Bioidentical Hormones

A vaginal cream with the components described can only be obtained from a compounding pharmacy following the ordering physician’s prescription. There are many high quality-compounding professional pharmacists practicing today throughout the US. Having a physician skilled in Women’s Health, who understands gynecoendocrinology, and is comfortably prescribing compounded pharmaceuticals is another requirement for success. It is this physician who will be monitoring your clinical response to treatment, evaluating you for any side effects you might have, and adjusting the dose of your compounded prescription to precisely meet your needs. All these elements are necessary to ensure a successful outcome for a woman on balanced hormone replacement therapy

In my opinion, the preferred way for a postmenopausal woman to use estradiol is topically because the dose that effectively reverses the deficiency state caused by menopause is 1/10th of the dose needed if given orally. The lower dose is possible because when given topically estradiol avoids passing through the liver before the rest of the body. On that first pass, the liver breaks down 90% of the estradiol absorbed in the gut from an oral tablet. Topical administration of estradiol has the added advantage of not stimulating the liver to increase clotting factor production. This response is triggered by the high concentration of estradiol detected by the liver. The high estradiol levels result in the liver producing clotting factors appropriate to protect pregnant women from uterine hemorrhage. This route of administration may ameliorate some of the stroke, heart attack, and dementia risk to the extent that high clotting factor levels contribute to them.

The surface of the vagina is ideal for absorption of steroid hormones. Applying them in an elegant cream base by applicator at bedtime is a simple way to deliver the product that serves two purposes. The hormones are easily and completely absorbed through the mucosa of the vagina, much more readily than through the skin because there is no cornyfied epithelium to penetrate. Secondly, the vagina, vulva and surrounding pelvic muscles are key targets for hormone replenishment in postmenopausal women. The pelvic region is often inadequately treated with other routes of administration be they topical, oral or intradermal capsule.

An adequate dose for most women to achieve systemic estrogen sufficiency with bone, skin, and vaginal health and to control vasomotor symptoms including hot flushes, perspiring, and insomnia is a dose of 0.05 mg nightly administered per vagina is usually adequate.

My preference is for use of synthetic bioidentical sex steroid hormones exclusively. There are several reasons for this with the most obvious being these are the hormones nature designed us our bodies to use. In my view, much of the harm seen in the Women’s Health Initiative and be squarely laid at the foot of the artificial progesterone used, MPA, medroxyprogesterone acetate, AKA Proveria. This is the progestin found in PremPro and PremPro is the drug that was used in the WHI that caused all the problems. Natural progesterone, on the other hand has been compared to MPA in studies (The PEPI Study) that looked at their effect on breast density. High breast density as seen in women with fibrocystic breast disease increases risk for breast cancer and is a marker for inflammation in the breast that plays a role in promotion of cancer. The results of a head to head mammogram study of postmenopausal women treated with the same oral estrogen but with 1/3rd given oral MPA, 1/3rd given oral natural progesterone, and 1/3rd given none because they did not have a uterus was very interesting. There was no increase in mammographic breast density in the estrogen only group, there was some in the natural progesterone group, and there was a whole lot in the MPA group. This is another reason I prefer synthetic bioidentical natural progesterone to artificial progestins.

A dose of 10 mg of natural progesterone administered in elegant base oil in water cream combined with the other sex steroids per vagina at bedtime is usually adequate to protect the uterus. Annual monitoring with Transvaginal ultrasound is a good way to be certain this approach is effective. There should be a minimal effect on mammogram density with this dose and use of it allows adoption of the every other year mammography recommendations of the USPHTF that avoids the pitfalls of annual testing.

The forgotten sex steroid is testosterone. It is a mystery why estradiol has gotten all the attention while testosterone has been abandoned by most scientists and clinicians but not all. To obtain hormonal balance and return women to a simulated pre-menopausal status requires the addition of an androgen. Testosterone is necessary for women to maintain their muscle and bone mass. The loss of ovarian testosterone production at menopause robs women of half their androgen source. This causes muscle to gradually degenerate into fat that is almost impossible to reverse in the absence of androgens. After menopause, the adrenal gland produces DHEA, which becomes the only source of both testosterone and estradiol for women. This is a critically important supply of androgen but is not adequate to forestall the onset of progressive frailty.

The hallmark of frailty is the loss of muscle and bone mass and the replacement of that tissue with fat. Androgen deficiency makes it very hard if not impossible to build new muscle tissue. You can eat very healthy food, practice daily vigorous exercise but it is all to no avail. If you are androgen deficient, the mesenchymal stem cells that become muscle, bone, cartilage, and other healthy tissues cannot change into those health tissues. They become fat instead. To become a muscle cell, testosterone must occupy its receptor in the nucleus. Without testosterone the stem cell default change state is into a fat cell. This is why everyone needs testosterone.

How much testosterone? For most women a dose of 1 mg of micronized synthetic human bioidentical testosterone administered in the vaginal cream with the other sex steroid hormones at bedtime is ideal.

Too much testosterone causes acne, unwanted facial hair or hair loss from the scalp. These issues are easily managed by lowering the dose,

Compounding Formula
Below is a suggested formula for a vaginal cream that fulfills the objectives outlined above. It is similar to the one I recommend for my patients on balanced hormone replacement therapy.

Balanced Hormone Replacement Therapy for Vaginal Administration*
Hormone Per 0.5 gm vaginal cream
Micronized estradiol 0.05 mg
Micronized progesterone 10 mg
Micronized testosterone 1.0 mg
Sig: ½ gram per vagina @ h.s.
*For postmenopausal women with a uterus. For those without a uterus delete the progesterone
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