Overview
A hydroxylated metabolite of estradiol or estrone that has a hydroxyl group at C3-beta, 16-alpha, and 17-beta position. Estriol is a major urinary estrogen. During pregnancy, large amount of estriol is produced by the placenta. Isomers with inversion of the hydroxyl group or groups are called epiestriol. Though estriol is used as part of the primarily North American phenomenon of bioidentical hormone replacement therapy, it is not approved for use by the FDA or Health Canada. It is however available in the United States by prescription filled only by compounding pharmacies. It has also been approved and marketed throughout Europe and Asia for approximately 40 years for the treatment of post-menopausal hot flashes.
Background
A hydroxylated metabolite of estradiol or estrone that has a hydroxyl group at C3-beta, 16-alpha, and 17-beta position. Estriol is a major urinary estrogen. During pregnancy, large amount of estriol is produced by the placenta. Isomers with inversion of the hydroxyl group or groups are called epiestriol. Though estriol is used as part of the primarily North American phenomenon of bioidentical hormone replacement therapy, it is not approved for use by the FDA or Health Canada. It is however available in the United States by prescription filled only by compounding pharmacies. It has also been approved and marketed throughout Europe and Asia for approximately 40 years for the treatment of post-menopausal hot flashes.
Indication
Used as a test to determine the general health of an unborn fetus.
Associated Conditions
- Cervicitis
- Menopausal and Postmenopausal Disorders
- Hypoestrogenism
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/04/30 | Phase 3 | Active, not recruiting | Hatice Tukenmez Kurnaz | ||
2022/04/19 | Not Applicable | Recruiting | MeLSyTech, Ltd | ||
2021/02/03 | Not Applicable | Completed | MeLSyTech, Ltd | ||
2020/10/05 | Phase 3 | Completed | |||
2019/11/12 | Phase 2 | Withdrawn | Aspen USA Inc | ||
2019/08/05 | Not Applicable | Active, not recruiting | Federal University of São Paulo | ||
2018/12/13 | Phase 2 | Completed | |||
2017/12/06 | Phase 1 | Completed | Galeno Desenvolvimento de Pesquisas Clínicas | ||
2017/11/17 | Phase 1 | Completed | Galeno Desenvolvimento de Pesquisas Clínicas | ||
2017/04/14 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| SHYNE BRANDS/BIOLabs PRO | 82018-0030 | TRANSDERMAL | 2 mg in 102 g | 6/1/2025 | |
| Beijing JUNGE Technology Co., Ltd. | 85212-0038 | CUTANEOUS | 0.2 g in 100 mL | 5/14/2025 | |
| SHYNE BRANDS/BIOLabs PRO | 82018-0028 | TRANSDERMAL | 240 mg in 102 g | 6/1/2025 |
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 |
|---|---|---|---|---|---|
| Estriol Cream | 国药准字HJ20170005 | 化学药品 | 乳膏剂 | 7/13/2020 | |
| Estrol Suppositories | 国药准字HJ20120386 | 化学药品 | 栓剂 | 3/1/2024 |
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 |
|---|---|---|---|---|---|
| OVESTIN OVULA 0.5mg pessary strip pack | 35632 | Medicine | A | 11/23/1992 | |
| Ovestin 1mg tablet blister pack | 14514 | Medicine | A | 9/20/1991 | |
| VESPEN estriol 1 mg/g cream tube | 290331 | Medicine | A | 8/7/2017 | |
| Ovestin 1mg/g cream tube | 14515 | Medicine | A | 9/20/1991 |