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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00219583




Registration number
NCT00219583
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 Efficacy and Safety Of UK-390,957 In Men With Premature Ejaculation
Scientific title
A Phase 2b, Multi-Centre, Double-Blind, Placebo-Controlled, Parallel Group Dose Response Study To Assess The Efficacy and Safety Of Oral UK390,957 In Men With Premature Ejaculation
Secondary ID [1] 0 0
A3871027
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
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

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 efficacy and safety
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Assessment of quality of sexual life
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- 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
- History of erectile dysfunction

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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 - Bondi Junction
Recruitment hospital [2] 0 0
Pfizer Investigational Site - St Leonards
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Spring Hill
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Malvern
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Bondi Junction
Recruitment postcode(s) [2] 0 0
- St Leonards
Recruitment postcode(s) [3] 0 0
- Spring Hill
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
- Malvern
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Mistelbach
Country [2] 0 0
Austria
State/province [2] 0 0
Salzburg
Country [3] 0 0
Canada
State/province [3] 0 0
Alberta
Country [4] 0 0
Canada
State/province [4] 0 0
British Columbia
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Brno
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Hradec Kralove
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Prague 5
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Praha 2
Country [11] 0 0
France
State/province [11] 0 0
Le Kremlin Bicetre
Country [12] 0 0
France
State/province [12] 0 0
Lyon Cedex 03
Country [13] 0 0
Germany
State/province [13] 0 0
Bavaria
Country [14] 0 0
Germany
State/province [14] 0 0
Hamburg
Country [15] 0 0
Germany
State/province [15] 0 0
Hannover
Country [16] 0 0
Germany
State/province [16] 0 0
Muenchen
Country [17] 0 0
Israel
State/province [17] 0 0
Beer Sheba
Country [18] 0 0
Israel
State/province [18] 0 0
Haifa
Country [19] 0 0
Israel
State/province [19] 0 0
Jerusalem
Country [20] 0 0
Israel
State/province [20] 0 0
Tel Hashomer
Country [21] 0 0
Israel
State/province [21] 0 0
Tel- Aviv
Country [22] 0 0
Italy
State/province [22] 0 0
Milan
Country [23] 0 0
Italy
State/province [23] 0 0
Roma
Country [24] 0 0
Netherlands
State/province [24] 0 0
Den Haag
Country [25] 0 0
Netherlands
State/province [25] 0 0
Nijmegen
Country [26] 0 0
Norway
State/province [26] 0 0
Bodø
Country [27] 0 0
Norway
State/province [27] 0 0
Moelv
Country [28] 0 0
Norway
State/province [28] 0 0
Oslo
Country [29] 0 0
Poland
State/province [29] 0 0
Bialystok
Country [30] 0 0
Poland
State/province [30] 0 0
Kielce
Country [31] 0 0
Poland
State/province [31] 0 0
Myslowice
Country [32] 0 0
Poland
State/province [32] 0 0
Warszawa
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Spain
State/province [35] 0 0
Malaga
Country [36] 0 0
Sweden
State/province [36] 0 0
Skovde
Country [37] 0 0
Sweden
State/province [37] 0 0
Stockholm
Country [38] 0 0
Turkey
State/province [38] 0 0
Adana
Country [39] 0 0
Turkey
State/province [39] 0 0
Ankara
Country [40] 0 0
Turkey
State/province [40] 0 0
Izmir

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

Ethics approval
Ethics application status

Summary
Brief summary
Assessment of efficacy and safety UK-390,957.
Trial website
https://clinicaltrials.gov/show/NCT00219583
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