- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00219635
Assessment Of Efficacy and Safety UK-390,957 In Men With Premature Ejaculation
November 5, 2012 updated by: Pfizer
A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Flexible Dose Study To Assess The Efficacy and Safety Of Oral UK-390,957 In Men With Premature Ejaculation
Assessment of efficacy and safety UK-390,957
Study Overview
Study Type
Interventional
Enrollment
138
Phase
- Phase 2
- Phase 3
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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New South Wales
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St Leonards, New South Wales, Australia
- Pfizer Investigational Site
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Victoria
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Malvern, Victoria, Australia
- Pfizer Investigational Site
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British Columbia
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Victoria, British Columbia, Canada
- Pfizer Investigational Site
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Ontario
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Barrie, Ontario, Canada
- Pfizer Investigational Site
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London, Ontario, Canada
- Pfizer Investigational Site
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Toronto, Ontario, Canada
- Pfizer Investigational Site
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Devon, United Kingdom
- Pfizer Investigational Site
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Staffordshire
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Nr Lichfield, Staffordshire, United Kingdom
- Pfizer Investigational Site
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Alabama
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Birmingham, Alabama, United States
- Pfizer Investigational Site
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California
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San Bernardino, California, United States
- Pfizer Investigational Site
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Louisiana
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Metairie, Louisiana, United States
- Pfizer Investigational Site
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Massachusetts
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Watertown, Massachusetts, United States
- Pfizer Investigational Site
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Missouri
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Kansas City, Missouri, United States
- Pfizer Investigational Site
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Washington, Missouri, United States
- Pfizer Investigational Site
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New York
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New York, New York, United States
- Pfizer Investigational Site
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Williamsville, New York, United States
- Pfizer Investigational Site
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Ohio
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Beachwood, Ohio, United States
- Pfizer Investigational Site
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Oregon
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Portland, Oregon, United States
- Pfizer Investigational Site
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Tennessee
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Knoxville, Tennessee, United States
- Pfizer Investigational Site
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Texas
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Dallas, Texas, United States
- Pfizer Investigational Site
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Houston, Texas, United States
- Pfizer Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, United States
- 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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Premature ejaculation as defined by DSM-IV
Exclusion Criteria:
- History of erectile dysfunction
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: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Assessment of efficacy and safety
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Secondary Outcome Measures
Outcome Measure |
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Assessment of quality of sexual life
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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, 2005
Primary Completion (Actual)
July 1, 2005
Study Completion (Actual)
July 1, 2005
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
November 7, 2012
Last Update Submitted That Met QC Criteria
November 5, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A3871029
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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PfizerCompletedEjaculationUnited States
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Alza Corporation, DE, USACompleted
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PfizerCompletedEjaculationItaly, Spain, Australia, Austria, Canada, Czech Republic, France, Germany, Israel, Norway, Poland, Sweden, Turkey, Netherlands
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Alza Corporation, DE, USACompleted
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Janssen Research & Development, LLCCompletedSexual Dysfunction, Physiological | EjaculationGermany, Spain, Portugal, Finland, Sweden, Austria
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Johnson & Johnson Pharmaceutical Research & Development...CompletedSexual Dysfunction | Ejaculation
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PfizerCompletedEjaculationItaly, United States, Australia, Austria, Canada, Czech Republic, France, Germany, Israel, Norway, Poland, Sweden, Turkey, United Kingdom
-
Janssen Research & Development, LLCCompletedEjaculationUnited States
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PfizerCompletedEjaculationUnited States
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PfizerCompletedEjaculationItaly, Spain, Australia, Austria, Canada, Czech Republic, France, Germany, Israel, Norway, Poland, Sweden, Turkey, Netherlands
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St George's, University of LondonCompleted
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St George's, University of LondonCompleted
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St George's, University of LondonThe Health FoundationCompleted
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PfizerViiV HealthcareCompleted
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PfizerTerminatedPulmonary Disease, Chronic ObstructiveAustralia, Canada, Czech Republic, Croatia, Spain, Hungary, Argentina, Singapore, United Kingdom, Chile
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PfizerCompletedPulmonary Disease, Chronic ObstructiveAustralia, United Kingdom, Argentina, Germany, India
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PfizerCompletedProstatic HyperplasiaNetherlands, Czech Republic, Slovakia