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Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00242710
First Posted: October 20, 2005
Last Update Posted: December 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention Phase
Endometrial Hyperplasia Osteoporosis Drug: Bazedoxifene/Conjugated Estrogen Drug: CE 0.45 mg/MPA 1.5mg Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Hyperplasia at Screening [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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:
  • Percentage of Days With Breast Pain [ 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 ]
    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 [ 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 ]
    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 [ Time Frame: 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 [ Time Frame: 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.

  • Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 24 [ Time Frame: 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.


Enrollment: 1083
Study Start Date: September 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
BZA 20mg/CE 0.625
Drug: Bazedoxifene/Conjugated Estrogen
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Experimental: Arm 2
BZA 20mg/CE 0.45
Drug: Bazedoxifene/Conjugated Estrogen
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Active Comparator: Arm 3
CE 0.45mg/MPA1.5mg
Drug: CE 0.45 mg/MPA 1.5mg
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Placebo Comparator: Arm 4
Placebo
Other: Placebo
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00242710


Locations
United States, California
Pfizer Investigational Site
Upland, California, United States, 91786
United States, Florida
Pfizer Investigational Site
Inverness, Florida, United States, 34452
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33409
United States, Georgia
Pfizer Investigational Site
Decatur, Georgia, United States, 30033
United States, Hawaii
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40536-0293
United States, Montana
Pfizer Investigational Site
Billings, Montana, United States, 59102
United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00242710     History of Changes
Other Study ID Numbers: 3115A1-304
First Submitted: October 18, 2005
First Posted: October 20, 2005
Results First Submitted: October 30, 2013
Results First Posted: December 20, 2013
Last Update Posted: December 20, 2013
Last Verified: October 2013

Keywords provided by Pfizer:
Endometrium
Uterus
Menopause

Additional relevant MeSH terms:
Osteoporosis
Hyperplasia
Endometrial Hyperplasia
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Estrogens
Estrogens, Conjugated (USP)
Bazedoxifene
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Bone Density Conservation Agents