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Bazedoxifene/Conjugated Estrogen

Phase 3

Endometrial Hyperplasia | Small molecule | Endocrine |Pfizer, Inc.|Last Updated: Dec 20, 2013

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment4,627
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00242710Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal WomenPHASE3 COMPLETED 1,083Sep 1, 2005Sep 1, 2008Dec 20, 20139 United States
NCT00675688Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal WomenPHASE3 COMPLETED 3,544Apr 1, 2002Jan 1, 2006May 12, 2008 -
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Study Endpoints
Primary Endpoints
Percentage of Participants With Hyperplasia at Screening
Screening

Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.

Percentage of Participants With Hyperplasia at Month 12
Month 12

Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.

Bone Mineral Density (BMD) of Lumbar Spine at Screening
Screening

BMD measurements of the anteroposterior lumbar spine were acquired by dual-energy x-ray absorptiometry (DXA), twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.

Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12
Baseline, Month 12

BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.

Bone Mineral Density (BMD) of Total Hip at Screening
Screening

BMD measurements of the total hip were acquired by DXA, twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.

Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 12
Baseline, Month 12

BMD measurements of the total hip were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.

To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women.
one year
Secondary Endpoints
Percentage of Days With Breast Pain
Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52
Percentage of Participants With Uterine Bleeding or Spotting
Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52
Percentage of Participants With Hyperplasia at Month 24
Month 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTALBZA 20mg/CE 0.625
Arm 2EXPERIMENTALBZA 20mg/CE 0.45
Arm 3ACTIVE_COMPARATORCE 0.45mg/MPA1.5mg
Arm 4PLACEBO_COMPARATORPlacebo
AEXPERIMENTAL -
BACTIVE_COMPARATOR -
CPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Bazedoxifene/Conjugated EstrogenDRUGSubjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
CE 0.45 mg/MPA 1.5mgDRUGSubjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
PlaceboOTHERSubjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Bazedoxifene/Conjugate Estrogens (CE)DRUG -
RaloxifeneDRUG -
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Eligibility Criteria
Age Range40 Years — 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Generally healthy, postmenopausal women, aged 40 to less than 65 years * Intact uterus * At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels \> 40 mIU/mL. Exclusion Criteria: * Use of oral estrogen-,...

Countries:United States
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