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Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

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.
 
ClinicalTrials.gov Identifier: NCT00242710
Recruitment Status : Completed
First Posted : October 20, 2005
Results First Posted : December 20, 2013
Last Update Posted : December 20, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 18, 2005
First Posted Date  ICMJE October 20, 2005
Results First Submitted Date  ICMJE October 30, 2013
Results First Posted Date  ICMJE December 20, 2013
Last Update Posted Date December 20, 2013
Study Start Date  ICMJE September 2005
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2013)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2005)
  • Incidence of hyperplasia as assessed by endometrial biopsies at screening and 1 year
  • For the osteoporosis substudy, bone mineral density of the spine and hip as measured at screening and 1 year.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2005)
  • Uterine bleeding/spotting and breast pain at screening and through 1 year (by
  • diary).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Endometrial Hyperplasia
  • Osteoporosis
Intervention  ICMJE
  • 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.
  • 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.
  • Other: Placebo
    Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Study Arms  ICMJE
  • Experimental: 1
    BZA 20mg/CE 0.625
    Intervention: Drug: Bazedoxifene/Conjugated Estrogen
  • Experimental: Arm 2
    BZA 20mg/CE 0.45
    Intervention: Drug: Bazedoxifene/Conjugated Estrogen
  • Active Comparator: Arm 3
    CE 0.45mg/MPA1.5mg
    Intervention: Drug: CE 0.45 mg/MPA 1.5mg
  • Placebo Comparator: Arm 4
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2010)
1083
Original Enrollment  ICMJE
 (submitted: October 19, 2005)
870
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00242710
Other Study ID Numbers  ICMJE 3115A1-304
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP