Assessment Of Safety Of UK-390,957
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
1 other identifier
interventional
1,058
13 countries
77
Brief Summary
To determine whether UK-390,957 is a safe treatment for premature ejaculation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2005
Shorter than P25 for phase_2
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedNovember 7, 2012
November 1, 2012
1.2 years
September 9, 2005
November 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of safety
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- No drug related serious adverse events
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (82)
Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
Atherton, California, United States
Pfizer Investigational Site
Beverly Hills, California, United States
Pfizer Investigational Site
Laguna Woods, California, United States
Pfizer Investigational Site
Newport Beach, California, United States
Pfizer Investigational Site
Redwood City, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Tarzana, California, United States
Pfizer Investigational Site
Walnut Creek, California, United States
Pfizer Investigational Site
Aurora, Colorado, United States
Pfizer Investigational Site
Waterbury, Connecticut, United States
Pfizer Investigational Site
Aventura, Florida, United States
Pfizer Investigational Site
New Port Richey, Florida, United States
Pfizer Investigational Site
Evansville, Indiana, United States
Pfizer Investigational Site
Fort Wayne, Indiana, United States
Pfizer Investigational Site
Indianapolis, Indiana, United States
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Madisonville, Kentucky, United States
Pfizer Investigational Site
Metairie, Louisiana, United States
Pfizer Investigational Site
Watertown, Massachusetts, United States
Pfizer Investigational Site
Saint Clair Shores, Michigan, United States
Pfizer Investigational Site
Minneapolis, Minnesota, United States
Pfizer Investigational Site
Southhaven, Mississippi, United States
Pfizer Investigational Site
Kansas City, Missouri, United States
Pfizer Investigational Site
Edison, New Jersey, United States
Pfizer Investigational Site
New Brunswick, New Jersey, United States
Pfizer Investigational Site
Vorhees, New Jersey, United States
Pfizer Investigational Site
Albany, New York, United States
Pfizer Investigational Site
Endwell, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
West Seneca, New York, United States
Pfizer Investigational Site
Williamsville, New York, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Beachwood, Ohio, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Germantown, Tennessee, United States
Pfizer Investigational Site
Knoxville, Tennessee, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Pfizer Investigational Site
Milan, Tennessee, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Milwaukee, Wisconsin, United States
Pfizer Investigational Site
Milwuakee, Wisconsin, United States
Pfizer Investigational Site
St Leonards, New South Wales, Australia
Pfizer Investigational Site
Spring Hill, Queensland, Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia
Pfizer Investigational Site
Malvern, Victoria, Australia
Pfizer Investigational Site
Nedlands, Western Australia, Australia
Pfizer Investigational Site
Mistelbach, Austria
Pfizer Investigational Site
Salzburg, Austria
Pfizer Investigational Site
Barrie, Ontario, Canada
Pfizer Investigational Site
London, Ontario, Canada
Pfizer Investigational Site
Oakville, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Montréal, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Brno, Czechia
Pfizer Investigational Site
Prague, Czechia
Pfizer Investigational Site
Lyon, France
Pfizer Investigational Site
Hamburg, Germany
Pfizer Investigational Site
Hanover, Germany
Pfizer Investigational Site
München, Germany
Pfizer Investigational Site
Beersheba, Israel
Pfizer Investigational Site
Haifa, Israel
Pfizer Investigational Site
Tel Aviv, Israel
Pfizer Investigational Site
Tel Litwinsky, Israel
Pfizer Investigational Site
Milan, Italy
Pfizer Investigational Site
Roma, Italy
Pfizer Investigational Site
Moelv, Norway
Pfizer Investigational Site
Oslo, Norway
Pfizer Investigational Site
Mysłowice, Poland
Pfizer Investigational Site
Warsaw, Poland
Pfizer Investigational Site
Skövde, Sweden
Pfizer Investigational Site
Stockholm, Sweden
Pfizer Investigational Site
Balcali, Adana, Turkey (Türkiye)
Pfizer Investigational Site
Samanpazarı, Ankara, Turkey (Türkiye)
Pfizer Investigational Site
Balçova, İzmir, Turkey (Türkiye)
Pfizer Investigational Site
Nr Lichfield, Staffordshire, United Kingdom
Pfizer Investigational Site
Devon, United Kingdom
Related Links
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- 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
March 1, 2006
Study Completion
March 1, 2006
Last Updated
November 7, 2012
Record last verified: 2012-11