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A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses

NCT ID: NCT00273416

Last Updated: 2006-08-24

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

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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The primary aim of this study is to assess how effective PF-00592379 is in restoring penile erections in patients with erectile dysfunction. Patients will attend for 4 treatment visits where they will receive the following in random order; 2 separate doses of PF-00592379, sildenafil 100mg used as a positive control, or placebo (dummy medication). The effect on penile erections will be assessed in the clinic using penile plethysmography (RigiScan PlusTM technique).

Detailed Description

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Conditions

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Impotence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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PF-00592379

Intervention Type DRUG

Sildenafil 100mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Erectile dysfunction, previous good response to an oral treatment for erectile dysfunction.

Exclusion Criteria

* Patients with high blood pressure or certain heart conditions (e.g. angina, heart failure), regardless of whether treated or not.
* Patients on nitrates or alpha-blocker medications.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Oslo, , Norway

Site Status

Pfizer Investigational Site

Belfast, Northern Ireland, United Kingdom

Site Status

Countries

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Norway United Kingdom

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7771002&StudyName=A+Randomized+Double+Blind%2C+Placebo+Controlled+Balanced+4%2DWay+Crossover+Study+To+Assess+The+Efficacy+Of+Single+Oral+Doses

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

Other Identifiers

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A7771002

Identifier Type: -

Identifier Source: org_study_id