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Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

Last updated on May 11, 2018

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

NCT00242710
Pfizer
Completed
Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

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Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
  • Endometrial Hyperplasia
  • Osteoporosis
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1083
September 2008
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
40 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00242710
3115A1-304
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2013

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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