What Is Estriol Vaginal?
It is a compounded vaginal preparation containing estriol — a naturally occurring, weaker form of estrogen — in the Ellage® vaginal base. Prescribers use vaginal estrogens to address local symptoms of the genitourinary syndrome of menopause (GSM). It is prepared by prescription for an individual patient.
How It Works
Estriol (E3) is a low-potency estrogen. When estrogen falls around menopause, the vaginal tissues can become thin and dry, with decreased elasticity and lubrication, often causing pain with sexual activity and urinary discomfort. Applied locally, vaginal estrogen works in the tissue where it is placed, and low-dose vaginal estrogen does not raise blood estrogen levels beyond the normal menopausal range. Bayview PharmacyJDDonline
What Is It Used For?
Vaginal estrogens are used for GSM symptoms such as vaginal dryness, burning, irritation, painful intercourse, and urinary symptoms. In a systematic review of postmenopausal women with GSM, low-dose vaginal estrogen lowered the rate of urinary tract infections. Selection and use are the prescriber's clinical decision. MDPI
Is Estriol FDA-Approved?
No. In the United States, estriol products are not available as FDA-approved drugs, so estriol is accessed through compounding; FDA-approved vaginal estrogen products (such as estradiol) do exist. Major menopause organizations note that compounded vaginal estrogen is not government-regulated, so whether to use a compounded estriol preparation is a decision between a patient and their prescriber. MDPIBayview Pharmacy
Safety Information
As a drug class, estrogens carry warnings, and estrogen labeling includes boxed warnings. At the same time, research on low-dose vaginal estrogen shows minimal systemic absorption and a reassuring local profile; guidelines advise that routine endometrial monitoring is not needed solely because a patient uses low-dose vaginal estrogen. Patient selection, dose, and follow-up are the prescriber's responsibility. MDPI
Quality and Compliance
Mixwell Compounding Pharmacy prepares this preparation in our purpose-built, USP <795>-compliant lab to the prescriber's exact strength, dispensed only with a valid prescription. Mixwell is a non-sterile pharmacy and does not prepare sterile products or injectables. Compounded medications are not reviewed or approved by the FDA. Nothing here promises a specific result, and compounded preparations are not presented as superior to commercially available products.
References
- The NAMS 2020 GSM Position Statement Editorial Panel. The 2020 Genitourinary Syndrome of Menopause Position Statement of The North American Menopause Society. Menopause. 2020;27(9):976–992.
- Genitourinary Syndrome of Menopause: AUA/SUFU/AUGS Guideline. American Urological Association; 2025.
- Raz R, Stamm WE. A controlled trial of intravaginal estriol in postmenopausal women with recurrent urinary tract infections. N Engl J Med. 1993;329(11):753–756. doi:10.1056/NEJM199309093291102.
- The 2022 Hormone Therapy Position Statement of The North American Menopause Society Advisory Panel. Menopause. 2022;29(7):767–794. doi:10.1097/GME.0000000000002028.
- Professional Compounding Centers of America (PCCA). Formulation science and compounding resources. https://www.pccarx.com/Blog/