CA2467222A1 - Use of estrogenic compounds in combination with progestogenic compounds in hormone-replacement therapy - Google Patents
Use of estrogenic compounds in combination with progestogenic compounds in hormone-replacement therapy Download PDFInfo
- Publication number
- CA2467222A1 CA2467222A1 CA002467222A CA2467222A CA2467222A1 CA 2467222 A1 CA2467222 A1 CA 2467222A1 CA 002467222 A CA002467222 A CA 002467222A CA 2467222 A CA2467222 A CA 2467222A CA 2467222 A1 CA2467222 A1 CA 2467222A1
- Authority
- CA
- Canada
- Prior art keywords
- component
- estrogenic
- progestogenic
- use according
- days
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
Links
- 230000000757 progestagenic effect Effects 0.000 title claims abstract 15
- 150000001875 compounds Chemical class 0.000 title 1
- 239000000262 estrogen Substances 0.000 title 1
- 238000002657 hormone replacement therapy Methods 0.000 title 1
- 230000001076 estrogenic effect Effects 0.000 claims abstract 19
- 238000000034 method Methods 0.000 claims abstract 13
- 239000000126 substance Substances 0.000 claims abstract 7
- 125000002887 hydroxy group Chemical group [H]O* 0.000 claims abstract 6
- 239000002243 precursor Substances 0.000 claims abstract 6
- 230000001548 androgenic effect Effects 0.000 claims abstract 5
- 125000004435 hydrogen atom Chemical group [H]* 0.000 claims abstract 5
- 241000124008 Mammalia Species 0.000 claims abstract 4
- 239000000203 mixture Substances 0.000 claims abstract 3
- 208000024891 symptom Diseases 0.000 claims abstract 3
- 125000004432 carbon atom Chemical group C* 0.000 claims abstract 2
- 229940088597 hormone Drugs 0.000 claims abstract 2
- 239000005556 hormone Substances 0.000 claims abstract 2
- 230000037396 body weight Effects 0.000 claims 8
- 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 claims 4
- 229960004400 levonorgestrel Drugs 0.000 claims 4
- FMGSKLZLMKYGDP-USOAJAOKSA-N dehydroepiandrosterone Chemical compound C1[C@@H](O)CC[C@]2(C)[C@H]3CC[C@](C)(C(CC4)=O)[C@@H]4[C@@H]3CC=C21 FMGSKLZLMKYGDP-USOAJAOKSA-N 0.000 claims 3
- FMGSKLZLMKYGDP-UHFFFAOYSA-N Dehydroepiandrosterone Natural products C1C(O)CCC2(C)C3CCC(C)(C(CC4)=O)C4C3CC=C21 FMGSKLZLMKYGDP-UHFFFAOYSA-N 0.000 claims 2
- 125000003545 alkoxy group Chemical group 0.000 claims 2
- 210000004914 menses Anatomy 0.000 claims 2
- 229960002847 prasterone Drugs 0.000 claims 2
- 210000002966 serum Anatomy 0.000 claims 2
- 208000024827 Alzheimer disease Diseases 0.000 claims 1
- 206010003210 Arteriosclerosis Diseases 0.000 claims 1
- LSNNMFCWUKXFEE-UHFFFAOYSA-M Bisulfite Chemical compound OS([O-])=O LSNNMFCWUKXFEE-UHFFFAOYSA-M 0.000 claims 1
- 239000004215 Carbon black (E152) Substances 0.000 claims 1
- BJJXHLWLUDYTGC-ANULTFPQSA-N Gestrinone Chemical compound C1CC(=O)C=C2CC[C@@H]([C@H]3[C@@](CC)([C@](CC3)(O)C#C)C=C3)C3=C21 BJJXHLWLUDYTGC-ANULTFPQSA-N 0.000 claims 1
- 206010027304 Menopausal symptoms Diseases 0.000 claims 1
- 208000001132 Osteoporosis Diseases 0.000 claims 1
- 239000003098 androgen Substances 0.000 claims 1
- 229940030486 androgens Drugs 0.000 claims 1
- 208000011775 arteriosclerosis disease Diseases 0.000 claims 1
- 125000004429 atom Chemical group 0.000 claims 1
- 208000010877 cognitive disease Diseases 0.000 claims 1
- 229960000766 danazol Drugs 0.000 claims 1
- POZRVZJJTULAOH-LHZXLZLDSA-N danazol Chemical compound C1[C@]2(C)[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=CC2=C1C=NO2 POZRVZJJTULAOH-LHZXLZLDSA-N 0.000 claims 1
- 229960004761 gestrinone Drugs 0.000 claims 1
- 229930195733 hydrocarbon Natural products 0.000 claims 1
- -1 hydrocarbon carboxylic Chemical class 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- LNOPIUAQISRISI-UHFFFAOYSA-N n'-hydroxy-2-propan-2-ylsulfonylethanimidamide Chemical compound CC(C)S(=O)(=O)CC(N)=NO LNOPIUAQISRISI-UHFFFAOYSA-N 0.000 claims 1
- XEZQLSOFXLPSJR-UHFFFAOYSA-N oxane-2-carbaldehyde Chemical compound O=CC1CCCCO1 XEZQLSOFXLPSJR-UHFFFAOYSA-N 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 150000003515 testosterones Chemical class 0.000 claims 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
- A61K31/565—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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
- A61P5/30—Oestrogens
Landscapes
- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Diabetes (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Endocrinology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Organic Chemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
One aspect of the present invention relates to method of hormone replacement in mammals, which method comprises the oral administration of an estrogenic component and a progestogenic component to a mammal in an effective amount to prevent or treat symptoms of hypoestrogenism, wherein the estrogenic component is selected from the group consisting of: substances represented by the following formula (I) in which formula R1, R2, R3, R4 independently are a hydrogen atom, a hydroxyl group or an alokxy group with 1-5 carbon atoms; each of R5, R6, R7, is a hydroxyl group; and no more than 3 of R1, R2, R3, R4 are hydrogen atoms; precursors capable of liberating a substance according to the aforementioned formula when used in the present method; and mixtures of one or more of the aforementioned substances and/or precursors. Another aspect of the invention concerned with a pharmaceutical kit comprising oral dosage units that contain the aforementioned estrogenic component and an progestrogenic component as well as an androgenic component.
Claims (16)
1. Use of an estrogenic component selected from the group consisting of substances represented by the following formula in which formula R1, R2, R3, R4 independently are a hydrogen atom, a hydroxyl group or an alkoxy group with 1-5 carbon atoms; each of R5, R6, R7 is a hydroxyl group; and no more than 3 of R1, R2, R3, R4 are hydrogen atoms;
precursors capable of liberating a substance according to the aforementioned formula when used in the present method which precursors are derivatives of the substances represented by the formula wherein the hydroaen atom of at least one of the hydroxyl groups in said formula has been substituted by an acyl radical of a hydrocarbon carboxylic, sulfonic or sulfamic acid of 1-25 carbon atoms tetrahydrofuranyl; tetrahydropyranal; or a straight or branched chain glycosydic residue containing 1-20 glycosidic units per residue; and mixtures of one or more of the aforementioned substances and/or precursors;
in the manufacture of a pharmaceutical composition for use in a method of hormone replacement in mammals, which method comprises the oral administration of said estrogenic component and a progestogenic component to a mammal in an effective amount to prevent or treat symptoms of hypoestrogenism.
precursors capable of liberating a substance according to the aforementioned formula when used in the present method which precursors are derivatives of the substances represented by the formula wherein the hydroaen atom of at least one of the hydroxyl groups in said formula has been substituted by an acyl radical of a hydrocarbon carboxylic, sulfonic or sulfamic acid of 1-25 carbon atoms tetrahydrofuranyl; tetrahydropyranal; or a straight or branched chain glycosydic residue containing 1-20 glycosidic units per residue; and mixtures of one or more of the aforementioned substances and/or precursors;
in the manufacture of a pharmaceutical composition for use in a method of hormone replacement in mammals, which method comprises the oral administration of said estrogenic component and a progestogenic component to a mammal in an effective amount to prevent or treat symptoms of hypoestrogenism.
