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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00219609




Registration number
NCT00219609
Ethics application status
Date submitted
9/09/2005
Date registered
22/09/2005
Date last updated
7/11/2012

Titles & IDs
Public title
Assessment Of Safety Of UK-390,957
Scientific 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
Secondary ID [1] 0 0
A3871028
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ejaculation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - UK-390,957

Treatment: Drugs: UK-390,957


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assessment of safety
Timepoint [1] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- No drug related serious adverse events

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - St Leonards
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Spring Hill
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Malvern
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
- St Leonards
Recruitment postcode(s) [2] 0 0
- Spring Hill
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Malvern
Recruitment postcode(s) [5] 0 0
- Nedlands
Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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California
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Colorado
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United States of America
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Connecticut
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Florida
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Indiana
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Tennessee
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Texas
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United States of America
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Wisconsin
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Austria
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Mistelbach
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Austria
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Salzburg
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Canada
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Ontario
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Canada
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Quebec
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Czech Republic
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Brno
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Czech Republic
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Prague 5
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Czech Republic
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Praha 2
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France
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Lyon Cedex 03
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Muenchen
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Israel
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Beer Sheba
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Israel
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Haifa
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Israel
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Tel Hashomer
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Israel
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Tel-Aviv
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Italy
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Milan
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Italy
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Roma
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Norway
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Moelv
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Norway
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Oslo
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Poland
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Myslowice
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Poland
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Warszawa
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Sweden
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Skovde
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Sweden
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Stockholm
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Izmir
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United Kingdom
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Staffordshire
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United Kingdom
State/province [49] 0 0
Devon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To determine whether UK-390,957 is a safe treatment for premature ejaculation.
Trial website
https://clinicaltrials.gov/show/NCT00219609
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications