Assessment Of Efficacy and Safety Of UK-390,957 In Men With Premature Ejaculation

November 5, 2012 updated by: Pfizer

A Phase 2b, Multi-Centre, Double-Blind, Placebo-Controlled, Parallel Group Dose Response Study To Assess The Efficacy and Safety Of Oral UK390,957 In Men With Premature Ejaculation

Assessment of efficacy and safety UK-390,957.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

460

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
      • Bondi Junction, New South Wales, Australia
        • Pfizer Investigational Site
      • 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
    • Alberta
      • Edmonton, Alberta, Canada
        • Pfizer Investigational Site
    • British Columbia
      • Victoria, British Columbia, Canada
        • Pfizer Investigational Site
    • Ontario
      • 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
      • Hradec Kralove, Czech Republic
        • Pfizer Investigational Site
      • Prague 5, Czech Republic
        • Pfizer Investigational Site
      • Praha 2, Czech Republic
        • Pfizer Investigational Site
  • France
      • Le Kremlin Bicetre, France
        • Pfizer Investigational Site
      • Lyon Cedex 03, France
        • Pfizer Investigational Site
  • Germany
      • Hamburg, Germany
        • Pfizer Investigational Site
      • Hannover, Germany
        • Pfizer Investigational Site
      • Muenchen, Germany
        • Pfizer Investigational Site
    • Bavaria
      • Muenchen, Bavaria, Germany
        • Pfizer Investigational Site
  • Israel
      • Beer Sheba, Israel
        • Pfizer Investigational Site
      • Haifa, Israel
        • Pfizer Investigational Site
      • Jerusalem, 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
  • Netherlands
      • Den Haag, Netherlands
        • Pfizer Investigational Site
      • Nijmegen, Netherlands
        • Pfizer Investigational Site
  • Norway
      • Bodø, Norway
        • Pfizer Investigational Site
      • Moelv, Norway
        • Pfizer Investigational Site
      • Oslo, Norway
        • Pfizer Investigational Site
  • Poland
      • Bialystok, Poland
        • Pfizer Investigational Site
      • Kielce, Poland
        • Pfizer Investigational Site
      • Myslowice, Poland
        • Pfizer Investigational Site
      • Warszawa, Poland
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain
        • Pfizer Investigational Site
      • Madrid, Spain
        • Pfizer Investigational Site
      • Malaga, Spain
        • Pfizer Investigational Site
    • Barcelona
      • Sabadell, Barcelona, Spain
        • 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

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
Assessment of efficacy and safety

Secondary Outcome Measures

Outcome Measure
Assessment of quality of sexual life

Collaborators and Investigators

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

Sponsor

Pfizer

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.

Helpful Links

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

August 1, 2004

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 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

  • A3871027

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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