Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

Official Title: “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.

Intervention(s) in this Clinical Trial

• 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: 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • BZA 20mg/CE 0.625
• Experimental: Arm 2
  • BZA 20mg/CE 0.45
• Active Comparator: Arm 3
  • CE 0.45mg/MPA1.5mg
• Placebo Comparator: Arm 4
  • Placebo

Primary Measures

• Incidence of hyperplasia as assessed by endometrial biopsies at screening and 1 year
  • Time Frame: 1 Year
    Safety Issue?: Yes
• For the osteoporosis substudy, bone mineral density of the spine and hip as measured at screening and 1 year.
  • Time Frame: 1 year
    Safety Issue?: No

Secondary Measures

• Uterine bleeding/spotting and breast pain at screening and through 1 year (by diary)
  • Time Frame: 1 Year
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00242710

Study ID Number: 3115A1-304

ClinicalTrials.gov Identifier: NCT00242710

Health Authority: United States: Food and Drug Administration

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