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

Last updated on May 11, 2018

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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Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
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
The 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Menopause
  • Osteoporosis
  • 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.
  • 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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1886
February 2011
February 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
40 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Chile,   Colombia,   Denmark,   Finland,   Hungary,   Mexico,   New Zealand,   Norway,   Poland,   United States
 
 
NCT00808132
3115A1-3307
B2311009
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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1-800-718-1021

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Contact

[email protected]



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