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Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

Primary Purpose

Menopause, Osteoporosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

bazedoxifene 20 mg/ conjugated estrogens 0.45 mg

bazedoxifene 20 mg/ conjugated estrogens 0.625 mg

bazedoxifene 20 mg

conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg

Placebo

About this trial

This is an interventional treatment trial for Menopause focused on measuring Postmenopausal Women, Bazedoxifene/Conjugated Estrogens

Eligibility Criteria

40 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm Description

bazedoxifene 20 mg/conjugated estrogens 0.45 mg

bazedoxifene 20 mg/conjugated estrogens 0.625 mg

bazedoxifene 20 mg

Prempro

Placebo

Outcomes

Primary Outcome Measures

Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study

Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis.

Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study

BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of 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. Mean percentage change from baseline of the 2 readings were reported.

Secondary Outcome Measures

Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study

BMD measurements of the anteroposterior lumbar spine were acquired by using DXA scans, twice at Month 6 for a subset of 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. Mean percentage change from baseline of the 2 readings were reported.

Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study

BMD measurements of the total hip were acquired by using DXA scans, twice at Month 6 and 12 for a subset of 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. Mean percentage change from baseline of the 2 readings were reported.

Percentage of Participants With Cumulative Amenorrhea: Main Study

Cumulative amenorrhea was defined as the absence of any bleeding or spotting for cumulative 4-week periods throughout 1-year study.

Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study

Breast density was assessed by digitalized mammograms which were centrally read by a single radiologist using specifically-developed software. Breast density was assessed for subset of participants who entered the breast density sub-study

Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study

Bone turnover is the removal of old bone from the body and its replacement by new bone. Bone turnover markers included serum osteocalcin, C-telopeptide, and procollagen type 1 N-propeptide (P1NP), were measured at Month 6 and Month 12 for a subset of participants who entered the osteoporosis substudy. Blood samples were collected to evaluate bone turnover markers levels.

Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study

Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study

Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study

MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.

Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study

Percentage of Participants With Uterine Bleeding

Percentage of participants with uterine bleeding were calculated for each 4-week period for 1-year on therapy.

Full Information

NCT ID

NCT00808132

First Posted

December 12, 2008

Last Updated

March 10, 2014

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00808132

Brief Title

Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.

6. Conditions and Keywords

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

Menopause, Osteoporosis

Keywords

Postmenopausal Women, Bazedoxifene/Conjugated Estrogens

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1886 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

bazedoxifene 20 mg/conjugated estrogens 0.45 mg

Arm Title

Arm Type

Experimental

Arm Description

bazedoxifene 20 mg/conjugated estrogens 0.625 mg

Arm Title

Arm Type

Experimental

Arm Description

bazedoxifene 20 mg

Arm Title

Arm Type

Active Comparator

Arm Description

Prempro

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

bazedoxifene 20 mg/ conjugated estrogens 0.45 mg

Intervention Description

One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year.

Intervention Type

Drug

Intervention Name(s)

bazedoxifene 20 mg/ conjugated estrogens 0.625 mg

Intervention Description

One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year.

Intervention Type

Drug

Intervention Name(s)

bazedoxifene 20 mg

Intervention Description

One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year.

Intervention Type

Drug

Intervention Name(s)

conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg

Other Intervention Name(s)

Prempro

Intervention Description

One capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

One capsule, placebo (over-encapsulated), once a day for one year.

Primary Outcome Measure Information:

Title

Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study

Description

Time Frame

Month 12

Title

Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study

Description

Time Frame

Baseline, Month 12

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study

Description

Time Frame

Baseline, Month 6

Title

Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study

Description

Time Frame

Baseline, Month 6, Month 12

Title

Percentage of Participants With Cumulative Amenorrhea: Main Study

Description

Cumulative amenorrhea was defined as the absence of any bleeding or spotting for cumulative 4-week periods throughout 1-year study.

Time Frame

Day 1 up to Day 364

Title

Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study

Description

Time Frame

Baseline, Month 12

Title

Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study

Description

Time Frame

Baseline, Month 6, 12

Title

Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study

Description

Time Frame

Baseline

Title

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study

Description

Time Frame

Baseline, Month 3

Title

Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study

Description

Time Frame

Baseline

Title

Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study

Description

Time Frame

Baseline, Month 3

Title

Percentage of Participants With Uterine Bleeding

Description

Percentage of participants with uterine bleeding were calculated for each 4-week period for 1-year on therapy.

