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1. WO2000040230 - HORMONE REPLACEMENT FOR BREAST CANCER PATIENTS

Publication Number WO/2000/040230
Publication Date 13.07.2000
International Application No. PCT/US2000/000096
International Filing Date 04.01.2000
Chapter 2 Demand Filed 02.08.2000
IPC
A61K 31/567 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopentahydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
565not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
567substituted in position 17 alpha, e.g. mestranol, norethandrolone
A61K 31/58 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopentahydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
58containing heterocyclic rings, e.g. aldosterone, danazol, stanozolol, pancuronium, digitogenin
A61K 31/585 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopentahydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
58containing heterocyclic rings, e.g. aldosterone, danazol, stanozolol, pancuronium, digitogenin
585containing lactone rings, e.g. oxandrolone, bufalin
CPC
A61K 31/567
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
565not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
567substituted in position 17 alpha, e.g. mestranol, norethandrolone
A61K 31/568
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
565not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
568substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
A61K 31/569
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
565not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
568substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
569substituted in position 17 alpha, e.g. ethisterone
A61K 31/575
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
575substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
A61K 31/58
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
58containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
A61K 31/585
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
58containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
585containing lactone rings, e.g. oxandrolone, bufalin
Applicants
  • CEDARS-SINAI MEDICAL CENTER [US/US]; 8700 Beverly Boulevard Los Angeles, CA 90048, US
Inventors
  • HUGHES, Claude, L., Jr.; US
Agents
  • PRETTY, SCHROEDER & POPLAWSKI, P.C.; 444 S. Flower St., 19th Floor Los Angeles, CA 90071, US
  • WINTER, BRANDL, FÜRNISS, HÜBNER, RÖSS, KAISER, POLTE; Alois-Steinecker-Strasse 22 D-85354 Freising, DE
Priority Data
09/226,06806.01.1999US
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) HORMONE REPLACEMENT FOR BREAST CANCER PATIENTS
(FR) SUBSTITUTION D'UN HORMONE CHEZ LES PATIENTES SOUFFRANT DU CANCER DU SEIN
Abstract
(EN)
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.
(FR)
L'invention concerne un procédé thérapeutique de substitution utilisant l'androgène qui vise à maintenir ou à restaurer la normalité physiologique d'une patiente, y compris la densité osseuse, la stabilité vasomotrice, la fonction sexuelle et la vitalité. L'invention concerne aussi un procédé pour traiter ou pour prévenir l'ostéoporose chez les femmes. Selon l'invention, on administre à une patiente des compositions pharmaceutiques comprenant un androgène non aromatisable, sans oestradiol ni composé oestrogène, et ce autrement que par voie digestive. La dose journalière administrée est comprise entre 5 et 500 microgrammes d'androgène non aromatisable. Les compositions pharmaceutiques servant à administrer un androgène non aromatisable à une patiente courant un risque plus élevé par rapport à la normale du cancer du sein ou du cancer endométrial permettent l'apport d'une dose efficace par voie transdermique, mucosale ou par tout autre moyen à l'exception de la voie digestive. Les androgènes non aromatisables considérés dans la présente invention comprennent, mais non de façon exclusive, 17-alpha-méthyl-19-nor-testostérone, danazole, fluoxymestérone, méthandrosténolone, oxandrolone, oxymétholone, stanozolole et testolactone. Parmi les androgènes utiles non aromatisables sont également considérés dans l'invention des progestines androgéniques, y compris désogestrel, norgestimate, noréthinedrone, acétate de noréthinedrone, norgestrel, diacétate d'éthynodiole et lévonorgestrel. L'absence dans ces compositions d'oestradiol ou de tout autre composé oestrogène tel que le testostérone permet d'éviter l'exposition de la patiente aux oestrogènes, qui augmente le risque du cancer. L'apport d'androgènes par des moyens autres que la voie digestive permet d'abaisser la dose efficace et, partant, de réduire les risques des effets virilisants et de toxicité potentielle vis-à-vis du foie, mieux que les préparations de remplacement existantes à base d'androgène.
Also published as
Latest bibliographic data on file with the International Bureau