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Estradiol/DRSP · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | - |
| Arm 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Estradiol/DRSP (Angeliq, BAY86-4891) | DRUG | Drospirenone (DRSP) 2mg and Estradiol 1mg. One cycle consists of 28 days. One tablet daily for 28 days given for a total of 4 cycles. Oral administration. |
| Placebo | DRUG | Same administration. |
Inclusion Criteria: * Chinese postmenopausal women with moderate to severe vasomotor symptoms Exclusion Criteria: * History of steroid hormone dependent malignant disease * Known or suspected malignant or premalignant disease * Current or history of severe heart, liver, renal, psychiatric disease...
Estradiol/DRSP is an investigational combination of estradiol and drospirenone being studied for the treatment of vasomotor symptoms, commonly known as hot flashes, in postmenopausal women. It is currently in Phase 3 clinical development.
Estradiol/DRSP is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the OTC market.
Estradiol/DRSP is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is no longer in active clinical trials.
Estradiol/DRSP has one completed Phase 3 clinical trial, identified as NCT00356447. This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of drospirenone/estradiol in 249 postmenopausal Chinese women with vasomotor symptoms.
Estradiol/DRSP combines estradiol, an estrogen hormone, with drospirenone, a progestin. This combination is designed to address vasomotor symptoms by supplementing declining estrogen levels in postmenopausal women, which helps regulate body temperature and reduce hot flashes.