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Bazedoxifene and conjugated estrogens

Phase 1

Postmenopause | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 23, 2010

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 Trials3
Total Enrollment102
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00706225Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal WomenPHASE1 COMPLETED 30 — — Jun 1, 2008Jul 1, 2008Sep 23, 20101 United States
NCT00550433Study Evaluating Bazedoxifene/CE in Postmenopausal WomenPHASE1 COMPLETED - — — Sep 1, 2007Nov 1, 2007Jan 16, 2008 - —
NCT00479778Study Of Pharmacokinetic (PK) Profile of Bazedoxifene (BZA) in 2 BZA/Conjugated Estrogen FormsPHASE1 COMPLETED 72 — — Apr 1, 2007Jul 1, 2007Dec 28, 20071 United States
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Study Endpoints
Primary Endpoints
To evaluate the potential pharmacokinetic (PK) interaction of multiple oral doses of bazedoxifene (BZA) and a single dose of conjugated estrogens (CE) when co administered to healthy postmenopausal women.
3 months
The plasma concentration data and pharmacokinetic (PK) parameters of BZA and CE.
Pharmacokinetic analyses.
Secondary Endpoints
To assess the safety of conjugated estrogens (CE) and bazedoxifene (BZA) when co administered to healthy postmenopausal women.
3 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTALBazedoxifene and Conjugated Estrogens (BZA \& CE)
Interventions
NameTypeDescription
Bazedoxifene and conjugated estrogensDRUGBazedoxifene 20 mg tablet once daily for 7 days. Conjugated Estrogens 0.625 mg tablet, single doses one week apart.
Bazedoxifene/Conjugated EstrogensDEVICE -
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Eligibility Criteria
Age Range35 Years — 70 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy, postmenopausal woman, (either naturally or surgically and have blood hormone levels consistent with a postmenopausal state for specified subjects) between the ages of 35 and 70 years, inclusive * Have not participated in a clinical drug study for at least 30 days prio...

Countries:United States
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