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
Sponsor study identifier
interventional
1,083
1 country
9
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
October 18, 2005
Actual (reported)October 20, 2005
Actual (reported)September 2008
Actual (reported)September 2008
Actual (reported)December 20, 2013
Actual (reported)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.
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
BZA 20mg/CE 0.625
BZA 20mg/CE 0.45
CE 0.45mg/MPA1.5mg
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.
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 CT.gov Call Center
Pfizer
1,083 participants (actual enrollment reported by the registry).
First Submitted
October 18, 2005
First Posted
October 20, 2005
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
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
Placebo
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Pfizer Investigational Site
Eugene, Oregon, 97401, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15206, United States
Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)Last Updated
December 20, 2013
Results First Posted
December 20, 2013
Record last verified: 2013-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: