Investigational Site

Jeffersonville, Indiana, United States

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Des Moines, Iowa, United States

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Shreveport, Louisiana, United States

Site Status

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Las Vegas, Nevada, United States

Site Status

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Garden City, 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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Pfizer Investigational Site

Poughkeepsie, New York, United States

Site Status

Pfizer Investigational Site

Fargo, North Dakota, United States

Site Status

Pfizer Investigational Site

Cincinnati, Ohio, United States

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Pfizer Investigational Site

Houston, Texas, United States

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San Antonio, Texas, United States

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Pfizer Investigational Site

Seattle, Washington, United States

Site Status

Pfizer Investigational Site

Spokane, Washington, United States

Site Status

Countries

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United States

References

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Kaminetsky JC, Stecher V, Tseng LJ. Quality of erections by age group in men with erectile dysfunction. Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.12976. Epub 2017 Sep 11.

Reference Type DERIVED
PMID: 28892218 (View on PubMed)

Cappelleri JC, Bushmakin AG, Symonds T, Schnetzler G. Scoring correspondence in outcomes related to erectile dysfunction treatment on a 4-point scale (SCORE-4). J Sex Med. 2009 Mar;6(3):809-19. doi: 10.1111/j.1743-6109.2008.01155.x. Epub 2009 Jan 7.

Reference Type DERIVED
PMID: 19143915 (View on PubMed)

Related Links

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Other Identifiers

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A1481236

Identifier Type: -

Identifier Source: org_study_id

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