DK200400365A - Anvendelse af et progestogen og et østrogen til fremstilling af et terapeutisk produkt til hormonbehandling af postmenopausale lidelser hos kvinder samt et sådant terapeutisk produkt - Google Patents

Anvendelse af et progestogen og et østrogen til fremstilling af et terapeutisk produkt til hormonbehandling af postmenopausale lidelser hos kvinder samt et sådant terapeutisk produkt Download PDF

Info

Publication number: DK200400365A
Authority: DK; Denmark
Prior art keywords: estrogen; progestogen; acetate; estradiol; norethindrone
Prior art date: 1983-08-05

Application number

DK200400365A

Other languages

English (en)

Inventor

Wolfe Bernard Martin Joseph

Plunkett Earl Robert

Original Assignee

Pre Jay Holdings Ltd

Woco Invest Ltd

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.)

1983-08-05

Filing date

2004-03-04

Publication date

2004-03-04

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=27060286&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK200400365(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2004-03-04 Application filed by Pre Jay Holdings Ltd, Woco Invest Ltd filed Critical Pre Jay Holdings Ltd

2004-03-04 Priority to DK200400365A priority Critical patent/DK175317B1/da

2004-03-04 Publication of DK200400365A publication Critical patent/DK200400365A/da

2004-08-16 Application granted granted Critical

2004-08-16 Publication of DK175317B1 publication Critical patent/DK175317B1/da

Links

229940011871 estrogen Drugs 0.000 title abstract description 57
239000000262 estrogen Substances 0.000 title abstract description 57
239000000583 progesterone congener Substances 0.000 title abstract description 35
230000001225 therapeutic effect Effects 0.000 title description 6
238000004519 manufacturing process Methods 0.000 title description 2
239000005556 hormone Substances 0.000 title 1
229940088597 hormone Drugs 0.000 title 1
239000007943 implant Substances 0.000 abstract 1
238000007918 intramuscular administration Methods 0.000 abstract 1
VIKNJXKGJWUCNN-XGXHKTLJSA-N norethisterone Chemical compound O=C1CC[C@@H]2[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 VIKNJXKGJWUCNN-XGXHKTLJSA-N 0.000 description 24
VOXZDWNPVJITMN-ZBRFXRBCSA-N 17β-estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 VOXZDWNPVJITMN-ZBRFXRBCSA-N 0.000 description 21
241000283073 Equus caballus Species 0.000 description 18
PSGAAPLEWMOORI-PEINSRQWSA-N medroxyprogesterone acetate Chemical compound C([C@@]12C)CC(=O)C=C1[C@@H](C)C[C@@H]1[C@@H]2CC[C@]2(C)[C@@](OC(C)=O)(C(C)=O)CC[C@H]21 PSGAAPLEWMOORI-PEINSRQWSA-N 0.000 description 16
229960004400 levonorgestrel Drugs 0.000 description 15
WWYNJERNGUHSAO-XUDSTZEESA-N (+)-Norgestrel Chemical compound O=C1CC[C@@H]2[C@H]3CC[C@](CC)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 WWYNJERNGUHSAO-XUDSTZEESA-N 0.000 description 14
229960002985 medroxyprogesterone acetate Drugs 0.000 description 14
QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 12
RSEPBGGWRJCQGY-RBRWEJTLSA-N Estradiol valerate Chemical compound C1CC2=CC(O)=CC=C2[C@@H]2[C@@H]1[C@@H]1CC[C@H](OC(=O)CCCC)[C@@]1(C)CC2 RSEPBGGWRJCQGY-RBRWEJTLSA-N 0.000 description 12
229940022663 acetate Drugs 0.000 description 12
229960005309 estradiol Drugs 0.000 description 12
229930182833 estradiol Natural products 0.000 description 12
229960004766 estradiol valerate Drugs 0.000 description 11
DNXHEGUUPJUMQT-CBZIJGRNSA-N Estrone Chemical compound OC1=CC=C2[C@H]3CC[C@](C)(C(CC4)=O)[C@@H]4[C@@H]3CCC2=C1 DNXHEGUUPJUMQT-CBZIJGRNSA-N 0.000 description 9
GLUUGHFHXGJENI-UHFFFAOYSA-N Piperazine Chemical compound C1CNCCN1 GLUUGHFHXGJENI-UHFFFAOYSA-N 0.000 description 7
150000001875 compounds Chemical class 0.000 description 7
DNXHEGUUPJUMQT-UHFFFAOYSA-N (+)-estrone Natural products OC1=CC=C2C3CCC(C)(C(CC4)=O)C4C3CCC2=C1 DNXHEGUUPJUMQT-UHFFFAOYSA-N 0.000 description 6
229960003399 estrone Drugs 0.000 description 6
IMONTRJLAWHYGT-ZCPXKWAGSA-N Norethindrone Acetate Chemical compound C1CC2=CC(=O)CC[C@@H]2[C@@H]2[C@@H]1[C@@H]1CC[C@](C#C)(OC(=O)C)[C@@]1(C)CC2 IMONTRJLAWHYGT-ZCPXKWAGSA-N 0.000 description 5
QMBJSIBWORFWQT-DFXBJWIESA-N Chlormadinone acetate Chemical compound C1=C(Cl)C2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(C)=O)(OC(=O)C)[C@@]1(C)CC2 QMBJSIBWORFWQT-DFXBJWIESA-N 0.000 description 4
LVHOURKCKUYIGK-RGUJTQARSA-N Dimethisterone Chemical compound C1([C@@H](C)C2)=CC(=O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@](C#CC)(O)[C@@]2(C)CC1 LVHOURKCKUYIGK-RGUJTQARSA-N 0.000 description 4
ICTXHFFSOAJUMG-SLHNCBLASA-N Norethynodrel Chemical compound C1CC(=O)CC2=C1[C@H]1CC[C@](C)([C@](CC3)(O)C#C)[C@@H]3[C@@H]1CC2 ICTXHFFSOAJUMG-SLHNCBLASA-N 0.000 description 4
229950006690 dimethisterone Drugs 0.000 description 4
229940081345 estropipate Drugs 0.000 description 4
HZEQBCVBILBTEP-ZFINNJDLSA-N estropipate Chemical compound C1CNCCN1.OS(=O)(=O)OC1=CC=C2[C@H]3CC[C@](C)(C(CC4)=O)[C@@H]4[C@@H]3CCC2=C1 HZEQBCVBILBTEP-ZFINNJDLSA-N 0.000 description 4
ONKUMRGIYFNPJW-KIEAKMPYSA-N ethynodiol diacetate Chemical compound C1C[C@]2(C)[C@@](C#C)(OC(C)=O)CC[C@H]2[C@@H]2CCC3=C[C@@H](OC(=O)C)CC[C@@H]3[C@H]21 ONKUMRGIYFNPJW-KIEAKMPYSA-N 0.000 description 4
229940012028 ethynodiol diacetate Drugs 0.000 description 4
HCFSGRMEEXUOSS-JXEXPEPMSA-N medrogestone Chemical compound C1=C(C)C2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(=O)C)(C)[C@@]1(C)CC2 HCFSGRMEEXUOSS-JXEXPEPMSA-N 0.000 description 4
RQZAXGRLVPAYTJ-GQFGMJRRSA-N megestrol acetate Chemical compound C1=C(C)C2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(C)=O)(OC(=O)C)[C@@]1(C)CC2 RQZAXGRLVPAYTJ-GQFGMJRRSA-N 0.000 description 4
229960004296 megestrol acetate Drugs 0.000 description 4
IMSSROKUHAOUJS-MJCUULBUSA-N mestranol Chemical compound C1C[C@]2(C)[C@@](C#C)(O)CC[C@H]2[C@@H]2CCC3=CC(OC)=CC=C3[C@H]21 IMSSROKUHAOUJS-MJCUULBUSA-N 0.000 description 4
229960001390 mestranol Drugs 0.000 description 4
229940053934 norethindrone Drugs 0.000 description 4
229960001652 norethindrone acetate Drugs 0.000 description 4
229960001858 norethynodrel Drugs 0.000 description 4
229960002831 norgestrienone Drugs 0.000 description 4
GVDMJXQHPUYPHP-FYQPLNBISA-N norgestrienone Chemical compound C1CC(=O)C=C2CC[C@@H]([C@H]3[C@@](C)([C@](CC3)(O)C#C)C=C3)C3=C21 GVDMJXQHPUYPHP-FYQPLNBISA-N 0.000 description 4
VOXZDWNPVJITMN-QXDIGNSFSA-N (8s,9r,13r,14r,17r)-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,17-diol Chemical compound OC1=CC=C2[C@@H]3CC[C@@](C)([C@@H](CC4)O)[C@H]4[C@H]3CCC2=C1 VOXZDWNPVJITMN-QXDIGNSFSA-N 0.000 description 3
BFPYWIDHMRZLRN-UHFFFAOYSA-N 17alpha-ethynyl estradiol Natural products OC1=CC=C2C3CCC(C)(C(CC4)(O)C#C)C4C3CCC2=C1 BFPYWIDHMRZLRN-UHFFFAOYSA-N 0.000 description 3
ATXHVCQZZJYMCF-XUDSTZEESA-N Allylestrenol Chemical compound C1CC[C@@H]2[C@H]3CC[C@](C)([C@](CC4)(O)CC=C)[C@@H]4[C@@H]3CCC2=C1 ATXHVCQZZJYMCF-XUDSTZEESA-N 0.000 description 3
BFPYWIDHMRZLRN-SLHNCBLASA-N Ethinyl estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 BFPYWIDHMRZLRN-SLHNCBLASA-N 0.000 description 3
YNVGQYHLRCDXFQ-XGXHKTLJSA-N Lynestrenol Chemical compound C1CC[C@@H]2[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 YNVGQYHLRCDXFQ-XGXHKTLJSA-N 0.000 description 3
QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 description 3
229960002692 allylestrenol Drugs 0.000 description 3
UWFYSQMTEOIJJG-FDTZYFLXSA-N cyproterone acetate Chemical compound C1=C(Cl)C2=CC(=O)[C@@H]3C[C@@H]3[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(C)=O)(OC(=O)C)[C@@]1(C)CC2 UWFYSQMTEOIJJG-FDTZYFLXSA-N 0.000 description 3
229960000978 cyproterone acetate Drugs 0.000 description 3
JGMOKGBVKVMRFX-HQZYFCCVSA-N dydrogesterone Chemical compound C1=CC2=CC(=O)CC[C@@]2(C)[C@H]2[C@@H]1[C@@H]1CC[C@H](C(=O)C)[C@@]1(C)CC2 JGMOKGBVKVMRFX-HQZYFCCVSA-N 0.000 description 3
229960004913 dydrogesterone Drugs 0.000 description 3
229940042344 estradiol / norethindrone Drugs 0.000 description 3
-1 etheresterone Chemical compound 0.000 description 3
229960002568 ethinylestradiol Drugs 0.000 description 3
229960000445 ethisterone Drugs 0.000 description 3
CHNXZKVNWQUJIB-CEGNMAFCSA-N ethisterone Chemical compound O=C1CC[C@]2(C)[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 CHNXZKVNWQUJIB-CEGNMAFCSA-N 0.000 description 3
FLGJKPPXEKYCBY-AKCFYGDASA-N quingestanol acetate Chemical compound C([C@H]1[C@@H]2CC[C@@]([C@]2(CC[C@@H]1[C@H]1CC2)C)(OC(=O)C)C#C)C=C1C=C2OC1CCCC1 FLGJKPPXEKYCBY-AKCFYGDASA-N 0.000 description 3
229950009172 quingestanol acetate Drugs 0.000 description 3
125000003903 2-propenyl group Chemical group [H]C([*])([H])C([H])=C([H])[H] 0.000 description 2
208000024172 Cardiovascular disease Diseases 0.000 description 2
208000033830 Hot Flashes Diseases 0.000 description 2
206010060800 Hot flush Diseases 0.000 description 2
208000017657 Menopausal disease Diseases 0.000 description 2
230000000740 bleeding effect Effects 0.000 description 2
210000000988 bone and bone Anatomy 0.000 description 2
229960001616 chlormadinone acetate Drugs 0.000 description 2
125000004122 cyclic group Chemical group 0.000 description 2
238000005115 demineralization Methods 0.000 description 2
230000002328 demineralizing effect Effects 0.000 description 2
229940083543 estradiol 1 mg Drugs 0.000 description 2
150000002632 lipids Chemical class 0.000 description 2
229960000606 medrogestone Drugs 0.000 description 2
230000002265 prevention Effects 0.000 description 2
210000004291 uterus Anatomy 0.000 description 2
241000237502 Ostreidae Species 0.000 description 1
ULFUTCYGWMQVIO-PCVRPHSVSA-N [(6s,8r,9s,10r,13s,14s,17r)-17-acetyl-6,10,13-trimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1h-cyclopenta[a]phenanthren-17-yl] acetate;[(8r,9s,13s,14s,17s)-3-hydroxy-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-17-yl] pentano Chemical compound C1CC2=CC(O)=CC=C2[C@@H]2[C@@H]1[C@@H]1CC[C@H](OC(=O)CCCC)[C@@]1(C)CC2.C([C@@]12C)CC(=O)C=C1[C@@H](C)C[C@@H]1[C@@H]2CC[C@]2(C)[C@@](OC(C)=O)(C(C)=O)CC[C@H]21 ULFUTCYGWMQVIO-PCVRPHSVSA-N 0.000 description 1
229940057122 estradiol / medroxyprogesterone Drugs 0.000 description 1
JKKFKPJIXZFSSB-CBZIJGRNSA-M estrone 3-sulfate(1-) Chemical compound [O-]S(=O)(=O)OC1=CC=C2[C@H]3CC[C@](C)(C(CC4)=O)[C@@H]4[C@@H]3CCC2=C1 JKKFKPJIXZFSSB-CBZIJGRNSA-M 0.000 description 1
125000004435 hydrogen atom Chemical group [H]* 0.000 description 1
229960004616 medroxyprogesterone Drugs 0.000 description 1
235000020636 oyster Nutrition 0.000 description 1
229960005141 piperazine Drugs 0.000 description 1
108090000623 proteins and genes Proteins 0.000 description 1
229940070710 valerate Drugs 0.000 description 1
NQPDZGIKBAWPEJ-UHFFFAOYSA-N valeric acid Chemical compound CCCCC(O)=O NQPDZGIKBAWPEJ-UHFFFAOYSA-N 0.000 description 1

