Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00808132
• Date of registration: 12/12/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
• Scientific title: A Double-Blind, Randomized, Placebo And Active- Controlled Efficacy And Safety Study Of The Effects Of Bazedoxifene/Conjugated Estrogens Combinations On Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women
• Date of first enrolment: January 2009
• Target sample size: 1886
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00808132
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Chile, Colombia, Denmark, Finland, Hungary, Mexico, New Zealand, Norway, Poland, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Generally healthy, postmenopausal women, aged 40 to 64 seeking treatment for
menopausal symptoms

- At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with
follicle-stimulating hormone (FSH) levels > 40 mIU/mL

- Intact Uterus

Exclusion Criteria:

- Use of oral estrogen, progestin, androgen, or selective estrogen receptor modulator
(SERM) containing drug products within 8 weeks before screening

- A history or active presence of clinically important medical disease: eg.
cardiovascular disease (stroke, heart attack), chronic renal or liver disease, breast
cancer, etc.



Age minimum: 40 Years
Age maximum: 64 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Osteoporosis

Menopause

Intervention(s)

Drug: bazedoxifene 20 mg

Drug: Placebo

Drug: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg

Drug: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg

Drug: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg

Primary Outcome(s)

Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study [Time Frame: Baseline, Month 12]

Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study [Time Frame: Month 12]

Secondary Outcome(s)

Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study [Time Frame: Baseline]

Percentage of Participants With Cumulative Amenorrhea: Main Study [Time Frame: Day 1 up to Day 364]

Percentage of Participants With Uterine Bleeding [Time Frame: Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52]

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study [Time Frame: Baseline, Month 3]

Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study [Time Frame: Baseline, Month 3]

Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study [Time Frame: Baseline, Month 6, 12]

Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study [Time Frame: Baseline]

Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study [Time Frame: Baseline, Month 12]

Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study [Time Frame: Baseline, Month 6]

Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study [Time Frame: Baseline, Month 6, Month 12]

Secondary ID(s)

B2311009

3115A1-3307

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/12/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00808132