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Assessment Of Efficacy and Safety 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

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
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1. Study Identification

Unique Protocol Identification Number
NCT00219635
Brief Title
Assessment Of Efficacy and Safety UK-390,957 In Men With Premature Ejaculation
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 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
138 (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
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Pfizer Investigational Site
City
San Bernardino
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Pfizer Investigational Site
City
Watertown
State/Province
Massachusetts
Country
United States
Facility Name
Pfizer Investigational Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
Washington
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Williamsville
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Beachwood
State/Province
Ohio
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Pfizer Investigational Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Pfizer Investigational Site
City
St Leonards
State/Province
New South Wales
Country
Australia
Facility Name
Pfizer Investigational Site
City
Malvern
State/Province
Victoria
Country
Australia
Facility Name
Pfizer Investigational Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Pfizer Investigational Site
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Nr Lichfield
State/Province
Staffordshire
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Devon
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3871029&StudyName=Assessment+Of+Efficacy+and+Safety+UK%2D390%2C957+In+Men+With+Premature+Ejaculation
Description
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