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Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00242710
Recruitment Status : Completed
First Posted : October 20, 2005
Results First Posted : December 20, 2013
Last Update Posted : December 20, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Endometrial Hyperplasia
Osteoporosis
Interventions Drug: Bazedoxifene/Conjugated Estrogen
Drug: CE 0.45 mg/MPA 1.5mg
Other: Placebo
Enrollment 1083
Recruitment Details  
Pre-assignment Details This main study also included osteoporosis substudy only for the purpose of the assessment of relevant parameters.
Arm/Group Title Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2. Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2. Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2. Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Period Title: Core Study (up to Year 1)
Started 373 353 183 174
Treated 361 349 179 172
Completed 287 289 132 143
Not Completed 86 64 51 31
Reason Not Completed
Adverse Event             30             25             23             14
Death             0             0             1             0
Physician Decision             0             1             0             1
Lost to Follow-up             8             8             7             3
Other             6             1             0             2
Protocol Violation             2             9             1             3
Withdrawal by Subject             27             16             15             6
Lack of Efficacy             1             0             0             0
Randomized but not Treated             12             4             4             2
Period Title: Period Between Core Study and Extension
Started 287 289 132 143
Completed 168 177 84 94
Not Completed 119 112 48 49
Reason Not Completed
Adverse Event             2             3             5             2
Physician Decision             1             1             0             0
Other             24             24             9             11
Extension not Available             17             21             8             7
Protocol Violation             0             0             2             1
Withdrawal by Subject             75             63             24             28
Period Title: Study Extension (up to Year 2)
Started 168 177 84 94
Completed 141 148 69 84
Not Completed 27 29 15 10
Reason Not Completed
Adverse Event             7             9             2             4
Death             0             0             0             1
Lost to Follow-up             7             7             5             0
Other             3             5             4             3
Protocol Violation             0             2             0             1
Withdrawal by Subject             10             6             4             1
Arm/Group Title Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo Total
Hide Arm/Group Description Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2. Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2. Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2. Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2. Total of all reporting groups
Overall Number of Baseline Participants 361 349 179 172 1061
Hide Baseline Analysis Population Description
Safety analysis set included all randomly assigned participants who took at least 1 dose of test article.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 361 participants 349 participants 179 participants 172 participants 1061 participants
54.62  (4.74) 54.44  (4.62) 54.30  (4.56) 54.19  (4.62) 54.44  (4.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 361 participants 349 participants 179 participants 172 participants 1061 participants
Female
361
 100.0%
349
 100.0%
179
 100.0%
172
 100.0%
1061
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Hyperplasia at Screening
Hide Description Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
Endometrial hyperplasia at screening was an exclusion criterion and participants who had hyperplasia were not included in the analysis. Therefore this data is not available.
Arm/Group Title Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Percentage of Participants With Hyperplasia at Month 12
Hide Description Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable (EE) analysis population for Year 1: all participants who were randomized and took at least 1 dose of test article, 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 Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Overall Number of Participants Analyzed 261 273 119 135
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.00
(0.00 to 1.14)
1.10
(0.30 to 2.82)
0.00
(0.00 to 2.49)
0.00
(0.00 to 2.19)
3.Primary Outcome
Title Bone Mineral Density (BMD) of Lumbar Spine at Screening
Hide Description BMD measurements of the anteroposterior lumbar spine were acquired by dual-energy x-ray absorptiometry (DXA), twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (MITT) population for BMD of lumber spine included all randomized participants took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 1.
Arm/Group Title Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Overall Number of Participants Analyzed 146 144 60 65
Mean (Standard Deviation)
Unit of Measure: grams per square centimeter (g/cm^2)
1.00  (0.12) 1.01  (0.12) 1.02  (0.12) 1.01  (0.12)
4.Primary Outcome
Title Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12
Hide Description BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population for BMD of lumber spine: all randomized participants who took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after test article administration was stopped were excluded) at Year 1. Missing values imputed using last observation carried forward (LOCF).
Arm/Group Title Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Overall Number of Participants Analyzed 146 144 60 65
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.80  (0.24) 0.80  (0.24) 2.22  (0.37) -1.56  (0.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments An analysis of covariance (ANCOVA) model was used with treatment and center 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 2.37
Confidence Interval (2-Sided) 95%
1.56 to 3.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments An ANCOVA model was used with treatment and center 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 2.36
Confidence Interval (2-Sided) 95%
1.56 to 3.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments An ANCOVA model was used with treatment and center 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 3.78
Confidence Interval (2-Sided) 95%
2.81 to 4.76
Estimation Comments [Not Specified]
5.Primary Outcome
Title Bone Mineral Density (BMD) of Total Hip at Screening
Hide Description BMD measurements of the total hip were acquired by DXA, twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population for BMD of total hip included all randomized participants who took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 1. Missing values were imputed using LOCF method.
Arm/Group Title Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Overall Number of Participants Analyzed 148 145 60 66
Mean (Standard Deviation)
Unit of Measure: g/cm^2
0.90  (0.11) 0.89  (0.11) 0.90  (0.10) 0.89  (0.11)
6.Primary Outcome
Title Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 12
Hide Description BMD measurements of the total hip were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population for BMD of total hip included all randomized participants who took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 1. Missing values were imputed using LOCF method.
Arm/Group Title Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Overall Number of Participants Analyzed 148 145 60 66
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.62  (0.19) 0.84  (0.19) 1.47  (0.29) -0.99  (0.27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments An ANCOVA model was used with treatment and center 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 1.61
Confidence Interval (2-Sided) 95%
0.97 to 2.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments An ANCOVA model was used with treatment and center 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 1.82
Confidence Interval (2-Sided) 95%
1.19 to 2.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments An ANCOVA model was used with treatment and center 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 2.46
Confidence Interval (2-Sided) 95%
1.69 to 3.23
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Days With Breast Pain
Hide Description Percentage of days with breast pain in each 4-week period (for example, Week 1 to 4, 5 to 8) calculated as the number of days on which a participants reported breast pain divided by total number of days with data recorded multiplied by 100. Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.
Time Frame Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population for breast pain: all randomized participants who took at least 1 dose of test article, and had data available at least for 5 of 7 days at screening and 20 days for at least 1 post-baseline interval. n=participants evaluable at specified time periods for each arm, respectively.
Arm/Group Title Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Overall Number of Participants Analyzed 347 329 168 163
Mean (Standard Error)
Unit of Measure: percentage of days
Week 1-4 (n=347, 329, 168, 163) 1.55  (0.49) 1.22  (0.51) 3.49  (0.65) 0.89  (0.66)
Week 5-8 (n=331, 323, 158, 158) 1.71  (0.68) 1.58  (0.68) 5.54  (0.91) 1.36  (0.92)
Week 9-12 (n=323, 317, 150, 152) 2.00  (0.68) 1.01  (0.68) 4.80  (0.93) 1.36  (0.92)
Week 13-16 (n=315, 310, 141, 150) 1.87  (0.60) 0.88  (0.61) 3.92  (0.84) 0.77  (0.81)
Week 17-20 (n=313, 309, 141, 149) 2.11  (0.63) 1.57  (0.64) 4.23  (0.88) 1.61  (0.85)
Week 21-24 (n=312, 306, 141, 147) 2.49  (0.78) 1.85  (0.79) 5.01  (1.08) 1.26  (1.06)
Week 25-28 (n=306, 298, 136, 144) 2.60  (0.77) 1.31  (0.78) 4.91  (1.07) 1.39  (1.04)
Week 29-32 (n=301, 297, 133, 143) 1.80  (0.62) 0.82  (0.63) 3.98  (0.87) 0.17  (0.84)
Week 33-36 (n=297, 294, 132, 143) 1.29  (0.57) 0.25  (0.58) 3.49  (0.80) -0.26  (0.77)
Week 37-40 (n=295, 288, 130, 140) 1.61  (0.62) 0.25  (0.64) 3.87  (0.88) 0.57  (0.85)
Week 41-44 (n=286, 285, 128, 140) 1.99  (0.66) 0.56  (0.67) 2.49  (0.92) 0.86  (0.89)
Week 45-48 (n=282, 284, 127, 140) 1.68  (0.67) 1.26  (0.68) 2.52  (0.94) 1.17  (0.90)
Week 49-52 (n=170, 171, 70, 91) 1.07  (1.12) 1.68  (1.16) 5.27  (1.69) 1.49  (1.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.373
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
-0.80 to 2.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.738
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
-1.70 to 2.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.539
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
-1.41 to 2.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.233
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
-0.71 to 2.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.605
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
-1.39 to 2.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.305
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
-1.12 to 3.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.299
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
-1.08 to 3.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.62
Confidence Interval (2-Sided) 95%
-0.27 to 3.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.080
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.55
Confidence Interval (2-Sided) 95%
-0.18 to 3.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.279
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
-0.85 to 2.92
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.260
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
-0.84 to 3.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.618
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
-1.50 to 2.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.810
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-3.78 to 2.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.654
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
-1.14 to 1.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.834
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
-1.84 to 2.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.744
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-2.41 to 1.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.909
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-1.70 to 1.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.963
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-1.94 to 1.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.625
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
-1.77 to 2.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.947
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-2.39 to 2.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.505
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
-1.25 to 2.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.564
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
-1.23 to 2.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.739
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-2.21 to 1.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.766
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-2.27 to 1.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.931
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%
-1.92 to 2.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.911
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
-3.17 to 3.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.61
Confidence Interval (2-Sided) 95%
0.92 to 4.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the 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]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.18
Confidence Interval (2-Sided) 95%
1.79 to 6.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.45
Confidence Interval (2-Sided) 95%
1.03 to 5.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
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%
1.01 to 5.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.61
Confidence Interval (2-Sided) 95%
0.36 to 4.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.75
Confidence Interval (2-Sided) 95%
0.96 to 6.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.52
Confidence Interval (2-Sided) 95%
0.78 to 6.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the 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]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.81
Confidence Interval (2-Sided) 95%
1.55 to 6.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the 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]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.75
Confidence Interval (2-Sided) 95%
1.68 to 5.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.30
Confidence Interval (2-Sided) 95%
1.05 to 5.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.63
Confidence Interval (2-Sided) 95%
-0.73 to 3.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.270
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%
-1.05 to 3.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.78
Confidence Interval (2-Sided) 95%
-0.41 to 7.97
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Uterine Bleeding or Spotting
Hide Description Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.
Time Frame Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population for uterine bleeding or spotting included all randomized participants who had received at least 1 dose of test article and had at least 1 day of on-therapy bleeding data. Imputation=LOCF. n=participants evaluable for this measure at specified time periods for each arm, respectively.
Arm/Group Title Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Overall Number of Participants Analyzed 330 315 159 155
Measure Type: Number
Unit of Measure: percentage of participants
Week 1-4 (n=330, 313, 159, 155) 5.45 4.15 19.50 4.52
Week 5-8 (n=320, 315, 153, 151) 2.19 2.86 23.53 3.31
Week 9-12 (n=316, 310, 147, 146) 2.53 4.52 25.17 2.74
Week 13-16 (n=310, 296, 137, 149) 2.90 2.70 16.79 1.34
Week 17-20 (n=315, 311, 144, 150) 2.22 1.61 16.67 0.67
Week 21-24 (n=311, 306, 142, 147) 0.96 1.31 16.20 2.72
Week 25-28 (n=294, 290, 131, 143) 2.04 1.38 9.92 2.10
Week 29-32 (n=298, 297, 135, 141) 0.67 2.02 11.11 0.71
Week 33-36 (n=296, 291, 134, 140) 2.03 2.75 11.94 2.86
Week 37-40 (n=282, 279, 131, 139) 2.13 2.87 11.45 2.88
Week 41-44 (n=285, 284, 132, 141) 1.40 1.06 8.33 2.84
Week 45-48 (n=280, 282, 130, 140) 1.79 2.48 11.54 2.86
Week 49-52 (n=45, 51, 15, 31) 0.00 1.96 33.33 6.45
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.826
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.534
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.516
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 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 0.446
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.218
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.733
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.736
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.449
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.489
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.163
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.813
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.777
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.448
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.507
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.669
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.281
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.689
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.437
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.227
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.758
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 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 0.554
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, 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 <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, 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 <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, 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 <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, 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 <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, 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 <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, 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 <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, 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 0.008
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, 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 <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, 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 0.005
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, 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 0.008
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, 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 0.062
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, 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 0.007
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, 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 0.029
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With Hyperplasia at Month 24
Hide Description Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
EE analysis population for Year 2 included all randomized participants who took at least 1 dose of test article, participated in study extension, had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had biopsy during Month 24, or had hyperplasia diagnosed before Month 24 and had no major protocol violations.
Arm/Group Title Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Overall Number of Participants Analyzed 131 142 66 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.00
(0.00 to 2.78)
4.93
(2.00 to 9.89)
0.00
(0.00 to 5.44)
0.00
(0.00 to 4.56)
10.Secondary Outcome
Title Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 24
Hide Description BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 24 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population for BMD of lumber spine: all participants who took at least 1 dose of test article, participated in study extension, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 2. Missing values imputed using LOCF method.
Arm/Group Title Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Overall Number of Participants Analyzed 87 87 40 39
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.96  (0.40) 0.86  (0.41) 2.39  (0.57) -2.29  (0.57)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments An ANCOVA model was used with treatment and center 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 3.25
Confidence Interval (2-Sided) 95%
1.92 to 4.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments An ANCOVA model was used with treatment and center 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 3.14
Confidence Interval (2-Sided) 95%
1.83 to 4.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments An ANCOVA model was used with treatment and center 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 4.68
Confidence Interval (2-Sided) 95%
3.13 to 6.23
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 24
Hide Description BMD measurements of the total hip were acquired by DXA, twice at Month 24 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population for BMD of total hip: all participants who took at least 1 dose of test article, participated in study extension, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 2. Missing values imputed using LOCF method.
Arm/Group Title Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description:
Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
Overall Number of Participants Analyzed 87 88 40 39
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.30  (0.31) 0.41  (0.32) 0.85  (0.44) -1.53  (0.45)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg, Placebo
Comments An ANCOVA model was used with treatment and center 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 1.83
Confidence Interval (2-Sided) 95%
0.80 to 2.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg, Placebo
Comments An ANCOVA model was used with treatment and center 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 1.94
Confidence Interval (2-Sided) 95%
0.92 to 2.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg, Placebo
Comments An ANCOVA model was used with treatment and center 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 2.38
Confidence Interval (2-Sided) 95%
1.17 to 3.59
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo
Hide Arm/Group Description Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2. Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2. Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2. Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
All-Cause Mortality
Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/361 (6.09%)   19/349 (5.44%)   7/179 (3.91%)   7/172 (4.07%) 
Blood and lymphatic system disorders         
Febrile neutropenia * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Cardiac disorders         
Coronary artery disease * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Myocardial infarction * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Eye disorders         
Vitreous haemorrhage * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Gastrointestinal disorders         
Abdominal pain * 1  0/361 (0.00%)  3/349 (0.86%)  1/179 (0.56%)  0/172 (0.00%) 
Faecal incontinence * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Gastritis * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Nausea * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Small intestinal obstruction * 1  0/361 (0.00%)  0/349 (0.00%)  1/179 (0.56%)  0/172 (0.00%) 
Vomiting * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  1/172 (0.58%) 
General disorders         
Chest pain * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Non-cardiac chest pain * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Sudden death * 1  0/361 (0.00%)  0/349 (0.00%)  0/179 (0.00%)  1/172 (0.58%) 
Hepatobiliary disorders         
Cholecystitis * 1  1/361 (0.28%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Cholecystitis acute * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Cholecystitis chronic * 1  0/361 (0.00%)  0/349 (0.00%)  0/179 (0.00%)  1/172 (0.58%) 
Infections and infestations         
Arthritis infective * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Cellulitis * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Pelvic abscess * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Pneumonia * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Injury, poisoning and procedural complications         
Accidental overdose * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Ankle fracture * 1  2/361 (0.55%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Cervical vertebral fracture * 1  0/361 (0.00%)  0/349 (0.00%)  0/179 (0.00%)  1/172 (0.58%) 
Concussion * 1  0/361 (0.00%)  0/349 (0.00%)  0/179 (0.00%)  1/172 (0.58%) 
Lung injury * 1  0/361 (0.00%)  0/349 (0.00%)  0/179 (0.00%)  1/172 (0.58%) 
Medication error * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Multiple drug overdose * 1  0/361 (0.00%)  0/349 (0.00%)  1/179 (0.56%)  0/172 (0.00%) 
Intentional overdose * 1  2/361 (0.55%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Rib fracture * 1  0/361 (0.00%)  0/349 (0.00%)  0/179 (0.00%)  1/172 (0.58%) 
Road traffic accident * 1  0/361 (0.00%)  0/349 (0.00%)  0/179 (0.00%)  1/172 (0.58%) 
Tendon rupture * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Tibia fracture * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Investigations         
Biopsy endometrium abnormal * 1  1/361 (0.28%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Musculoskeletal chest pain * 1  0/361 (0.00%)  0/349 (0.00%)  0/179 (0.00%)  1/172 (0.58%) 
Synovitis * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Acute myeloid leukaemia * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Basal cell carcinoma * 1  0/361 (0.00%)  3/349 (0.86%)  1/179 (0.56%)  0/172 (0.00%) 
Lung adenocarcinoma stage III * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Malignant melanoma * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  2/172 (1.16%) 
Ovarian germ cell teratoma benign * 1  0/361 (0.00%)  0/349 (0.00%)  0/179 (0.00%)  1/172 (0.58%) 
Squamous cell carcinoma of skin * 1  1/361 (0.28%)  0/349 (0.00%)  1/179 (0.56%)  1/172 (0.58%) 
Tonsil cancer * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Nervous system disorders         
Transient ischaemic attack * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Psychiatric disorders         
Alcohol abuse * 1  0/361 (0.00%)  0/349 (0.00%)  1/179 (0.56%)  0/172 (0.00%) 
Completed suicide * 1  0/361 (0.00%)  0/349 (0.00%)  1/179 (0.56%)  0/172 (0.00%) 
Major depression * 1  0/361 (0.00%)  0/349 (0.00%)  1/179 (0.56%)  0/172 (0.00%) 
Renal and urinary disorders         
Calculus ureteric * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Stress urinary incontinence * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Reproductive system and breast disorders         
Cervical dysplasia * 1  0/361 (0.00%)  1/349 (0.29%)  0/179 (0.00%)  0/172 (0.00%) 
Cystocele * 1  0/361 (0.00%)  0/349 (0.00%)  1/179 (0.56%)  0/172 (0.00%) 
Fibrocystic breast disease * 1  0/361 (0.00%)  0/349 (0.00%)  1/179 (0.56%)  0/172 (0.00%) 
Ovarian mass * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Rectocele * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Vaginal prolapse * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthmatic crisis * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Pneumothorax * 1  0/361 (0.00%)  0/349 (0.00%)  0/179 (0.00%)  1/172 (0.58%) 
Surgical and medical procedures         
Hip arthroplasty * 1  1/361 (0.28%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
Vascular disorders         
Deep vein thrombosis * 1  3/361 (0.83%)  0/349 (0.00%)  0/179 (0.00%)  0/172 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   322/361 (89.20%)   309/349 (88.54%)   165/179 (92.18%)   152/172 (88.37%) 
Blood and lymphatic system disorders         
Lymphadenopathy * 1  0/361 (0.00%)  5/349 (1.43%)  2/179 (1.12%)  4/172 (2.33%) 
Cardiac disorders         
Palpitations * 1  7/361 (1.94%)  0/349 (0.00%)  2/179 (1.12%)  4/172 (2.33%) 
Ear and labyrinth disorders         
Ear pain * 1  3/361 (0.83%)  4/349 (1.15%)  4/179 (2.23%)  1/172 (0.58%) 
Vertigo * 1  3/361 (0.83%)  7/349 (2.01%)  1/179 (0.56%)  2/172 (1.16%) 
Gastrointestinal disorders         
Abdominal distension * 1  5/361 (1.39%)  6/349 (1.72%)  8/179 (4.47%)  3/172 (1.74%) 
Abdominal pain * 1  20/361 (5.54%)  28/349 (8.02%)  17/179 (9.50%)  5/172 (2.91%) 
Abdominal pain lower * 1  10/361 (2.77%)  17/349 (4.87%)  9/179 (5.03%)  3/172 (1.74%) 
Abdominal pain upper * 1  32/361 (8.86%)  22/349 (6.30%)  12/179 (6.70%)  7/172 (4.07%) 
Constipation * 1  23/361 (6.37%)  16/349 (4.58%)  9/179 (5.03%)  9/172 (5.23%) 
Diarrhoea * 1  21/361 (5.82%)  22/349 (6.30%)  11/179 (6.15%)  14/172 (8.14%) 
Dyspepsia * 1  19/361 (5.26%)  21/349 (6.02%)  11/179 (6.15%)  18/172 (10.47%) 
Flatulence * 1  2/361 (0.55%)  7/349 (2.01%)  3/179 (1.68%)  3/172 (1.74%) 
Gastrooesophageal reflux disease * 1  10/361 (2.77%)  7/349 (2.01%)  2/179 (1.12%)  2/172 (1.16%) 
Nausea * 1  25/361 (6.93%)  20/349 (5.73%)  14/179 (7.82%)  10/172 (5.81%) 
Stomach discomfort * 1  8/361 (2.22%)  10/349 (2.87%)  7/179 (3.91%)  4/172 (2.33%) 
Toothache * 1  19/361 (5.26%)  19/349 (5.44%)  12/179 (6.70%)  4/172 (2.33%) 
Vomiting * 1  11/361 (3.05%)  10/349 (2.87%)  8/179 (4.47%)  5/172 (2.91%) 
General disorders         
Fatigue * 1  10/361 (2.77%)  13/349 (3.72%)  7/179 (3.91%)  8/172 (4.65%) 
Non-cardiac chest pain * 1  6/361 (1.66%)  7/349 (2.01%)  4/179 (2.23%)  7/172 (4.07%) 
Oedema peripheral * 1  9/361 (2.49%)  10/349 (2.87%)  4/179 (2.23%)  4/172 (2.33%) 
Pain * 1  17/361 (4.71%)  15/349 (4.30%)  3/179 (1.68%)  12/172 (6.98%) 
Pyrexia * 1  4/361 (1.11%)  5/349 (1.43%)  4/179 (2.23%)  6/172 (3.49%) 
Immune system disorders         
Hypersensitivity * 1  10/361 (2.77%)  9/349 (2.58%)  3/179 (1.68%)  2/172 (1.16%) 
Seasonal allergy * 1  11/361 (3.05%)  7/349 (2.01%)  5/179 (2.79%)  5/172 (2.91%) 
Infections and infestations         
Bronchitis * 1  17/361 (4.71%)  18/349 (5.16%)  7/179 (3.91%)  13/172 (7.56%) 
Gastroenteritis * 1  6/361 (1.66%)  10/349 (2.87%)  9/179 (5.03%)  4/172 (2.33%) 
Gastroenteritis viral * 1  11/361 (3.05%)  12/349 (3.44%)  6/179 (3.35%)  3/172 (1.74%) 
Influenza * 1  43/361 (11.91%)  35/349 (10.03%)  24/179 (13.41%)  14/172 (8.14%) 
Localised infection * 1  2/361 (0.55%)  4/349 (1.15%)  4/179 (2.23%)  1/172 (0.58%) 
Nasopharyngitis * 1  83/361 (22.99%)  82/349 (23.50%)  42/179 (23.46%)  30/172 (17.44%) 
Onychomycosis * 1  2/361 (0.55%)  4/349 (1.15%)  5/179 (2.79%)  1/172 (0.58%) 
Oral herpes * 1  3/361 (0.83%)  4/349 (1.15%)  5/179 (2.79%)  1/172 (0.58%) 
Pharyngitis * 1  11/361 (3.05%)  7/349 (2.01%)  6/179 (3.35%)  6/172 (3.49%) 
Sinusitis * 1  32/361 (8.86%)  23/349 (6.59%)  9/179 (5.03%)  13/172 (7.56%) 
Tooth abscess * 1  7/361 (1.94%)  7/349 (2.01%)  4/179 (2.23%)  7/172 (4.07%) 
Tooth infection * 1  5/361 (1.39%)  7/349 (2.01%)  8/179 (4.47%)  5/172 (2.91%) 
Upper respiratory tract infection * 1  29/361 (8.03%)  35/349 (10.03%)  15/179 (8.38%)  12/172 (6.98%) 
Urinary tract infection * 1  26/361 (7.20%)  21/349 (6.02%)  11/179 (6.15%)  9/172 (5.23%) 
Vulvovaginal mycotic infection * 1  12/361 (3.32%)  20/349 (5.73%)  16/179 (8.94%)  2/172 (1.16%) 
Injury, poisoning and procedural complications         
Arthropod bite * 1  6/361 (1.66%)  8/349 (2.29%)  3/179 (1.68%)  1/172 (0.58%) 
Back injury * 1  4/361 (1.11%)  7/349 (2.01%)  1/179 (0.56%)  2/172 (1.16%) 
Contusion * 1  3/361 (0.83%)  8/349 (2.29%)  3/179 (1.68%)  1/172 (0.58%) 
Excoriation * 1  2/361 (0.55%)  1/349 (0.29%)  4/179 (2.23%)  1/172 (0.58%) 
Fall * 1  4/361 (1.11%)  7/349 (2.01%)  2/179 (1.12%)  2/172 (1.16%) 
Joint sprain * 1  8/361 (2.22%)  8/349 (2.29%)  3/179 (1.68%)  2/172 (1.16%) 
Muscle strain * 1  4/361 (1.11%)  6/349 (1.72%)  3/179 (1.68%)  4/172 (2.33%) 
Post procedural haemorrhage * 1  8/361 (2.22%)  5/349 (1.43%)  4/179 (2.23%)  2/172 (1.16%) 
Procedural pain * 1  16/361 (4.43%)  20/349 (5.73%)  9/179 (5.03%)  12/172 (6.98%) 
Investigations         
Weight increased * 1  10/361 (2.77%)  8/349 (2.29%)  4/179 (2.23%)  8/172 (4.65%) 
Metabolism and nutrition disorders         
Hypercholesterolaemia * 1  6/361 (1.66%)  3/349 (0.86%)  5/179 (2.79%)  4/172 (2.33%) 
Hyperlipidaemia * 1  14/361 (3.88%)  6/349 (1.72%)  6/179 (3.35%)  13/172 (7.56%) 
Obesity * 1  2/361 (0.55%)  0/349 (0.00%)  2/179 (1.12%)  4/172 (2.33%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  55/361 (15.24%)  56/349 (16.05%)  22/179 (12.29%)  28/172 (16.28%) 
Arthritis * 1  2/361 (0.55%)  9/349 (2.58%)  2/179 (1.12%)  0/172 (0.00%) 
Back pain * 1  60/361 (16.62%)  66/349 (18.91%)  33/179 (18.44%)  23/172 (13.37%) 
Muscle spasms * 1  37/361 (10.25%)  29/349 (8.31%)  16/179 (8.94%)  10/172 (5.81%) 
Musculoskeletal pain * 1  16/361 (4.43%)  13/349 (3.72%)  8/179 (4.47%)  9/172 (5.23%) 
Musculoskeletal stiffness * 1  7/361 (1.94%)  7/349 (2.01%)  2/179 (1.12%)  4/172 (2.33%) 
Myalgia * 1  34/361 (9.42%)  28/349 (8.02%)  16/179 (8.94%)  16/172 (9.30%) 
Neck pain * 1  17/361 (4.71%)  17/349 (4.87%)  11/179 (6.15%)  14/172 (8.14%) 
Osteoarthritis * 1  11/361 (3.05%)  1/349 (0.29%)  2/179 (1.12%)  3/172 (1.74%) 
Osteoporosis * 1  3/361 (0.83%)  7/349 (2.01%)  1/179 (0.56%)  5/172 (2.91%) 
Pain in extremity * 1  39/361 (10.80%)  39/349 (11.17%)  19/179 (10.61%)  27/172 (15.70%) 
Pain in jaw * 1  3/361 (0.83%)  0/349 (0.00%)  4/179 (2.23%)  1/172 (0.58%) 
Nervous system disorders         
Dizziness * 1  13/361 (3.60%)  19/349 (5.44%)  11/179 (6.15%)  5/172 (2.91%) 
Headache * 1  94/361 (26.04%)  78/349 (22.35%)  58/179 (32.40%)  41/172 (23.84%) 
Migraine * 1  7/361 (1.94%)  11/349 (3.15%)  6/179 (3.35%)  3/172 (1.74%) 
Sciatica * 1  3/361 (0.83%)  3/349 (0.86%)  0/179 (0.00%)  4/172 (2.33%) 
Sinus headache * 1  28/361 (7.76%)  14/349 (4.01%)  5/179 (2.79%)  9/172 (5.23%) 
Tension headache * 1  1/361 (0.28%)  2/349 (0.57%)  4/179 (2.23%)  3/172 (1.74%) 
Psychiatric disorders         
Anxiety * 1  10/361 (2.77%)  4/349 (1.15%)  7/179 (3.91%)  6/172 (3.49%) 
Depression * 1  6/361 (1.66%)  9/349 (2.58%)  6/179 (3.35%)  7/172 (4.07%) 
Insomnia * 1  25/361 (6.93%)  17/349 (4.87%)  10/179 (5.59%)  13/172 (7.56%) 
Renal and urinary disorders         
Haematuria * 1  2/361 (0.55%)  3/349 (0.86%)  3/179 (1.68%)  5/172 (2.91%) 
Reproductive system and breast disorders         
Breast pain * 1  18/361 (4.99%)  18/349 (5.16%)  19/179 (10.61%)  7/172 (4.07%) 
Endometrial hyperplasia * 1  0/361 (0.00%)  7/349 (2.01%)  0/179 (0.00%)  0/172 (0.00%) 
Endometrial hypertrophy * 1  5/361 (1.39%)  7/349 (2.01%)  4/179 (2.23%)  1/172 (0.58%) 
Genital haemorrhage * 1  18/361 (4.99%)  29/349 (8.31%)  28/179 (15.64%)  10/172 (5.81%) 
Metrorrhagia * 1  9/361 (2.49%)  4/349 (1.15%)  10/179 (5.59%)  4/172 (2.33%) 
Uterine haemorrhage * 1  2/361 (0.55%)  2/349 (0.57%)  7/179 (3.91%)  1/172 (0.58%) 
Uterine spasm * 1  4/361 (1.11%)  2/349 (0.57%)  7/179 (3.91%)  1/172 (0.58%) 
Vaginal discharge * 1  7/361 (1.94%)  10/349 (2.87%)  6/179 (3.35%)  3/172 (1.74%) 
Vaginal haemorrhage * 1  13/361 (3.60%)  18/349 (5.16%)  22/179 (12.29%)  4/172 (2.33%) 
Vulvovaginal pruritus * 1  7/361 (1.94%)  5/349 (1.43%)  6/179 (3.35%)  1/172 (0.58%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  21/361 (5.82%)  20/349 (5.73%)  17/179 (9.50%)  9/172 (5.23%) 
Nasal congestion * 1  9/361 (2.49%)  8/349 (2.29%)  6/179 (3.35%)  4/172 (2.33%) 
Pharyngolaryngeal pain * 1  21/361 (5.82%)  19/349 (5.44%)  11/179 (6.15%)  16/172 (9.30%) 
Pulmonary congestion * 1  2/361 (0.55%)  10/349 (2.87%)  4/179 (2.23%)  1/172 (0.58%) 
Rhinorrhoea * 1  2/361 (0.55%)  3/349 (0.86%)  1/179 (0.56%)  5/172 (2.91%) 
Sinus congestion * 1  14/361 (3.88%)  15/349 (4.30%)  6/179 (3.35%)  3/172 (1.74%) 
Skin and subcutaneous tissue disorders         
Dermatitis contact * 1  7/361 (1.94%)  7/349 (2.01%)  5/179 (2.79%)  3/172 (1.74%) 
Night sweats * 1  6/361 (1.66%)  7/349 (2.01%)  3/179 (1.68%)  4/172 (2.33%) 
Rash * 1  9/361 (2.49%)  16/349 (4.58%)  7/179 (3.91%)  6/172 (3.49%) 
Vascular disorders         
Hot flush * 1  38/361 (10.53%)  37/349 (10.60%)  11/179 (6.15%)  7/172 (4.07%) 
Hypertension * 1  14/361 (3.88%)  11/349 (3.15%)  7/179 (3.91%)  6/172 (3.49%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00242710    
Other Study ID Numbers: 3115A1-304
First Submitted: October 18, 2005
First Posted: October 20, 2005
Results First Submitted: October 30, 2013
Results First Posted: December 20, 2013
Last Update Posted: December 20, 2013