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Assessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation

Primary Purpose

Ejaculation

Status
Completed
Phase
Phase 2
Locations
United States
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
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  • 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
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  • 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
August 30, 2005
Last Updated
November 5, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00143117
Brief Title
Assessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation
Official Title
A Phase 2b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Dose Response 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
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
To determine whether UK-390,957 is an effective and safe treatment for premature ejaculation.

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
Tucson
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Atherton
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Beverly Hills
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Laguna Woods
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Newport Beach
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Redwood City
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Tarzana
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Pfizer Investigational Site
City
Waterbury
State/Province
Connecticut
Country
United States
Facility Name
Pfizer Investigational Site
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Wayne
State/Province
Indiana
Country
United States
Facility Name
Pfizer Investigational Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Pfizer Investigational Site
City
Michigan City
State/Province
Indiana
Country
United States
Facility Name
Pfizer Investigational Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Pfizer Investigational Site
City
Madisonville
State/Province
Kentucky
Country
United States
Facility Name
Pfizer Investigational Site
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Pfizer Investigational Site
City
Milford
State/Province
Massachusetts
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Clair Shores
State/Province
Michigan
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Pfizer Investigational Site
City
Southhaven
State/Province
Mississippi
Country
United States
Facility Name
Pfizer Investigational Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
Reno
State/Province
Nevada
Country
United States
Facility Name
Pfizer Investigational Site
City
Edison
State/Province
New Jersey
Country
United States
Facility Name
Pfizer Investigational Site
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
Pfizer Investigational Site
City
Voorhees
State/Province
New Jersey
Country
United States
Facility Name
Pfizer Investigational Site
City
Albany
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Endwell
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
West Seneca
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
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Beachwood
State/Province
Ohio
Country
United States
Facility Name
Pfizer Investigational Site
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Pfizer Investigational Site
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
Pfizer Investigational Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Pfizer Investigational Site
City
Milan
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
Fort Worth
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
Plano
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3871022&StudyName=Assessment+of+Efficacy+and+Safety+of+UK%2D390%2C957+in+Men+With+Premature+Ejaculation
Description
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Assessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation

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