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Biest 50:50 | Hormones & Vitality

The 50:50 ratio is the prescription, not fine print.

A compounded 50:50 estradiol and estriol prescription with the ratio stated plainly and prepared for the individual patient.

About 10 minutes. No charge unless your clinician approves.

Licensed cliniciansCompounded by a licensed 503A pharmacyNo clinic visit
What It Is

The point is the fit, not the label.

Biest combines two bioidentical estrogens, estriol and estradiol, in one topical preparation. Estradiol is the body’s most potent estrogen. Estriol is weaker. Here, they are compounded in a 50:50 ratio and prepared as a measured cream to the prescription your clinician writes for you.

That flexibility is the entire reason Biest exists.

Commercial hormone products are intentionally standardized. Compounding gives a clinician another option when a specific ratio, strength, or cream base is clinically appropriate for an individual patient.

Individualized compounding gives your clinician a tailored tool when the available standard formats do not fit your documented clinical needs cleanly.

The 50:50 ratio tells you exactly how estradiol and estriol are balanced. Your clinician decides whether that blend has a specific clinical reason to be individualized, and a licensed pharmacy prepares the compounded prescription.

Read the evidence →
Who It's For

For the patient who needs tailoring, not a trend.

01

Standard Options Did Not Fit Cleanly

You have tried or considered commercial estradiol formats and, with your clinician, have a specific reason to look at a different strength, combination, or base.

02

The Daily Cream Makes Sense for Your Routine

A measured topical cream may fit your preferences and daily habits better than a patch or tablet. Preference belongs in the decision, alongside the medical reasons that matter more.

03

You Want the Variables in Clinical Hands

Ratio, strength, base, dose, and follow-up create more room to tailor. That flexibility is valuable only when someone qualified is responsible for using it well.

Compounded Biest 50:50 is not an FDA-approved drug product, and compounded bioidentical hormones have not been shown to be safer or more effective than FDA-approved hormone therapy. A licensed provider determines whether a compounded preparation fits your case, or whether an approved therapy serves you better.

This might not be the right fit if:
  • History of breast cancer or another estrogen-dependent malignancy
  • Unexplained vaginal bleeding
  • History of blood clots, stroke, or heart attack
  • Active liver disease
  • Pregnancy or planned pregnancy

Your intake screens for all contraindications. Every candidate is evaluated by a licensed clinician before any prescription is issued. No prescription is issued without clearance.

Your Plan

Biest 50:50, prescribed with care.

Compounded by a licensed 503A pharmacy. Prescribed by a licensed provider after clinical review.

One price covers the provider, the prescription if approved, the pharmacy, and the follow-up.
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The Evidence

What the research shows

Consensus report · National Academies · 2020

The National Academies found insufficient evidence for compounded bioidentical hormone therapy.

2020
consensus report convened at the FDA’s request
The detail

The question has been reviewed at the highest level available. At the FDA’s request, the National Academies of Sciences, Engineering, and Medicine convened a committee that reviewed the uses of compounded bioidentical hormone therapy and the evidence behind its marketing claims, with a prioritized focus that included estradiol and estriol. Its 2020 consensus report concluded, in its own words, that given the paucity of data on the safety and effectiveness of compounded bioidentical hormone therapy there is insufficient evidence to support its overall clinical utility as a treatment for menopause symptoms.1

Consensus report · Recommendation 1

Prescribers should restrict compounding to a documented allergy or documented need for a different dosage form.

Recommendation 1
patient preference alone should not determine use
The detail

That report also made a specific prescribing recommendation. Recommendation 1 is that prescribers restrict the use of compounded bioidentical hormone therapy to a documented allergy to an active pharmaceutical ingredient or excipient of an FDA-approved drug product, or a documented requirement for a different dosage form, and that patient preference alone should not determine use. That recommendation is why an individualized preparation has to be justified rather than requested.1

Systematic review and meta-analysis · 29 randomized trials

The one positive efficacy finding was for vaginal androgen, not a compounded estrogen cream.

29 trials · 1,808 women
compounded preparations compared with placebo or FDA-approved products
The detail

The most recent systematic review and meta-analysis of the field pooled 29 randomized controlled trials reported in 40 articles, covering 1,808 perimenopausal and postmenopausal women, comparing compounded preparations with placebo or with FDA-approved products. It found no adverse change in lipid profile or glucose metabolism with compounded androgen, no change in endometrial thickness and no serious adverse events across the included trials. Its one positive efficacy finding was for compounded vaginal androgen in vaginal atrophy symptoms, standardized mean difference minus 0.66, 95 percent confidence interval minus 1.28 to minus 0.04, not for a compounded estrogen cream.2

Randomized · double-masked · placebo-controlled · 596 women · 3 years

On estrogen alone, hyperplasia was common; every estrogen plus progestin regimen matched placebo.

27.7 vs 0.8 percent
simple hyperplasia on estrogen alone versus placebo
The detail

What unopposed estrogen does to the uterine lining is established, and it is why progesterone is in this conversation. In the Postmenopausal Estrogen/Progestin Interventions trial, a 3-year randomized, double-masked, placebo-controlled trial in 596 postmenopausal women aged 45 to 64, women on estrogen alone developed simple hyperplasia in 27.7 percent of cases, complex hyperplasia in 22.7 percent and atypical hyperplasia in 11.8 percent, against 0.8 percent, 0.8 percent and 0 percent on placebo, p less than 0.001, while all three estrogen plus progestin regimens matched placebo, p equals 0.16.3

What it does not show

Applicability

No randomized trial has tested this 50:50 estriol and estradiol cream.

50:50
estriol to estradiol cream, untested in any controlled trial
The detail

No randomized trial has tested this preparation as sold. There is no controlled trial of a 50:50 estriol and estradiol compounded cream for menopausal symptoms in the published literature, so there is no efficacy figure, no dose-response curve and no safety database that belongs to this specific formulation. The National Academies committee that reviewed the whole field reached the same conclusion about the category: insufficient evidence to support routine clinical use.1

Applicability

Estradiol’s randomized results belong to approved products, not to a compounded cream.

The detail

The estradiol trial evidence does not transfer to it. The randomized results behind estradiol come from specific FDA-approved gels, patches, tablets and vaginal products, each tested at defined strengths against placebo in defined populations, and each manufactured under the review that established its strength, purity and delivery. A compounded cream containing estradiol is not those products and cannot claim their results. Compounded preparations are not reviewed by the FDA for safety, effectiveness or quality.4

Regulatory status

There is no FDA-approved drug containing estriol, so half the formula has no labeling.

The detail

Half of this formula has no approved product to reason from. The FDA states that there are no FDA-approved drugs containing estriol, that marketed drugs containing estriol are compounded drugs which are not FDA-approved, and that it does not have evidence that drugs containing estriol are safe and effective or are safer forms of estrogen. There is therefore no approved labeling, no established dose and no approved-product safety database for the estriol component.4

Safety evidence

There are too few trials to assess breast cancer, endometrial cancer or cardiovascular risk.

The detail

The safety questions here are open, not answered. The same meta-analysis that found no adverse metabolic signal concluded explicitly that there are insufficient randomized trials of compounded bioidentical hormone therapy to assess the clinical risk of breast cancer, endometrial cancer or cardiovascular disease, and that clinical cardiovascular events, endometrial biopsy and breast cancer risk were not studied at all. Absence of evidence is not evidence that the risks of the estrogen class stop applying to a compounded estrogen.12

  1. National Academies of Sciences, Engineering, and Medicine. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A… Washington, DC: National Academies Press; 2020.DOI
  2. Liu Y, Yuan Y, Day AJ, Zhang W, John P, Ng DJ, Banov D. Safety and efficacy of compounded bioidentical hormone therapy (cBHT)… Menopause. 2022.
  3. The Writing Group for the PEPI Trial Effects of hormone replacement… JAMA. 1996.
  4. US Food and Drug Administration. Menopause. Consumer information on women's health topics, content current as of December 14, 2023.FDA
Important Safety Information
Boxed warning

The approved labeling for estradiol is therefore the best available guide to what this class does, and it carries a boxed warning that estrogen without a progestogen increases the risk of endometrial cancer in a woman who still has a uterus, so unopposed estrogen is not an appropriate plan in that situation and progesterone belongs in the conversation.

Do not use if you have

  • A history of breast cancer or another estrogen-dependent cancer
  • Unexplained vaginal bleeding
  • A prior blood clot, stroke or heart attack
  • An inherited clotting disorder
  • Liver disease
  • A known anaphylactic reaction, angioedema, or hypersensitivity to the product
  • Pregnancy

Serious risks

  • Stroke, deep vein thrombosis and pulmonary embolism
  • Gallbladder disease
  • Probable dementia in women who begin therapy at 65 or older
  • Breast cancer when estrogen and a progestogen are taken together over longer use
  • Compounding has not been shown to reduce any of them

Commonly reported

  • Breast tenderness
  • Irregular vaginal bleeding or spotting
  • Headache
  • Irritation where the cream is applied

Because it is a cream

  • Estradiol applied to skin can transfer to another person through skin contact before it dries

Reported effects follow the estrogen class. This is a compounded preparation, which means it has not been reviewed by the FDA for safety, effectiveness, or quality, and estriol is not a component of any FDA-approved drug product, so there is no approved labeling for that half of the formula. A licensed provider decides whether an individualized preparation is the right call for your case, and a licensed 503A pharmacy prepares it only after that decision.

Questions

Asked and answered.

You are not charged, and you are not left guessing. Your clinician explains the reasoning and, where it helps, what a better path might look like. Reviews are typically completed in under 24 hours.

Because there is a specific patient in front of them, not because compounded therapy is inherently better. A clinician may decide that a particular strength, ratio, or cream base serves that patient’s needs in a way available commercial products do not. Many patients are better served by FDA-approved therapy. Good prescribing is knowing which case you are.

Compounded medications are prepared after your prescription is written rather than pulled from a warehouse shelf. That adds pharmacy preparation time after clinician review. Your care team keeps you updated as the prescription moves from approval to compounding and shipment.

Compounded Biest has not been shown safer or more effective than FDA-approved hormone therapy, and be wary of anyone who tells you otherwise. It carries the same class risks, including blood clots, stroke, and, with combined use over time, breast cancer. Biest is an individualized option your provider may consider, held to the same risk conversation as everything else.

$89/mo, all-inclusiveBiest 50:50
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