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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
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
Timepoint [2] 0 0
Baseline, Month 6, Month 12
Secondary outcome [3] 0 0
Percentage of Participants With Cumulative Amenorrhea: Main 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
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
Timepoint [5] 0 0
Baseline, Month 6, 12
Secondary outcome [6] 0 0
Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study
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
Timepoint [7] 0 0
Baseline, Month 3
Secondary outcome [8] 0 0
Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study
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
Timepoint [9] 0 0
Baseline, Month 3
Secondary outcome [10] 0 0
Percentage of Participants With Uterine Bleeding
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
Sex
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
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
Accrual to date
Final
1886
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
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
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Illinois
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Indiana
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Kansas
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Kentucky
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Maine
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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Nevada
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Argentina
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Buenos Aires
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Chile
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RM
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Colombia
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Antioquia
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Atlantico
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Colombia
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Cundinamarca
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Aalborg
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Denmark
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Ballerup
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Denmark
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Vejle
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Finland
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Kuopio
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Finland
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Oulu
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Hungary
State/province [48] 0 0
Bekescsaba
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Hungary
State/province [49] 0 0
Budapest
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Hungary
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Debrecen
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Hungary
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Kecskemet
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Hungary
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Nyiregyhaza
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Hungary
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Tatabanya
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Mexico
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D.F
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New Zealand
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NZ
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Christchurch
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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
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Warszawa
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Poland
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Wroclaw

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00808132