CreamVaginalNon sterile Rx only

Estriol / Testosterone Vaginal Cream

Anhydrous Vaginal Combination

Estriol and testosterone compounded together in the Ellage anhydrous base for vaginal use. Non sterile, prepared to a prescriber's order in Chino, CA.

Reviewed by Linda Pungpravat, Compounding Pharmacist, RPh Mixwell Compounding Pharmacy, Chino, CA

USP <795> compliant
USP <800> hazardous drug lab
PCCA member

At a Glance

Preparation details for Estriol / Testosterone Vaginal Cream
Dosage form	Cream
Route	Vaginal
Active ingredients	Estriol, Testosterone
Technology	Anhydrous Vaginal Combination
Strengths in literature	Estradiol vaginal cream: 0.01% (FDA label). No FDA labeled strengths for estriol or for testosterone in women.
Commercial product	No U.S. commercial product
Strength and directions	Per prescriber
Dispensing	Valid prescription

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Phone (909) 378-7301. Fax (909) 378-7071

Clinical Advantages

Two actives in one vaginal preparation
Strengths set by the prescriber
Anhydrous Ellage base, no added water
Longer default beyond use date than water based creams
Non sterile preparation

How It Works

What are the two medicines?

Estriol is an estrogen. No FDA approved estriol product is listed on DailyMed. FDA labeling for estrogen vaginal cream is written for estradiol, which is labeled for moderate to severe vulvar and vaginal atrophy due to menopause [1].
Testosterone is an androgen and a Schedule III controlled substance. FDA labeling for AndroGel is for adult men with testosterone deficiency, and the label states it is not indicated for use in women [2].

No FDA label covers testosterone applied in the vagina, or this combination.

What is a vaginal cream?

A vaginal cream is a semi-solid preparation applied inside the vagina, usually with an applicator. The medicine is mixed evenly through a base that holds it in place.

What is the Ellage base?

Ellage is a PCCA base made for vaginal use. Its manufacturer describes it as anhydrous, meaning it has no added water, with a water activity below 0.6 [3]. These are the manufacturer's descriptions.

What compounding in Ellage provides

Two medicines combined in one uniform preparation, so the patient uses one product
Strength of each medicine set by the prescriber, instead of a fixed commercial strength
A water free base, which USP 795 gives a default beyond use date of up to 180 days, longer than a water based cream [4]
A base chosen for vaginal application

How much of either medicine is absorbed from the vagina is not described in FDA labeling for testosterone. The estradiol vaginal cream label states that systemic absorption can occur [1].

When prescribers choose it

OB/GYN, women's health, and menopause medicine prescribers who want one custom vaginal preparation
Prescribers who want a combination or strengths that no commercial product offers

Clinical Details

What does the evidence show?

No FDA approved product contains this combination, and the FDA has not reviewed this preparation.
FDA approved estradiol vaginal cream 0.01% is labeled for moderate to severe vulvar and vaginal atrophy due to menopause [1].
The AndroGel label states it is not indicated for use in women [2].

Findings come from the cited studies and do not promise any individual outcome.

Why is it compounded, and how is it typically used?

Why it is compounded

No commercial product combines estriol and testosterone for vaginal use [1][2]. A prescriber who wants this combination orders it compounded.

Dosage forms and strengths

Strength of each medicine set by the prescriber
Anhydrous Ellage base
Quantities matched to the prescription

Dosing is the prescriber's decision.

How Mixwell prepares it

Mixwell compounds this cream in Chino, California under USP 795 standards for non sterile preparations [4]. Testosterone is a Schedule III controlled substance, so a valid prescription is required. Our pharmacist confirms the strengths with the prescriber and assigns the beyond use date. Finished creams ship across California.

Safety information

Estradiol vaginal cream labeling has a boxed warning for endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia. It states estrogens should be used at the lowest effective dose for the shortest duration, and that systemic absorption can occur [1].

That label lists as contraindications undiagnosed abnormal genital bleeding, known or past breast cancer, blood clots, stroke or heart attack, liver disease, and pregnancy [1].

AndroGel labeling has a boxed warning that children exposed to the gel can develop virilization. It states the product is not indicated for use in women, and lists use in pregnant women as a contraindication because it can cause virilization of a female fetus [2].

No FDA labeling describes the safety of these two medicines together in the vagina. Patient selection, dosing, and monitoring are the prescriber's responsibility. Patients should talk with their own healthcare professional before using any medication.

References

Estradiol vaginal cream, USP, 0.01%. Prescribing information. DailyMed
ANDROGEL (testosterone) gel 1.62%. Prescribing information. DailyMed
PCCA. Ellage base, manufacturer description. Used only to describe the base, not as evidence for any clinical claim.
United States Pharmacopeia. General Chapter 795, Pharmaceutical Compounding: Nonsterile Preparations. USP NF. Official November 1, 2023.

What to include on the prescription

APIs and strengths
Base or vehicle
Quantity
Directions for use
Refills
Allergies or dye free needs

Call (909) 378-7301 Fax (909) 378-7071

Compounded in Chino, CA. Delivered across California.

Chino
Chino Hills
Ontario
Pomona
Diamond Bar
Rancho Cucamonga
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Mixwell Compounding Pharmacy 13788 Roswell Ave, Ste 158, Chino, CA 91710
(909) 378-7301

Compounded medications are not reviewed or approved by the FDA. Dispensed only with a valid prescription. Mixwell is a non sterile pharmacy and does not prepare sterile products or injectables. Compounded preparations are not presented as superior to commercially available products, and nothing here promises a specific result. Mixwell does not accept insurance. Call for pricing.

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