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Percentage of Participants With Breast Tenderness

Description

Percentage of participants who reported at least 1 day of breast tenderness during each 4-week period for 1-year on therapy was calculated.

Time Frame

Screening, 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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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.

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

Birmingham

State/Province

Alabama

ZIP/Postal Code

35235

Country

United States

Facility Name

Pfizer Investigational Site

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Pfizer Investigational Site

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85225

Country

United States

Facility Name

Pfizer Investigational Site

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85308

Country

United States

Facility Name

Pfizer Investigational Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85206

Country

United States

Facility Name

Pfizer Investigational Site

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

Pfizer Investigational Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

Country

United States

Facility Name

Pfizer Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85710

Country

United States

Facility Name

Pfizer Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Pfizer Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85715

Country

United States

Facility Name

Pfizer Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72223

Country

United States

Facility Name

Pfizer Investigational Site

City

Carmichael

State/Province

California

ZIP/Postal Code

95608

Country

United States

Facility Name

Pfizer Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95821

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Pfizer Investigational Site

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Pfizer Investigational Site

City

Vista

State/Province

California

ZIP/Postal Code

92083

Country

United States

Facility Name

Pfizer Investigational Site

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Pfizer Investigational Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Pfizer Investigational Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80910

Country

United States

Facility Name

Pfizer Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

Pfizer Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

Facility Name

Pfizer Investigational Site

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80228

Country

United States

Facility Name

Pfizer Investigational Site

City

New London

State/Province

Connecticut

ZIP/Postal Code

06320

Country

United States

Facility Name

Pfizer Investigational Site

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33472

Country

United States

Facility Name

Pfizer Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33759

Country

United States

Facility Name

Pfizer Investigational Site

City

Crystal River

State/Province

Florida

ZIP/Postal Code

34429

Country

United States

Facility Name

Pfizer Investigational Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32114

Country

United States

Facility Name

Pfizer Investigational Site

City

Deland

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

Pfizer Investigational Site

City

Ft. Lauderdale

State/Province

Florida

ZIP/Postal Code

33316

Country

United States

Facility Name

Pfizer Investigational Site

City

Ft. Lauderdale

State/Province

Florida

ZIP/Postal Code

33328

Country

United States

Facility Name

Pfizer Investigational Site

City

Ft. Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

Pfizer Investigational Site

City

Lake Worth

State/Province

Florida

ZIP/Postal Code

33461

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami Springs

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Facility Name

Pfizer Investigational Site

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Pfizer Investigational Site

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33781

Country

United States

Facility Name

Pfizer Investigational Site

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33323

Country

United States

Facility Name

Pfizer Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Pfizer Investigational Site

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Pfizer Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Pfizer Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

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

Decatur

State/Province

Georgia

ZIP/Postal Code

30319

Country

United States

Facility Name

Pfizer Investigational Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31405

Country

United States

Facility Name

Pfizer Investigational Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Facility Name

Pfizer Investigational Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

Pfizer Investigational Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Pfizer Investigational Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Pfizer Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60610

Country

United States

Facility Name

Pfizer Investigational Site

City

Rockford

State/Province

Illinois

ZIP/Postal Code

61107

Country

United States

Facility Name

Pfizer Investigational Site

City

South Bend

State/Province

Indiana

ZIP/Postal Code

46601

Country

United States

Facility Name

Pfizer Investigational Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66210

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

Lousiville

State/Province

Kentucky

ZIP/Postal Code

40291

Country

United States

Facility Name

Pfizer Investigational Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

4401

Country

United States

Facility Name

Pfizer Investigational Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106

Country

United States

Facility Name

Pfizer Investigational Site

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49009

Country

United States

Facility Name

Pfizer Investigational Site

City

Paw Paw

State/Province

Michigan

ZIP/Postal Code

49079

Country

United States

Facility Name

Pfizer Investigational Site

City

Saginaw

State/Province

Michigan

ZIP/Postal Code

48604

Country

United States

Facility Name

Pfizer Investigational Site

City

Southfield

State/Province

Michigan

ZIP/Postal Code

48034

Country

United States

Facility Name

Pfizer Investigational Site

City

Brooklyn Center

State/Province

Minnesota

ZIP/Postal Code

55430

Country

United States

Facility Name

Pfizer Investigational Site

City

Chaska

State/Province

Minnesota

ZIP/Postal Code

55318

Country

United States

Facility Name

Pfizer Investigational Site

City

Robbinsdale

State/Province

Minnesota

ZIP/Postal Code

55422

Country

United States

Facility Name

Pfizer Investigational Site

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63131

Country

United States

Facility Name

Pfizer Investigational Site

City

Billings

State/Province

Montana

ZIP/Postal Code

59101

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

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

Country

United States

Facility Name

Pfizer Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

Pfizer Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Pfizer Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89146