2. Use according to claim 1, wherein the symptoms of hypoestrogenism are selected from the group consisting of osteoporosis, arteriosclerosis, climacteric symptoms, cognitive disturbances and Alzheimer's disease.
3. Use according to claim 1 or 2, wherein R3 represents a hydroxyl group or an alkoxy group.
4. Use according to any one of claims 1-3, wherein at least 3 of the groups R1, R2, R3 and R4 represent hydrogen atoms.
5. Use according to any one of claims 1-4, wherein the method comprises the uninterrupted oral administration of the estrogenic component during a period of at least 10 days, preferably of at least 20 days.
6. Use according to claim 5, wherein the method comprises the uninterrupted oral administration, during a period of at least 10 days, of a combination of the estrogenic component and a progestogenic component.
7. Use according to claim 6, wherein the method comprises the uninterrupted oral administration of the combination of the estrogenic component and the progestogenic component during a period of at least 28, preferably at least 60 days.
8. Use according to claim 6, wherein the method comprises an interval of at least 2 days, preferably of 3-9 days, during which no progestogenic component and no estrogenic component is administered and wherein the resulting decrease in serum concentration of the progestogenic component and the estrogenic component induces menses.
9. Use according to claim 6, wherein the method comprises the uninterrupted oral administration of the estrogenic component during a period of at least 28 days, preferably at least 60 days, and wherein, following the combined administration of the estrogenic component and the progestogenic component, the estrogenic component and no progestogenic component are administered during 3-18 consecutive days and the resulting decrease in serum concentration of the progestogenic component induces menses.
10. Use according to any one of claims 1-9, wherein the method comprises the at least once daily oral administration of the estrogenic component and/or the progestogenic component during a period of at least 10, preferably at least 20 days.
11. Use according to any one of claims 1-10, wherein the estrogenic component is orally administered in an amount of less than 1 mg per kg of bodyweight per day, preferably of less than 400 µg per kg of bodyweight per day, more preferably of less than 200 µg per kg of bodyweight per day.
12. Use according to any one of claims 1-11, wherein the estrogenic component is orally administered in an amount of at least 1 µg per kg of bodyweight per day, preferably of at least 2 µg per kg of bodyweight per day, more preferably of at least 5 µg per kg of bodyweight per day.
13. Use according to any one of claims 1-12, wherein the progestogenic component is administered in an amount which is equivalent to a daily oral dosage of 0.3 to 20 µg levonorgestrel per kg of bodyweight, preferably of 0.5-5 µg levonorgestrel per kg of bodyweight.
14. A pharmaceutical kit comprising at least 20 oral dosage units that contain the estrogenic component as defined in claim 1 and/or a progestogenic component and/or an androgenic component, wherein at least 10 units contain between 0.01 and 20 mg of the estrogenic component, at least 10 units contain the progestogenic component in an amount equivalent to 30-750 µg levonorgestrel and at least 10 dosage units contain the androgenic component in an amount equivalent to 5-250 mg dehydroepiandrosterone.
15. Pharmaceutical kit according to claim 14, comprising at least 10 oral dosage units that contain between 0.01 and 20 mg of the estrogenic component, the progestogenic component in an amount equivalent to 30-750 µg levonorgestrel and the androgenic component in an amount equivalent to 5-250 mg dehydroepiandrosterone.
