Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242710
• Other study ID #: 3115A1-304
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2005
• Last updated: October 30, 2013
• Start date: September 2005
• Est. completion date: September 2008

Study information

• Verified date: October 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1083
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Endometrial Hyperplasia
• Hyperplasia
• Osteoporosis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Billings	Montana
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Eugene	Oregon
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Inverness	Florida
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Upland	California
United States	Pfizer Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Hyperplasia at Screening	Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.	Screening	Yes
Primary	Percentage of Participants With Hyperplasia at Month 12	Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.	Month 12	Yes
Primary	Bone Mineral Density (BMD) of Lumbar Spine at Screening	BMD measurements of the anteroposterior lumbar spine were acquired by dual-energy x-ray absorptiometry (DXA), twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.	Screening	No
Primary	Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12	BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.	Baseline, Month 12	No
Primary	Bone Mineral Density (BMD) of Total Hip at Screening	BMD measurements of the total hip were acquired by DXA, twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.	Screening	No
Primary	Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 12	BMD measurements of the total hip were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.	Baseline, Month 12	No
Secondary	Percentage of Days With Breast Pain	Percentage of days with breast pain in each 4-week period (for example, Week 1 to 4, 5 to 8) calculated as the number of days on which a participants reported breast pain divided by total number of days with data recorded multiplied by 100. Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.	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	No
Secondary	Percentage of Participants With Uterine Bleeding or Spotting	Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.	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	No
Secondary	Percentage of Participants With Hyperplasia at Month 24	Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.	Month 24	Yes
Secondary	Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 24	BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 24 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.	Baseline, Month 24	No
Secondary	Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 24	BMD measurements of the total hip were acquired by DXA, twice at Month 24 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.	Baseline, Month 24	No

External Links

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