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
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- 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

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Health & Medical Sciences (AREA)
Public Health (AREA)
Veterinary Medicine (AREA)
Pharmacology & Pharmacy (AREA)
Epidemiology (AREA)
Life Sciences & Earth Sciences (AREA)
Animal Behavior & Ethology (AREA)
General Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Medicinal Chemistry (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Steroid Compounds (AREA)
Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Medicines Containing Plant Substances (AREA)
Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Medicinal Preparation (AREA)
Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Description

PATENTKRAV 1. Anvendelse af et progestogen og et østrogen til fremstilling af terapeutiske produkter, som indeholder 20 til 120 kombinerede daglige dosisenheder indeholdende et progestogen og et østrogen, og eventuelt også 3 til 7 separate daglige dosisenheder progestogen indeholdende progestogenet uden østrogenet, til behandling af post-menopausale lidelser hos kvinder med intakt uterus, hvilken behandling er udvalgt blandt kontrol af hedeture, hindring eller retardering af udviklingen af demineralisering af knogler og hindring af ændringer i lipi-der, som prædisponerer for cardiovasculære lidelser, og hvor behandlingen bevirker undgåelse eller minimering af blødning, ved kontinuerlig, uafbrudt, oral administrering af progestogenet, og enten kontinuerlig, uafbrudt, oral administrering af østrogenet, hvor progestogenet og østrogenet administreres sammen én gang dagligt i form af én af de kombinerede dosisenheder, eller cyclisk, oral administrering af østrogenet, hvor progestogenet og østrogenet administreres sammen én gang dagligt i form af de kombinerede dosisenheder i 20 til 120 dage, og progestogenet uden østrogenet administreres én gang dagligt i form af progestogendosisenhederne i 3 til 7 dage, og hvor mængden af østrogen svarer til en daglig oralt indgivet mængde af østradiol på mellem 0,5 og 2,0 mg, og dosisenheden eller dosisenhederne yderligere er indrettet til en uafbrudt administrering af progestogen i en mængde, der svarer til en daglig oralt indgivet mængde af laevo-norgestrel på mellem 0,025 og 0,075 mg, og hvor hver dosisenhed som progestogen indeholder et progestogen valgt blandt følgende forbindelser: Laevo-norgestrel, dl-Norgestrel, norethin-dron (norethisteron), norethindron (norethisteron) acetat, ethynodioldiacetat, dydrogesteron, medroxyprogesteronacetat, norethynodrel, allylestrenol, lyno-estrenol, quingestanolacetat, medrogeston, norgestrienon, dimethisteron, ethi-steron, cyproteronacetat, chlormadinonacetat og megestrolacetat, og som østrogen indeholder et østrogen valgt blandt følgende forbindelser: Østradiol, østradiol - 17/?, østradiolvalerat, konjugerede ekvin-østrogener, østron, pipe-razinøstronsulfat (østropipat), ethinyløstradiol, mestranol og quinestranol, dog således at det terapeutiske produkt ikke udgøres af kombinerede dosisenheder indrettet til daglig uafbrudt administrering af 2 mg østradiolvalerat og 1 mg norethindron (norethisteron) acetat. 2. Anvendelse ifølge krav 1, hvor progestogenet er valgt blandt følgende forbindelser i en dosis fra det angivne minimum op til det angivne maksimum:

Dosis, minimum (mg) Dosis, maksimum (mg) Laevo-norgestrel 0,025 0,05 dl-Norgestrel 0,05 0,1

Norethindron (norethisteron) 0,15 0,3

Norethindron (norethisteron) acetat 0,1 0,2

Ethynodioldiacetat 0,1 0,3

Dydrogesteron 5 10

Medroxyprogesteronacetat 1 2,5

Norethynodrel 0,2 1

Allylestrenol 1 2

Lynoestrenol 0,1 0,2

Quingestanolacetat 0,05 0,2

Medrogeston 1 2

Norgestrienon 0,02 0,05

Dimethisteron 0,5 1

Ethisteron 1 2,5

Cyproteronacetat 0,1 0,5

Chlormadinonacetat 0,1 0,3

Megestrolacetat 0,1 1 3. Anvendelse ifølge et hvilket som helst af de foregående krav, hvor østrogenet er valgt blandt følgende forbindelser i en dosis fra det angivne minimum op til det angivne maksimum:

Dosis, minimum (mg) Dosis, maksimum (mg) Østradiol 0,5 1 Østradiol -17/? 0,5 1 Østrad iolvalerat 0,5 1

Konjugerede ekvin-østrogener 0,3 0,6 østron 0,3 0,6

Piperazinøstronsulfat (østropipat) 0,25 0,5

Ethinyløstradiol 0,005 0,01

Mestranol 0,005 0,015

Quinestranot 0,005 0,01 4. Anvendelse ifølge et hvilket som helst af de foregående krav, hvor østrogenet er valgt blandt østradiol, 17p-østradiol, østradiolvalerat og konjugerede ekvin-østrogener. 5. Anvendelse ifølge et hvilket som helst af de foregående krav, hvor pro-gestogenet er valgt blandt laevo-norgestrel, dl-norgestrel, norethindron, nor-ethindronacetat og medroxyprogesteronacetat. 6. Anvendelse ifølge et hvilket som helst af de foregående krav, hvor østrogenet og progestogenet er valgt blandt følgende kombinationer: Østradiol/laevo-norgestrel Østradiol-17/?/laevo-norgestrel Østradiolvalerat/laevo-norgestrel

Konjugerede ekvin-østrogener/laevo-norgestrel Østradiol/dl-norgestrel Østradiol-17/?/dl-norgestrel Østradiolvalerat/dl-norgestrel

Konjugerede ekvin-østrogener/dl-norgestrel Østradiol/norethindron Østradiol-17/?/norethindron (norethisteron) Østradiolvalerat/norethindron (norethisteron)

Konjugerede ekvin-østrogener/norethindron (norethisteron) Østrad io!/Noreth ind ronacetat Østradiol-17/?/norethindron (norethisteron) acetat Østradiolvalerat/norethindron (norethisteron) acetat

Konjugerede ekvin-østrogener/norethindron (norethisteron) acetat Østrad iol/medroxyprogesteronacetat Østrad iol-17/?/medroxyprogesteronacetat Østradiolvalerat/medroxyprogesteronacetat

Konjugerede ekvin-østrogener/medroxyprogesteronacetat. 7. Anvendelse ifølge et hvilket som helst af de foregående krav, hvor østrogenet er østradio!-17/?, og progestogenet er valgt blandt dl-norgestrel, laevo-norgestrel, norethindron og norethindronacetat. 8. Anvendelse ifølge et hvilket som helst af kravene 1 til 6, hvor progestogenet er medroxyprogesteronacetat, og østrogenet er konjugerede ekvin-østro-gener. 9. Anvendelse ifølge et hvilket som helst af de foregående krav, hvor behandlingen er en kontinuerlig, uafbrudt, én gang daglig administrering af progestogenet og østrogenet, og samtlige dosisenheder er de kombinerede dosisenheder indeholdende østrogenet og progestogenet 10. Terapeutisk produkt indeholdende 20 til 120 kombinerede daglige dosisenheder indeholdende et progestogen og et østrogen, og eventuelt også 3 til 7 separate daglige dosisenheder progestogen indeholdende progestogenet uden østrogenet, til behandling af post-menopausale lidelser hos kvinder med intakt uterus, hvilken behandling er udvalgt blandt kontrol af hedeture, hindring eller retardering af udviklingen af demineralisering af knogler og hindring af ændringer i lipi-der, som prædisponerer for cardiovasculære lidelser, og hvor behandlingen bevirker undgåelse eller minimering af blødning, ved kontinuerlig, uafbrudt, oral administrering af progestogenet, og enten kontinuerlig, uafbrudt, oral administrering af østrogenet, hvor pro-gestogenet og østrogenet administreres sammen én gang dagligt i form af én af de kombinerede dosisenheder, eller cyclisk, oral administrering af østrogenet, hvor progestogenet og østrogenet administreres sammen én gang dagligt i form af de kombinerede dosisenheder i 20 til 120 dage, og progestogenet uden østrogenet administreres én gang dagligt i form af progestogendosisenhederne i 3 til 7 dage, og hvor mængden af østrogen svarer til en dagligt oralt indgivet mængde af østradiol på mellem 0,5 og 2,0 mg, og dosisenheden eller dosisenhederne yderligere er indrettet til er uafbrudt administrering af progestogen i en mængde, der svarer til en daglig oralt indgivet mængde af laevo-norgestrel på mellem 0,025 og 0,075 mg, og hvor hver dosisenhed som progestogen indeholder et progestogen valgt blandt følgende forbindelser: laevo-norgestrel, dl-norgestrel, norethindron (norethisteron), norethindron (norethisteron) acetat, ethynodioldiacetat, dydro-gesteron, medroxyprogesteronacetat, norethynodrel, allylestrenol, lynoestrenol, quingestanolacetat, medrogeston, norgestrienon, dimethisteron, ethisteron, cy-proteronacetat, chlormadinonacetat og megestrolacetat, og som østrogen indeholder et østrogen valgt blandt følgende forbindelser: østradiol, østradiol -Μβ, østradiolvalerat, konjugerede ekvin-østrogener, østron, piperazinøstron-sulfat (østropipat), ethinyløstradiol, mestranol og quinestranol, dog således at det terapeutiske produkt ikke udgøres af kombinerede dosisenheder indrettet til daglig uafbrudt administrering af 2 mg østradiolvalerat og 1 mg norethindron (norethisteron) acetat. 11. Produkt ifølge krav 10, hvor progestogenet er valgt blandt følgende forbindelser i en dosis fra det angivne minimum op til det angivne maksimum:

Dosis, minimum (mg) Dosis, maksimum (mg) Laevo-norgestrel 0,025 0,05 dl-Norgestrel 0,05 0,1

Norethindron (norethisteron) 0,15 0,3

Norethindron (norethisteron) acetat 0,1 0,2

Ethynodioldiacetat 0,1 0,3

Dydrogesteron 5 10

Medroxyprogesteronacetat 1 2,5

Norethynodrel 0,2 1

Allylestrenol 1 2

Lynoestrenol 0,1 0,2

Quingestanolacetat 0,05 0,2

Medrogeston 1 2

Norgestrienon 0,02 0,05

Dimethisteron 0,5 1

Ethisteron 1 2,5

Cyproteronacetat 0,1 0,5

Chlormadinonacetat 0,1 0,3

Megestrolacetat 0,1 1 12. Produkt ifølge krav 10 eller krav 11, hvor østrogenet er valgt blandt følgende forbindelser i en dosis fra det angivne minimum op til det angivne maksimum:

Dosis, minimum (mal Dosis, maksimum (mg) Østradiol 0,5 1 Østradiol -17β 0,5 1 Østradiolvalerat 0,5 1

Konjugerede ekvin-østrogener 0,3 0,6 Østron 0,3 0,6

Piperazinøstronsulfat (østropipat) 0,25 0,5

Ethinyløstradio! 0,005 0,01

Mestranol 0,005 0,015

Quinestranol 0,005 0,01 13. Produkt ifølge et hvilket som helst af kravene 10 til 12, hvor østrogenet er valgt blandt østradiol, 17p-østradiol, østradiolvalerat og konjugerede ekvin-østrogener. 14. Produkt ifølge et hvilket som helst af kravene 10 til 13, hvor progestoge-net er valgt blandt laevo-norgestrel, dl-norgestrel, norethindron, norethindron-acetat og medroxyprogesteronacetat. 15. Produkt ifølge et hvilket som helst af kravene 10 til 14, hvor østrogenet og progestogenet er valgt blandt følgende kombinationer: Østradiol/laevo-norgestrel Østradiol-17/?/laevo-norgestrel Østradiolvalerat/laevo-norgestrel

Konjugerede ekvin-østrogener/laevo-norgestrel Østradiol/dl-norgestrel Østradiol-17/?/dl-norgestrel Østradiolvalerat/dl-norgestrel

Konjugerede ekvin-østrogener/dl-norgestrel Østradiol/norethindron Østradiol-17/?/norethindron (norethisteron) Østradiolvalerat/norethindron (norethisteron)

Konjugerede ekvin-østrogener/norethindron (norethisteron) Østradiol/Norethindronacetat Østradiol -17^/norethindron (norethisteron) acetat Østradiolvalerat/norethindron (norethisteron) acetat

Konjugerede ekvin-østrogener/norethindron (norethisteron) acetat Østradiol/medroxyprogesteronacetat Østradiol-17/?/medroxyproge$teronacetat Østradiolvalerat/medroxyprogesteronacetat

Konjugerede ekvin-østrogener/medroxyprogesteronacetat. 16. Produkt ifølge et hvilket som helst af kravene 10 til 15, hvor østrogenet er østradiol-17β, og progestogenet er valgt blandt dl-norgestrel, laevo-norgestrel, norethindron og norethindronacetat. 17. Produkt ifølge et hvilket som helst af kravene 10 til 15, hvor progestoge-net er medroxyprogesteronacetat, og østrogenet er konjugerede ekvin-østro-gener. 18. Produkt ifølge et hvilket som helst af kravene 10 til 17, hvor samtlige dosisenheder er de kombinerede dosisenheder indeholdende østrogenet og pro-gestogenet. 19. Produkt ifølge krav 17 hvor mængden af konjugerede ekvin-østrogener er 0,3 til 0,6 mg og mængden af medroxyprogesteronacetat er 1 til 2,5 mg.

