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UK-390,957

Phase 2

Ejaculation | Small molecule | Other |Pfizer, Inc.|Last Updated: Nov 7, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials4
Total Enrollment2,116
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00219609Assessment Of Safety Of UK-390,957PHASE2 COMPLETED 1,058Jan 1, 2005Mar 1, 2006Nov 7, 201282 United States, Australia +12
NCT00219635Assessment Of Efficacy and Safety UK-390,957 In Men With Premature EjaculationPHASE2 COMPLETED 138Jan 1, 2005Jul 1, 2005Nov 7, 201222 United States, Australia +2
NCT00143117Assessment of Efficacy and Safety of UK-390,957 in Men With Premature EjaculationPHASE2 COMPLETED 460Aug 1, 2004Jun 1, 2005Nov 7, 201251 United States
NCT00219583Assessment Of Efficacy and Safety Of UK-390,957 In Men With Premature EjaculationPHASE2 COMPLETED 460Aug 1, 2004Jun 1, 2005Nov 7, 201249 Australia, Austria +12
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Study Endpoints
Primary Endpoints
Assessment of safety
Assessment of efficacy and safety
Secondary Endpoints
Assessment of quality of sexual life
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
UK-390,957DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites82

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

Countries:United StatesAustraliaAustriaCanadaCzechiaFranceGermanyIsraelItalyNorwayPolandSwedenTurkey (Türkiye)United KingdomNetherlandsSpain
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