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Premarin

Phase 1

Postmenopause | Small molecule | Other |Pfizer, Inc.|Last Updated: Jun 22, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials3
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00745173Study Evaluating Premarin and Bazedoxifene Potential InteractionPHASE1 COMPLETED 30Sep 1, 2008Oct 1, 2008Feb 12, 20091 United States
NCT00543634Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal WomenPHASE1 COMPLETED 30Oct 1, 2007Dec 1, 2007Jun 22, 20101 United States
NCT00472927Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)PHASE1 COMPLETED -May 1, 2007Aug 1, 2007Dec 6, 20071 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetic (absorption, distribution, breakdown and elimination in the body) parameters
3 months
Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA).
4 days
Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components)
Secondary Endpoints
To continue assessment of the safety profile as well as the tolerability the two drugs administered in combination in this population.
3 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1OTHER -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
PremarinDRUG -
Premarin/MPADRUG0.625 mg/2.5 mg X4
Provera 10 mgDRUG2.5 mg of MPA, 4 tablets dissoved in water
Premarin/MPA 0.45 mg/1.5 mgDRUG -
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Eligibility Criteria
Age Range35 Years — 70 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * For inclusion into the study, women must be healthy and postmenopausal (either naturally or surgically) between the ages of 35 and 70, inclusive. * Blood hormone levels must be consistent with a postmenopausal state (for specified subjects). * They can either be a non-smoker o...

Countries:United States
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