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Trial record 3 of 3 for:    "Endometrial Hyperplasia" | "Bazedoxifene"

Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

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ClinicalTrials.gov Identifier: NCT00808132
Recruitment Status : Completed
First Posted : December 15, 2008
Results First Posted : December 20, 2013
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Menopause
Osteoporosis
Interventions Drug: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg
Drug: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg
Drug: bazedoxifene 20 mg
Drug: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg
Drug: Placebo
Enrollment 1886
Recruitment Details  
Pre-assignment Details This main study also included 3 sub-studies only for the purpose of the assessment of relevant parameters: breast density sub-study, osteoporosis sub-study (OSS), and sleep sub-study. A participant could participate in more than 1 sub-study.
Arm/Group Title Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg Bazedoxifene 20 mg Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Period Title: Overall Study
Started 455 481 239 228 483
Treated 445 474 230 220 474
Completed 357 393 185 159 383
Not Completed 98 88 54 69 100
Reason Not Completed
Adverse Event             34             33             16             31             33
Death             0             0             0             0             1
Physician Decision             0             1             0             0             0
Lost to Follow-up             8             10             11             8             9
Protocol Violation             8             9             4             9             5
Withdrawal by Subject             27             18             2             7             16
Other             6             4             6             2             15
Randomized, but not treated             10             7             9             8             9
Unsatisfactory response             5             6             6             4             12
Arm/Group Title Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg Bazedoxifene 20 mg Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg Placebo Total
Hide Arm/Group Description Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. Total of all reporting groups
Overall Number of Baseline Participants 445 474 230 220 474 1843
Hide Baseline Analysis Population Description
Safety population included all randomized participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 445 participants 474 participants 230 participants 220 participants 474 participants 1843 participants
54.43  (4.02) 53.89  (4.00) 54.07  (4.01) 54.15  (4.50) 54.19  (4.07) 54.15  (4.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 445 participants 474 participants 230 participants 220 participants 474 participants 1843 participants
Female
445
 100.0%
474
 100.0%
230
 100.0%
220
 100.0%
474
 100.0%
1843
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study
Hide Description Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable (EE) population included all randomized participants who took at least 1 dose of study drug, who had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had a biopsy during Month 12, or had hyperplasia diagnosed before Month 12 and had no major protocol violations.
Arm/Group Title Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg Bazedoxifene 20 mg Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Overall Number of Participants Analyzed 335 368 169 149 354
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Definition 1
0.30 [1] 
(NA to 1.41)
0.54 [1] 
(NA to 1.70)
0.00 [1] 
(NA to 1.76)
0.00 [1] 
(NA to 1.99)
0.85 [1] 
(NA to 2.18)
Definition 2
0.30 [1] 
(NA to 1.41)
0.27 [1] 
(NA to 1.28)
0.00 [1] 
(NA to 1.76)
0.00 [1] 
(NA to 1.99)
0.28 [1] 
(NA to 1.33)
[1]
Only upper limit of 95% confidence interval (1-sided) was calculated.
2.Primary Outcome
Title Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study
Hide Description BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of 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. Mean percentage change from baseline of the 2 readings were reported.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (MITT) population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had a baseline and at least 1 post baseline value. Last Observation Carried Forward (LOCF) method was used to impute missing values.
Arm/Group Title Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg Bazedoxifene 20 mg Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Overall Number of Participants Analyzed 119 139 56 59 139
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change
0.24  (0.29) 0.60  (0.27) 0.07  (0.40) 1.30  (0.39) -1.28  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Analysis of covariance (ANCOVA) model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
0.822 to 2.201
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.87
Confidence Interval (2-Sided) 95%
1.209 to 2.533
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study
Hide Description BMD measurements of the anteroposterior lumbar spine were acquired by using DXA scans, twice at Month 6 for a subset of 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. Mean percentage change from baseline of the 2 readings were reported.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had baseline and at least 1 post baseline value. LOCF method was used to impute missing values. Here "N" signifies participants who were evaluable for this outcome measure.
Arm/Group Title Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg Bazedoxifene 20 mg Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Overall Number of Participants Analyzed 115 136 55 58 135
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change
0.12  (0.28) 0.51  (0.26) 0.00  (0.39) 0.64  (0.37) -0.68  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.139 to 1.470
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.556 to 1.830
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study
Hide Description BMD measurements of the total hip were acquired by using DXA scans, twice at Month 6 and 12 for a subset of 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. Mean percentage change from baseline of the 2 readings were reported.
Time Frame Baseline, Month 6, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT for osteoporosis sub-study. LOCF method was used to impute missing values. Here "n" signifies participants who were evaluable at specified time points for each arm, respectively.
Arm/Group Title Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg Bazedoxifene 20 mg Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Overall Number of Participants Analyzed 119 139 56 59 139
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change
Change at Month 6 (n=117, 136, 55, 57, 134) 0.43  (0.18) 0.66  (0.17) 0.32  (0.25) 0.45  (0.24) -0.90  (0.17)
Change at Month 12 (n=119, 139, 56, 59, 139) 0.50  (0.20) 0.89  (0.18) 0.47  (0.27) 0.71  (0.26) -0.72  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
0.901 to 1.742
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.756 to 1.671
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.56
Confidence Interval (2-Sided) 95%
1.152 to 1.962
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.60
Confidence Interval (2-Sided) 95%
1.164 to 2.044
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Cumulative Amenorrhea: Main Study
Hide Description Cumulative amenorrhea was defined as the absence of any bleeding or spotting for cumulative 4-week periods throughout 1-year study.
Time Frame Day 1 up to Day 364
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all randomized participants who received at least 1 dose of the study drug, and had at least 1 day of on-therapy bleeding data. Here “N” signifies participants who were evaluable for this outcome measure.
Arm/Group Title Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg Bazedoxifene 20 mg Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Overall Number of Participants Analyzed 355 390 187 158 379
Measure Type: Number
Unit of Measure: Percentage of Participants
87.89 84.87 82.35 54.43 83.91
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.138
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.765
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study
Hide Description Breast density was assessed by digitalized mammograms which were centrally read by a single radiologist using specifically-developed software. Breast density was assessed for subset of participants who entered the breast density sub-study
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol (PP) population included all randomized participants who met inclusion criteria for breast density sub-study, who had a baseline and at least 1 post-baseline breast density evaluation and did not have substantial protocol violations. Here "N" signifies participants who were evaluable for this outcome measure.
Arm/Group Title Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg Bazedoxifene 20 mg Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Overall Number of Participants Analyzed 186 190 97 68 181
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change
-0.38  (0.22) -0.45  (0.22) -0.25  (0.30) 1.60  (0.35) -0.32  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.832
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.632 to 0.509
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.651
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.696 to 0.436
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study
Hide Description Bone turnover is the removal of old bone from the body and its replacement by new bone. Bone turnover markers included serum osteocalcin, C-telopeptide, and procollagen type 1 N-propeptide (P1NP), were measured at Month 6 and Month 12 for a subset of participants who entered the osteoporosis substudy. Blood samples were collected to evaluate bone turnover markers levels.
Time Frame Baseline, Month 6, 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT for osteoporosis substudy. Here "N" signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable at specified time points for each arm respectively.
Arm/Group Title Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg Bazedoxifene 20 mg Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Overall Number of Participants Analyzed 115 136 57 56 134
Median (Inter-Quartile Range)
Unit of Measure: Percent Change
Osteocalcin: Month 6 (n=115, 136, 56, 56, 134)
-25.21
(-33.79 to -14.00)
-27.79
(-38.12 to 15.31)
-15.60
(-22.48 to -6.75)
-25.34
(-38.37 to -9.65)
-3.19
(-15.32 to 10.21)
Osteocalcin: Month 12 (n=104, 127, 52, 50, 125)
-30.46
(-40.77 to -18.79)
-37.02
(-46.87 to -23.50)
-16.05
(-33.67 to 2.13)
-32.79
(-48.90 to -13.03)
-5.28
(-19.29 to 11.16)
C-Telopeptide: Month 6 (n=115, 136, 56, 56, 133)
-34.16
(-48.76 to -17.35)
-41.41
(-58.94 to -25.00)
-29.37
(-40.81 to -8.23)
-54.05
(-68.67 to -34.66)
-10.17
(-26.57 to 8.62)
C-Telopeptide: Month 12 (n=104, 127, 52,50,124)
-40.86
(-55.74 to -24.04)
-50.06
(-63.47 to -29.90)
-27.39
(-49.55 to 0.74)
-52.56
(-69.17 to -26.58)
-5.52
(-30.37 to 19.93)
P1NP: Month 6 (n=114,135, 57, 56, 133)
-33.73
(-43.68 to -18.26)
-30.26
(-48.52 to -14.16)
-17.38
(-33.86 to -2.53)
-39.99
(-51.66 to -14.73)
5.99
(-18.77 to 12.77)
P1NP: Month 12 (n=103, 127, 53, 50, 125)
-42.38
(-49.71 to -24.16)
-43.58
(-58.66 to -24.91)
-23.97
(-40.42 to -7.33)
-50.19
(-62.91 to -20.83)
-11.13
(-26.66 to 6.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Bazedoxifene 20 mg
Comments Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0074
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Bazedoxifene 20 mg
Comments Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Bazedoxifene 20 mg
Comments Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Bazedoxifene 20 mg
Comments Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg, Placebo
Comments Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg, Placebo
Comments Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Bazedoxifene 20 mg
Comments C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1058
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Bazedoxifene 20 mg
Comments C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Bazedoxifene 20 mg
Comments C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Bazedoxifene 20 mg
Comments C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg, Placebo
Comments C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg, Placebo
Comments C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Bazedoxifene 20 mg
Comments P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0029
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Bazedoxifene 20 mg
Comments P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0046
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Bazedoxifene 20 mg
Comments P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0043
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Bazedoxifene 20 mg
Comments P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg, Placebo
Comments P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg, Placebo
Comments P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study
Hide Description Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.
Arm/Group Title Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg Bazedoxifene 20 mg Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Overall Number of Participants Analyzed 112 121 47 52 111
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
SD (n=112, 121, 47, 52, 111) 48.9  (22.9) 48.2  (21.7) 50.5  (24.4) 50.4  (21.1) 47.8  (24.6)
Snoring (n=110, 121, 47, 51, 108) 32.1  (30.1) 27.6  (26.9) 37.9  (30.7) 33.1  (29.6) 34.4  (30.5)
ASoB or H (n=112, 121, 47,52,111) 12.5  (19.2) 11.9  (19.4) 13.2  (20.1) 13.1  (20.2) 12.1  (20.4)
Somnolence (n=112, 121, 47, 52, 111) 36.3  (21.6) 30.0  (20.1) 34.6  (23.5) 28.7  (19.4) 31.2  (19.2)
SA (n=112, 121, 47, 52, 111) 39.3  (24.3) 41.7  (23.9) 37.4  (23.2) 36.5  (20.6) 40.3  (23.6)
SPI I (n=112, 121, 47, 52, 111) 44.5  (17.3) 42.0  (16.7) 44.7  (18.2) 44.9  (16.0) 43.4  (18.1)
SPI II (n=112, 121, 47, 52, 111) 45.5  (17.2) 43.2  (16.8) 46.4  (18.0) 45.2  (16.1) 43.7  (18.3)
SQ (n=111, 121, 47, 52, 111) 6.2  (1.1) 6.1  (1.1) 5.9  (1.1) 6.2  (1.3) 6.2  (1.1)
9.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study
Hide Description Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.
Arm/Group Title Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg Bazedoxifene 20 mg Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Overall Number of Participants Analyzed 112 121 47 52 111
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
SD (n=112, 121, 47, 52, 111) -17.27  (2.01) -18.18  (1.94) -11.64  (2.94) -18.01  (2.79) -14.34  (2.01)
Snoring (n=110, 121, 47, 51, 108) -5.86  (1.83) -5.38  (1.76) -2.54  (2.67) -2.90  (2.55) -2.71  (1.84)
ASoB or H (n=112,121,47,52,111) -4.26  (1.41) -5.81  (1.35) -3.12  (2.06) -3.62  (1.95) -3.63  (1.40)
Somnolence (n=112,121,47,52,111) -10.54  (1.53) -9.72  (1.48) -6.12  (2.25) -7.36  (2.14) -10.55  (1.53)
SA (n=112, 121, 47, 52, 111) 14.22  (2.40) 14.30  (2.32) 9.10  (3.52) 15.10  (3.34) 11.46  (2.40)
SPI I (n=112, 121, 47, 52, 111) -13.19  (1.51) -13.99  (1.46) -8.92  (2.21) -13.71  (2.09) -11.84  (1.50)
SPI II (n=112, 121, 47, 52,111) -14.01  (1.51) -14.53  (1.46) -9.64  (2.21) -14.12  (2.10) -12.04  (1.51)
SQ (n=111, 121, 47, 52, 111) 0.28  (0.10) 0.44  (0.09) 0.32  (0.14) 0.41  (0.13) 0.36  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.253
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.93
Confidence Interval (2-Sided) 95%
-7.96 to 2.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.127
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.84
Confidence Interval (2-Sided) 95%
-8.78 to 1.10
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.180
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.15
Confidence Interval (2-Sided) 95%
-7.76 to 1.46
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.247
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.67
Confidence Interval (2-Sided) 95%
-7.19 to 1.85
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.726
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.63
Confidence Interval (2-Sided) 95%
-4.15 to 2.90
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.218
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.17
Confidence Interval (2-Sided) 95%
-5.63 to 1.29
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.996
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-3.85 to 3.87
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.665
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean DIfference
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
-2.94 to 4.60
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Sleep adequacy: Month 3, ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.368
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.76
Confidence Interval (2-Sided) 95%
-3.26 to 8.78
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Sleep adequacy: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.345
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.84
Confidence Interval (2-Sided) 95%
-3.07 to 8.75
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.482
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.35
Confidence Interval (2-Sided) 95%
-5.12 to 2.42
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.254
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean DIfference
Estimated Value -2.15
Confidence Interval (2-Sided) 95%
-5.86 to 1.55
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.308
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.97
Confidence Interval (2-Sided) 95%
-5.76 to 1.82
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.190
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.48
Confidence Interval (2-Sided) 95%
-6.20 to 1.23
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.550
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.32 to 0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.477
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.15 to 0.32
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study
Hide Description MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.
Arm/Group Title Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg Bazedoxifene 20 mg Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Overall Number of Participants Analyzed 111 121 47 52 112
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Vasomotor function (n=111, 121, 47, 52, 112) 5.40  (1.564) 5.60  (1.468) 5.87  (1.246) 5.65  (1.620) 5.62  (1.596)
Psychosocial function (n=111, 121, 47, 52, 112) 3.46  (1.716) 3.41  (1.628) 3.49  (1.663) 3.48  (1.793) 3.22  (1.522)
Physical function (n=111, 121, 47, 52, 112) 3.74  (1.377) 3.58  (1.385) 3.96  (1.475) 3.74  (1.409) 3.58  (1.445)
Sexual function (n=110, 121, 47, 52, 112) 3.74  (2.200) 3.63  (2.182) 4.05  (2.265) 3.73  (2.238) 3.83  (2.243)
MENQOL Total Score (n=110, 121, 47, 52, 112) 4.07  (1.227) 4.05  (1.246) 4.34  (1.156) 4.15  (1.314) 4.06  (1.155)
11.Secondary Outcome
Title Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study
Hide Description MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here "N": maximum number of participants who were evaluable for this outcome and "n": participants who were evaluable at specified time points for each arm.
Arm/Group Title Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg Bazedoxifene 20 mg Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Overall Number of Participants Analyzed 111 121 47 52 112
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
Vasomotor function (n=111, 121, 47, 52, 112) -2.37  (0.17) -2.75  (0.17) -1.25  (0.25) -3.19  (0.24) -1.45  (0.17)
Psychosocial function (n=111, 121, 47, 52, 112) -0.67  (0.12) -0.84  (0.12) -0.47  (0.18) -0.83  (0.17) -0.74  (0.12)
Physical function (n=111, 121, 47, 52, 112) -0.92  (0.10) -1.11  (0.10) -0.67  (0.15) -0.76  (0.14) -0.87  (0.10)
Sexual function (n=110, 121, 47, 52, 112) -1.20  (0.16) -1.40  (0.15) -0.09  (0.23) -0.76  (0.22) -1.04  (0.16)
MENQOL Total Score (n=110, 121, 47, 52, 112) -1.27  (0.10) -1.53  (0.10) -0.63  (0.15) -1.39  (0.14) -1.03  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.680
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.493
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.698
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.428
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants With Uterine Bleeding
Hide Description Percentage of participants with uterine bleeding were calculated for each 4-week period for 1-year on therapy.
Time Frame Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all randomized participants who took at least 1 dose of the study drug, and had at least 1 day of on-therapy bleeding data. Here “N” signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm respectively.
Arm/Group Title Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg Bazedoxifene 20 mg Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Overall Number of Participants Analyzed 440 468 229 216 470
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 1-4 (n=440, 468, 229, 216, 470) 3.86 6.20 5.68 20.83 4.68
Week 5-8 (n=428, 458, 221, 205, 462) 4.44 5.02 3.62 24.39 4.11
Week 9-12 (n=417, 451, 217, 199, 452) 2.16 3.55 2.76 25.63 4.42
Week 13-16 (n=415, 446, 213, 196, 446) 2.41 2.91 3.29 24.49 3.36
Week 17-20 (n=399,426,201,184,427) 2.26 2.58 2.49 18.48 3.51
Week 21-24 (n=395, 424, 199, 183, 423) 2.78 2.12 2.01 18.58 3.31
Week 25-28 (n=393, 422, 197, 182, 420) 2.04 2.13 1.02 14.84 3.33
Week 29-32 (n=376, 416, 194, 173, 405) 1.60 1.68 1.55 12.14 1.73
Week 33-36 (n=373, 413, 192, 170, 399) 0.54 2.91 2.08 12.94 2.26
Week 37-40 (n=373, 411, 191, 168, 394) 1.61 2.92 1.57 14.29 4.82
Week 41-44 (n=363, 396, 188, 162, 386) 1.38 1.26 0.00 13.58 1.55
Week 45-48 (n=358, 394, 188, 160, 383) 0.84 2.28 0.53 14.38 2.09
Week 49-52 (n=357, 392, 187, 159, 380) 1.68 1.28 1.07 8.81 1.58
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 1-4: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.624
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 5-8: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.868
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 9-12: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 13-16: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.425
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg
Comments Week 17-20: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.307
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 21-24: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.689
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 25-28: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.285
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 29-32: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 33-36: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.065
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 37-40: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 41-44: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 45-48: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.226
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 49-52: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 1-4: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 5-8: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 9-12: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 13-16: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 17-20: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 21-24: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 25-28: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 29-32: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 33-36: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 37-40: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 41-44: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 45-48: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 49-52: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 1-4: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.317
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 5-8: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.531
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 9-12: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.610
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 13-16: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.848
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 17-20: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.551
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 21-24: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.300
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 25-28: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.299
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 29-32: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 33-36: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.660
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 37-40: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.199
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 37 Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 41-44: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.770
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 45-48: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 39 Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 49-52: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.769
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 40 Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 1-4: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 41 Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 5-8: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 42 Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 9-12: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 43 Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 13-16: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 44 Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 17-20: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 45 Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 21-24: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 46 Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 25-28: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 47 Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 29-32: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 48 Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 33-36: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 49 Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 37-40: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 50 Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 41-44: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 51 Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 45-48: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 52 Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg
Comments Week 49-52: The Fisher exact test was used for comparisons between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
13.Other Pre-specified Outcome
Title Percentage of Participants With Breast Tenderness
Hide Description Percentage of participants who reported at least 1 day of breast tenderness during each 4-week period for 1-year on therapy was calculated.
Time Frame Screening, Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all randomized participants who took 1 dose of study drug and had at least 20 days of data available at screening and at least 20 continuous days of data in at least one 4-week interval after baseline.
Arm/Group Title Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg Bazedoxifene 20 mg Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Overall Number of Participants Analyzed 429 449 220 206 457
Measure Type: Number
Unit of Measure: Percentage of Participants
Screening (n=429, 449, 220, 206, 457) 6.29 6.46 4.55 7.28 6.56
Week 1-4 (n=426, 449, 220, 205, 457) 9.39 9.13 5.91 20.49 8.32
Week 5-8 (n=423, 447, 216, 202, 456) 8.04 6.94 7.87 24.26 8.55
Week 9-12 (n=412, 439, 212, 196, 447) 5.83 7.97 6.60 23.98 5.37
Week 13-16 (n=411, 433, 208, 193, 440) 7.06 8.31 8.65 21.24 5.91
Week 17-20 (n=395, 412, 197, 181, 420) 4.05 4.37 6.09 17.13 4.29
Week 21-24 (n=391, 410, 195, 180, 416) 4.60 3.90 5.64 15.00 4.33
Week 25-28 (n=389, 409, 193, 179, 416) 3.08 5.62 4.15 15.64 4.09
Week 29-32 (n=372, 403, 190, 171, 401) 4.57 3.97 1.58 15.20 2.00
Week 33-36 (n=369, 401, 188, 168, 395) 2.98 3.49 3.19 12.50 2.28
Week 37-40 (n=369, 399, 187, 166, 390) 4.07 4.01 2.67 12.05 3.08
Week 41-44 (n=359, 384, 184, 159, 382) 3.62 2.60 1.63 9.43 2.62
Week 45-48 (n=354, 382, 184, 157, 379) 3.67 3.14 2.17 10.83 3.17
Week 49-52 (n=353, 380, 183, 156, 376) 3.12 2.89 1.64 9.62 2.66
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.546
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.821
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.698
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.446
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.892
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.810
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.473
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.453
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.391
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.407
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.644
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo
Comments Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.666
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.641
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.361
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.100
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo
Comments Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]