Assessment Of Safety Of UK-390,957

November 5, 2012 updated by: Pfizer

A Phase 2 Multi-Center, Open Label Long-Term Extension Trial To Assess The Safety Of Oral Uk-390,957 Administered As Required In Adult Men With Premature Ejaculation

To determine whether UK-390,957 is a safe treatment for premature ejaculation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1058

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

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia
        • Pfizer Investigational Site
    • Queensland
      • Spring Hill, Queensland, Australia
        • Pfizer Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia
        • Pfizer Investigational Site
    • Victoria
      • Malvern, Victoria, Australia
        • Pfizer Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Pfizer Investigational Site
  • Austria
      • Mistelbach, Austria
        • Pfizer Investigational Site
      • Salzburg, Austria
        • Pfizer Investigational Site
  • Canada
    • Ontario
      • Barrie, Ontario, Canada
        • Pfizer Investigational Site
      • London, Ontario, Canada
        • Pfizer Investigational Site
      • Oakville, Ontario, Canada
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • Pfizer Investigational Site
      • Montréal, Quebec, Canada
        • Pfizer Investigational Site
  • Czech Republic
      • Brno, Czech Republic
        • Pfizer Investigational Site
      • Prague 5, Czech Republic
        • Pfizer Investigational Site
      • Praha 2, Czech Republic
        • Pfizer Investigational Site
  • France
      • Lyon Cedex 03, France
        • Pfizer Investigational Site
  • Germany
      • Hamburg, Germany
        • Pfizer Investigational Site
      • Hannover, Germany
        • Pfizer Investigational Site
      • Muenchen, Germany
        • Pfizer Investigational Site
  • Israel
      • Beer Sheba, Israel
        • Pfizer Investigational Site
      • Haifa, Israel
        • Pfizer Investigational Site
      • Tel Hashomer, Israel
        • Pfizer Investigational Site
      • Tel-Aviv, Israel
        • Pfizer Investigational Site
  • Italy
      • Milan, Italy
        • Pfizer Investigational Site
      • Roma, Italy
        • Pfizer Investigational Site
  • Norway
      • Moelv, Norway
        • Pfizer Investigational Site
      • Oslo, Norway
        • Pfizer Investigational Site
  • Poland
      • Myslowice, Poland
        • Pfizer Investigational Site
      • Warszawa, Poland
        • Pfizer Investigational Site
  • Sweden
      • Skovde, Sweden
        • Pfizer Investigational Site
      • Stockholm, Sweden
        • Pfizer Investigational Site
  • Turkey
    • Adana
      • Balcali, Adana, Turkey
        • Pfizer Investigational Site
    • Ankara
      • Samanpazari, Ankara, Turkey
        • Pfizer Investigational Site
    • Izmir
      • Balcova, Izmir, Turkey
        • Pfizer Investigational Site
  • United Kingdom
      • Devon, United Kingdom
        • Pfizer Investigational Site
    • Staffordshire
      • Nr Lichfield, Staffordshire, United Kingdom
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States
        • Pfizer Investigational Site
    • California
      • Anaheim, California, United States
        • Pfizer Investigational Site
      • Atherton, California, United States
        • Pfizer Investigational Site
      • Beverly Hills, California, United States
        • Pfizer Investigational Site
      • Laguna Woods, California, United States
        • Pfizer Investigational Site
      • Newport Beach, California, United States
        • Pfizer Investigational Site
      • Redwood City, California, United States
        • Pfizer Investigational Site
      • San Diego, California, United States
        • Pfizer Investigational Site
      • Tarzana, California, United States
        • Pfizer Investigational Site
      • Walnut Creek, California, United States
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States
        • Pfizer Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States
        • Pfizer Investigational Site
    • Florida
      • Aventura, Florida, United States
        • Pfizer Investigational Site
      • New Port Richey, Florida, United States
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, United States
        • Pfizer Investigational Site
      • Fort Wayne, Indiana, United States
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States
        • Pfizer Investigational Site
      • Madisonville, Kentucky, United States
        • Pfizer Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States
        • Pfizer Investigational Site
    • Massachusetts
      • Watertown, Massachusetts, United States
        • Pfizer Investigational Site
    • Michigan
      • Saint Clair Shores, Michigan, United States
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Pfizer Investigational Site
    • Mississippi
      • Southhaven, Mississippi, United States
        • Pfizer Investigational Site
    • Missouri
      • Kansas City, Missouri, United States
        • Pfizer Investigational Site
    • New Jersey
      • Edison, New Jersey, United States
        • Pfizer Investigational Site
      • New Brunswick, New Jersey, United States
        • Pfizer Investigational Site
      • Vorhees, New Jersey, United States
        • Pfizer Investigational Site
    • New York
      • Albany, New York, United States
        • Pfizer Investigational Site
      • Endwell, New York, United States
        • Pfizer Investigational Site
      • New York, New York, United States
        • Pfizer Investigational Site
      • West Seneca, New York, United States
        • Pfizer Investigational Site
      • Williamsville, New York, United States
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Pfizer Investigational Site
      • Durham, North Carolina, United States
        • Pfizer Investigational Site
    • Ohio
      • Beachwood, Ohio, United States
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • Pfizer Investigational Site
    • Tennessee
      • Germantown, Tennessee, United States
        • Pfizer Investigational Site
      • Knoxville, Tennessee, United States
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States
        • Pfizer Investigational Site
      • Milan, Tennessee, United States
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States
        • Pfizer Investigational Site
      • Houston, Texas, United States
        • Pfizer Investigational Site
      • San Antonio, Texas, United States
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Pfizer Investigational Site
      • Milwuakee, Wisconsin, United States
        • Pfizer Investigational Site

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:

  • Subjects will have completed one of the phase 2 trials (A3871022/ A3871027/ A3871029) and will have met the diagnostic criteria for premature ejaculation as defined by DSM-IV

Exclusion Criteria:

  • No drug related serious adverse events

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assessment of safety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

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)

March 1, 2006

Study Completion (Actual)

March 1, 2006

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

Other Study ID Numbers

  • A3871028

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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