AU2003279000A1 - 17Beta-ESTRADIOL/LEVONORGESTREL TRANSDERM PATCH FOR HORMONE REPLACEMENT THERAPY - Google Patents
17Beta-ESTRADIOL/LEVONORGESTREL TRANSDERM PATCH FOR HORMONE REPLACEMENT THERAPY Download PDFInfo
- Publication number
- AU2003279000A1 AU2003279000A1 AU2003279000A AU2003279000A AU2003279000A1 AU 2003279000 A1 AU2003279000 A1 AU 2003279000A1 AU 2003279000 A AU2003279000 A AU 2003279000A AU 2003279000 A AU2003279000 A AU 2003279000A AU 2003279000 A1 AU2003279000 A1 AU 2003279000A1
- Authority
- AU
- Australia
- Prior art keywords
- day
- estradiol
- levonorgestrel
- delivery rate
- lng
- 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.)
- Abandoned
Links
- 229960004400 levonorgestrel Drugs 0.000 title claims description 94
- 229960005309 estradiol Drugs 0.000 title claims description 51
- 238000002657 hormone replacement therapy Methods 0.000 title claims description 11
- 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 title description 46
- 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 description 100
- 238000000034 method Methods 0.000 claims description 37
- 239000000203 mixture Substances 0.000 claims description 22
- 230000000694 effects Effects 0.000 claims description 11
- 230000037317 transdermal delivery Effects 0.000 claims description 7
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 claims description 6
- 239000003937 drug carrier Substances 0.000 claims description 5
- VOXZDWNPVJITMN-UHFFFAOYSA-N 13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,17-diol Chemical compound OC1=CC=C2C3CCC(C)(C(CC4)O)C4C3CCC2=C1 VOXZDWNPVJITMN-UHFFFAOYSA-N 0.000 claims 1
- 238000011282 treatment Methods 0.000 description 37
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- 239000000902 placebo Substances 0.000 description 15
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- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 14
- 230000002411 adverse Effects 0.000 description 12
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- 230000001149 cognitive effect Effects 0.000 description 3
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- 239000000262 estrogen Substances 0.000 description 3
- 229940088597 hormone Drugs 0.000 description 3
- 239000005556 hormone Substances 0.000 description 3
- 238000009533 lab test Methods 0.000 description 3
- 230000027939 micturition Effects 0.000 description 3
- 239000000583 progesterone congener Substances 0.000 description 3
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- 102000012673 Follicle Stimulating Hormone Human genes 0.000 description 2
- 108010079345 Follicle Stimulating Hormone Proteins 0.000 description 2
- 102000004895 Lipoproteins Human genes 0.000 description 2
- 108090001030 Lipoproteins Proteins 0.000 description 2
- 206010027304 Menopausal symptoms Diseases 0.000 description 2
- RJKFOVLPORLFTN-LEKSSAKUSA-N Progesterone Chemical class C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H](C(=O)C)[C@@]1(C)CC2 RJKFOVLPORLFTN-LEKSSAKUSA-N 0.000 description 2
- 206010046306 Upper respiratory tract infection Diseases 0.000 description 2
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- ARIWANIATODDMH-UHFFFAOYSA-N rac-1-monolauroylglycerol Chemical compound CCCCCCCCCCCC(=O)OCC(O)CO ARIWANIATODDMH-UHFFFAOYSA-N 0.000 description 2
- 230000002829 reductive effect Effects 0.000 description 2
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- 230000005186 women's health Effects 0.000 description 2
- RQFMPXMLRRPOJH-ORADRBJOSA-N (8r,9s,10r,13s,14s,17r)-13-ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one;(8r,9s,13s,14s,17s)-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.O=C1CC[C@@H]2[C@H]3CC[C@](CC)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 RQFMPXMLRRPOJH-ORADRBJOSA-N 0.000 description 1
- HIQIXEFWDLTDED-UHFFFAOYSA-N 4-hydroxy-1-piperidin-4-ylpyrrolidin-2-one Chemical compound O=C1CC(O)CN1C1CCNCC1 HIQIXEFWDLTDED-UHFFFAOYSA-N 0.000 description 1
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- 208000003174 Brain Neoplasms Diseases 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
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- 206010046914 Vaginal infection Diseases 0.000 description 1
- 201000008100 Vaginitis Diseases 0.000 description 1
