Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
bazedoxifene/conjugated estrogens · 2 trials · 2 indications
Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis.
BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of 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. Mean percentage change from baseline of the 2 readings were reported.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | bazedoxifene 20 mg/conjugated estrogens 0.45 mg |
| 2 | EXPERIMENTAL | bazedoxifene 20 mg/conjugated estrogens 0.625 mg |
| 3 | EXPERIMENTAL | bazedoxifene 20 mg |
| 4 | ACTIVE_COMPARATOR | Prempro |
| 5 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| bazedoxifene 20 mg/ conjugated estrogens 0.45 mg | DRUG | One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year. |
| bazedoxifene 20 mg/ conjugated estrogens 0.625 mg | DRUG | One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year. |
| bazedoxifene 20 mg | DRUG | One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year. |
| conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg | DRUG | One capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year. |
| Placebo | DRUG | One capsule, placebo (over-encapsulated), once a day for one year. |
| bazedoxifene/conjugated estrogens | DRUG | - |
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: ...
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.