Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bazedoxifene/Conjugated Estrogen · 4 trials · 4 indications
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 | - |
| 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 64, with last natural menstrual period completed at lease 6 months ago * Intact uterus * Seeking treatment for hot flushes and experiencing 7 moderate to severe hot flushes per day or 50 per week Exclusion Criteria: * Histo...
Bazedoxifene is an investigational small molecule being studied for conditions related to menopause, including postmenopausal osteoporosis, vaginal atrophy, endometrial hyperplasia, and vasomotor symptoms associated with menopause. It is being developed by Pfizer, Inc. (PFE) and is currently in Phase 3 clinical development.
Bazedoxifene is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. The drug is an investigational small molecule in Phase 3 clinical development for multiple menopause-related conditions, including osteoporosis and vasomotor symptoms.
Bazedoxifene is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Pfizer, Inc. (PFE) is the developer, and the drug is being studied for postmenopausal osteoporosis, vaginal atrophy, and vasomotor symptoms associated with menopause.
Bazedoxifene has completed three clinical trials. One Phase 3 trial (NCT00238732) evaluated Bazedoxifene with conjugated estrogens for vasomotor symptoms and vaginal atrophy in 650 women. A Phase 2 trial (NCT00238745) studied dose-response in 375 Japanese patients with postmenopausal osteoporosis. Two Phase 1 trials (NCT00479778, NCT00706225) assessed pharmacokinetics and drug interactions in healthy postmenopausal women.
Bazedoxifene has been studied in combination with conjugated estrogens. Clinical trials such as NCT00238732 evaluated Bazedoxifene with conjugated estrogen combinations for vasomotor symptoms and vaginal atrophy, and NCT00479778 examined the pharmacokinetic profile of Bazedoxifene in two Bazedoxifene and conjugated estrogen forms.
Bazedoxifene is a small molecule being developed for menopause-related conditions. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being studied for its effects on postmenopausal osteoporosis, vaginal atrophy, and vasomotor symptoms.