- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00273416
A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses
August 23, 2006 updated by: Pfizer
A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses Of PF-00592379 On Erectile Function, Using 100mg Sildenafil As A Positive Control
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
32
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oslo, Norway, 0277
- Pfizer Investigational Site
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Northern Ireland
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Belfast, Northern Ireland, United Kingdom, BT9 6AD
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).
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Secondary Outcome Measures
Outcome Measure |
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Duration and quality of penile erections recorded in a self-assessment diary.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Study Registration Dates
First Submitted
January 4, 2006
First Submitted That Met QC Criteria
January 4, 2006
First Posted (Estimate)
January 9, 2006
Study Record Updates
Last Update Posted (Estimate)
August 24, 2006
Last Update Submitted That Met QC Criteria
August 23, 2006
Last Verified
August 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A7771002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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