Overview
The conjugated estrogens are noncrystalline mixtures of purified female sex hormones obtained either by its isolation from the urine of pregnant mares or by synthetic generation from vegetal material. Both of these products are later conjugated to natrium sulfate by ester bonds in order to make them more water soluble. The conjugated estrogen product contains a mix of estrogen from which about 50% is represented by estrone sulfate followed by 25% of equilin sulfate, 15% of 17-alpha-dehydroequilenin sulfate, 3% of equilenin sulfate, 5% of 17-alpha and 17-beta-dihydroequilenin sulfate, 2% of 17-alpha-estradiolsulfate and 3% of 17-beta-estradiolsulfate. It also presents a large number of unidentified molecules with weak estrogenic activity as well as non-human molecules when it is obtained from pregnant mares urine. The conjugated estrogen mixture was approved for marketing in US in 1942 based on the efficacy against certain conditions. However, until 1986 official clinical trials were performed and this product was determined to be effective for the treatment of osteoporosis. The currently approved product of conjugated estrogens was developed by Wyeth Ayerst and FDA approved in 2003.
Background
The conjugated estrogens are noncrystalline mixtures of purified female sex hormones obtained either by its isolation from the urine of pregnant mares or by synthetic generation from vegetal material. Both of these products are later conjugated to natrium sulfate by ester bonds in order to make them more water soluble. The conjugated estrogen product contains a mix of estrogen from which about 50% is represented by estrone sulfate followed by 25% of equilin sulfate, 15% of 17-alpha-dehydroequilenin sulfate, 3% of equilenin sulfate, 5% of 17-alpha and 17-beta-dihydroequilenin sulfate, 2% of 17-alpha-estradiolsulfate and 3% of 17-beta-estradiolsulfate. It also presents a large number of unidentified molecules with weak estrogenic activity as well as non-human molecules when it is obtained from pregnant mares urine. The conjugated estrogen mixture was approved for marketing in US in 1942 based on the efficacy against certain conditions. However, until 1986 official clinical trials were performed and this product was determined to be effective for the treatment of osteoporosis. The currently approved product of conjugated estrogens was developed by Wyeth Ayerst and FDA approved in 2003.
Indication
The conjugated estrogens are indicated for several different conditions including:
Associated Conditions
- Abnormal Uterine Bleeding
- Atrophic Vaginitis
- Atrophy of vulva
- Kraurosis Vulvae
- Menopause
- Metastatic Breast Cancer
- Moderate to Severe Vasomotor Symptoms
- Osteoporosis
- Androgen-dependent tumor Advanced Prostate Carcinoma
- Hypoestrogenism
- Moderate Dyspareunia
- Moderate Vulvar and Vaginal Atrophy
- Severe Dyspareunia
- Severe Vulvar and Vaginal Atrophy
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2020/07/20 | Phase 1 | Recruiting | |||
2020/05/07 | Early Phase 1 | Terminated | Carol Fabian, MD | ||
2019/06/25 | Phase 4 | Completed | |||
2019/06/10 | Phase 3 | UNKNOWN | |||
2017/08/30 | N/A | Completed | |||
2017/01/11 | Phase 4 | Terminated | |||
2016/08/09 | Phase 4 | Withdrawn | |||
2016/04/06 | Phase 2 | Completed | |||
2015/05/01 | Phase 4 | Completed | |||
2014/08/11 | Phase 4 | Terminated | Medstar Health Research Institute |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1106 | ORAL | 0.45 mg in 1 1 | 5/6/2025 | |
Physicians Total Care, Inc. | 54868-3799 | ORAL | 0.625 mg in 1 1 | 11/1/2012 | |
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1107 | ORAL | 0.625 mg in 1 1 | 5/6/2025 | |
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1100 | ORAL | 0.3 mg in 1 1 | 9/20/2018 | |
Aphena Pharma Solutions - Tennessee, Inc. | 43353-688 | ORAL | 0.625 mg in 1 1 | 7/18/2012 | |
State of Florida DOH Central Pharmacy | 53808-0770 | ORAL | 0.625 mg in 1 1 | 5/27/2010 | |
U.S. Pharmaceuticals | 63539-122 | ORAL | 0.45 mg in 1 1 | 7/1/2022 | |
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1101 | ORAL | 0.45 mg in 1 1 | 9/20/2018 | |
A-S Medication Solutions | 50090-0573 | ORAL | 0.625 mg in 1 1 | 5/15/2019 | |
Physicians Total Care, Inc. | 54868-5540 | ORAL | 0.625 mg in 1 1 | 11/1/2012 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Conjugated Estrogens Tablets | 国药准字H20090165 | 化学药品 | 片剂 | 4/2/2024 | |
Conjugated Estrogens Tablets | 国药准字H20090170 | 化学药品 | 片剂 | 4/2/2024 | |
Conjugated Estrogens Tablets | 国药准字H20090172 | 化学药品 | 片剂 | 4/2/2024 | |
Conjugated Estrogens Cream | 国药准字H20051718 | 化学药品 | 乳膏剂 | 8/21/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
PREMARIN | 177673 | Medicine | A | 5/28/2012 | |
PREMARIN conjugated estrogens 0.625mg tablet blister pack | 177674 | Medicine | A | 5/28/2012 | |
DUAVIVE 0.45/20 conjugated estrogens/bazedoxifene (as acetate) 0.45 mg/20 mg modified release tablet blister pack | 262525 | Medicine | A | 12/15/2016 |