Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00808132
Collaborator
(none)
1,886
178
5
25
10.6
0.4
Study Details
Study Description
Brief Summary
The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1886 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Randomized, Placebo And Active- Controlled Efficacy And Safety Study Of The Effects Of Bazedoxifene/Conjugated Estrogens Combinations On Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women
Study Start Date
:
Jan 1, 2009
Actual Primary Completion Date
:
Feb 1, 2011
Actual Study Completion Date
:
Feb 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 bazedoxifene 20 mg/conjugated estrogens 0.45 mg |
Drug: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg
One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year.
|
| Experimental: 2 bazedoxifene 20 mg/conjugated estrogens 0.625 mg |
Drug: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg
One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year.
|
| Experimental: 3 bazedoxifene 20 mg |
Drug: bazedoxifene 20 mg
One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year.
|
| Active Comparator: 4 Prempro |
Drug: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg
One capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year.
Other Names:
|
| Placebo Comparator: 5 Placebo |
Drug: Placebo
One capsule, placebo (over-encapsulated), once a day for one year.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study [Month 12]
Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis.
- Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study [Baseline, Month 12]
BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.
Secondary Outcome Measures
- Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study [Baseline, Month 6]
BMD measurements of the anteroposterior lumbar spine were acquired by using DXA scans, twice at Month 6 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.
- Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study [Baseline, Month 6, Month 12]
BMD measurements of the total hip were acquired by using DXA scans, twice at Month 6 and 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.
- Percentage of Participants With Cumulative Amenorrhea: Main Study [Day 1 up to Day 364]
Cumulative amenorrhea was defined as the absence of any bleeding or spotting for cumulative 4-week periods throughout 1-year study.
- Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study [Baseline, Month 12]
Breast density was assessed by digitalized mammograms which were centrally read by a single radiologist using specifically-developed software. Breast density was assessed for subset of participants who entered the breast density sub-study
- Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study [Baseline, Month 6, 12]
Bone turnover is the removal of old bone from the body and its replacement by new bone. Bone turnover markers included serum osteocalcin, C-telopeptide, and procollagen type 1 N-propeptide (P1NP), were measured at Month 6 and Month 12 for a subset of participants who entered the osteoporosis substudy. Blood samples were collected to evaluate bone turnover markers levels.
- Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study [Baseline]
Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study [Baseline, Month 3]
Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.
- Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study [Baseline]
MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.
- Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study [Baseline, Month 3]
MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.
- Percentage of Participants With Uterine Bleeding [Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52]
Percentage of participants with uterine bleeding were calculated for each 4-week period for 1-year on therapy.
Other Outcome Measures
- Percentage of Participants With Breast Tenderness [Screening, Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52]
Percentage of participants who reported at least 1 day of breast tenderness during each 4-week period for 1-year on therapy was calculated.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 64 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Generally healthy, postmenopausal women, aged 40 to 64 seeking treatment for menopausal symptoms
-
At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels > 40 mIU/mL
-
Intact Uterus
Exclusion Criteria:
-
Use of oral estrogen, progestin, androgen, or selective estrogen receptor modulator (SERM) containing drug products within 8 weeks before screening
-
A history or active presence of clinically important medical disease: eg. cardiovascular disease (stroke, heart attack), chronic renal or liver disease, breast cancer, etc.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35235 |
| 2 | Pfizer Investigational Site | Mobile | Alabama | United States | 36608 |
| 3 | Pfizer Investigational Site | Chandler | Arizona | United States | 85225 |
| 4 | Pfizer Investigational Site | Glendale | Arizona | United States | 85308 |
| 5 | Pfizer Investigational Site | Mesa | Arizona | United States | 85206 |
| 6 | Pfizer Investigational Site | Peoria | Arizona | United States | 85381 |
| 7 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85032 |
| 8 | Pfizer Investigational Site | Scottsdale | Arizona | United States | 85251 |
| 9 | Pfizer Investigational Site | Tucson | Arizona | United States | 85710 |
| 10 | Pfizer Investigational Site | Tucson | Arizona | United States | 85712 |
| 11 | Pfizer Investigational Site | Tucson | Arizona | United States | 85715 |
| 12 | Pfizer Investigational Site | Little Rock | Arkansas | United States | 72223 |
| 13 | Pfizer Investigational Site | Carmichael | California | United States | 95608 |
| 14 | Pfizer Investigational Site | Sacramento | California | United States | 95821 |
| 15 | Pfizer Investigational Site | San Diego | California | United States | 92103 |
| 16 | Pfizer Investigational Site | San Diego | California | United States | 92108 |
| 17 | Pfizer Investigational Site | San Diego | California | United States | 92123 |
| 18 | Pfizer Investigational Site | Upland | California | United States | 91786 |
| 19 | Pfizer Investigational Site | Vista | California | United States | 92083 |
| 20 | Pfizer Investigational Site | Walnut Creek | California | United States | 94598 |
| 21 | Pfizer Investigational Site | Colorado Springs | Colorado | United States | 80907 |
| 22 | Pfizer Investigational Site | Colorado Springs | Colorado | United States | 80910 |
| 23 | Pfizer Investigational Site | Denver | Colorado | United States | 80218 |
| 24 | Pfizer Investigational Site | Denver | Colorado | United States | 80220 |
| 25 | Pfizer Investigational Site | Lakewood | Colorado | United States | 80228 |
| 26 | Pfizer Investigational Site | New London | Connecticut | United States | 06320 |
| 27 | Pfizer Investigational Site | Boynton Beach | Florida | United States | 33472 |
| 28 | Pfizer Investigational Site | Clearwater | Florida | United States | 33759 |
| 29 | Pfizer Investigational Site | Crystal River | Florida | United States | 34429 |
| 30 | Pfizer Investigational Site | Daytona Beach | Florida | United States | 32114 |
| 31 | Pfizer Investigational Site | Deland | Florida | United States | 32720 |
| 32 | Pfizer Investigational Site | Ft. Lauderdale | Florida | United States | 33316 |
| 33 | Pfizer Investigational Site | Ft. Lauderdale | Florida | United States | 33328 |
| 34 | Pfizer Investigational Site | Ft. Myers | Florida | United States | 33916 |
| 35 | Pfizer Investigational Site | Lake Worth | Florida | United States | 33461 |
| 36 | Pfizer Investigational Site | Miami Springs | Florida | United States | 33166 |
| 37 | Pfizer Investigational Site | Miami | Florida | United States | 33143 |
| 38 | Pfizer Investigational Site | Miami | Florida | United States | 33169 |
| 39 | Pfizer Investigational Site | New Port Richey | Florida | United States | 34652 |
| 40 | Pfizer Investigational Site | Pinellas Park | Florida | United States | 33781 |
| 41 | Pfizer Investigational Site | Sunrise | Florida | United States | 33323 |
| 42 | Pfizer Investigational Site | Tampa | Florida | United States | 33606 |
| 43 | Pfizer Investigational Site | Vero Beach | Florida | United States | 32960 |
| 44 | Pfizer Investigational Site | Atlanta | Georgia | United States | 30342 |
| 45 | Pfizer Investigational Site | Augusta | Georgia | United States | 30909 |
| 46 | Pfizer Investigational Site | Decatur | Georgia | United States | 30033 |
| 47 | Pfizer Investigational Site | Decatur | Georgia | United States | 30319 |
| 48 | Pfizer Investigational Site | Savannah | Georgia | United States | 31405 |
| 49 | Pfizer Investigational Site | Savannah | Georgia | United States | 31406 |
| 50 | Pfizer Investigational Site | Boise | Idaho | United States | 83702 |
| 51 | Pfizer Investigational Site | Idaho Falls | Idaho | United States | 83404 |
| 52 | Pfizer Investigational Site | Meridian | Idaho | United States | 83642 |
| 53 | Pfizer Investigational Site | Chicago | Illinois | United States | 60610 |
| 54 | Pfizer Investigational Site | Rockford | Illinois | United States | 61107 |
| 55 | Pfizer Investigational Site | South Bend | Indiana | United States | 46601 |
| 56 | Pfizer Investigational Site | Overland Park | Kansas | United States | 66210 |
| 57 | Pfizer Investigational Site | Lexington | Kentucky | United States | 40536-0293 |
| 58 | Pfizer Investigational Site | Lousiville | Kentucky | United States | 40291 |
| 59 | Pfizer Investigational Site | Bangor | Maine | United States | 4401 |
| 60 | Pfizer Investigational Site | Ann Arbor | Michigan | United States | 48106 |
| 61 | Pfizer Investigational Site | Kalamazoo | Michigan | United States | 49009 |
| 62 | Pfizer Investigational Site | Paw Paw | Michigan | United States | 49079 |
| 63 | Pfizer Investigational Site | Saginaw | Michigan | United States | 48604 |
| 64 | Pfizer Investigational Site | Southfield | Michigan | United States | 48034 |
| 65 | Pfizer Investigational Site | Brooklyn Center | Minnesota | United States | 55430 |
| 66 | Pfizer Investigational Site | Chaska | Minnesota | United States | 55318 |
| 67 | Pfizer Investigational Site | Robbinsdale | Minnesota | United States | 55422 |
| 68 | Pfizer Investigational Site | St Louis | Missouri | United States | 63131 |
| 69 | Pfizer Investigational Site | Billings | Montana | United States | 59101 |
| 70 | Pfizer Investigational Site | Billings | Montana | United States | 59102 |
| 71 | Pfizer Investigational Site | Lincoln | Nebraska | United States | 68510 |
| 72 | Pfizer Investigational Site | Omaha | Nebraska | United States | 68131 |
| 73 | Pfizer Investigational Site | Las Vegas | Nevada | United States | 89128 |
| 74 | Pfizer Investigational Site | Las Vegas | Nevada | United States | 89146 |
| 75 | Pfizer Investigational Site | North Las Vegas | Nevada | United States | 89030 |
| 76 | Pfizer Investigational Site | Reno | Nevada | United States | 89502 |
| 77 | Pfizer Investigational Site | Lebanon | New Hampshire | United States | 03756 |
| 78 | Pfizer Investigational Site | Brick | New Jersey | United States | 08723 |
| 79 | Pfizer Investigational Site | New Brunswick | New Jersey | United States | 08901 |
| 80 | Pfizer Investigational Site | Albuquerque | New Mexico | United States | 87102 |
| 81 | Pfizer Investigational Site | Albuquerque | New Mexico | United States | 87106 |
| 82 | Pfizer Investigational Site | New York | New York | United States | 10032 |
| 83 | Pfizer Investigational Site | Port Jefferson | New York | United States | 11777 |
| 84 | Pfizer Investigational Site | Charlotte | North Carolina | United States | 29209 |
| 85 | Pfizer Investigational Site | Kernersville | North Carolina | United States | 27284 |
| 86 | Pfizer Investigational Site | Winston-Salem | North Carolina | United States | 27103 |
| 87 | Pfizer Investigational Site | Bismarck | North Dakota | United States | 58501 |
| 88 | Pfizer Investigational Site | Fargo | North Dakota | United States | 58103 |
| 89 | Pfizer Investigational Site | Minot | North Dakota | United States | 58701 |
| 90 | Pfizer Investigational Site | Akron | Ohio | United States | 44311 |
| 91 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45236 |
| 92 | Pfizer Investigational Site | Cleveland | Ohio | United States | 44106-6010 |
| 93 | Pfizer Investigational Site | Cleveland | Ohio | United States | 44122 |
| 94 | Pfizer Investigational Site | Columbus | Ohio | United States | 43213 |
| 95 | Pfizer Investigational Site | Dayton | Ohio | United States | 45439 |
| 96 | Pfizer Investigational Site | Englewood | Ohio | United States | 45322 |
| 97 | Pfizer Investigational Site | Mayfield Heights | Ohio | United States | 44124 |
| 98 | Pfizer Investigational Site | Eugene | Oregon | United States | 97401 |
| 99 | Pfizer Investigational Site | Medford | Oregon | United States | 97504 |
| 100 | Pfizer Investigational Site | Portland | Oregon | United States | 97205 |
| 101 | Pfizer Investigational Site | Erie | Pennsylvania | United States | 16502 |
| 102 | Pfizer Investigational Site | Hopwood | Pennsylvania | United States | 15445 |
| 103 | Pfizer Investigational Site | Jenkintown | Pennsylvania | United States | 19046 |
| 104 | Pfizer Investigational Site | Johnstown | Pennsylvania | United States | 15905 |
| 105 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19104 |
| 106 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19114 |
| 107 | Pfizer Investigational Site | Pittsburgh | Pennsylvania | United States | 15206 |
| 108 | Pfizer Investigational Site | West Reading | Pennsylvania | United States | 19611 |
| 109 | Pfizer Investigational Site | Wexford | Pennsylvania | United States | 15090 |
| 110 | Pfizer Investigational Site | Warwick | Rhode Island | United States | 02886 |
| 111 | Pfizer Investigational Site | Bluffton | South Carolina | United States | 29910 |
| 112 | Pfizer Investigational Site | Greer | South Carolina | United States | 29651 |
| 113 | Pfizer Investigational Site | Hilton Head Island | South Carolina | United States | 29926 |
| 114 | Pfizer Investigational Site | Sioux Falls | South Dakota | United States | 57104 |
| 115 | Pfizer Investigational Site | Sioux Falls | South Dakota | United States | 57105 |
| 116 | Pfizer Investigational Site | Sioux Falls | South Dakota | United States | 67105 |
| 117 | Pfizer Investigational Site | Watertown | South Dakota | United States | 57201 |
| 118 | Pfizer Investigational Site | Chattanooga | Tennessee | United States | 37404 |
| 119 | Pfizer Investigational Site | Jackson | Tennessee | United States | 38305 |
| 120 | Pfizer Investigational Site | Knoxville | Tennessee | United States | 37920 |
| 121 | Pfizer Investigational Site | Memphis | Tennessee | United States | 38120 |
| 122 | Pfizer Investigational Site | Nashville | Tennessee | United States | 37203 |
| 123 | Pfizer Investigational Site | Corpus Christi | Texas | United States | 78414 |
| 124 | Pfizer Investigational Site | Dallas | Texas | United States | 75390 |
| 125 | Pfizer Investigational Site | Denton | Texas | United States | 76210 |
| 126 | Pfizer Investigational Site | Fort Worth | Texas | United States | 76104 |
| 127 | Pfizer Investigational Site | Houston | Texas | United States | 77030 |
| 128 | Pfizer Investigational Site | Irving | Texas | United States | 75061 |
| 129 | Pfizer Investigational Site | Irving | Texas | United States | 75062 |
| 130 | Pfizer Investigational Site | Plano | Texas | United States | 75093 |
| 131 | Pfizer Investigational Site | San Antonio | Texas | United States | 78154 |
| 132 | Pfizer Investigational Site | San Antonio | Texas | United States | 78217 |
| 133 | Pfizer Investigational Site | San Antonio | Texas | United States | 78229 |
| 134 | Pfizer Investigational Site | Waco | Texas | United States | 76712 |
| 135 | Pfizer Investigational Site | Pleasant Grove | Utah | United States | 84062 |
| 136 | Pfizer Investigational Site | Salt Lake City | Utah | United States | 84117 |
| 137 | Pfizer Investigational Site | Sandy | Utah | United States | 84070 |
| 138 | Pfizer Investigational Site | Charlottesville | Virginia | United States | 22903 |
| 139 | Pfizer Investigational Site | Norfolk | Virginia | United States | 23502 |
| 140 | Pfizer Investigational Site | Norfolk | Virginia | United States | 23507 |
| 141 | Pfizer Investigational Site | Richmond | Virginia | United States | 23294 |
| 142 | Pfizer Investigational Site | Seattle | Washington | United States | 98105 |
| 143 | Pfizer Investigational Site | Tacoma | Washington | United States | 98405 |
| 144 | Pfizer Investigational Site | Caba | Buenos Aires | Argentina | C1012AAR |
| 145 | Pfizer Investigational Site | Caba | Buenos Aires | Argentina | C1425AGC |
| 146 | Pfizer Investigational Site | Buenos Aires | Argentina | C1117ABH | |
| 147 | Pfizer Investigational Site | Buenos Aires | Argentina | C1128AAF | |
| 148 | Pfizer Investigational Site | Randwick | New South Wales | Australia | 2031 |
| 149 | Pfizer Investigational Site | St Leonards | New South Wales | Australia | 2065 |
| 150 | Pfizer Investigational Site | Perth | Western Australia | Australia | 6009 |
| 151 | Pfizer Investigational Site | Santiago | RM | Chile | 8320152 |
| 152 | Pfizer Investigational Site | Medellin | Antioquia | Colombia | |
| 153 | Pfizer Investigational Site | Barranquilla | Atlantico | Colombia | |
| 154 | Pfizer Investigational Site | Bogota | Cundinamarca | Colombia | |
| 155 | Pfizer Investigational Site | Aalborg | Denmark | 9000 | |
| 156 | Pfizer Investigational Site | Ballerup | Denmark | 2750 | |
| 157 | Pfizer Investigational Site | Vejle | Denmark | 7100 | |
| 158 | Pfizer Investigational Site | Kuopio | Finland | 70110 | |
| 159 | Pfizer Investigational Site | Oulu | Finland | 90 100 | |
| 160 | Pfizer Investigational Site | Bekescsaba | Hungary | H-5600 | |
| 161 | Pfizer Investigational Site | Budapest | Hungary | 1106 | |
| 162 | Pfizer Investigational Site | Budapest | Hungary | H-1125 | |
| 163 | Pfizer Investigational Site | Debrecen | Hungary | H-4012 | |
| 164 | Pfizer Investigational Site | Debrecen | Hungary | H-4043 | |
| 165 | Pfizer Investigational Site | Kecskemet | Hungary | 6000 | |
| 166 | Pfizer Investigational Site | Nyiregyhaza | Hungary | H-4400 | |
| 167 | Pfizer Investigational Site | Tatabanya | Hungary | H-2800 | |
| 168 | Pfizer Investigational Site | D.F | Mexico | ||
| 169 | Pfizer Investigational Site | Dunedin | NZ | New Zealand | |
| 170 | Pfizer Investigational Site | Wellington | NZ | New Zealand | |
| 171 | Pfizer Investigational Site | Christchurch | New Zealand | 8014 | |
| 172 | Pfizer Investigational Site | Alesund | Norway | NO-6003 | |
| 173 | Pfizer Investigational Site | Hamar | Norway | NO-2317 | |
| 174 | Pfizer Investigational Site | Lublin | Poland | 20-090 | |
| 175 | Pfizer Investigational Site | Poznan | Poland | 60-535 | |
| 176 | Pfizer Investigational Site | Warszawa | Poland | 01-809 | |
| 177 | Pfizer Investigational Site | Warszawa | Poland | 02-341 | |
| 178 | Pfizer Investigational Site | Wroclaw | Poland | 50-088 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00808132
Other Study ID Numbers:
- 3115A1-3307
- B2311009
First Posted:
Dec 15, 2008
Last Update Posted:
Apr 8, 2014
Last Verified:
Mar 1, 2014
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | This main study also included 3 sub-studies only for the purpose of the assessment of relevant parameters: breast density sub-study, osteoporosis sub-study (OSS), and sleep sub-study. A participant could participate in more than 1 sub-study. |
| Arm/Group Title | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. |
| Period Title: Overall Study | |||||
| STARTED | 455 | 481 | 239 | 228 | 483 |
| Treated | 445 | 474 | 230 | 220 | 474 |
| COMPLETED | 357 | 393 | 185 | 159 | 383 |
| NOT COMPLETED | 98 | 88 | 54 | 69 | 100 |
Baseline Characteristics
| Arm/Group Title | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Total of all reporting groups |
| Overall Participants | 445 | 474 | 230 | 220 | 474 | 1843 |
| Age (Years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [Years] |
54.43
(4.02)
|
53.89
(4.00)
|
54.07
(4.01)
|
54.15
(4.50)
|
54.19
(4.07)
|
54.15
(4.09)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
445
100%
|
474
100%
|
230
100%
|
220
100%
|
474
100%
|
1843
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study |
|---|---|
| Description | Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis. |
| Time Frame | Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy evaluable (EE) population included all randomized participants who took at least 1 dose of study drug, who had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had a biopsy during Month 12, or had hyperplasia diagnosed before Month 12 and had no major protocol violations. |
| Arm/Group Title | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. |
| Measure Participants | 335 | 368 | 169 | 149 | 354 |
| Definition 1 |
0.30
0.1%
|
0.54
0.1%
|
0.00
0%
|
0.00
0%
|
0.85
0.2%
|
| Definition 2 |
0.30
0.1%
|
0.27
0.1%
|
0.00
0%
|
0.00
0%
|
0.28
0.1%
|
| Title | Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study |
|---|---|
| Description | BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported. |
| Time Frame | Baseline, Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intent-to-Treat (MITT) population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had a baseline and at least 1 post baseline value. Last Observation Carried Forward (LOCF) method was used to impute missing values. |
| Arm/Group Title | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. |
| Measure Participants | 119 | 139 | 56 | 59 | 139 |
| Least Squares Mean (Standard Error) [Percent Change] |
0.24
(0.29)
|
0.60
(0.27)
|
0.07
(0.40)
|
1.30
(0.39)
|
-1.28
(0.28)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Analysis of covariance (ANCOVA) model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares (LS) Mean Difference |
| Estimated Value | 1.51 | |
| Confidence Interval |
(2-Sided) 95% 0.822 to 2.201 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 1.87 | |
| Confidence Interval |
(2-Sided) 95% 1.209 to 2.533 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study |
|---|---|
| Description | BMD measurements of the anteroposterior lumbar spine were acquired by using DXA scans, twice at Month 6 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported. |
| Time Frame | Baseline, Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had baseline and at least 1 post baseline value. LOCF method was used to impute missing values. Here "N" signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. |
| Measure Participants | 115 | 136 | 55 | 58 | 135 |
| Least Squares Mean (Standard Error) [Percent Change] |
0.12
(0.28)
|
0.51
(0.26)
|
0.00
(0.39)
|
0.64
(0.37)
|
-0.68
(0.27)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.017 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.80 | |
| Confidence Interval |
(2-Sided) 95% 0.139 to 1.470 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 1.19 | |
| Confidence Interval |
(2-Sided) 95% 0.556 to 1.830 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study |
|---|---|
| Description | BMD measurements of the total hip were acquired by using DXA scans, twice at Month 6 and 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported. |
| Time Frame | Baseline, Month 6, Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT for osteoporosis sub-study. LOCF method was used to impute missing values. Here "n" signifies participants who were evaluable at specified time points for each arm, respectively. |
| Arm/Group Title | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. |
| Measure Participants | 119 | 139 | 56 | 59 | 139 |
| Change at Month 6 (n=117, 136, 55, 57, 134) |
0.43
(0.18)
|
0.66
(0.17)
|
0.32
(0.25)
|
0.45
(0.24)
|
-0.90
(0.17)
|
| Change at Month 12 (n=119, 139, 56, 59, 139) |
0.50
(0.20)
|
0.89
(0.18)
|
0.47
(0.27)
|
0.71
(0.26)
|
-0.72
(0.18)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 1.32 | |
| Confidence Interval |
(2-Sided) 95% 0.901 to 1.742 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 1.21 | |
| Confidence Interval |
(2-Sided) 95% 0.756 to 1.671 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 1.56 | |
| Confidence Interval |
(2-Sided) 95% 1.152 to 1.962 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 1.60 | |
| Confidence Interval |
(2-Sided) 95% 1.164 to 2.044 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With Cumulative Amenorrhea: Main Study |
|---|---|
| Description | Cumulative amenorrhea was defined as the absence of any bleeding or spotting for cumulative 4-week periods throughout 1-year study. |
| Time Frame | Day 1 up to Day 364 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population included all randomized participants who received at least 1 dose of the study drug, and had at least 1 day of on-therapy bleeding data. Here "N" signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. |
| Measure Participants | 355 | 390 | 187 | 158 | 379 |
| Number [Percentage of Participants] |
87.89
19.8%
|
84.87
17.9%
|
82.35
35.8%
|
54.43
24.7%
|
83.91
17.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.138 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.765 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study |
|---|---|
| Description | Breast density was assessed by digitalized mammograms which were centrally read by a single radiologist using specifically-developed software. Breast density was assessed for subset of participants who entered the breast density sub-study |
| Time Frame | Baseline, Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-Protocol (PP) population included all randomized participants who met inclusion criteria for breast density sub-study, who had a baseline and at least 1 post-baseline breast density evaluation and did not have substantial protocol violations. Here "N" signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. |
| Measure Participants | 186 | 190 | 97 | 68 | 181 |
| Least Squares Mean (Standard Error) [Percent Change] |
-0.38
(0.22)
|
-0.45
(0.22)
|
-0.25
(0.30)
|
1.60
(0.35)
|
-0.32
(0.23)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.832 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.632 to 0.509 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.651 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.13 | |
| Confidence Interval |
(2-Sided) 95% -0.696 to 0.436 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study |
|---|---|
| Description | Bone turnover is the removal of old bone from the body and its replacement by new bone. Bone turnover markers included serum osteocalcin, C-telopeptide, and procollagen type 1 N-propeptide (P1NP), were measured at Month 6 and Month 12 for a subset of participants who entered the osteoporosis substudy. Blood samples were collected to evaluate bone turnover markers levels. |
| Time Frame | Baseline, Month 6, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT for osteoporosis substudy. Here "N" signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable at specified time points for each arm respectively. |
| Arm/Group Title | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. |
| Measure Participants | 115 | 136 | 57 | 56 | 134 |
| Osteocalcin: Month 6 (n=115, 136, 56, 56, 134) |
-25.21
|
-27.79
|
-15.60
|
-25.34
|
-3.19
|
| Osteocalcin: Month 12 (n=104, 127, 52, 50, 125) |
-30.46
|
-37.02
|
-16.05
|
-32.79
|
-5.28
|
| C-Telopeptide: Month 6 (n=115, 136, 56, 56, 133) |
-34.16
|
-41.41
|
-29.37
|
-54.05
|
-10.17
|
| C-Telopeptide: Month 12 (n=104, 127, 52,50,124) |
-40.86
|
-50.06
|
-27.39
|
-52.56
|
-5.52
|
| P1NP: Month 6 (n=114,135, 57, 56, 133) |
-33.73
|
-30.26
|
-17.38
|
-39.99
|
5.99
|
| P1NP: Month 12 (n=103, 127, 53, 50, 125) |
-42.38
|
-43.58
|
-23.97
|
-50.19
|
-11.13
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Bazedoxifene 20 mg |
|---|---|---|
| Comments | Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0074 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Bazedoxifene 20 mg |
|---|---|---|
| Comments | Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Bazedoxifene 20 mg |
|---|---|---|
| Comments | Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Bazedoxifene 20 mg |
|---|---|---|
| Comments | Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg, Placebo |
|---|---|---|
| Comments | Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg, Placebo |
|---|---|---|
| Comments | Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0016 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg, Placebo |
|---|---|---|
| Comments | Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg, Placebo |
|---|---|---|
| Comments | Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Bazedoxifene 20 mg |
|---|---|---|
| Comments | C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1058 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Bazedoxifene 20 mg |
|---|---|---|
| Comments | C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0024 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Bazedoxifene 20 mg |
|---|---|---|
| Comments | C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Bazedoxifene 20 mg |
|---|---|---|
| Comments | C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg, Placebo |
|---|---|---|
| Comments | C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg, Placebo |
|---|---|---|
| Comments | C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0012 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg, Placebo |
|---|---|---|
| Comments | C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg, Placebo |
|---|---|---|
| Comments | C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Bazedoxifene 20 mg |
|---|---|---|
| Comments | P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0029 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Bazedoxifene 20 mg |
|---|---|---|
| Comments | P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0046 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Bazedoxifene 20 mg |
|---|---|---|
| Comments | P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0043 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Bazedoxifene 20 mg |
|---|---|---|
| Comments | P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg, Placebo |
|---|---|---|
| Comments | P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0016 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg, Placebo |
|---|---|---|
| Comments | P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg, Placebo |
|---|---|---|
| Comments | P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg, Placebo |
|---|---|---|
| Comments | P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study |
|---|---|
| Description | Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm. |
| Arm/Group Title | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. |
| Measure Participants | 112 | 121 | 47 | 52 | 111 |
| SD (n=112, 121, 47, 52, 111) |
48.9
(22.9)
|
48.2
(21.7)
|
50.5
(24.4)
|
50.4
(21.1)
|
47.8
(24.6)
|
| Snoring (n=110, 121, 47, 51, 108) |
32.1
(30.1)
|
27.6
(26.9)
|
37.9
(30.7)
|
33.1
(29.6)
|
34.4
(30.5)
|
| ASoB or H (n=112, 121, 47,52,111) |
12.5
(19.2)
|
11.9
(19.4)
|
13.2
(20.1)
|
13.1
(20.2)
|
12.1
(20.4)
|
| Somnolence (n=112, 121, 47, 52, 111) |
36.3
(21.6)
|
30.0
(20.1)
|
34.6
(23.5)
|
28.7
(19.4)
|
31.2
(19.2)
|
| SA (n=112, 121, 47, 52, 111) |
39.3
(24.3)
|
41.7
(23.9)
|
37.4
(23.2)
|
36.5
(20.6)
|
40.3
(23.6)
|
| SPI I (n=112, 121, 47, 52, 111) |
44.5
(17.3)
|
42.0
(16.7)
|
44.7
(18.2)
|
44.9
(16.0)
|
43.4
(18.1)
|
| SPI II (n=112, 121, 47, 52, 111) |
45.5
(17.2)
|
43.2
(16.8)
|
46.4
(18.0)
|
45.2
(16.1)
|
43.7
(18.3)
|
| SQ (n=111, 121, 47, 52, 111) |
6.2
(1.1)
|
6.1
(1.1)
|
5.9
(1.1)
|
6.2
(1.3)
|
6.2
(1.1)
|
| Title | Percentage of Participants With Breast Tenderness |
|---|---|
| Description | Percentage of participants who reported at least 1 day of breast tenderness during each 4-week period for 1-year on therapy was calculated. |
| Time Frame | Screening, Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population included all randomized participants who took 1 dose of study drug and had at least 20 days of data available at screening and at least 20 continuous days of data in at least one 4-week interval after baseline. |
| Arm/Group Title | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. |
| Measure Participants | 429 | 449 | 220 | 206 | 457 |
| Screening (n=429, 449, 220, 206, 457) |
6.29
1.4%
|
6.46
1.4%
|
4.55
2%
|
7.28
3.3%
|
6.56
1.4%
|
| Week 1-4 (n=426, 449, 220, 205, 457) |
9.39
2.1%
|
9.13
1.9%
|
5.91
2.6%
|
20.49
9.3%
|
8.32
1.8%
|
| Week 5-8 (n=423, 447, 216, 202, 456) |
8.04
1.8%
|
6.94
1.5%
|
7.87
3.4%
|
24.26
11%
|
8.55
1.8%
|
| Week 9-12 (n=412, 439, 212, 196, 447) |
5.83
1.3%
|
7.97
1.7%
|
6.60
2.9%
|
23.98
10.9%
|
5.37
1.1%
|
| Week 13-16 (n=411, 433, 208, 193, 440) |
7.06
1.6%
|
8.31
1.8%
|
8.65
3.8%
|
21.24
9.7%
|
5.91
1.2%
|
| Week 17-20 (n=395, 412, 197, 181, 420) |
4.05
0.9%
|
4.37
0.9%
|
6.09
2.6%
|
17.13
7.8%
|
4.29
0.9%
|
| Week 21-24 (n=391, 410, 195, 180, 416) |
4.60
1%
|
3.90
0.8%
|
5.64
2.5%
|
15.00
6.8%
|
4.33
0.9%
|
| Week 25-28 (n=389, 409, 193, 179, 416) |
3.08
0.7%
|
5.62
1.2%
|
4.15
1.8%
|
15.64
7.1%
|
4.09
0.9%
|
| Week 29-32 (n=372, 403, 190, 171, 401) |
4.57
1%
|
3.97
0.8%
|
1.58
0.7%
|
15.20
6.9%
|
2.00
0.4%
|
| Week 33-36 (n=369, 401, 188, 168, 395) |
2.98
0.7%
|
3.49
0.7%
|
3.19
1.4%
|
12.50
5.7%
|
2.28
0.5%
|
| Week 37-40 (n=369, 399, 187, 166, 390) |
4.07
0.9%
|
4.01
0.8%
|
2.67
1.2%
|
12.05
5.5%
|
3.08
0.6%
|
| Week 41-44 (n=359, 384, 184, 159, 382) |
3.62
0.8%
|
2.60
0.5%
|
1.63
0.7%
|
9.43
4.3%
|
2.62
0.6%
|
| Week 45-48 (n=354, 382, 184, 157, 379) |
3.67
0.8%
|
3.14
0.7%
|
2.17
0.9%
|
10.83
4.9%
|
3.17
0.7%
|
| Week 49-52 (n=353, 380, 183, 156, 376) |
3.12
0.7%
|
2.89
0.6%
|
1.64
0.7%
|
9.62
4.4%
|
2.66
0.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.546 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.821 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.698 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.446 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.892 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.810 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.473 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.030 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.453 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.391 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.407 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.644 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.666 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.641 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.361 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.100 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.142 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.906 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.798 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.258 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.058 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.230 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.360 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.892 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.912 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.791 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study |
|---|---|
| Description | Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment. |
| Time Frame | Baseline, Month 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm. |
| Arm/Group Title | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. |
| Measure Participants | 112 | 121 | 47 | 52 | 111 |
| SD (n=112, 121, 47, 52, 111) |
-17.27
(2.01)
|
-18.18
(1.94)
|
-11.64
(2.94)
|
-18.01
(2.79)
|
-14.34
(2.01)
|
| Snoring (n=110, 121, 47, 51, 108) |
-5.86
(1.83)
|
-5.38
(1.76)
|
-2.54
(2.67)
|
-2.90
(2.55)
|
-2.71
(1.84)
|
| ASoB or H (n=112,121,47,52,111) |
-4.26
(1.41)
|
-5.81
(1.35)
|
-3.12
(2.06)
|
-3.62
(1.95)
|
-3.63
(1.40)
|
| Somnolence (n=112,121,47,52,111) |
-10.54
(1.53)
|
-9.72
(1.48)
|
-6.12
(2.25)
|
-7.36
(2.14)
|
-10.55
(1.53)
|
| SA (n=112, 121, 47, 52, 111) |
14.22
(2.40)
|
14.30
(2.32)
|
9.10
(3.52)
|
15.10
(3.34)
|
11.46
(2.40)
|
| SPI I (n=112, 121, 47, 52, 111) |
-13.19
(1.51)
|
-13.99
(1.46)
|
-8.92
(2.21)
|
-13.71
(2.09)
|
-11.84
(1.50)
|
| SPI II (n=112, 121, 47, 52,111) |
-14.01
(1.51)
|
-14.53
(1.46)
|
-9.64
(2.21)
|
-14.12
(2.10)
|
-12.04
(1.51)
|
| SQ (n=111, 121, 47, 52, 111) |
0.28
(0.10)
|
0.44
(0.09)
|
0.32
(0.14)
|
0.41
(0.13)
|
0.36
(0.10)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.253 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -2.93 | |
| Confidence Interval |
(2-Sided) 95% -7.96 to 2.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.127 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -3.84 | |
| Confidence Interval |
(2-Sided) 95% -8.78 to 1.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.180 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -3.15 | |
| Confidence Interval |
(2-Sided) 95% -7.76 to 1.46 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.247 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -2.67 | |
| Confidence Interval |
(2-Sided) 95% -7.19 to 1.85 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.726 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.63 | |
| Confidence Interval |
(2-Sided) 95% -4.15 to 2.90 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.218 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -2.17 | |
| Confidence Interval |
(2-Sided) 95% -5.63 to 1.29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.996 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.01 | |
| Confidence Interval |
(2-Sided) 95% -3.85 to 3.87 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.665 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean DIfference |
| Estimated Value | 0.83 | |
| Confidence Interval |
(2-Sided) 95% -2.94 to 4.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Sleep adequacy: Month 3, ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.368 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 2.76 | |
| Confidence Interval |
(2-Sided) 95% -3.26 to 8.78 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Sleep adequacy: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.345 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 2.84 | |
| Confidence Interval |
(2-Sided) 95% -3.07 to 8.75 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.482 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.35 | |
| Confidence Interval |
(2-Sided) 95% -5.12 to 2.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.254 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean DIfference |
| Estimated Value | -2.15 | |
| Confidence Interval |
(2-Sided) 95% -5.86 to 1.55 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.308 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.97 | |
| Confidence Interval |
(2-Sided) 95% -5.76 to 1.82 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.190 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -2.48 | |
| Confidence Interval |
(2-Sided) 95% -6.20 to 1.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.550 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.07 | |
| Confidence Interval |
(2-Sided) 95% -0.32 to 0.17 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.477 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.09 | |
| Confidence Interval |
(2-Sided) 95% -0.15 to 0.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study |
|---|---|
| Description | MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm. |
| Arm/Group Title | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. |
| Measure Participants | 111 | 121 | 47 | 52 | 112 |
| Vasomotor function (n=111, 121, 47, 52, 112) |
5.40
(1.564)
|
5.60
(1.468)
|
5.87
(1.246)
|
5.65
(1.620)
|
5.62
(1.596)
|
| Psychosocial function (n=111, 121, 47, 52, 112) |
3.46
(1.716)
|
3.41
(1.628)
|
3.49
(1.663)
|
3.48
(1.793)
|
3.22
(1.522)
|
| Physical function (n=111, 121, 47, 52, 112) |
3.74
(1.377)
|
3.58
(1.385)
|
3.96
(1.475)
|
3.74
(1.409)
|
3.58
(1.445)
|
| Sexual function (n=110, 121, 47, 52, 112) |
3.74
(2.200)
|
3.63
(2.182)
|
4.05
(2.265)
|
3.73
(2.238)
|
3.83
(2.243)
|
| MENQOL Total Score (n=110, 121, 47, 52, 112) |
4.07
(1.227)
|
4.05
(1.246)
|
4.34
(1.156)
|
4.15
(1.314)
|
4.06
(1.155)
|
| Title | Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study |
|---|---|
| Description | MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. |
| Time Frame | Baseline, Month 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here "N": maximum number of participants who were evaluable for this outcome and "n": participants who were evaluable at specified time points for each arm. |
| Arm/Group Title | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. |
| Measure Participants | 111 | 121 | 47 | 52 | 112 |
| Vasomotor function (n=111, 121, 47, 52, 112) |
-2.37
(0.17)
|
-2.75
(0.17)
|
-1.25
(0.25)
|
-3.19
(0.24)
|
-1.45
(0.17)
|
| Psychosocial function (n=111, 121, 47, 52, 112) |
-0.67
(0.12)
|
-0.84
(0.12)
|
-0.47
(0.18)
|
-0.83
(0.17)
|
-0.74
(0.12)
|
| Physical function (n=111, 121, 47, 52, 112) |
-0.92
(0.10)
|
-1.11
(0.10)
|
-0.67
(0.15)
|
-0.76
(0.14)
|
-0.87
(0.10)
|
| Sexual function (n=110, 121, 47, 52, 112) |
-1.20
(0.16)
|
-1.40
(0.15)
|
-0.09
(0.23)
|
-0.76
(0.22)
|
-1.04
(0.16)
|
| MENQOL Total Score (n=110, 121, 47, 52, 112) |
-1.27
(0.10)
|
-1.53
(0.10)
|
-0.63
(0.15)
|
-1.39
(0.14)
|
-1.03
(0.10)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.680 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.493 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.698 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.055 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.428 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.071 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | Percentage of Participants With Uterine Bleeding |
|---|---|
| Description | Percentage of participants with uterine bleeding were calculated for each 4-week period for 1-year on therapy. |
| Time Frame | Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population included all randomized participants who took at least 1 dose of the study drug, and had at least 1 day of on-therapy bleeding data. Here "N" signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable at specified time points for each arm respectively. |
| Arm/Group Title | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. |
| Measure Participants | 440 | 468 | 229 | 216 | 470 |
| Week 1-4 (n=440, 468, 229, 216, 470) |
3.86
0.9%
|
6.20
1.3%
|
5.68
2.5%
|
20.83
9.5%
|
4.68
1%
|
| Week 5-8 (n=428, 458, 221, 205, 462) |
4.44
1%
|
5.02
1.1%
|
3.62
1.6%
|
24.39
11.1%
|
4.11
0.9%
|
| Week 9-12 (n=417, 451, 217, 199, 452) |
2.16
0.5%
|
3.55
0.7%
|
2.76
1.2%
|
25.63
11.7%
|
4.42
0.9%
|
| Week 13-16 (n=415, 446, 213, 196, 446) |
2.41
0.5%
|
2.91
0.6%
|
3.29
1.4%
|
24.49
11.1%
|
3.36
0.7%
|
| Week 17-20 (n=399,426,201,184,427) |
2.26
0.5%
|
2.58
0.5%
|
2.49
1.1%
|
18.48
8.4%
|
3.51
0.7%
|
| Week 21-24 (n=395, 424, 199, 183, 423) |
2.78
0.6%
|
2.12
0.4%
|
2.01
0.9%
|
18.58
8.4%
|
3.31
0.7%
|
| Week 25-28 (n=393, 422, 197, 182, 420) |
2.04
0.5%
|
2.13
0.4%
|
1.02
0.4%
|
14.84
6.7%
|
3.33
0.7%
|
| Week 29-32 (n=376, 416, 194, 173, 405) |
1.60
0.4%
|
1.68
0.4%
|
1.55
0.7%
|
12.14
5.5%
|
1.73
0.4%
|
| Week 33-36 (n=373, 413, 192, 170, 399) |
0.54
0.1%
|
2.91
0.6%
|
2.08
0.9%
|
12.94
5.9%
|
2.26
0.5%
|
| Week 37-40 (n=373, 411, 191, 168, 394) |
1.61
0.4%
|
2.92
0.6%
|
1.57
0.7%
|
14.29
6.5%
|
4.82
1%
|
| Week 41-44 (n=363, 396, 188, 162, 386) |
1.38
0.3%
|
1.26
0.3%
|
0.00
0%
|
13.58
6.2%
|
1.55
0.3%
|
| Week 45-48 (n=358, 394, 188, 160, 383) |
0.84
0.2%
|
2.28
0.5%
|
0.53
0.2%
|
14.38
6.5%
|
2.09
0.4%
|
| Week 49-52 (n=357, 392, 187, 159, 380) |
1.68
0.4%
|
1.28
0.3%
|
1.07
0.5%
|
8.81
4%
|
1.58
0.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 1-4: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.624 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 5-8: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.868 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 9-12: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.087 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 13-16: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.425 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg |
|---|---|---|
| Comments | Week 17-20: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.307 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 21-24: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.689 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 25-28: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.285 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 29-32: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.000 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 33-36: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.065 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 37-40: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 41-44: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.000 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 45-48: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.226 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Placebo |
|---|---|---|
| Comments | Week 49-52: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.000 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 1-4: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 5-8: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 9-12: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 13-16: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 17-20: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 21-24: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 25-28: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 29-32: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 33-36: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 37-40: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 41-44: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 45-48: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 49-52: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 1-4: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.317 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 5-8: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.531 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 9-12: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.610 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 13-16: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.848 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 17-20: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.551 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 21-24: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.300 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 25-28: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.299 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 29-32: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.000 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 33-36: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.660 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 37-40: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.199 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 37
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 41-44: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.770 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 38
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 45-48: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.000 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 39
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Placebo |
|---|---|---|
| Comments | Week 49-52: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.769 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 40
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 1-4: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 41
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 5-8: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 42
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 9-12: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 43
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 13-16: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 44
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 17-20: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 45
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 21-24: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 46
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 25-28: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 47
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 29-32: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 48
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 33-36: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 49
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 37-40: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 50
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 41-44: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 51
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 45-48: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 52
| Statistical Analysis Overview | Comparison Group Selection | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg, Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg |
|---|---|---|
| Comments | Week 49-52: The Fisher exact test was used for comparisons between groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Adverse Events
| Time Frame | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo | |||||
| Arm/Group Description | Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year. | |||||
All Cause Mortality |
||||||||||
| Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 16/445 (3.6%) | 17/474 (3.6%) | 5/230 (2.2%) | 13/220 (5.9%) | 18/474 (3.8%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Leukocytosis | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
| Cardiac disorders | ||||||||||
| Angina pectoris | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Arteriosclerosis coronary artery | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Atrial fibrillation | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Myocardial infarction | 1/445 (0.2%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Congenital, familial and genetic disorders | ||||||||||
| Atrial septal defect | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Acute vestibular syndrome | 1/445 (0.2%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Vertigo | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Vertigo positional | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Endocrine disorders | ||||||||||
| Autoimmune thyroiditis | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal pain upper | 1/445 (0.2%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Colitis ulcerative | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Duodenitis | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Erosive oesophagitis | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Gastritis | 1/445 (0.2%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Gastritis erosive | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Gastrointestinal haemorrhage | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Ileus | 0/445 (0%) | 0/474 (0%) | 1/230 (0.4%) | 0/220 (0%) | 0/474 (0%) | |||||
| General disorders | ||||||||||
| Non-cardiac chest pain | 1/445 (0.2%) | 0/474 (0%) | 1/230 (0.4%) | 1/220 (0.5%) | 1/474 (0.2%) | |||||
| Pyrexia | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Cholecystitis | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
| Cholecystitis acute | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Cholelithiasis | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Infections and infestations | ||||||||||
| Appendicitis | 1/445 (0.2%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Cellulitis | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Diverticulitis | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Lyme disease | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Pneumonia | 0/445 (0%) | 0/474 (0%) | 1/230 (0.4%) | 0/220 (0%) | 0/474 (0%) | |||||
| Pneumonia bacterial | 0/445 (0%) | 0/474 (0%) | 1/230 (0.4%) | 0/220 (0%) | 0/474 (0%) | |||||
| Pyelonephritis | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Clavicle fracture | 0/445 (0%) | 0/474 (0%) | 1/230 (0.4%) | 0/220 (0%) | 0/474 (0%) | |||||
| Contusion | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
| Head injury | 0/445 (0%) | 0/474 (0%) | 1/230 (0.4%) | 0/220 (0%) | 0/474 (0%) | |||||
| Humerus fracture | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Muscle rupture | 1/445 (0.2%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Patella fracture | 0/445 (0%) | 0/474 (0%) | 1/230 (0.4%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Procedural pain | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Road traffic accident | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
| Thoracic vertebral fracture | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Traumatic lung injury | 0/445 (0%) | 0/474 (0%) | 1/230 (0.4%) | 0/220 (0%) | 0/474 (0%) | |||||
| Investigations | ||||||||||
| Alanine aminotransferase increased | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Aspartate aminotransferase increased | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Dehydration | 0/445 (0%) | 0/474 (0%) | 1/230 (0.4%) | 0/220 (0%) | 0/474 (0%) | |||||
| Hypoglycaemia | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Intervertebral disc protrusion | 2/445 (0.4%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Osteosclerosis | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
| Pain in extremity | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Basal cell carcinoma | 2/445 (0.4%) | 2/474 (0.4%) | 1/230 (0.4%) | 3/220 (1.4%) | 2/474 (0.4%) | |||||
| Benign fallopian tube neoplasm | 0/445 (0%) | 0/474 (0%) | 1/230 (0.4%) | 0/220 (0%) | 0/474 (0%) | |||||
| Breast cancer | 1/445 (0.2%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Breast cancer metastatic | 1/445 (0.2%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Breast cancer stage II | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
| Colon cancer stage IV | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
| Hepatic cancer metastatic | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
| Hodgkin's disease | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Lung cancer metastatic | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
| Malignant melanoma | 2/445 (0.4%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Metastases to spine | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
| Salivary gland adenoma | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Squamous cell carcinoma | 1/445 (0.2%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
| Squamous cell carcinoma of skin | 1/445 (0.2%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Nervous system disorders | ||||||||||
| Cerebrovascular accident | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Complex partial seizures | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Migraine | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
| Migraine with aura | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Anxiety | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Anxiety disorder | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Depression | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Nephrolithiasis | 0/445 (0%) | 1/474 (0.2%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Haemoptysis | 1/445 (0.2%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Urticaria | 0/445 (0%) | 0/474 (0%) | 1/230 (0.4%) | 0/220 (0%) | 0/474 (0%) | |||||
| Vascular disorders | ||||||||||
| Circulatory collapse | 1/445 (0.2%) | 0/474 (0%) | 0/230 (0%) | 0/220 (0%) | 0/474 (0%) | |||||
| Deep vein thrombosis | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
