Quality of Erection Study

NCT ID: NCT00159900

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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-01-31

Brief Summary

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The study objective is to evaluate the effect that sildenafil citrate has on the hardness of erections in males with erectile dysfunction, based on subject responses to question 5 on the Event Log (hardness of erection) as measured at the end of double blind treatment (week 6).

Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Sildenafil Citrate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male subjects aged 18-55
* Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.)

Exclusion Criteria

* Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction \[Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening\]
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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

Belo Horizonte, Minas Gerais, Brazil

Site Status

Pfizer Investigational Site

Rio de Janeiro, Rio de Janeiro, Brazil

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Pfizer Investigational Site

Rio Claro, São Paulo, Brazil

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Pfizer Investigational Site

São Paulo, São Paulo, Brazil

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Pfizer Investigational Site

São Paulo, São Paulo, Brazil

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Pfizer Investigational Site

Frankfurt, , Germany

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Pfizer Investigational Site

Marburg, , Germany

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Pfizer Investigational Site

München, , Germany

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Pfizer Investigational Site

München, , Germany

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Pfizer Investigational Site

Rosenheim, , Germany

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Pfizer Investigational Site

Starnberg, , Germany

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Pfizer Investigational Site

Catania, , Italy

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Pfizer Investigational Site

Florence, , Italy

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Pfizer Investigational Site

Roma, , Italy

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Pfizer Investigational Site

Lodz, , Poland

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Pfizer Investigational Site

Lodz, , Poland

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Pfizer Investigational Site

Lublin, , Poland

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Pfizer Investigational Site

Szczecin, , Poland

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Pfizer Investigational Site

Warsaw, , Poland

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Pfizer Investigational Site

Bursa, , Turkey (Türkiye)

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Pfizer Investigational Site

Diyarbakır, , Turkey (Türkiye)

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Pfizer Investigational Site

Istanbul, , Turkey (Türkiye)

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Pfizer Investigational Site

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Brazil Germany Italy Poland Turkey (Türkiye)

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)

Other Identifiers

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A1481222

Identifier Type: -

Identifier Source: org_study_id

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