Title:  Transdermal application of naturally occurring steroid hormones

United States Patent:  6,228,852

Appl. No.:  889529

The invention features a physiologically acceptable cream that contains estrogen, progesterone, and testosterone molecules that are identical to the estrogen, progesterone, and testosterone molecules naturally produced by the human body. The cream may be self-administered to the skin and is useful as a means of hormone replacement therapy, which may begin at around the time of menopause.

SUMMARY OF THE INVENTION

The invention features a method of hormone replacement therapy, whereby a combination of native estrogen, native progesterone, and native testosterone are administered transdermally to a patient in need of such therapy. The hormones are synthesized from compounds obtained from a plant source (preferably such as a soybean or yam plant), micronized, and dissolved in a physiologically acceptable cream that can be applied to the skin. Preferably the cream is self-administered to areas of the skin that overlie fatty tissue. Examples of such areas are the lower abdomen and inner thighs. Persons most likely to benefit from the method of the invention are women who are approaching, or who have already come to, the end of their child-bearing years. However, hormone deficiencies caused by events other than menopause can also be treated by the invention.

Preferably, the ratio, by weight, of estrogen to progesterone to testosterone is approximately 1-5 to 10-500 to 1-5, respectively. Most preferably, the ratio, by weight of estrogen to progesterone to testosterone is 1 to 200-250 to 1, most preferably 1 to 250 to 1. The concentration of estrogen in the cream may range from 0.1 to 10 mg/teaspoon, the concentration of progesterone may range from 20 to 2,000 mg/teaspoon, and the concentration of testosterone may range from 0.1 to 10 mg/teaspoon. Preferably, a teaspoon of cream will contain 2-6 mg estrogen, 600-1000 mg progesterone, and 2-6 mg testosterone. More preferably, a teaspoon of cream will contain 4 mg estrogen, 800 mg progesterone, and 4 mg testosterone. The cream may be applied one or more times per day, fourteen or more days per month. Preferably, the site of application is varied.

The invention preferably employs a physiologically acceptable cream consisting of native estrogen, native progesterone, and native testosterone. The cream may also contain an adrenal androgen, such as DHEA (dehydroepiandrosterone), which is produced by the adrenal cortex. A cream that contains native DHEA in addition to the three native sex hormones would be capable of replenishing all of the hormones that normally decline at around the time of menopause.

Claim 1 of 20 Claims

What is claimed is:

1. A method of hormone replacement therapy, said method comprising administering to the skin of a patient in need of said therapy a physiologically acceptable formulation comprising native estrogen, native progesterone, and native testosterone in a ratio, by weight, of 1-5:10-500:1-5, in concentrations sufficient to raise circulating hormone levels to values found in the early luteal phase in premenopausal ovulatory women.

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