16. Pharmaceutical kit according to claim 14 or 15, wherein the androgenic component is selected from selected from the group consisting of dehydroepiandrosterone (DHEA), danazol, gestrinone, testosterone esters, precursors capable of liberating these androgens when used in the present method and mixtures thereof.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP01204377.4 | 2001-11-15 | ||
| EP01204377 | 2001-11-15 | ||
| EP02075695.3 | 2002-02-21 | ||
| EP02075695 | 2002-02-21 | ||
| PCT/NL2002/000332 WO2003041718A1 (en) | 2001-11-15 | 2002-05-23 | Use of estrogenic compounds in combination with progestogenic compounds in hormone-replacement therapy |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2467222A1 true CA2467222A1 (en) | 2003-05-22 |
| CA2467222C CA2467222C (en) | 2010-06-08 |
Family
ID=26077031
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2467222A Expired - Lifetime CA2467222C (en) | 2001-11-15 | 2002-05-23 | Use of estrogenic compounds in combination with progestogenic compounds in hormone-replacement therapy |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US8026228B2 (en) |
| EP (1) | EP1446128B1 (en) |
| AT (1) | ATE347365T1 (en) |
| CA (1) | CA2467222C (en) |
| CY (1) | CY1105957T1 (en) |
| DE (1) | DE60216630T2 (en) |
| DK (1) | DK1446128T3 (en) |
| ES (1) | ES2278925T3 (en) |
| PT (1) | PT1446128E (en) |
| WO (1) | WO2003041718A1 (en) |
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| JP2006526025A (en) * | 2003-05-28 | 2006-11-16 | エントレメッド インコーポレイテッド | Anti-angiogenic agent |
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| AU4543200A (en) | 1999-04-16 | 2000-11-02 | Dittgen, Michael | Pharmaceutical or cosmetic compositions for the local, intradermal application of hormones |
| AU5137900A (en) | 1999-05-28 | 2000-12-18 | University Of Cincinnati, The | Antisense oligonucleotides for fertility and menstrual cycle regulation and for chemopreventive and chemotherapeutic use |
| WO2001030356A1 (en) | 1999-10-25 | 2001-05-03 | Laboratoire Theramex | Hormonal composition based on a progestational agent and an oestrogen and use thereof |
| DE60129550T2 (en) | 2000-05-12 | 2008-04-10 | The Government Of The United States Of America, As Represented By The Department | USE OF LOW DOSE ESTROGENS IN COMBINATION WITH IMMUNOTHERAPEIC COMPOUNDS FOR THE TREATMENT OF IMMUNE DISEASES |
| US6936599B2 (en) | 2001-04-25 | 2005-08-30 | The Regents Of The University Of California | Estriol therapy for multiple sclerosis and other autoimmune diseases |
| EP1260225A1 (en) | 2001-05-18 | 2002-11-27 | Pantarhei Bioscience B.V. | A pharmaceutical composition for use in hormone replacement therapy |
-
2002
- 2002-05-23 PT PT02738962T patent/PT1446128E/en unknown
- 2002-05-23 EP EP02738962A patent/EP1446128B1/en not_active Expired - Lifetime
- 2002-05-23 CA CA2467222A patent/CA2467222C/en not_active Expired - Lifetime
- 2002-05-23 DK DK02738962T patent/DK1446128T3/en active
- 2002-05-23 DE DE60216630T patent/DE60216630T2/en not_active Expired - Lifetime
- 2002-05-23 ES ES02738962T patent/ES2278925T3/en not_active Expired - Lifetime
- 2002-05-23 WO PCT/NL2002/000332 patent/WO2003041718A1/en active IP Right Grant
- 2002-05-23 AT AT02738962T patent/ATE347365T1/en not_active IP Right Cessation
- 2002-05-23 US US10/495,707 patent/US8026228B2/en active Active
-
2007
- 2007-01-29 CY CY20071100107T patent/CY1105957T1/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CA2467222C (en) | 2010-06-08 |
| DK1446128T3 (en) | 2007-04-02 |
| EP1446128A1 (en) | 2004-08-18 |
| ATE347365T1 (en) | 2006-12-15 |
| ES2278925T3 (en) | 2007-08-16 |
| WO2003041718A1 (en) | 2003-05-22 |
| DE60216630T2 (en) | 2007-09-20 |
| US8026228B2 (en) | 2011-09-27 |
| EP1446128B1 (en) | 2006-12-06 |
| US20050070488A1 (en) | 2005-03-31 |
| PT1446128E (en) | 2007-03-30 |
| CY1105957T1 (en) | 2011-04-06 |
| DE60216630D1 (en) | 2007-01-18 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKEX | Expiry |
Effective date: 20220524 |