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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: Bazedoxifene/Conjugated Estrogen
  • BZA 20mg/CE 0.625mg daily oral administration, BZA 20mg/CE 0.45, CE 0.45mg/MPA1.5mg
• Other: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • BZA 20mg/CE 0.625
• Active Comparator: 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 Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Information obtained from ClinicalTrials.gov on October 07, 2008

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