Assessment Of Safety Of UK-390,957

Ejaculation Clinical Trial

Official title:

A Phase 2 Multi-Center, Open Label Long-Term Extension Trial To Assess The Safety Of Oral Uk-390,957 Administered As Required In Adult Men With Premature Ejaculation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219609
• Other study ID #: A3871028
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 9, 2005
• Last updated: November 5, 2012
• Start date: January 2005
• Est. completion date: March 2006

Study information

• Verified date: November 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine whether UK-390,957 is a safe treatment for premature ejaculation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1058
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects will have completed one of the phase 2 trials (A3871022/ A3871027/ A3871029) and will have met the diagnostic criteria for premature ejaculation as defined by DSM-IV

Exclusion Criteria:

• No drug related serious adverse events

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ejaculation

Intervention

Drug:
• UK-390,957

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Adelaide	South Australia
Australia	Pfizer Investigational Site	Malvern	Victoria
Australia	Pfizer Investigational Site	Nedlands	Western Australia
Australia	Pfizer Investigational Site	Spring Hill	Queensland
Australia	Pfizer Investigational Site	St Leonards	New South Wales
Austria	Pfizer Investigational Site	Mistelbach
Austria	Pfizer Investigational Site	Salzburg
Canada	Pfizer Investigational Site	Barrie	Ontario
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Montréal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Oakville	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Prague 5
Czech Republic	Pfizer Investigational Site	Praha 2
France	Pfizer Investigational Site	Lyon Cedex 03
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Hannover
Germany	Pfizer Investigational Site	Muenchen
Israel	Pfizer Investigational Site	Beer Sheba
Israel	Pfizer Investigational Site	Haifa
Israel	Pfizer Investigational Site	Tel Hashomer
Israel	Pfizer Investigational Site	Tel-Aviv
Italy	Pfizer Investigational Site	Milan
Italy	Pfizer Investigational Site	Roma
Norway	Pfizer Investigational Site	Moelv
Norway	Pfizer Investigational Site	Oslo
Poland	Pfizer Investigational Site	Myslowice
Poland	Pfizer Investigational Site	Warszawa
Sweden	Pfizer Investigational Site	Skovde
Sweden	Pfizer Investigational Site	Stockholm
Turkey	Pfizer Investigational Site	Balcali	Adana
Turkey	Pfizer Investigational Site	Balcova	Izmir
Turkey	Pfizer Investigational Site	Samanpazari	Ankara
United Kingdom	Pfizer Investigational Site	Devon
United Kingdom	Pfizer Investigational Site	Nr Lichfield	Staffordshire
United States	Pfizer Investigational Site	Albany	New York
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Atherton	California
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Aventura	Florida
United States	Pfizer Investigational Site	Beachwood	Ohio
United States	Pfizer Investigational Site	Beverly Hills	California
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Edison	New Jersey
United States	Pfizer Investigational Site	Endwell	New York
United States	Pfizer Investigational Site	Evansville	Indiana
United States	Pfizer Investigational Site	Fort Wayne	Indiana
United States	Pfizer Investigational Site	Germantown	Tennessee
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	Laguna Woods	California
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Madisonville	Kentucky
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Metairie	Louisiana
United States	Pfizer Investigational Site	Milan	Tennessee
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	Milwuakee	Wisconsin
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	New Brunswick	New Jersey
United States	Pfizer Investigational Site	New Port Richey	Florida
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Redwood City	California
United States	Pfizer Investigational Site	Saint Clair Shores	Michigan
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Southhaven	Mississippi
United States	Pfizer Investigational Site	Tarzana	California
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Vorhees	New Jersey
United States	Pfizer Investigational Site	Walnut Creek	California
United States	Pfizer Investigational Site	Waterbury	Connecticut
United States	Pfizer Investigational Site	Watertown	Massachusetts
United States	Pfizer Investigational Site	West Seneca	New York
United States	Pfizer Investigational Site	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Czech Republic,  France,  Germany,  Israel,  Italy,  Norway,  Poland,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of safety

External Links

•   To obtain contact information for a study center near you, click here.