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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


Phase 3
40 Years
64 Years
Not Enrolling
Female
Menopause, Osteoporosis

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Incidence of Endometrial Hyperplasia and Changes in Bone Mineral Density

Outcome Time Frame:

1 Year

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3115A1-3307

NCT ID:

NCT00808132

Start Date:

January 2009

Completion Date:

February 2011

Related Keywords:

  • Menopause
  • Osteoporosis
  • Postmenopausal Women
  • Bazedoxifene/Conjugated Estrogens
  • Endometrial Hyperplasia
  • Osteoporosis
  • Osteoporosis, Postmenopausal
  • Adenoma

Name

Location

Pfizer Investigational Site Birmingham, Alabama  35205
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Crestview Hills, Kentucky  41017
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Rochester, Minnesota  55905
Pfizer Investigational Site Cincinnait, Ohio  45236
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Richmond, Virginia  23249
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Flagstaff, Arizona  86001
Pfizer Investigational Site North Little Rock, Arkansas  72117
Pfizer Investigational Site Aurora, Colorado  80012
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Carmel, Indiana  46032
Pfizer Investigational Site Kansas City, Kansas  66112
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Las Vegas, Nevada  89128
Pfizer Investigational Site Santa Fe, New Mexico  87505
Pfizer Investigational Site Asheville, North Carolina  28801
Pfizer Investigational Site Eugene, Oregon  97401
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Easley,, South Carolina  29640
Pfizer Investigational Site Farmington, Connecticut  06030-3805
Pfizer Investigational Site Omaha, Nebraska  68198
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Livingston, New Jersey  07039
Pfizer Investigational Site Salt Lake City, Utah  84112
Pfizer Investigational Site Billings, Montana  59101
Pfizer Investigational Site Lebanon, New Hampshire  03766
Pfizer Investigational Site Lewistown, Idaho  83501
Pfizer Investigational Site Bangor, Maine  04401
Pfizer Investigational Site Bismarck, North Dakota  58503
Pfizer Investigational Site Aberdeen, South Dakota  57401
Pfizer Investigational Site Providence, Rhode Island  02906