| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00242710 | Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women | PHASE3 | COMPLETED | 1,083 | — | — | Sep 1, 2005 | Sep 1, 2008 | Dec 20, 2013 | 9 | United States |
| NCT00675688 | Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women | PHASE3 | COMPLETED | 3,544 | — | — | Apr 1, 2002 | Jan 1, 2006 | May 12, 2008 | - | — |
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | BZA 20mg/CE 0.625 |
| Arm 2 | EXPERIMENTAL | BZA 20mg/CE 0.45 |
| Arm 3 | ACTIVE_COMPARATOR | CE 0.45mg/MPA1.5mg |
| Arm 4 | PLACEBO_COMPARATOR | Placebo |
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| C | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Bazedoxifene/Conjugated Estrogen | DRUG | 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 | DRUG | Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study. |
| Placebo | OTHER | Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study. |
| Bazedoxifene/Conjugate Estrogens (CE) | DRUG | - |
| Raloxifene | DRUG | - |
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-,...