Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00242710
First received: October 18, 2005
Last updated: October 30, 2013
Last verified: October 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   40 Years to 65 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00242710     History of Changes
Other Study ID Numbers: 3115A1-304
Study First Received: October 18, 2005
Results First Received: October 30, 2013
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Endometrium
Uterus
Menopause

Additional relevant MeSH terms:
Endometrial Hyperplasia
Hyperplasia
Osteoporosis
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Estrogens, Conjugated (USP)
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014