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Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied

NCT ID: NCT00301262

Last Updated: 2021-02-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-09-30

Brief Summary

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Men's quality of life (QoL) is potentially affected by mild erectile dysfunction (ED) to the same extent as it is by moderate and severe ED. This study will provide controlled clinical data measuring efficacy, QoL parameters and satisfaction changes in men with mild ED treated with Viagra versus those treated with a placebo. With an open-label extension, this study will also provide all study subjects the opportunity to receive the active drug treatment for 6 weeks.

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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

Interventions

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Viagra (Sildenafil citrate)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men above age of majority
* Mild erectile dysfunction (IIEF-EF 22-25) and sexual dissatisfaction (IIEF-OS 7 or less)

Exclusion Criteria

* Use of more than 4 doses of any PDE5 inhibitor in the past 12 weeks and use of any PDE5 inhibitor in the past 4 weeks
* Subjects currently taking any other commercially available drug or non-drug treatment for ED
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

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

Calgary, Alberta, Canada

Site Status

Pfizer Investigational Site

Calgary, Alberta, Canada

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Pfizer Investigational Site

Edmonton, Alberta, Canada

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Pfizer Investigational Site

Langley, British Columbia, Canada

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Pfizer Investigational Site

Surrey, British Columbia, Canada

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Pfizer Investigational Site

Vancouver, British Columbia, Canada

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Pfizer Investigational Site

Vancouver, British Columbia, Canada

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Pfizer Investigational Site

Victoria, British Columbia, Canada

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Pfizer Investigational Site

Bay Roberts, Newfoundland and Labrador, Canada

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Pfizer Investigational Site

Halifax, Nova Scotia, Canada

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Pfizer Investigational Site

Barrie, Ontario, Canada

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Pfizer Investigational Site

Corunna, Ontario, Canada

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Pfizer Investigational Site

Kingston, Ontario, Canada

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Pfizer Investigational Site

London, Ontario, Canada

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Pfizer Investigational Site

Oakville, Ontario, Canada

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Pfizer Investigational Site

Sarnia, Ontario, Canada

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Pfizer Investigational Site

Toronto, Ontario, Canada

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Pfizer Investigational Site

Toronto, Ontario, Canada

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Pfizer Investigational Site

Chicoutimi, Quebec, Canada

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Pfizer Investigational Site

L'Ancienne-Lorette, Quebec, Canada

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Pfizer Investigational Site

Montreal, Quebec, Canada

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Pfizer Investigational Site

Montreal, Quebec, Canada

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Pfizer Investigational Site

Montreal, Quebec, Canada

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Pfizer Investigational Site

Pointe-Claire, Quebec, Canada

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Pfizer Investigational Site

Saint-Léonard, Quebec, Canada

Site Status

Pfizer Investigational Site

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

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)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481238&StudyName=Impact%20Of%20Viagra%20On%20Sexual%20Satisfaction%20Of%20Men%20With%20Mild%20Erectile%20Dysfunction%20Who%20Are%20Sexually%20Dissatisfied

To obtain contact information for a study center near you, click here.

Other Identifiers

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A1481238

Identifier Type: -

Identifier Source: org_study_id

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