Clinical trial NCT00219609: Assessment Of Safety Of UK-390,957
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ejaculation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 1058
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

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