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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


Phase 3
40 Years
65 Years
Not Enrolling
Female
Endometrial Hyperplasia, Osteoporosis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of hyperplasia as assessed by endometrial biopsies at screening and 1 year

Outcome Time Frame:

1 Year

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3115A1-304

NCT ID:

NCT00242710

Start Date:

September 2005

Completion Date:

September 2008

Related Keywords:

  • Endometrial Hyperplasia
  • Osteoporosis
  • Endometrium
  • Uterus
  • Menopause
  • Endometrial Hyperplasia
  • Hyperplasia
  • Osteoporosis
  • Adenoma

Name

Location
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Crestview Hills, Kentucky  41017
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Eugene, Oregon  97401
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Billings, Montana  59101
Pfizer Investigational Site Honolulu, Hawaii  96813