DK200400365A 1983-08-05 2004-03-04 Anvendelse af et progestogen og et östrogen til fremstilling af et terapeutisk produkt til hormonbehandling af postmenopausale lidelser hos kvinder samt et sådant terapeutisk produkt DK175317B1 (da)

Priority Applications (1)

Application Number	Priority Date	Filing Date	Title
DK200400365A DK175317B1 (da)	1983-08-05	2004-03-04	Anvendelse af et progestogen og et östrogen til fremstilling af et terapeutisk produkt til hormonbehandling af postmenopausale lidelser hos kvinder samt et sådant terapeutisk produkt

Applications Claiming Priority (8)

Application Number	Priority Date	Filing Date	Title
US52083483A	1983-08-05	1983-08-05
US52083483		1983-08-05
US06/635,236 US4826831A (en)	1983-08-05	1984-07-27	Method of hormonal treatment for menopausal or post-menopausal disorders involving continuous administration of progestogens and estrogens
US63523684		1984-07-27
DK198403770A DK165390C (da)	1983-08-05	1984-08-03	Anvendelse af et progestogen og et østrogen til fremstllling af et terapeutisk produkt til hormonbehandling af postmenopausale lidelser hos kvinder samt et sådant terapeutisk produkt
DK377084		1984-08-03
DK200400365A DK175317B1 (da)	1983-08-05	2004-03-04	Anvendelse af et progestogen og et östrogen til fremstilling af et terapeutisk produkt til hormonbehandling af postmenopausale lidelser hos kvinder samt et sådant terapeutisk produkt
DK200400365		2004-03-04

Publications (2)

Publication Number	Publication Date
DK200400365A true DK200400365A (da)	2004-03-04
DK175317B1 DK175317B1 (da)	2004-08-16

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ID=27060286

Family Applications (2)

Application Number	Title	Priority Date	Filing Date
DK198403770A DK165390C (da)	1983-08-05	1984-08-03	Anvendelse af et progestogen og et østrogen til fremstllling af et terapeutisk produkt til hormonbehandling af postmenopausale lidelser hos kvinder samt et sådant terapeutisk produkt
DK200400365A DK175317B1 (da)	1983-08-05	2004-03-04	Anvendelse af et progestogen og et östrogen til fremstilling af et terapeutisk produkt til hormonbehandling af postmenopausale lidelser hos kvinder samt et sådant terapeutisk produkt

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Application Number	Title	Priority Date	Filing Date
DK198403770A DK165390C (da)	1983-08-05	1984-08-03	Anvendelse af et progestogen og et østrogen til fremstllling af et terapeutisk produkt til hormonbehandling af postmenopausale lidelser hos kvinder samt et sådant terapeutisk produkt

Country Status (12)

Country	Link
US (2)	US4826831A (da)
EP (1)	EP0136011B2 (da)
AT (1)	ATE147987T1 (da)
CA (1)	CA1240927A (da)
DE (5)	DE10075037I2 (da)
DK (2)	DK165390C (da)
IL (1)	IL72556A (da)
LU (5)	LU90107I2 (da)
MX (1)	MX9203720A (da)
NL (5)	NL970026I1 (da)
NZ (1)	NZ209066A (da)
PH (1)	PH24052A (da)

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1984
- 1984-07-27 US US06/635,236 patent/US4826831A/en not_active Ceased
- 1984-07-31 IL IL72556A patent/IL72556A/xx not_active IP Right Cessation
- 1984-07-31 CA CA000460073A patent/CA1240927A/en not_active Expired
- 1984-07-31 NZ NZ209066A patent/NZ209066A/en unknown
- 1984-08-02 EP EP84305260A patent/EP0136011B2/en not_active Expired - Lifetime
- 1984-08-02 DE DE10075037C patent/DE10075037I2/de active Active
- 1984-08-02 DE DE3486442T patent/DE3486442T3/de not_active Expired - Lifetime
- 1984-08-02 DE DE1997175086 patent/DE19775086I2/de active Active
- 1984-08-02 AT AT84305260T patent/ATE147987T1/de active
- 1984-08-02 DE DE10199001C patent/DE10199001I2/de active Active
- 1984-08-02 DE DE10199010C patent/DE10199010I2/de active Active
- 1984-08-03 PH PH31063A patent/PH24052A/en unknown
- 1984-08-03 DK DK198403770A patent/DK165390C/da active Protection Beyond IP Right Term
1992
- 1992-06-29 MX MX9203720A patent/MX9203720A/es active IP Right Grant
1995
- 1995-10-13 US US08/542,941 patent/USRE36247E/en not_active Expired - Lifetime
1997
- 1997-07-21 LU LU90107C patent/LU90107I2/fr unknown
- 1997-07-22 NL NL970026C patent/NL970026I1/nl unknown
- 1997-10-22 NL NL970037C patent/NL970037I2/nl unknown
1998
- 1998-11-20 NL NL980038C patent/NL980038I2/nl unknown
1999
- 1999-01-27 LU LU90343C patent/LU90343I2/fr unknown
2000
- 2000-10-23 NL NL300022C patent/NL300022I2/nl unknown
- 2000-12-13 LU LU90696C patent/LU90696I2/fr unknown
- 2000-12-13 LU LU90697C patent/LU90697I2/fr unknown
2001
- 2001-01-04 NL NL300033C patent/NL300033I2/nl unknown
2004
- 2004-03-04 DK DK200400365A patent/DK175317B1/da active Protection Beyond IP Right Term
- 2004-07-30 LU LU91096C patent/LU91096I2/xx unknown

Also Published As

Publication number	Publication date
LU90696I2 (fr)	2001-02-13
MX9203720A (es)	1992-07-31
DE3486442T3 (de)	2005-05-12
DE10075037I1 (de)	2001-03-01
LU91096I2 (fr)	2004-11-30
NL300022I1 (nl)	2001-01-02
EP0136011B1 (en)	1997-01-22
DK377084A (da)	1985-02-06
DE10199001I2 (de)	2010-07-08
PH24052A (en)	1990-03-05
DK377084D0 (da)	1984-08-03
DE19775086I2 (de)	2001-08-23
LU90343I2 (fr)	1999-03-29
NL300033I2 (nl)	2004-04-01
DK175317B1 (da)	2004-08-16
DE3486442D1 (de)	1997-03-06
DE10199010I2 (de)	2010-01-28
DE10199010I1 (de)	2002-05-08
NZ209066A (en)	1988-01-08
DK165390B (da)	1992-11-23
NL970037I2 (nl)	2004-04-01
CA1240927A (en)	1988-08-23
EP0136011B2 (en)	2004-06-09
IL72556A (en)	1989-05-15
USRE36247E (en)	1999-07-06
IL72556A0 (en)	1984-11-30
LU90107I2 (fr)	1997-12-17
NL980038I2 (nl)	2005-06-01
NL300033I1 (nl)	2001-03-01
US4826831A (en)	1989-05-02
LU90697I2 (fr)	2001-02-13
DE10075037I2 (de)	2010-01-28
DE3486442T2 (de)	1997-06-05
NL970026I1 (nl)	1997-10-01
EP0136011A2 (en)	1985-04-03
NL980038I1 (nl)	1999-02-01
DE10199001I1 (de)	2002-03-14
NL300022I2 (nl)	2004-04-01
ATE147987T1 (de)	1997-02-15
EP0136011A3 (en)	1986-07-16
NL970037I1 (nl)	1998-02-02
DK165390C (da)	2004-04-26

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Publication	Publication Date	Title
DK200400365A (da)	2004-03-04	Anvendelse af et progestogen og et østrogen til fremstilling af et terapeutisk produkt til hormonbehandling af postmenopausale lidelser hos kvinder samt et sådant terapeutisk produkt
KR960001371B1 (ko)	1996-01-26	폐경기 전의 여성용 혼합 제형 및 이를 포함하는 팩
KR100186780B1 (ko)	1999-05-01	피임제제
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CA2267743A1 (en)	2000-09-30	Low dose estrogen interrupted hormone replacement therapy
RU2001117204A (ru)	2003-05-20	Трехфазный пероральный контрацептив
JP2000502108A (ja)	2000-02-22	ゲストゲンとエストロゲン併用によるほ乳動物の避妊法とキット
ATE271386T1 (de)	2004-08-15	Orale einstufige empfängnisverhütungsmethode und kombinationspräparat das gestagen und estrogen enthält
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DK0917466T3 (da)	2004-12-20	Oralt antikonceptionsmiddel
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EP1389117A1 (en)	2004-02-18	Means and method for hormonal contraception
JP2005527574A (ja)	2005-09-15	ホルモン補充療法におけるトリメゲストンと組み合わせた結合型エストロゲンの使用
JP2005527577A (ja)	2005-09-15	ホルモン補充療法
DK200101066A (da)	2001-07-06	Farmaceutisk præparat til hormonbehandling
Elstein	1979	Oral contraception reviewed
MXPA01010976A (es)	2002-07-22	Uso de antiprogestagenos en terapia combinada.