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conjugated estrogens/progestin

Phase 1

Estrogen Replacement Therapy | Small molecule | Other |Pfizer, Inc.|Last Updated: Dec 6, 2007

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00401219Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference FormulationPHASE1 COMPLETED -Nov 1, 2006Feb 1, 2007Dec 6, 2007 -
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Study Endpoints
Primary Endpoints
Pharmacokinetic blood samples for unconjugated and total (unconjugated plus conjugated) estrogens and MPA will be obtained. The following pharmacokinetic parameters will be determined: Cmax, Tmax, t½, AUC0-T, AUC0-¥.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
conjugated estrogens/progestin (MPA)DRUG -
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Eligibility Criteria
Age Range35 Years — 70 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Healthy, postmenopausal women ages 35 to 70 years, inclusive. * Naturally postmenopausal women must not have had a menstrual period for at least six months, but less than 12 months, as confirmed by a blood test; or for at least 12 months with no blood hormone test confirmation...

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