search
Back to results

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

Primary Purpose

Ejaculation

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
UK-390,957
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ejaculation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Premature ejaculation as defined by DSM-IV Exclusion Criteria: History of erectile dysfunction

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Assessment of efficacy and safety

Secondary Outcome Measures

Assessment of quality of sexual life

Full Information

First Posted
September 9, 2005
Last Updated
November 5, 2012
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00219583
Brief Title
Assessment Of Efficacy and Safety Of UK-390,957 In Men With Premature Ejaculation
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
Assessment of efficacy and safety UK-390,957.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ejaculation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
460 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
UK-390,957
Primary Outcome Measure Information:
Title
Assessment of efficacy and safety
Secondary Outcome Measure Information:
Title
Assessment of quality of sexual life

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Premature ejaculation as defined by DSM-IV Exclusion Criteria: History of erectile dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bondi Junction
State/Province
New South Wales
Country
Australia
Facility Name
Pfizer Investigational Site
City
St Leonards
State/Province
New South Wales
Country
Australia
Facility Name
Pfizer Investigational Site
City
Spring Hill
State/Province
Queensland
Country
Australia
Facility Name
Pfizer Investigational Site
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Pfizer Investigational Site
City
Malvern
State/Province
Victoria
Country
Australia
Facility Name
Pfizer Investigational Site
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
Pfizer Investigational Site
City
Mistelbach
Country
Austria
Facility Name
Pfizer Investigational Site
City
Salzburg
Country
Austria
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Pfizer Investigational Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Oakville
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Brno
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Hradec Kralove
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Prague 5
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 2
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Le Kremlin Bicetre
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon Cedex 03
Country
France
Facility Name
Pfizer Investigational Site
City
Muenchen
State/Province
Bavaria
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hannover
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
Country
Germany
Facility Name
Pfizer Investigational Site
City
Beer Sheba
Country
Israel
Facility Name
Pfizer Investigational Site
City
Haifa
Country
Israel
Facility Name
Pfizer Investigational Site
City
Jerusalem
Country
Israel
Facility Name
Pfizer Investigational Site
City
Tel Hashomer
Country
Israel
Facility Name
Pfizer Investigational Site
City
Tel- Aviv
Country
Israel
Facility Name
Pfizer Investigational Site
City
Milan
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
Country
Italy
Facility Name
Pfizer Investigational Site
City
Den Haag
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Nijmegen
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Bodø
Country
Norway
Facility Name
Pfizer Investigational Site
City
Moelv
Country
Norway
Facility Name
Pfizer Investigational Site
City
Oslo
Country
Norway
Facility Name
Pfizer Investigational Site
City
Bialystok
Country
Poland
Facility Name
Pfizer Investigational Site
City
Kielce
Country
Poland
Facility Name
Pfizer Investigational Site
City
Myslowice
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
Country
Poland
Facility Name
Pfizer Investigational Site
City
Sabadell
State/Province
Barcelona
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
Country
Spain
Facility Name
Pfizer Investigational Site
City
Malaga
Country
Spain
Facility Name
Pfizer Investigational Site
City
Skovde
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Balcali
State/Province
Adana
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Samanpazari
State/Province
Ankara
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Balcova
State/Province
Izmir
Country
Turkey

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3871027&StudyName=Assessment+Of+Efficacy+and+Safety+Of+UK%2D390%2C957+In+Men+With+Premature+Ejaculation++
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs