What Is Estriol / Progesterone Vaginal Suppository?
It is a compounded vaginal suppository combining estriol — a weak estrogen — with progesterone, delivering both hormones locally to the vaginal and pelvic tissues. It is prepared by prescription for an individual patient.
How the Ingredients Work
Estriol — a Weak Estrogen
Estriol is a low-potency estrogen. Very low-dose transvaginal estrogens, as creams, tablets, and rings, are effective for vaginal atrophy and urinary symptoms.
Progesterone — Targeted to the Uterus
Vaginal progesterone has a "uterine first-pass effect."
Why the Vaginal Route?
Because of the uterine first-pass effect, vaginally delivered hormones concentrate in the uterus and nearby tissues with low systemic exposure, and progesterone given vaginally is delivered directly to the uterus — its target organ.
Is It FDA-Approved?
No. Estriol is not an FDA-approved drug in the United States, and this estriol-plus-progesterone suppository is a compounded preparation. FDA-approved vaginal estrogen (estradiol) and FDA-approved vaginal progesterone products exist separately.
What Should Prescribers Know About Compounded Hormones?
Compounded bioidentical hormones are not FDA-regulated, and professional guidance generally favors FDA-approved products. If progesterone is intended for endometrial protection, the dose must be adequate — that determination is the prescriber's responsibility.
Safety Information
Estrogens carry class warnings, including boxed warnings. Patient selection, dosing, endometrial considerations, and evaluation of any abnormal bleeding are the prescriber's responsibility. Mixwell prepares the suppository as written and makes no recommendation about therapy.
Quality and Compliance — Hazardous Drug Handling
Because these are hormones, handled as hazardous drugs, Mixwell compounds in a purpose-built lab meeting USP <800> (hazardous drug) standards, including HD negative-pressure containment, 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
- Bulletti C, de Ziegler D, Flamigni C, et al. Targeted drug delivery in gynaecology: the first uterine pass effect. Hum Reprod. 1997;12(5):1073–1079.
- Cicinelli E. Intravaginal oestrogen and progestin administration: advantages and disadvantages. Best Pract Res Clin Obstet Gynaecol. 2008;22(2):391–405.
- 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.
- American College of Obstetricians and Gynecologists. Compounded Bioidentical Menopausal Hormone Therapy. Clinical Consensus. Obstet Gynecol. 2023.
