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Label indication Lopreeza is indicated for: Lopreeza is an estrogen and progestin combination indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2) Limitations of Use : When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to… FDA label
Estradiol · 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 is used to treat vasomotor symptoms, the hot flashes and night sweats associated with menopause. In this program it is being developed as estradiol alone and as a combination of estradiol with drospirenone for postmenopausal women with vasomotor symptoms. It is a small molecule in Phase 3 development.
Estradiol works as an agonist at ESR1, the estrogen receptor alpha. By binding and activating this nuclear receptor, it mimics endogenous estrogen signaling, which helps restore hormonal balance and reduce the vasomotor symptoms that follow the decline in estrogen levels after menopause.
Bayer AG is developing estradiol, including the estradiol and drospirenone combination, for vasomotor symptoms. Bayer trades on the OTC market under the ticker BAYRY. The program is in Phase 3 clinical development.
Estradiol is in Phase 3 development for vasomotor symptoms. It is an investigational therapy and is not approved for this use based on the available program information. The Phase 3 study in this program has been completed.
The Phase 3 trial NCT00356447 evaluated the safety and efficacy of drospirenone and estradiol in postmenopausal Chinese women with vasomotor symptoms. It was a randomized, double-blind, placebo-controlled study that enrolled 249 women aged 45 years and older in China and is now completed.
Yes. Estradiol is also known as E2 0.3mg, and the estradiol and drospirenone combination is known as Angeliq or BAY86-4891. These names refer to the same Bayer program, which pairs estradiol with drospirenone for vasomotor symptoms.