NCT00219583

Brief Summary

Assessment of efficacy and safety UK-390,957.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
460

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_2

Geographic Reach
13 countries

43 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

August 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 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

10 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 (49)

Pfizer Investigational Site

Bondi Junction, New South Wales, Australia

Location

Pfizer Investigational Site

St Leonards, New South Wales, Australia

Location

Pfizer Investigational Site

Spring Hill, Queensland, Australia

Location

Pfizer Investigational Site

Adelaide, South Australia, Australia

Location

Pfizer Investigational Site

Malvern, Victoria, Australia

Location

Pfizer Investigational Site

Nedlands, Western Australia, Australia

Location

Pfizer Investigational Site

Mistelbach, Austria

Location

Pfizer Investigational Site

Salzburg, Austria

Location

Pfizer Investigational Site

Edmonton, Alberta, Canada

Location

Pfizer Investigational Site

Victoria, British Columbia, Canada

Location

Pfizer Investigational Site

London, Ontario, Canada

Location

Pfizer Investigational Site

Oakville, Ontario, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, Canada

Location

Pfizer Investigational Site

Montréal, Quebec, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, Canada

Location

Pfizer Investigational Site

Brno, Czechia

Location

Pfizer Investigational Site

Hradec Králové, Czechia

Location

Pfizer Investigational Site

Prague, Czechia

Location

Pfizer Investigational Site

Le Kremlin-Bicêtre, France

Location

Pfizer Investigational Site

Lyon, France

Location

Pfizer Investigational Site

Munich, Bavaria, Germany

Location

Pfizer Investigational Site

Hamburg, Germany

Location

Pfizer Investigational Site

Hanover, Germany

Location

Pfizer Investigational Site

München, Germany

Location

Pfizer Investigational Site

Beersheba, Israel

Location

Pfizer Investigational Site

Haifa, Israel

Location

Pfizer Investigational Site

Jerusalem, Israel

Location

Pfizer Investigational Site

Tel Aviv, Israel

Location

Pfizer Investigational Site

Tel Litwinsky, Israel

Location

Pfizer Investigational Site

Milan, Italy

Location

Pfizer Investigational Site

Roma, Italy

Location

Pfizer Investigational Site

Nijmegen, Netherlands

Location

Pfizer Investigational Site

The Hague, Netherlands

Location

Pfizer Investigational Site

Bodø, Norway

Location

Pfizer Investigational Site

Moelv, Norway

Location

Pfizer Investigational Site

Oslo, Norway

Location

Pfizer Investigational Site

Bialystok, Poland

Location

Pfizer Investigational Site

Kielce, Poland

Location

Pfizer Investigational Site

Mysłowice, Poland

Location

Pfizer Investigational Site

Warsaw, Poland

Location

Pfizer Investigational Site

Barcelona, Barcelona, Spain

Location

Pfizer Investigational Site

Sabadell, Barcelona, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, Spain

Location

Pfizer Investigational Site

Málaga, Malaga, Spain

Location

Pfizer Investigational Site

Skövde, Sweden

Location

Pfizer Investigational Site

Stockholm, Sweden

Location

Pfizer Investigational Site

Balcali, Adana, Turkey (Türkiye)

Location

Pfizer Investigational Site

Samanpazarı, Ankara, Turkey (Türkiye)

Location

Pfizer Investigational Site

Balçova, İzmir, Turkey (Türkiye)

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

August 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

November 7, 2012

Record last verified: 2012-11

Locations

PL(4)CZ(3)ES(4)NO(3)SE(2)NL(2)TU(3)IL(5)FR(2)DE(4)IT(2)AU(2)CA(7)