Clinical trial NCT00242710: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometrial Hyperplasia
Osteoporosis
Keywords: Endometrium
Uterus
Menopause
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-20
Enrollment: 1083
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Hyperplasia at Screening
timeFrame: Screening
measure: Percentage of Participants With Hyperplasia at Month 12
timeFrame: Month 12
measure: Bone Mineral Density (BMD) of Lumbar Spine at Screening
timeFrame: Screening
measure: Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12
timeFrame: Baseline, Month 12
measure: Bone Mineral Density (BMD) of Total Hip at Screening
timeFrame: Screening
measure: Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 12
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Percentage of Days With Breast Pain
timeFrame: Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52
measure: Percentage of Participants With Uterine Bleeding or Spotting
timeFrame: Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52
measure: Percentage of Participants With Hyperplasia at Month 24
timeFrame: Month 24
measure: Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 24
timeFrame: Baseline, Month 24
measure: Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 24
timeFrame: Baseline, Month 24
Other outcomes:
Locations:
city: Upland
country: United States
facility: Pfizer Investigational Site
state: California
city: Inverness
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Billings
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: