Phase 3
Completed N=1,886
Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
Source: ClinicalTrials.gov NCT00808132 ↗Enrolled (actual)
1,886
Serious AEs
3.7%
Results posted
Dec 2013
Primary outcomePrimary: Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study — 0.30; 0.54; 0.00; 0.00 Percentage of Participants
Summary
The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study |
0.30; 0.54; 0.00; 0.00; 0.85; 0.30 | — |
| PRIMARY Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study |
0.24; 0.60; 0.07; 1.30; -1.28 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study |
0.12; 0.51; 0.00; 0.64; -0.68 | 0.017 sig |
| SECONDARY Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study |
0.43; 0.66; 0.32; 0.45; -0.90; 0.50 | <0.001 sig |
| SECONDARY Percentage of Participants With Cumulative Amenorrhea: Main Study |
87.89; 84.87; 82.35; 54.43; 83.91 | 0.138 |
| SECONDARY Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study |
-0.38; -0.45; -0.25; 1.60; -0.32 | 0.832 |
| SECONDARY Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study |
-25.21; -27.79; -15.60; -25.34; -3.19; -30.46 | <0.001 sig |
| SECONDARY Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study |
48.9; 48.2; 50.5; 50.4; 47.8; 32.1 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study |
-17.27; -18.18; -11.64; -18.01; -14.34; -5.86 | 0.253 |
| SECONDARY Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study |
5.40; 5.60; 5.87; 5.65; 5.62; 3.46 | — |
| SECONDARY Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study |
-2.37; -2.75; -1.25; -3.19; -1.45; -0.67 | <0.001 sig |
| SECONDARY Percentage of Participants With Uterine Bleeding |
3.86; 6.20; 5.68; 20.83; 4.68; 4.44 | 0.624 |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00808132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.