WO2000040230A3 - Hormone replacement for breast cancer patients - Google Patents

Hormone replacement for breast cancer patients Download PDF

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Publication number
WO2000040230A3
WO2000040230A3 PCT/US2000/000096 US0000096W WO0040230A3 WO 2000040230 A3 WO2000040230 A3 WO 2000040230A3 US 0000096 W US0000096 W US 0000096W WO 0040230 A3 WO0040230 A3 WO 0040230A3
Authority
WO
WIPO (PCT)
Prior art keywords
androgen
aromatizable
woman
risk
testosterone
Prior art date
Application number
PCT/US2000/000096
Other languages
French (fr)
Other versions
WO2000040230A2 (en
Inventor
Claude L Hughes Jr
Original Assignee
Cedars Sinai Medical Center
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cedars Sinai Medical Center filed Critical Cedars Sinai Medical Center
Priority to AU22236/00A priority Critical patent/AU2223600A/en
Publication of WO2000040230A2 publication Critical patent/WO2000040230A2/en
Publication of WO2000040230A3 publication Critical patent/WO2000040230A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A61K31/585—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin containing lactone rings, e.g. oxandrolone, bufalin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/567—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A61K31/569—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone substituted in position 17 alpha, e.g. ethisterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin

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.
PCT/US2000/000096 1999-01-06 2000-01-04 Hormone replacement for breast cancer patients WO2000040230A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU22236/00A AU2223600A (en) 1999-01-06 2000-01-04 Hormone replacement for breast cancer patients

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US22606899A 1999-01-06 1999-01-06
US09/226,068 1999-01-06

Publications (2)

Publication Number Publication Date
WO2000040230A2 WO2000040230A2 (en) 2000-07-13
WO2000040230A3 true WO2000040230A3 (en) 2001-05-17

Family

ID=22847416

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2000/000096 WO2000040230A2 (en) 1999-01-06 2000-01-04 Hormone replacement for breast cancer patients

Country Status (2)

Country Link
AU (1) AU2223600A (en)
WO (1) WO2000040230A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9125816B2 (en) 2000-08-30 2015-09-08 Besins Healthcare Inc. Pharmaceutical composition and method for treating hypogonadism

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2277522B1 (en) * 2002-03-01 2012-11-21 UCB Manufacturing, Inc. Methods for increasing or decreasing bone density and identifying molecules
US20030191096A1 (en) * 2002-04-03 2003-10-09 Leonard Thomas W. Method of hormonal therapy
GB0227243D0 (en) * 2002-11-21 2002-12-31 Univ Aberdeen Genetic markers for bone mass
BRPI0620542A2 (en) † 2005-11-23 2011-11-16 Dow Global Technologies Inc copolymer comprising interpolymerized ethylene with at least one c3-10 (alpha) -olefin and polymer blend

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0330786A1 (en) * 1988-03-01 1989-09-06 Masao Igarashi Topical drug delivery systems containing danazol
EP0474374A1 (en) * 1990-08-10 1992-03-11 Ortho Pharmaceutical Corporation Method for treatment of bone wasting diseases using a progestin
EP0587047A2 (en) * 1992-09-07 1994-03-16 JENAPHARM GmbH Gestagenes containing pharmaceutical composition
DE4405899A1 (en) * 1994-02-18 1995-08-24 Schering Ag Agent for transdermal application containing desogestrel
WO1998032465A1 (en) * 1997-01-27 1998-07-30 Lg Chemical Limited Composition for the transdermal administration of steroid drugs

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0330786A1 (en) * 1988-03-01 1989-09-06 Masao Igarashi Topical drug delivery systems containing danazol
EP0474374A1 (en) * 1990-08-10 1992-03-11 Ortho Pharmaceutical Corporation Method for treatment of bone wasting diseases using a progestin
EP0587047A2 (en) * 1992-09-07 1994-03-16 JENAPHARM GmbH Gestagenes containing pharmaceutical composition
DE4405899A1 (en) * 1994-02-18 1995-08-24 Schering Ag Agent for transdermal application containing desogestrel
WO1998032465A1 (en) * 1997-01-27 1998-07-30 Lg Chemical Limited Composition for the transdermal administration of steroid drugs

