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PD-0299685

Phase 2

Hot Flashes | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 16, 2011

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment527
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00314964Study Evaluating PD-0299685 for the Treatment of Vasomotor Symptoms (Hot Flashes / Flushes) Associated With MenopausePHASE2 COMPLETED 527 — — Aug 1, 2006Jul 1, 2007Mar 16, 201180 United States, Australia +4
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Study Endpoints
Primary Endpoints
Effectiveness of PD-0299685 in reducing both the frequency and severity of vasomotor symptoms, from baseline to week 4 and week 12.
Secondary Endpoints
To assess the safety profile of PD-0299685; the benefit of PD-0299685 in quality of life measures and treatment satisfaction of PD-0299685, when compared with placebo.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
PD-0299685DRUG -
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Eligibility Criteria
Age Range40 Years — 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites80

Inclusion Criteria: * Postmenopausal as defined by 6 months of spontaneous amenorrhea with serum FSH levels \>40mlU/ml and estradiol \< than = 25 pg/mL or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy and FSH levels \> 40 mlU/ml and estradiol \< than = 25 pg/mL * Women r...

Countries:United StatesAustraliaCanadaFranceSouth AfricaSpain
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