NCT00219635

Brief Summary

Assessment of efficacy and safety UK-390,957

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_2

Geographic Reach
4 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

November 7, 2012

Status Verified

November 1, 2012

Enrollment Period

6 months

First QC Date

September 9, 2005

Last Update Submit

November 5, 2012

Conditions

Ejaculation

Outcome Measures

Primary Outcomes (1)

  • Assessment of efficacy and safety

Secondary Outcomes (1)

  • Assessment of quality of sexual life

Interventions

UK-390,957DRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Premature ejaculation as defined by DSM-IV

You may not qualify if:

  • History of erectile dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Pfizer Investigational Site

Birmingham, Alabama, United States

Location

Pfizer Investigational Site

San Bernardino, California, United States

Location

Pfizer Investigational Site

Metairie, Louisiana, United States

Location

Pfizer Investigational Site

Watertown, Massachusetts, United States

Location

Pfizer Investigational Site

Kansas City, Missouri, United States

Location

Pfizer Investigational Site

Washington, Missouri, United States

Location

Pfizer Investigational Site

New York, New York, United States

Location

Pfizer Investigational Site

Williamsville, New York, United States

Location

Pfizer Investigational Site

Beachwood, Ohio, United States

Location

Pfizer Investigational Site

Portland, Oregon, United States

Location

Pfizer Investigational Site

Knoxville, Tennessee, United States

Location

Pfizer Investigational Site

Dallas, Texas, United States

Location

Pfizer Investigational Site

Houston, Texas, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, United States

Location

Pfizer Investigational Site

St Leonards, New South Wales, Australia

Location

Pfizer Investigational Site

Malvern, Victoria, Australia

Location

Pfizer Investigational Site

Victoria, British Columbia, Canada

Location

Pfizer Investigational Site

Barrie, Ontario, Canada

Location

Pfizer Investigational Site

London, Ontario, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, Canada

Location

Pfizer Investigational Site

Nr Lichfield, Staffordshire, United Kingdom

Location

Pfizer Investigational Site

Devon, United Kingdom

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 22, 2005

Study Start

January 1, 2005

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

November 7, 2012

Record last verified: 2012-11

Locations

AU(2)CA(4)US(14)GB(2)