Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

Phase 3

Completed

• Conditions: Endometrial Hyperplasia; Osteoporosis
• Interventions: Other: Placebo; Drug: Bazedoxifene/Conjugated Estrogen; Drug: CE 0.45 mg/MPA 1.5mg

• Registration Number: NCT00242710
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-10-18
• Study First Submitted QC: 2005-10-19
• Study First Posted: 2005-10-20
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Disposition First Submitted: 2009-02-26
• Disposition First Submitted QC: 2009-09-24
• Disposition First Posted: 2009-09-28
• Status Verified: 2013-10
• Results First Submitted: 2013-10-30
• Results First Submitted QC: 2013-10-30
• Last Update Submitted: 2013-10-30
• Results First Posted: 2013-12-20
• Last Update Posted: 2013-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1083

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 4	Placebo	Placebo
1	Bazedoxifene/Conjugated Estrogen	BZA 20mg/CE 0.625
Arm 3	CE 0.45 mg/MPA 1.5mg	CE 0.45mg/MPA1.5mg
Arm 2	Bazedoxifene/Conjugated Estrogen	BZA 20mg/CE 0.45

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density (BMD) of Lumbar Spine at Screening	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.
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12	Baseline, 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.
Bone Mineral Density (BMD) of Total Hip at Screening	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.
Percentage of Participants With Hyperplasia at Screening	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.
Percentage of Participants With Hyperplasia at Month 12	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.
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 12	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
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 days with breast pain in each 4-week period (for example, Week 1 to 4, 5 to 8) calculated as the number of days on which a participants reported breast pain divided by total number of days with data recorded multiplied by 100. Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.
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	Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 24	Baseline, Month 24	BMD measurements of the total hip were acquired by DXA, twice at Month 24 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 Participants With Hyperplasia at Month 24	Month 24	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.
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 24	Baseline, Month 24	BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 24 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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Pittsburgh, Pennsylvania, United States