What Is DHEA / Estriol Vaginal?
It is a compounded vaginal preparation that combines DHEA (also called prasterone) with estriol — a weaker form of estrogen — in the Ellage® vaginal base. Prescribers use vaginal hormones for local symptoms of the genitourinary syndrome of menopause (GSM). It is prepared by prescription for an individual patient.
How the Ingredients Work
DHEA (Prasterone) — a Hormone Precursor
DHEA is an inactive precursor hormone. Inside vaginal cells, DHEA is converted locally into androgens and estrogens that act on nearby tissue — a process called intracrinology — while serum sex-steroid levels generally remain within the normal postmenopausal range. Drugs.com
Estriol — a Weak Estrogen
Estriol is a low-potency estrogen that acts locally on vaginal tissue when applied in the area.
Is There an FDA-Approved Version?
Partly. Intravaginal prasterone (DHEA), sold as Intrarosa, was FDA-approved in 2016 for moderate-to-severe dyspareunia — painful intercourse — due to vulvar and vaginal atrophy in postmenopausal women. However, this compounded combination of DHEA with estriol is not an FDA-approved product, and estriol itself is not FDA-approved in the United States. Compounding may be chosen when a prescriber wants a custom strength, an added ingredient, or a different form than the commercial insert. PubMed
What Does the Research Show?
In two pivotal phase 3 randomized trials, vaginal prasterone significantly improved the signs and symptoms of vaginal atrophy — including vaginal pH, cell measures, and dyspareunia — without raising serum hormone levels beyond the normal postmenopausal range. That evidence is for prasterone on its own; the DHEA-plus-estriol combination is a prescriber-directed compounded option rather than a separately FDA-tested product. Hormonesandwellness
Safety Information
The prasterone label notes that DHEA is converted to estrogen in the body, that estrogen medicines are not for use in certain patients, and that it is intended only for women past menopause. Estrogens as a class carry warnings, including boxed warnings on labeling. Patient selection, dosing, and monitoring are the prescriber's responsibility. Oxford Academic
Quality and Compliance — Hazardous Drug Handling
Because these are hormones, which are handled as hazardous drugs, Mixwell prepares this preparation in a purpose-built lab that meets USP <795> standards for non-sterile compounding and USP <800> standards for hazardous drugs, including HD negative-pressure containment. It is dispensed only with a valid prescription for an individual patient. 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
- INTRAROSA (prasterone) Prescribing Information. U.S. Food and Drug Administration; 2016.
- Prasterone (Intrarosa) for Dyspareunia. STEPS. American Family Physician. 2019;99(2):117–118.
- 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.
- Professional Compounding Centers of America (PCCA). Formulation science and compounding resources. https://www.pccarx.com/Blog/
