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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/01/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2006
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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California
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Colorado
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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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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
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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/ct2/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
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries