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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00808132




Registration number
NCT00808132
Ethics application status
Date submitted
12/12/2008
Date registered
15/12/2008
Date last updated
8/04/2014

Titles & IDs
Public title
Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
Scientific 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
Secondary ID [1] 0 0
B2311009
Secondary ID [2] 0 0
3115A1-3307
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menopause 0 0
Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bazedoxifene 20 mg/ conjugated estrogens 0.45 mg
Treatment: Drugs - bazedoxifene 20 mg/ conjugated estrogens 0.625 mg
Treatment: Drugs - bazedoxifene 20 mg
Treatment: Drugs - conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg
Treatment: Drugs - Placebo

Experimental: 1 - bazedoxifene 20 mg/conjugated estrogens 0.45 mg

Experimental: 2 - bazedoxifene 20 mg/conjugated estrogens 0.625 mg

Experimental: 3 - bazedoxifene 20 mg

Active Comparator: 4 - Prempro

Placebo Comparator: 5 - Placebo


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: bazedoxifene 20 mg
One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year.

Treatment: Drugs: 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.

Treatment: Drugs: Placebo
One capsule, placebo (over-encapsulated), once a day for one year.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study - 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.
Timepoint [1] 0 0
Month 12
Primary outcome [2] 0 0
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study - 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.
Timepoint [2] 0 0
Baseline, Month 12
Secondary outcome [1] 0 0
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study - 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.
Timepoint [1] 0 0
Baseline, Month 6
Secondary outcome [2] 0 0
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study - 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.
Timepoint [2] 0 0
Baseline, Month 6, Month 12
Secondary outcome [3] 0 0
Percentage of Participants With Cumulative Amenorrhea: Main Study - Cumulative amenorrhea was defined as the absence of any bleeding or spotting for cumulative 4-week periods throughout 1-year study.
Timepoint [3] 0 0
Day 1 up to Day 364
Secondary outcome [4] 0 0
Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study - 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
Timepoint [4] 0 0
Baseline, Month 12
Secondary outcome [5] 0 0
Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study - 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.
Timepoint [5] 0 0
Baseline, Month 6, 12
Secondary outcome [6] 0 0
Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study - 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.
Timepoint [6] 0 0
Baseline
Secondary outcome [7] 0 0
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study - 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.
Timepoint [7] 0 0
Baseline, Month 3
Secondary outcome [8] 0 0
Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study - 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.
Timepoint [8] 0 0
Baseline
Secondary outcome [9] 0 0
Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study - 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.
Timepoint [9] 0 0
Baseline, Month 3
Secondary outcome [10] 0 0
Percentage of Participants With Uterine Bleeding - Percentage of participants with uterine bleeding were calculated for each 4-week period for 1-year on therapy.
Timepoint [10] 0 0
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

Eligibility
Key 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
Minimum age
40 Years
Maximum age
64 Years
Gender
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Randwick
Recruitment hospital [2] 0 0
Pfizer Investigational Site - St Leonards
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Maine
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Montana
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
Nevada
Country [21] 0 0
United States of America
State/province [21] 0 0
New Hampshire
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
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New Mexico
Country [24] 0 0
United States of America
State/province [24] 0 0
New York
Country [25] 0 0
United States of America
State/province [25] 0 0
North Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
North Dakota
Country [27] 0 0
United States of America
State/province [27] 0 0
Ohio
Country [28] 0 0
United States of America
State/province [28] 0 0
Oregon
Country [29] 0 0
United States of America
State/province [29] 0 0
Pennsylvania
Country [30] 0 0
United States of America
State/province [30] 0 0
Rhode Island
Country [31] 0 0
United States of America
State/province [31] 0 0
South Carolina
Country [32] 0 0
United States of America
State/province [32] 0 0
South Dakota
Country [33] 0 0
United States of America
State/province [33] 0 0
Tennessee
Country [34] 0 0
United States of America
State/province [34] 0 0
Texas
Country [35] 0 0
United States of America
State/province [35] 0 0
Utah
Country [36] 0 0
United States of America
State/province [36] 0 0
Virginia
Country [37] 0 0
United States of America
State/province [37] 0 0
Washington
Country [38] 0 0
Argentina
State/province [38] 0 0
Buenos Aires
Country [39] 0 0
Chile
State/province [39] 0 0
RM
Country [40] 0 0
Colombia
State/province [40] 0 0
Antioquia
Country [41] 0 0
Colombia
State/province [41] 0 0
Atlantico
Country [42] 0 0
Colombia
State/province [42] 0 0
Cundinamarca
Country [43] 0 0
Denmark
State/province [43] 0 0
Aalborg
Country [44] 0 0
Denmark
State/province [44] 0 0
Ballerup
Country [45] 0 0
Denmark
State/province [45] 0 0
Vejle
Country [46] 0 0
Finland
State/province [46] 0 0
Kuopio
Country [47] 0 0
Finland
State/province [47] 0 0
Oulu
Country [48] 0 0
Hungary
State/province [48] 0 0
Bekescsaba
Country [49] 0 0
Hungary
State/province [49] 0 0
Budapest
Country [50] 0 0
Hungary
State/province [50] 0 0
Debrecen
Country [51] 0 0
Hungary
State/province [51] 0 0
Kecskemet
Country [52] 0 0
Hungary
State/province [52] 0 0
Nyiregyhaza
Country [53] 0 0
Hungary
State/province [53] 0 0
Tatabanya
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Mexico
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D.F
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New Zealand
State/province [55] 0 0
NZ
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New Zealand
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Christchurch
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Norway
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Alesund
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Norway
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Hamar
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Poland
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Lublin
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Poland
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Poznan
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Poland
State/province [61] 0 0
Warszawa
Country [62] 0 0
Poland
State/province [62] 0 0
Wroclaw

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00808132
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications