Estriol

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.

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
Effect of Local Estriol Treatment Before Vaginal Repair Surgery	2024/04/30	NCT06391372	Phase 3	Active, not recruiting	Hatice Tukenmez Kurnaz
Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser	2022/04/19	NCT05335317	Not Applicable	Recruiting	MeLSyTech, Ltd
Vulvovaginal Atrophy Correction Using Neodymium Laser	2021/02/03	NCT04735549	Not Applicable	Completed	MeLSyTech, Ltd
Study to Determine Efficacy & Safety of a Low Concentration Estriol (0.005%) in Postmenopausal Vaginal Atrophy.	2020/10/05	NCT04574999	Phase 3	Completed	Italfarmaco S.A
A Randomized Controlled Phase 2 Study to Determine Lowest Efficacious Dose of Ovestin in Vulvar and Vaginal Atrophy	2019/11/12	NCT04159493	Phase 2	Withdrawn	Aspen USA Inc
LASER and Radiofrequency and Genitourinary Syndrome of Menopause	2019/08/05	NCT04045379	Not Applicable	Active, not recruiting	Federal University of São Paulo
Vaginal Estriol in Multiple Sclerosis	2018/12/13	NCT03774407	Phase 2	Completed	Texas Tech University Health Sciences Center
Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days	2017/12/06	NCT03363997	Phase 1	Completed	Galeno Desenvolvimento de Pesquisas Clínicas
Estriol and Trimegestone Dose-response Trial With Single Dose Application of Vaginal Rings	2017/11/17	NCT03343912	Phase 1	Completed	Galeno Desenvolvimento de Pesquisas Clínicas
Use of Estriol at Distal Third of Vagina Improving Coital Pain in Post-menopause Women	2017/04/14	NCT03116022	Phase 1	Completed	University of Sao Paulo

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
3.6oz BiEST 2.5 Estrogen Cream	SHYNE BRANDS/BIOLabs PRO	82018-0030	TRANSDERMAL	2 mg in 102 g	6/1/2025
Arthcal ESTROGEN	Beijing JUNGE Technology Co., Ltd.	85212-0038	CUTANEOUS	0.2 g in 100 mL	5/14/2025
Balance Plus Cream	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
No NMPA approvals found for this drug.

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	Aspen Pharmacare Australia Pty Ltd	Medicine	A	11/23/1992
Ovestin 1mg tablet blister pack	14514	Aspen Pharmacare Australia Pty Ltd	Medicine	A	9/20/1991
VESPEN estriol 1 mg/g cream tube	290331	Aspen Pharmacare Australia Pty Ltd	Medicine	A	8/7/2017
Ovestin 1mg/g cream tube	14515	Aspen Pharmacare Australia Pty Ltd	Medicine	A	9/20/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
OVESTINON 1 mg/g CREMA VAGINAL	Aspen Pharma Trading Limited	61533	CREMA VAGINAL	Medicamento Sujeto A Prescripción Médica	Commercialized
BLISSEL 50 microgramos/g GEL VAGINAL	Italfarmaco S.A.	72726	GEL VAGINAL	Medicamento Sujeto A Prescripción Médica	Commercialized
OVESTINON 0,5 mg OVULOS	Aspen Pharma Trading Limited	57467	ÓVULO	Medicamento Sujeto A Prescripción Médica	Commercialized
FEMMYN 0,03 MG ÓVULOS	Kern Pharma S.L.	82222	ÓVULO	Medicamento Sujeto A Prescripción Médica	Commercialized
GELISTROL 50 microgramos/g GEL VAGINAL	Italfarmaco S.A.	72727	GEL VAGINAL	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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