Non-Patent Citations (9)

* Cited by examiner, † Cited by third party
Title
DAVIS S.R.: "The clinical use of androgens in female sexual disorders.", JOURNAL OF SEX AND MARITAL THERAPY, (1998) 24/3 (153-163)., XP000934164 *
MYERS L S ET AL: "Effects of estrogen, androgen, and progestin on sexual psychophysiology and behavior in postmenopausal women.", JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM, (1990 APR) 70 (4) 1124-31., XP000861804 *
OEHLERT G.: "[Treatment of disturbances of sexual function in women using ovulation inhibitors]. BEOBACHTUNGEN BEI DER BEHANDLUNG SEXUELLER FUNKTIONSSTORUNGEN DER FRAU WAHREND DER EINNAHME VON OVULATIONSHEMMERN.", Z.ALLG.MED., (1974) 50/31 (1414-1416). CODEN: ZACMAH, XP000934196 *
PERJU A ET AL: "THE PHARMACOKINETICS OF METHYLTESTOSTERONE ADMINISTERED IN TABLET FORM IN A SINGLE INTRAVAGINAL DOSE AND CLINICAL EVALUATION IN SOME GYNECOLOGICAL AND SENOLOGICAL INVOLVEMENTS", REVISTA DE PEDIATRIE OBSTETRICA SI GINECOLOGIE SERIA OBSTETRICA SI, vol. 35, no. 1, 1987, 1987, pages 67 - 75, XP000934116, ISSN: 0377-4961 *
RAISZ LAWRENCE G ET AL: "Comparison of the effects of estrogen alone and estrogen plus androgen on biochemical markers of bone formation and resorption in postmenopausal women.", JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM, vol. 81, no. 1, 1996, pages 37 - 43, XP000934187, ISSN: 0021-972X *
RECKER R R ET AL: "EFFECT OF ESTROGENS AND CALCIUM CARBONATE ON BONE LOSS IN POST MENOPAUSAL WOMEN", ANNALS OF INTERNAL MEDICINE, vol. 87, no. 6, 1977, EN, pages 649 - 655, XP000934160, ISSN: 0003-4819 *
SCHENNETTEN F ET AL: "[Therapy of the postmenopausal osteoporosis using methyltestosterone plus ergocalciferol or methylandrostenedione]. Zur Therapie der postmenopausischen Osteoporose mit Methyltestosteron plus Ergocalciferol oder Methylandrostendiol.", MEDIZINISCHE WELT, (1976 FEB 27) 27 (9) 444-5., XP000934087 *
WARNOCK JULIA JILL K ET AL: "Female hypoactive sexual desire disorder due to androgen deficiency: Clinical and psychometric issues.", PSYCHOPHARMACOLOGY BULLETIN, vol. 33, no. 4, 1997, pages 761 - 766, XP000934033, ISSN: 0048-5764 *
WATTS NELSON B ET AL: "Comparison of Oral Estrogens and Estrogens Plus Androgen on Bone Mineral Density, Menopausal Symptoms and Lipid-Lipoprotein Profiles in Surgical Menopause.", OBSTETRICS & GYNECOLOGY, vol. 85, no. 4, 1995, pages 529 - 537, XP000934017, ISSN: 0029-7844 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9125816B2 (en) 2000-08-30 2015-09-08 Besins Healthcare Inc. Pharmaceutical composition and method for treating hypogonadism
US9132089B2 (en) 2000-08-30 2015-09-15 Besins Healthcare Inc. Pharmaceutical composition and method for treating hypogonadism

Also Published As

Publication number Publication date
AU2223600A (en) 2000-07-24
WO2000040230A2 (en) 2000-07-13

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