Country

United States

Facility Name

Pfizer Investigational Site

City

North Las Vegas

State/Province

Nevada

ZIP/Postal Code

89030

Country

United States

Facility Name

Pfizer Investigational Site

City

Reno

State/Province

Nevada

ZIP/Postal Code

89502

Country

United States

Facility Name

Pfizer Investigational Site

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Pfizer Investigational Site

City

Brick

State/Province

New Jersey

ZIP/Postal Code

08723

Country

United States

Facility Name

Pfizer Investigational Site

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

Facility Name

Pfizer Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Pfizer Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Pfizer Investigational Site

City

Port Jefferson

State/Province

New York

ZIP/Postal Code

11777

Country

United States

Facility Name

Pfizer Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

29209

Country

United States

Facility Name

Pfizer Investigational Site

City

Kernersville

State/Province

North Carolina

ZIP/Postal Code

27284

Country

United States

Facility Name

Pfizer Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Pfizer Investigational Site

City

Bismarck

State/Province

North Dakota

ZIP/Postal Code

58501

Country

United States

Facility Name

Pfizer Investigational Site

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

Pfizer Investigational Site

City

Minot

State/Province

North Dakota

ZIP/Postal Code

58701

Country

United States

Facility Name

Pfizer Investigational Site

City

Akron

State/Province

Ohio

ZIP/Postal Code

44311

Country

United States

Facility Name

Pfizer Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45236

Country

United States

Facility Name

Pfizer Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106-6010

Country

United States

Facility Name

Pfizer Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Pfizer Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Pfizer Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45439

Country

United States

Facility Name

Pfizer Investigational Site

City

Englewood

State/Province

Ohio

ZIP/Postal Code

45322

Country

United States

Facility Name

Pfizer Investigational Site

City

Mayfield Heights

State/Province

Ohio

ZIP/Postal Code

44124

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

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Pfizer Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97205

Country

United States

Facility Name

Pfizer Investigational Site

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16502

Country

United States

Facility Name

Pfizer Investigational Site

City

Hopwood

State/Province

Pennsylvania

ZIP/Postal Code

15445

Country

United States

Facility Name

Pfizer Investigational Site

City

Jenkintown

State/Province

Pennsylvania

ZIP/Postal Code

19046

Country

United States

Facility Name

Pfizer Investigational Site

City

Johnstown

State/Province

Pennsylvania

ZIP/Postal Code

15905

Country

United States

Facility Name

Pfizer Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Pfizer Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19114

Country

United States

Facility Name

Pfizer Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15206

Country

United States

Facility Name

Pfizer Investigational Site

City

West Reading

State/Province

Pennsylvania

ZIP/Postal Code

19611

Country

United States

Facility Name

Pfizer Investigational Site

City

Wexford

State/Province

Pennsylvania

ZIP/Postal Code

15090

Country

United States

Facility Name

Pfizer Investigational Site

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

Facility Name

Pfizer Investigational Site

City

Bluffton

State/Province

South Carolina

ZIP/Postal Code

29910

Country

United States

Facility Name

Pfizer Investigational Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Pfizer Investigational Site

City

Hilton Head Island

State/Province

South Carolina

ZIP/Postal Code

29926

Country

United States

Facility Name

Pfizer Investigational Site

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57104

Country

United States

Facility Name

Pfizer Investigational Site

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Facility Name

Pfizer Investigational Site

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

67105

Country

United States

Facility Name

Pfizer Investigational Site

City

Watertown

State/Province

South Dakota

ZIP/Postal Code

57201

Country

United States

Facility Name

Pfizer Investigational Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Pfizer Investigational Site

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Pfizer Investigational Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

Pfizer Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Facility Name

Pfizer Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Pfizer Investigational Site

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78414

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Pfizer Investigational Site

City

Denton

State/Province

Texas

ZIP/Postal Code

76210

Country

United States

Facility Name

Pfizer Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Pfizer Investigational Site

City

Irving

State/Province

Texas

ZIP/Postal Code

75061

Country

United States

Facility Name

Pfizer Investigational Site

City

Irving

State/Province

Texas

ZIP/Postal Code

75062

Country

United States

Facility Name

Pfizer Investigational Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78154

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Pfizer Investigational Site

City

Waco

State/Province

Texas

ZIP/Postal Code

76712

Country

United States

Facility Name

Pfizer Investigational Site

City

Pleasant Grove

State/Province

Utah

ZIP/Postal Code

84062

Country

United States

Facility Name

Pfizer Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84117

Country

United States

Facility Name

Pfizer Investigational Site

City

Sandy

State/Province

Utah

ZIP/Postal Code

84070

Country

United States

Facility Name

Pfizer Investigational Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Facility Name

Pfizer Investigational Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Pfizer Investigational Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Pfizer Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Pfizer Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Pfizer Investigational Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Pfizer Investigational Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1012AAR

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1425AGC

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1117ABH

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1128AAF

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Randwick

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

Facility Name

Pfizer Investigational Site

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Pfizer Investigational Site

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Pfizer Investigational Site

City

Santiago

State/Province

ZIP/Postal Code

8320152

Country

Chile

Facility Name

Pfizer Investigational Site

City

Medellin

State/Province

Antioquia

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Barranquilla

State/Province

Atlantico

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Bogota

State/Province

Cundinamarca

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Ballerup

ZIP/Postal Code

2750

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Kuopio

ZIP/Postal Code

70110

Country

Finland

Facility Name

Pfizer Investigational Site

City

Oulu

ZIP/Postal Code

90 100

Country

Finland

Facility Name

Pfizer Investigational Site

City

Bekescsaba

ZIP/Postal Code

H-5600

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Budapest

ZIP/Postal Code

1106

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Budapest

ZIP/Postal Code

H-1125

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Debrecen

ZIP/Postal Code

H-4012

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Debrecen

ZIP/Postal Code

H-4043

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Kecskemet

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Nyiregyhaza

ZIP/Postal Code

H-4400

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Tatabanya

ZIP/Postal Code

H-2800

Country

Hungary

Facility Name

Pfizer Investigational Site

City

D.F

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Dunedin

State/Province

Country

New Zealand

Facility Name

Pfizer Investigational Site

City

Wellington

State/Province

Country

New Zealand

Facility Name

Pfizer Investigational Site

City

Christchurch

ZIP/Postal Code

8014

Country

New Zealand

Facility Name

Pfizer Investigational Site

City

Alesund

ZIP/Postal Code

NO-6003

Country

Norway

Facility Name

Pfizer Investigational Site

City

Hamar

ZIP/Postal Code

NO-2317

Country

Norway

Facility Name

Pfizer Investigational Site

City

Lublin

ZIP/Postal Code

20-090

Country

Poland

Facility Name

Pfizer Investigational Site

City

Poznan

ZIP/Postal Code

60-535

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

01-809

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

02-341

Country

Poland

Facility Name

Pfizer Investigational Site

City

Wroclaw

ZIP/Postal Code

50-088

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

24438370

Citation

Pinkerton JV, Harvey JA, Lindsay R, Pan K, Chines AA, Mirkin S, Archer DF; SMART-5 Investigators. Effects of bazedoxifene/conjugated estrogens on the endometrium and bone: a randomized trial. J Clin Endocrinol Metab. 2014 Feb;99(2):E189-98. doi: 10.1210/jc.2013-1707. Epub 2014 Jan 17.

Results Reference

derived

PubMed Identifier

23635731

Citation

Pinkerton JV, Harvey JA, Pan K, Thompson JR, Ryan KA, Chines AA, Mirkin S. Breast effects of bazedoxifene-conjugated estrogens: a randomized controlled trial. Obstet Gynecol. 2013 May;121(5):959-968. doi: 10.1097/AOG.0b013e31828c5974.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3115A1-3307&StudyName=Study%20Evaluating%20The%20Effects%20Of%20Bazedoxifene/Conjugated%20Estrogens%20On%20Endometrial%20Safety%20And%20Postmenopausal%20Osteoporosis

Description

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Learn more about this trial

Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

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Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

Menopause, Osteoporosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

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