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Arzoxifene

Phase 3

Postmenopausal Bone Loss | Small molecule | Musculoskeletal |Eli Lilly and Company|Last Updated: Mar 9, 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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00085956Effects of Arzoxifene on Bone Mass and the UterusPHASE3 COMPLETED 300 — — Apr 1, 2004Feb 1, 2007Mar 9, 20071 United States
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Study Endpoints
Primary Endpoints
The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women
The effects of arzoxifene on the uterus (womb) in post menopausal women
The safety of arzoxifene and any side effects that might be associated with its use
Secondary Endpoints
The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density
The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease
The effects of arzoxifene on breast density
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
ArzoxifeneDRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range45 Years — 60 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Female * 45 to 60 years of age, inclusive * At least 2 years since last menstrual cycle * Intact uterus (womb). Exclusion Criteria: * Existing fracture of the spine. * Bone disorders, other than low bone mass * History of cancer in the last 5 years. Also, any history, at any...

Countries:United States
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