Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women
A Double-Blind, Randomized, Placebo- And Active-Controlled Efficacy And Safety Study Of Bazedoxifene/Conjugated Estrogens Combinations For Prevention Of Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women
1 other identifier
interventional
1,083
1 country
9
Brief Summary
The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2005
Typical duration for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 18, 2005
CompletedFirst Posted
Study publicly available on registry
October 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
December 20, 2013
CompletedDecember 20, 2013
October 1, 2013
3 years
October 18, 2005
October 30, 2013
October 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Percentage of Participants With Hyperplasia at Screening
Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.
Screening
Percentage of Participants With Hyperplasia at Month 12
Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.
Month 12
Bone Mineral Density (BMD) of Lumbar Spine at Screening
BMD measurements of the anteroposterior lumbar spine were acquired by dual-energy x-ray absorptiometry (DXA), twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Screening
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12
BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Baseline, Month 12
Bone Mineral Density (BMD) of Total Hip at Screening
BMD measurements of the total hip were acquired by DXA, twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Screening
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 12
BMD measurements of the total hip were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Baseline, Month 12
Secondary Outcomes (5)
Percentage of Days With Breast Pain
Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52
Percentage of Participants With Uterine Bleeding or Spotting
Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52
Percentage of Participants With Hyperplasia at Month 24
Month 24
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 24
Baseline, Month 24
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 24
Baseline, Month 24
Study Arms (4)
1
EXPERIMENTALBZA 20mg/CE 0.625
Arm 2
EXPERIMENTALBZA 20mg/CE 0.45
Arm 3
ACTIVE COMPARATORCE 0.45mg/MPA1.5mg
Arm 4
PLACEBO COMPARATORPlacebo
Interventions
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Eligibility Criteria
You may qualify if:
- Generally healthy, postmenopausal women, aged 40 to less than 65 years
- Intact uterus
- At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels \> 40 mIU/mL.
You may not qualify if:
- Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks before screening (12 weeks for the osteoporosis substudy)
- A history or active presence of clinically important medical disease
- Malabsorption disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (9)
Pfizer Investigational Site
Upland, California, 91786, United States
Pfizer Investigational Site
Inverness, Florida, 34452, United States
Pfizer Investigational Site
West Palm Beach, Florida, 33409, United States
Pfizer Investigational Site
Decatur, Georgia, 30033, United States
Pfizer Investigational Site
Honolulu, Hawaii, 96814, United States
Pfizer Investigational Site
Lexington, Kentucky, 40536-0293, United States
Pfizer Investigational Site
Billings, Montana, 59102, United States
Pfizer Investigational Site
Eugene, Oregon, 97401, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15206, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2005
First Posted
October 20, 2005
Study Start
September 1, 2005
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
December 20, 2013
Results First Posted
December 20, 2013
Record last verified: 2013-10