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filingDate 2000-01-04-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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publicationDate 2000-07-13-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber WO-0040230-A2
titleOfInvention Hormone replacement for breast cancer patients
abstract Disclosed is a method of androgen replacement therapy to maintain or restore a woman's physiologic normality, including her bone density, vasomoter stability, sexual function, and energy. Also described is a method of treating or preventing osteoporosis in women. A woman is administered pharmaceutical compositions, comprising a non-aromatizable androgen, without estradiol or any estrogenic compound, by a route other than the digestive tract, such that 5 to 500 micrograms of the non-aromatizable androgen is administered daily. Pharmaceutical compositions for delivering a non-aromatizable androgen to a woman at higher than normal risk of breast cancer or endometrial cancer, are formulated to deliver an effective dose transdermally, transmucosally or by any delivery route, except the digestive tract. Non-aromatizable androgens that are contemplated include, but are not limited to, methyltestosterone, 17-alpha-methyl-19-nor-testosterone, danazol, fluoxymesterone, methandrostenolone, oxandrolone, oxymetholone, stanozolol, and testolactone. But also contemplated amoung useful non-aromatizable androgens are androgenic progestins, including desogestrel, norgestimate, norethindrone, norethinedrone acetate, norgestrel, ethynodiol diacetate and levonorgestrel. The absence from these compositions of estradiol, or any estrogenic compound, such as testosterone, avoids the estrogen exposure which increases the cancer risk. Androgen delivery other than by ingestion permits lower effective doses and thus lowers the risk of virilizing effects and potential liver toxicity than previously available androgen replacement preparations.
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