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PD-0299685

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment527

FDA Designations

No designations recorded

Clinical trial landscape

PD-0299685 · 1 trial · 1 indication

Phase 2 1
NCT00314964Study Evaluating PD-0299685 for the Treatment of Vasomotor Symptoms (Hot Flashes / Flushes) Associated With MenopauseHot Flashes
COMPLETED527 Analytics
PHASE2COMPLETED
Study Evaluating PD-0299685 for the Treatment of Vasomotor Symptoms (Hot Flashes / Flushes) Associated With Menopause
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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 to 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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Frequently asked questions about PD-0299685

What is PD-0299685 used for?

PD-0299685 is an investigational small molecule being developed for the treatment of hot flashes, also known as vasomotor symptoms, associated with menopause. It is being studied in the endocrine therapeutic area.

Who makes PD-0299685?

PD-0299685 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE.

What phase is PD-0299685 in?

PD-0299685 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.

What clinical trials is PD-0299685 in?

PD-0299685 has been studied in one completed Phase 2 clinical trial, identified as NCT00314964. This trial evaluated the drug for the treatment of vasomotor symptoms (hot flashes) associated with menopause and enrolled 527 female participants aged 40 years and older.

Is PD-0299685 the same as any other drug?

PD-0299685 is the primary name for this investigational drug. No alternative names have been disclosed for this compound.