| Hypertensive emergency | 0/445 (0%) | 0/474 (0%) | 0/230 (0%) | 1/220 (0.5%) | 0/474 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg | Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg | Bazedoxifene 20 mg | Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 407/445 (91.5%) | 426/474 (89.9%) | 207/230 (90%) | 197/220 (89.5%) | 423/474 (89.2%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal discomfort | 11/445 (2.5%) | 13/474 (2.7%) | 8/230 (3.5%) | 6/220 (2.7%) | 10/474 (2.1%) | |||||
| Abdominal distension | 9/445 (2%) | 13/474 (2.7%) | 4/230 (1.7%) | 7/220 (3.2%) | 13/474 (2.7%) | |||||
| Abdominal pain | 23/445 (5.2%) | 34/474 (7.2%) | 15/230 (6.5%) | 13/220 (5.9%) | 31/474 (6.5%) | |||||
| Abdominal pain lower | 5/445 (1.1%) | 5/474 (1.1%) | 6/230 (2.6%) | 8/220 (3.6%) | 3/474 (0.6%) | |||||
| Abdominal pain upper | 21/445 (4.7%) | 21/474 (4.4%) | 7/230 (3%) | 9/220 (4.1%) | 17/474 (3.6%) | |||||
| Constipation | 20/445 (4.5%) | 25/474 (5.3%) | 14/230 (6.1%) | 14/220 (6.4%) | 20/474 (4.2%) | |||||
| Diarrhoea | 33/445 (7.4%) | 36/474 (7.6%) | 13/230 (5.7%) | 13/220 (5.9%) | 24/474 (5.1%) | |||||
| Dyspepsia | 24/445 (5.4%) | 13/474 (2.7%) | 9/230 (3.9%) | 11/220 (5%) | 14/474 (3%) | |||||
| Flatulence | 13/445 (2.9%) | 9/474 (1.9%) | 2/230 (0.9%) | 4/220 (1.8%) | 11/474 (2.3%) | |||||
| Gastritis | 4/445 (0.9%) | 2/474 (0.4%) | 5/230 (2.2%) | 2/220 (0.9%) | 3/474 (0.6%) | |||||
| Gastrooesophageal reflux disease | 4/445 (0.9%) | 4/474 (0.8%) | 1/230 (0.4%) | 0/220 (0%) | 12/474 (2.5%) | |||||
| Nausea | 32/445 (7.2%) | 29/474 (6.1%) | 8/230 (3.5%) | 11/220 (5%) | 26/474 (5.5%) | |||||
| Toothache | 21/445 (4.7%) | 20/474 (4.2%) | 8/230 (3.5%) | 8/220 (3.6%) | 17/474 (3.6%) | |||||
| Vomiting | 14/445 (3.1%) | 10/474 (2.1%) | 7/230 (3%) | 6/220 (2.7%) | 12/474 (2.5%) | |||||
| General disorders | ||||||||||
| Fatigue | 12/445 (2.7%) | 12/474 (2.5%) | 7/230 (3%) | 4/220 (1.8%) | 12/474 (2.5%) | |||||
| Oedema peripheral | 10/445 (2.2%) | 4/474 (0.8%) | 3/230 (1.3%) | 4/220 (1.8%) | 5/474 (1.1%) | |||||
| Pain | 20/445 (4.5%) | 24/474 (5.1%) | 16/230 (7%) | 7/220 (3.2%) | 22/474 (4.6%) | |||||
| Pyrexia | 10/445 (2.2%) | 10/474 (2.1%) | 5/230 (2.2%) | 5/220 (2.3%) | 6/474 (1.3%) | |||||
| Immune system disorders | ||||||||||
| Seasonal allergy | 14/445 (3.1%) | 14/474 (3%) | 4/230 (1.7%) | 6/220 (2.7%) | 9/474 (1.9%) | |||||
| Infections and infestations | ||||||||||
| Bronchitis | 8/445 (1.8%) | 14/474 (3%) | 8/230 (3.5%) | 9/220 (4.1%) | 14/474 (3%) | |||||
| Cystitis | 10/445 (2.2%) | 11/474 (2.3%) | 8/230 (3.5%) | 6/220 (2.7%) | 6/474 (1.3%) | |||||
| Ear infection | 3/445 (0.7%) | 6/474 (1.3%) | 1/230 (0.4%) | 6/220 (2.7%) | 4/474 (0.8%) | |||||
| Gastroenteritis | 3/445 (0.7%) | 5/474 (1.1%) | 4/230 (1.7%) | 5/220 (2.3%) | 7/474 (1.5%) | |||||
| Influenza | 27/445 (6.1%) | 30/474 (6.3%) | 18/230 (7.8%) | 13/220 (5.9%) | 23/474 (4.9%) | |||||
| Nasopharyngitis | 91/445 (20.4%) | 72/474 (15.2%) | 44/230 (19.1%) | 32/220 (14.5%) | 65/474 (13.7%) | |||||
| Sinusitis | 42/445 (9.4%) | 37/474 (7.8%) | 19/230 (8.3%) | 12/220 (5.5%) | 33/474 (7%) | |||||
| Tooth infection | 8/445 (1.8%) | 11/474 (2.3%) | 6/230 (2.6%) | 3/220 (1.4%) | 11/474 (2.3%) | |||||
| Upper respiratory tract infection | 36/445 (8.1%) | 38/474 (8%) | 9/230 (3.9%) | 13/220 (5.9%) | 30/474 (6.3%) | |||||
| Urinary tract infection | 30/445 (6.7%) | 20/474 (4.2%) | 14/230 (6.1%) | 5/220 (2.3%) | 33/474 (7%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Contusion | 7/445 (1.6%) | 3/474 (0.6%) | 4/230 (1.7%) | 4/220 (1.8%) | 15/474 (3.2%) | |||||
| Muscle strain | 7/445 (1.6%) | 9/474 (1.9%) | 8/230 (3.5%) | 5/220 (2.3%) | 16/474 (3.4%) | |||||
| Post procedural haemorrhage | 9/445 (2%) | 8/474 (1.7%) | 4/230 (1.7%) | 5/220 (2.3%) | 13/474 (2.7%) | |||||
| Procedural pain | 26/445 (5.8%) | 36/474 (7.6%) | 6/230 (2.6%) | 14/220 (6.4%) | 30/474 (6.3%) | |||||
| Investigations | ||||||||||
| Blood cholesterol increased | 10/445 (2.2%) | 5/474 (1.1%) | 7/230 (3%) | 1/220 (0.5%) | 7/474 (1.5%) | |||||
| Gamma-glutamyltransferase increased | 10/445 (2.2%) | 3/474 (0.6%) | 2/230 (0.9%) | 2/220 (0.9%) | 3/474 (0.6%) | |||||
| Low density lipoprotein increased | 4/445 (0.9%) | 3/474 (0.6%) | 5/230 (2.2%) | 1/220 (0.5%) | 4/474 (0.8%) | |||||
| Weight increased | 11/445 (2.5%) | 13/474 (2.7%) | 5/230 (2.2%) | 9/220 (4.1%) | 22/474 (4.6%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 42/445 (9.4%) | 49/474 (10.3%) | 22/230 (9.6%) | 19/220 (8.6%) | 47/474 (9.9%) | |||||
| Arthritis | 4/445 (0.9%) | 2/474 (0.4%) | 5/230 (2.2%) | 0/220 (0%) | 1/474 (0.2%) | |||||
| Back pain | 52/445 (11.7%) | 64/474 (13.5%) | 29/230 (12.6%) | 25/220 (11.4%) | 65/474 (13.7%) | |||||
| Muscle spasms | 48/445 (10.8%) | 45/474 (9.5%) | 26/230 (11.3%) | 14/220 (6.4%) | 33/474 (7%) | |||||
| Musculoskeletal pain | 31/445 (7%) | 34/474 (7.2%) | 10/230 (4.3%) | 9/220 (4.1%) | 31/474 (6.5%) | |||||
| Myalgia | 32/445 (7.2%) | 28/474 (5.9%) | 21/230 (9.1%) | 13/220 (5.9%) | 25/474 (5.3%) | |||||
| Neck pain | 21/445 (4.7%) | 23/474 (4.9%) | 9/230 (3.9%) | 6/220 (2.7%) | 20/474 (4.2%) | |||||
| Pain in extremity | 45/445 (10.1%) | 46/474 (9.7%) | 17/230 (7.4%) | 31/220 (14.1%) | 45/474 (9.5%) | |||||
| Nervous system disorders | ||||||||||
| Dizziness | 17/445 (3.8%) | 16/474 (3.4%) | 7/230 (3%) | 9/220 (4.1%) | 11/474 (2.3%) | |||||
| Headache | 96/445 (21.6%) | 109/474 (23%) | 48/230 (20.9%) | 54/220 (24.5%) | 122/474 (25.7%) | |||||
| Migraine | 7/445 (1.6%) | 8/474 (1.7%) | 5/230 (2.2%) | 3/220 (1.4%) | 12/474 (2.5%) | |||||
| Sinus headache | 12/445 (2.7%) | 14/474 (3%) | 7/230 (3%) | 7/220 (3.2%) | 15/474 (3.2%) | |||||
| Psychiatric disorders | ||||||||||
| Anxiety | 9/445 (2%) | 16/474 (3.4%) | 4/230 (1.7%) | 7/220 (3.2%) | 9/474 (1.9%) | |||||
| Depression | 13/445 (2.9%) | 9/474 (1.9%) | 6/230 (2.6%) | 5/220 (2.3%) | 9/474 (1.9%) | |||||
| Insomnia | 27/445 (6.1%) | 25/474 (5.3%) | 15/230 (6.5%) | 12/220 (5.5%) | 32/474 (6.8%) | |||||
| Renal and urinary disorders | ||||||||||
| Haematuria | 6/445 (1.3%) | 5/474 (1.1%) | 7/230 (3%) | 1/220 (0.5%) | 8/474 (1.7%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Breast pain | 4/445 (0.9%) | 11/474 (2.3%) | 2/230 (0.9%) | 4/220 (1.8%) | 2/474 (0.4%) | |||||
| Breast tenderness | 17/445 (3.8%) | 19/474 (4%) | 5/230 (2.2%) | 26/220 (11.8%) | 18/474 (3.8%) | |||||
| Metrorrhagia | 5/445 (1.1%) | 5/474 (1.1%) | 2/230 (0.9%) | 8/220 (3.6%) | 6/474 (1.3%) | |||||
| Pelvic pain | 6/445 (1.3%) | 8/474 (1.7%) | 1/230 (0.4%) | 6/220 (2.7%) | 8/474 (1.7%) | |||||
| Uterine haemorrhage | 2/445 (0.4%) | 5/474 (1.1%) | 1/230 (0.4%) | 7/220 (3.2%) | 5/474 (1.1%) | |||||
| Uterine spasm | 11/445 (2.5%) | 6/474 (1.3%) | 6/230 (2.6%) | 7/220 (3.2%) | 8/474 (1.7%) | |||||
| Vaginal discharge | 6/445 (1.3%) | 7/474 (1.5%) | 2/230 (0.9%) | 4/220 (1.8%) | 11/474 (2.3%) | |||||
| Vaginal haemorrhage | 30/445 (6.7%) | 29/474 (6.1%) | 14/230 (6.1%) | 37/220 (16.8%) | 36/474 (7.6%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Cough | 24/445 (5.4%) | 30/474 (6.3%) | 10/230 (4.3%) | 11/220 (5%) | 30/474 (6.3%) | |||||
| Nasal congestion | 15/445 (3.4%) | 8/474 (1.7%) | 9/230 (3.9%) | 6/220 (2.7%) | 11/474 (2.3%) | |||||
| Oropharyngeal pain | 25/445 (5.6%) | 26/474 (5.5%) | 12/230 (5.2%) | 22/220 (10%) | 16/474 (3.4%) | |||||
| Sinus congestion | 13/445 (2.9%) | 21/474 (4.4%) | 4/230 (1.7%) | 7/220 (3.2%) | 13/474 (2.7%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Alopecia | 9/445 (2%) | 9/474 (1.9%) | 3/230 (1.3%) | 4/220 (1.8%) | 6/474 (1.3%) | |||||
| Night sweats | 5/445 (1.1%) | 12/474 (2.5%) | 4/230 (1.7%) | 6/220 (2.7%) | 12/474 (2.5%) | |||||
| Rash | 8/445 (1.8%) | 15/474 (3.2%) | 4/230 (1.7%) | 6/220 (2.7%) | 5/474 (1.1%) | |||||
| Vascular disorders | ||||||||||
| Hot flush | 27/445 (6.1%) | 37/474 (7.8%) | 20/230 (8.7%) | 11/220 (5%) | 40/474 (8.4%) | |||||
| Hypertension | 15/445 (3.4%) | 9/474 (1.9%) | 4/230 (1.7%) | 6/220 (2.7%) | 13/474 (2.7%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00808132
Other Study ID Numbers:
- 3115A1-3307
- B2311009
First Posted:
Dec 15, 2008
Last Update Posted:
Apr 8, 2014
Last Verified:
Mar 1, 2014