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

Last updated on October 11, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35235 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Menopause, Osteoporosis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-64 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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00808132
Pfizer
Completed
Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

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Descriptive Information
Brief Title  ICMJE Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Menopause
  • Osteoporosis
Intervention  ICMJE
  • Drug: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg
    One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year.
  • Drug: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg
    One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year.
  • Drug: bazedoxifene 20 mg
    One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year.
  • Drug: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg
    One capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year.
    Other Name: Prempro
  • Drug: Placebo
    One capsule, placebo (over-encapsulated), once a day for one year.
Study Arms  ICMJE
  • Experimental: 1
    bazedoxifene 20 mg/conjugated estrogens 0.45 mg
    Intervention: Drug: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg
  • Experimental: 2
    bazedoxifene 20 mg/conjugated estrogens 0.625 mg
    Intervention: Drug: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg
  • Experimental: 3
    bazedoxifene 20 mg
    Intervention: Drug: bazedoxifene 20 mg
  • Active Comparator: 4
    Prempro
    Intervention: Drug: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg
  • Placebo Comparator: 5
    Placebo
    Intervention: Drug: Placebo
Publications *


*   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: March 10, 2014)
1886
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2008)
1720
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion DateFebruary 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 40 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Chile,   Colombia,   Denmark,   Finland,   Hungary,   Mexico,   New Zealand,   Norway,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00808132
Other Study ID Numbers  ICMJE 3115A1-3307
B2311009
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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