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Premarin Vaginal

Phase 1

Atrophic Vaginitis | Small molecule | Other |Pfizer, Inc.|Last Updated: May 28, 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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00167921Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic VaginitisPHASE1 COMPLETED 24 — — Oct 1, 2005 -May 28, 20072 United States
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Study Endpoints
Primary Endpoints
To characterize the systemic exposure and bioavailability at steady state of Premarin® Vaginal Cream compared with oral Premarin® tablets in postmenopausal women with atrophic vaginitis.
Secondary Endpoints
To estimate the systemic exposure in postmenopausal women taking a typical regimen.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Interventions
NameTypeDescription
Premarin® Vaginal CreamDRUG -
Premarin® oral tabletsDRUG -
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Eligibility Criteria
Age Range45 Years — 80 Years
SexFEMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Generally healthy postmenopausal women. * Intact uterus. * Clinical diagnosis of moderate to severe atrophic vaginitis.

Countries:United States
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