Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Bazedoxifene/Conjugated Estrogen

CE 0.45 mg/MPA 1.5mg

Placebo

About this trial

This is an interventional prevention trial for Endometrial Hyperplasia focused on measuring Endometrium, Uterus, Menopause

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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. 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

Arm 2

Arm 3

Arm 4

Arm Description

BZA 20mg/CE 0.625

BZA 20mg/CE 0.45

CE 0.45mg/MPA1.5mg

Placebo

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

Percentage of Days With Breast Pain

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

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 Hyperplasia at 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

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.

Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at 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.

Full Information

NCT ID

NCT00242710

First Posted

October 18, 2005

Last Updated

October 30, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00242710

Brief Title

Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Hyperplasia, Osteoporosis

Keywords

Endometrium, Uterus, Menopause

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1083 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Description

BZA 20mg/CE 0.625

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

BZA 20mg/CE 0.45

Arm Title

Arm 3

Arm Type

Active Comparator

Arm Description

CE 0.45mg/MPA1.5mg

Arm Title

Arm 4

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Bazedoxifene/Conjugated Estrogen

Intervention Description

Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.

Intervention Type

Drug

Intervention Name(s)

Bazedoxifene/Conjugated Estrogen

Intervention Description

Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.

Intervention Type

Drug

Intervention Name(s)

CE 0.45 mg/MPA 1.5mg

Intervention Description

Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.

Primary Outcome Measure Information:

Title

Percentage of Participants With Hyperplasia at Screening

Description

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.

Time Frame

Screening

Title

Percentage of Participants With Hyperplasia at Month 12

Description

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.

Time Frame

Month 12

Title

Bone Mineral Density (BMD) of Lumbar Spine at Screening

Description

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.

Time Frame

Screening

Title

Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12

Description

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.

Time Frame

Baseline, Month 12

Title

Bone Mineral Density (BMD) of Total Hip at Screening

Description

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.

Time Frame

Screening

Title

Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 12

Description

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.

Time Frame

Baseline, Month 12

Secondary Outcome Measure Information:

Title

Percentage of Days With Breast Pain

Description

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.

Time Frame

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

Title

Percentage of Participants With Uterine Bleeding or Spotting

Description

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.

Time Frame

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

Title

Percentage of Participants With Hyperplasia at Month 24

Description

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.

Time Frame

Month 24

Title

Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 24

Description

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.

Time Frame

Baseline, Month 24

Title

Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 24

Description

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.

Time Frame

Baseline, Month 24

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Pfizer Investigational Site

City

Inverness

State/Province

Florida

ZIP/Postal Code

34452

Country

United States

Facility Name

Pfizer Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

Pfizer Investigational Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Pfizer Investigational Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

Pfizer Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536-0293

Country

United States

Facility Name

Pfizer Investigational Site

City

Billings

State/Province

Montana

ZIP/Postal Code

59102

Country

United States

Facility Name

Pfizer Investigational Site

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

Pfizer Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15206

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3115A1-304&StudyName=Study%20Evaluating%20Bazedoxifene/Conjugated%20Estrogens%20Combinations%20In%20Postmenopausal%20Women

Description

To obtain contact information for a study center near you, click here.

Endometrial Hyperplasia, Osteoporosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial