Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication DUAVEE is indicated in women with a uterus for: DUAVEE is a combination of conjugated estrogens with an estrogen agonist/antagonist indicated for treatment of the following conditions in women with a uterus: • Treatment of moderate to severe vasomotor symptoms associated with menopause ( 1.1 ) • Prevention of postmenopausal osteoporosis ( 1.2 ) Limitation of Use : DUAVEE should be used for the shortest duration… FDA label
Also known as Duavee
CE/BZA · 1 trial · 1 indication
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
| Arm | Type | Description |
|---|---|---|
| Non-Obese | OTHER | BMI \<30 kg/m\^2 |
| Obese | OTHER | BMI \>= 30 kg/m\^2 |
| Name | Type | Description |
|---|---|---|
| CE/BZA | DRUG | CE 0.45mg/BZA 20mg tablets, single dose |
| Itraconazole | DRUG | Two 100 mg capsules, once daily for 7 days |
Inclusion Criteria: * Generally healthy postmenopausal women, aged 40-64. Intact Uterus Exclusion Criteria: * The use of oral, vaginal, or transdermal estrogen, androgen or progestin-containing medications within 30 days before study drug administration.
CE/BZA is an investigational small molecule drug combination being developed by Pfizer for endometrial hyperplasia. It combines conjugated estrogens with bazedoxifene. The asset has been studied in a Phase 1 clinical trial and is not yet approved. Its development stage remains early clinical testing.
CE/BZA is being developed for the treatment of endometrial hyperplasia, a condition involving overgrowth of the uterine lining. The only registered trial of this asset enrolled healthy postmenopausal women rather than patients with the condition, so the endometrial hyperplasia indication reflects the intended development direction rather than a completed efficacy study.
Pfizer, Inc. is the developer of CE/BZA. Pfizer trades on the New York Stock Exchange under the ticker PFE. The company sponsored the Phase 1 pharmacokinetic study of the combination in postmenopausal women.
CE/BZA is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
CE/BZA has been evaluated in one completed Phase 1 trial, NCT02100553. The study examined the effects of multiple-dose itraconazole administration on the single-dose pharmacokinetics of conjugated estrogens and bazedoxifene in non-obese and obese postmenopausal women. It enrolled 24 participants in the United States and has completed.