A big learning for us was that you could get bioidentical hormones that were also FDA-approved.
At first, we thought you had to use compounded products to get ones that were bioidentical. Not true!
*** To understand what having FDA approval can assure you about a menopausal hormone therapy product, we highly encourage you to read this post.
Defining Terms in the Chart: What do Active Pharmaceutical Ingredient, Bioidentical, Excipient and Route of Administration Mean?
ACTIVE PHARMACEUTICAL INGREDIENT (API): the molecule that is active in a product.
EXCIPIENTS: these are binders, coloring, flow agents, and other ingredients mixed in with the API to produce the final product (excipients are explained in more detail here).
BIOIDENTICAL: the structure of the active ingredient of the product is identical to the hormone your body produces. However, the ingredients of a bioidentical product, whether in a compounded version or an FDA-approved product, are all manufactured in a lab. None comes directly from nature or is “natural”. This idea of “natural” has long been associated with compounded products but it is a misconception.
COMPOUNDING: the creation of custom drugs using FDA-approved APIs and mixing them with excipients to tailor a remedy to a specific prescription.
ROUTE OF ADMINISTRATION: how the product gets into your body. (route, types of product)
ORAL: a product you take by mouth (tablet, capsule or sublingual)
TRANSDERMAL: a product you apply to your skin (cream, patch or gel)
VAGINAL: a product you insert in your vagina (cream, gel, insert/tablet, ring)
Note: Transdermal estrogen has a safer risk profile than oral estrogen with respect to blood clots, stroke, and cholesterol changes because it does not have the effect on the liver that oral estrogen does. This would be especially pertinent for a woman with a personal or family history of these medical issues.1,2
THREE TYPES OF ESTROGEN
— Estrone (referred to as E1): produced in fat tissue after a women reaches menopause
— Estradiol (referred to as E2): produced by the ovaries during the reproductive years
— Estriol (referred to as E3): produced by the placenta during pregnancy
We think it’s helpful to understand menopausal hormone therapy products according to four things:
- Hormone type (estrogen or progesterone; we do not cover testosterone here)
- Bioidentical vs. Non-bioidentical (we used to use “synthetic” for products that weren’t bioidentical, but synthetic means made through a chemical process and both bioidentical vs. non-bioidentical are synthetic.)
- FDA – approved vs. compounded (not FDA – approved)
- Route of administration (how you take it)
Understanding the subtle but real difference among MHT options is important. We’ve written a three-part blog post to help you do that. You can find those here:
Hormone |
Route of
|
Bioidentical
|
Non-Bioidentical
|
|---|---|---|---|
| Estrogen | Oral | FDA-approved Estrace®, generics (17β-estradiol) Available compounded (not FDA-approved) Estradiol (E2), estriol (E3), biestrogen (E2E3), triestrogen (E1E2E3) |
FDA-approved Premarin® (conjugated equine estrogens, CEE) Menest® (esterified estrogens) |
| Estrogen | Transdermal (cream, gel, patch) |
FDA-approved Divigel®, EstroGel®, Elestrin® (estradiol topical gel E2) Evamist® (estradiol transdermal spray E2) Alora®, Estraderm®, Minivelle®, Vivelle – dot® (estradiol patch) – twice weekly Climara®, Menostar® (estradiol patch) – weekly Available compounded (not FDA-approved) Estradiol (E2); estriol (E3); bioestrogen (bi-est): 20% E2 and 80% E3; triestrogen (tri-est, triple-est): 10% E1, 10% E2, and 80% E3 |
None |
| Estrogen | Vaginal | FDA-approved Imvexxy®, vaginal insert (17β-estradiol) Vagifem®, vaginal insert (estradiol hemihydrate) Yuvafem®, vaginal insert (estradiol hemihydrate) Estring®, vaginal ring(17β-estradiol) Femring®, vaginal ring (estradiol acetate) Estrace®, vaginal cream (17β-estradiol) Estragyn®, vaginal cream (estrone) |
FDA-approved Premarin® vaginal cream (conjugated estrogens) |
| Progesterone | Oral | FDA-approved Prometrium®, generics (progesterone, USP) Available compounded (not FDA-approved) Progesterone, USP |
None |
| Progesterone | Transdermal (cream, gel) |
Available compounded (not FDA-approved) Progesterone, USP |
None |
| Progesterone | Vaginal | FDA-approved Crinone® (progesterone, USP gel) Endometrin® (progesterone, USP insert) Available compounded (not FDA-approved) progesterone, USP |
None |
| Progestin | Oral | None | FDA-approved Provera® (medroxyprogesterone acetate) Aygestin®, Ortho Micronor®, Camila®, Errin®, Jolivette®, Jencycla®, Nor-QD®, Nor-Be® “Minipill” progestin-only birth control (norethindrone acetate) |
| Combination | Oral | FDA-approved Bijuvia® (estradiol/progesterone) |
FDA-approved Activella®, Lopreeza®, Amabelz®, Mimivey® (estradiol/norethindrone acetate) Angeliq® (estradiol/drospirenone) FemHrt®, Fyavolv®, Jinteli® (norethindrone acetate/ethinyl estradiol) Prempro® (conjugated estrogen/medroxyprogesterone) |
| Combination | Transdermal (patch) | None | FDA-approved ClimaraPro® (estradiol/levonorgestrel) Combipatch® (estradiol/norethindrone acetate) |
Last updated: April 2024
REFERENCES
1. Is transdermal menopausal hormone therapy a safer option than oral therapy? Bette Liu, Canadian Medical Association Journal, 2013.
2. Risk of Gall Bladder Disease With Hormone Replacement Therapy Patches Lower Than With HRT Pills, Science Daily, 2008