Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

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NCT00242710

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Study Location
Pfizer Investigational Site
Upland, California, 91786, United States
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Endometrial Hyperplasia, Osteoporosis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Endometrial Hyperplasia, OsteoporosisStudy Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
NCT00675688
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Endometrial Hyperplasia, OsteoporosisStudy Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women
NCT00242710
  1. Upland, California
  2. Inverness, Florida
  3. West Palm Beach, Florida
  4. Decatur, Georgia
  5. Honolulu, Hawaii
  6. Lexington, Kentucky
  7. Billings, Montana
  8. Eugene, Oregon
  9. Pittsburgh, Pennsylvania
Female
40 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
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