Title:  Hormone replacement therapy

United States Patent:  6,326,366

Assignee:  Protein Technologies International (St. Louis, MO)

Filed:  August 22, 2000

The present invention relates to a hormone replacement therapy, and a composition useful therein, for women having reduced levels of endogenous estrogen. A mammalian estrogen and an isoflavone which is incapable of being metabolized to equol are co-administered to a woman having a reduced level of endogenous estrogen. The hormone replacement therapy is effective to inhibit or prevent diseases or conditions resulting from, or exacerbated by, a reduction in endogenous estrogen including: coronary heart disease, cardiovascular disease, osteoporosis, loss of cognitive function, urinary incontinence, weight gain, fat mass gain, and vasomotor symptoms. A composition for use in the hormone replacement therapy of the present invention contains a mammalian estrogen and at least one isoflavone, where the isoflavone is incapable of being metabolized to equol by a human, and where the composition contains less than 10% by weight of isoflavones and phytoestrogens capable of being metabolized to equol by a human.

SUMMARY OF THE INVENTION

In one aspect, the invention is a composition for use in a hormone replacement therapy for a woman. The composition contains a combination of a mammalian estrogen and at least one isoflavone compound. The isoflavone compound is incapable of being metabolized to equol by a human. In a preferred embodiment the isoflavone is selected from genistein, genistin, 6"-O-malonylgenistin, 6"-O-acetylgenistin, glycitein, glycitin, 6"-O-malonylglycitin, biochanin A, and mixtures thereof.

In another aspect, the invention is a hormone replacement therapy regimen comprising co-administering a therapeutically effective amount of a combination of a mammalian estrogen and an isoflavone to a woman having reduced levels of endogenous estrogen, where the isoflavone is incapable of being metabolized to equol by a human. Preferably the hormone replacement therapy regimen is administered in an amount therapeutically effective to reduce the risk of cardiovascular disease, coronary heart disease, osteoporosis, declining mental cognition, urinary incontinence, weight and fat mass gain, and/or vasomotor symptoms. In a preferred embodiment, the isoflavone is selected from genistein, genistin, 6"-O-malonylgenistin, 6"-O-acetylgenistin, glycitein, glycitin, 6"-O-malonylglycitin, biochanin A, or a mixture thereof.

In a further aspect, the invention is a method for reducing the risk of cardiovascular disease, coronary heart disease, osteoporosis, loss of cognitive function, urinary incontinence, weight and fat mass gain, and/or vasomotor symptoms in a woman having reduced levels of endogenous estrogen wherein a therapeutically effective amount of a combination of a mammalian estrogen and an isoflavone are administered to the woman. The administered isoflavone is incapable of being metabolized to equol in a human. Preferably the isoflavone is selected from genistein, genistin, 6"-O-malonylgenistin, 6"-O-acetylgenistin, glycitein, glycitin, 6"-O-malonylglycitin, biochanin A, or mixtures thereof.

Claim 1 of 37 Claims

What is claimed is:

1. A composition for use in a hormone replacement therapy for a woman comprising a combination of mammalian estrogen and at least one isoflavone, wherein said isoflavone is incapable of being metabolized to equol by a human, and where said composition contains less than 10% by weight of isoflavones and phytoestrogens capable of being metabolized to equol by a human.

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