Overview
Esterified estrogens contain a mixture of estrogenic substances; the principle component is estrone. Preparations contain 75% to 85% sodium estrone sulfate and 6% to 15% sodium equilin sulfate such that the total is not <90%. Esterified estrogens are a man-made mixture of estrogens that are used to treat symptoms of menopause such as hot flashes, vaginal dryness, vaginal burning or irritation, or other hormonal changes in the vagina. It is being also for the prevention and treatment of osteoporosis.
Background
Esterified estrogens contain a mixture of estrogenic substances; the principle component is estrone. Preparations contain 75% to 85% sodium estrone sulfate and 6% to 15% sodium equilin sulfate such that the total is not <90%. Esterified estrogens are a man-made mixture of estrogens that are used to treat symptoms of menopause such as hot flashes, vaginal dryness, vaginal burning or irritation, or other hormonal changes in the vagina. It is being also for the prevention and treatment of osteoporosis.
Indication
Esterified estrogens are indicated to replace estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. It is also indicated for the treatment of symptoms of breast cancer in both men and women. In men it can be used for the treatment of advanced prostate cancer. It is also indicated for the treatment of menopausal symptoms.
Associated Conditions
- Hypogonadism
- Metastatic Breast Cancer
- Premature Ovarian Failure (POF)
- Advanced carcinoma of the prostate
- Moderate Menopausal Vasomotor Symptoms
- Moderate Vulvovaginal atrophy
- Severe Vasomotor Symptoms Associated With Menopause
- Severe menopausal vulvovaginal atrophy
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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No clinical trials found
No clinical trials found for this drug
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
ORAL | 0.625 mg in 1 1 | 2024/01/10 | 69315-283 | ||
ORAL | 0.625 mg in 1 1 | 2017/12/01 | 63629-1980 | ||
ORAL | 1.25 mg in 1 1 | 2017/12/01 | 63629-1979 | ||
ORAL | 0.625 mg in 1 1 | 2022/04/26 | 63629-9178 | ||
ORAL | 0.625 mg in 1 1 | 2023/12/31 | 53746-077 | ||
ORAL | 1.25 mg in 1 1 | 2023/12/31 | 53746-078 | ||
ORAL | 1.25 mg in 1 1 | 2020/01/22 | 15310-010 | ||
ORAL | 0.625 mg in 1 1 | 2020/01/22 | 15310-020 | ||
ORAL | 1.25 mg in 1 1 | 2017/12/01 | 72162-1747 | ||
ORAL | 1.25 mg in 1 1 | 2017/12/01 | 62559-149 |
EMA Approved Products
Product Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
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No EMA products found
No EMA products found for this drug
HSA Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval Number |
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No HSA products found
No HSA products found for this drug
NMPA Approved Products
Product Name | Approval Number | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
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No NMPA products found
No NMPA products found for this drug
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Registration Date |
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No PPB products found
No PPB products found for this drug
TGA Approved Products
Product Name | ARTG ID | Sponsor | Status | Registration Date | Ingredient |
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No TGA products found
No TGA products found for this drug