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UK-390, 957

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment2,116

FDA Designations

No designations recorded

Clinical trial landscape

UK-390, 957 · 4 trials · 1 indication

Phase 2 4
NCT00219609Assessment Of Safety Of UK-390,957Ejaculation
COMPLETED1,058 Analytics
NCT00219635Assessment Of Efficacy and Safety UK-390,957 In Men With Premature EjaculationEjaculation
COMPLETED138 Analytics
NCT00143117Assessment of Efficacy and Safety of UK-390,957 in Men With Premature EjaculationEjaculation
COMPLETED460 Analytics
NCT00219583Assessment Of Efficacy and Safety Of UK-390,957 In Men With Premature EjaculationEjaculation
COMPLETED460 Analytics
PHASE2COMPLETED
Assessment Of Safety Of UK-390,957
EjaculationUnlock trial analytics
PHASE2COMPLETED
Assessment Of Efficacy and Safety UK-390,957 In Men With Premature Ejaculation
EjaculationUnlock trial analytics
PHASE2COMPLETED
Assessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation
EjaculationUnlock trial analytics
PHASE2COMPLETED
Assessment Of Efficacy and Safety Of UK-390,957 In Men With Premature Ejaculation
EjaculationUnlock trial analytics

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 to 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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Frequently asked questions about UK-390, 957

What is UK-390,957 used for?

UK-390,957 is an investigational small molecule being developed for men with premature ejaculation. It is in Phase 2 clinical development and has been studied in four completed trials with a total enrollment of 2,116 participants. The drug is not approved and remains under clinical investigation.

Who makes UK-390,957?

UK-390,957 is being developed by Pfizer, Inc. (NYSE: PFE). The company has sponsored four Phase 2 clinical trials of the drug, all of which have been completed. The trials enrolled men aged 18 years and older with premature ejaculation.

What phase is UK-390,957 in?

UK-390,957 is in Phase 2 clinical development. All four of its clinical trials are Phase 2 studies and have been completed. The drug is investigational and has not been approved by regulatory authorities. Its development status is based on the completed Phase 2 trials.

What clinical trials is UK-390,957 in?

UK-390,957 has been studied in four completed Phase 2 trials: NCT00143117, NCT00219583, NCT00219609, and NCT00219635. These trials assessed the efficacy and safety of the drug in men with premature ejaculation, with enrollments ranging from 138 to 1,058 participants across multiple countries.

Is UK-390,957 the same as dapoxetine?

No, UK-390,957 is not the same as dapoxetine. UK-390,957 is a distinct investigational compound developed by Pfizer for premature ejaculation. Dapoxetine is a separate drug. The clinical trials for UK-390,957 are registered under their own NCT numbers and do not reference dapoxetine.