- 201000007096 Vulvovaginal Candidiasis Diseases 0.000 description 1
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- 238000006243 chemical reaction Methods 0.000 description 1
- 229940107243 climara pro Drugs 0.000 description 1
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- 208000011099 endometrial disease Diseases 0.000 description 1
- 210000004696 endometrium Anatomy 0.000 description 1
- 210000002919 epithelial cell Anatomy 0.000 description 1
- 229940023205 estradiol / levonorgestrel Drugs 0.000 description 1
- 229940088468 estradiol / levonorgestrel transdermal system Drugs 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 201000005884 exanthem Diseases 0.000 description 1
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- 229940068939 glyceryl monolaurate Drugs 0.000 description 1
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- VIDRYROWYFWGSY-UHFFFAOYSA-N sotalol hydrochloride Chemical compound Cl.CC(C)NCC(O)C1=CC=C(NS(C)(=O)=O)C=C1 VIDRYROWYFWGSY-UHFFFAOYSA-N 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
-
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/10—Drugs for disorders of the urinary system of the bladder
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
-
- 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
- A61P5/34—Gestagens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
Landscapes
- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- Urology & Nephrology (AREA)
- Endocrinology (AREA)
- Dermatology (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Reproductive Health (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/259,892 US20040062794A1 (en) | 2002-09-30 | 2002-09-30 | 17Beta- estradiol/levonorgestrel transdermal patch for hormone replacement therapy |
| US10/259,892 | 2002-09-30 | ||
| PCT/US2003/030493 WO2004030675A1 (en) | 2002-09-30 | 2003-09-29 | 17β-ESTRADIOL/LEVONORGESTREL TRANSDERM PATCH FOR HORMONE REPLACEMENT THERAPY |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AU2003279000A1 true AU2003279000A1 (en) | 2004-04-23 |
Family
ID=32029580
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2003279000A Abandoned AU2003279000A1 (en) | 2002-09-30 | 2003-09-29 | 17Beta-ESTRADIOL/LEVONORGESTREL TRANSDERM PATCH FOR HORMONE REPLACEMENT THERAPY |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US20040062794A1 (enExample) |
| EP (1) | EP1545547A1 (enExample) |
| JP (1) | JP2006508071A (enExample) |
| CN (1) | CN1684690A (enExample) |
| AU (1) | AU2003279000A1 (enExample) |
| BR (1) | BR0314959A (enExample) |
| CA (1) | CA2495055A1 (enExample) |
| IL (1) | IL166678A0 (enExample) |
| MX (1) | MXPA05003364A (enExample) |
| RU (1) | RU2005113686A (enExample) |
| WO (1) | WO2004030675A1 (enExample) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7889336B2 (en) * | 2008-02-01 | 2011-02-15 | Vladimir Yankov | Optical integrated nanospectrometer |
| HRP20211377T1 (hr) | 2011-11-23 | 2022-01-07 | Therapeuticsmd, Inc. | Prirodne kombinirane hormonske supstitucijske formulacije i terapije |
| US9180091B2 (en) | 2012-12-21 | 2015-11-10 | Therapeuticsmd, Inc. | Soluble estradiol capsule for vaginal insertion |
| MX2019006513A (es) * | 2016-12-05 | 2019-08-14 | Therapeuticsmd Inc | Formulaciones y terapias de reemplazo de hormonas de combinacion natural. |
Family Cites Families (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4292965A (en) * | 1978-12-29 | 1981-10-06 | The Population Council, Inc. | Intravaginal ring |
| US4927687A (en) * | 1984-10-01 | 1990-05-22 | Biotek, Inc. | Sustained release transdermal drug delivery composition |
| US5560922A (en) * | 1986-05-30 | 1996-10-01 | Rutgers, The State University Of New Jersey | Transdermal absorption dosage unit using a polyacrylate adhesive polymer and process |
| US5023084A (en) * | 1986-12-29 | 1991-06-11 | Rutgers, The State University Of New Jersey | Transdermal estrogen/progestin dosage unit, system and process |
| US4788062A (en) * | 1987-02-26 | 1988-11-29 | Alza Corporation | Transdermal administration of progesterone, estradiol esters, and mixtures thereof |
| US4900734A (en) * | 1987-08-27 | 1990-02-13 | Maxson Wayne S | Novel pharmaceutical composition containing estradiol and progesterone for oral administration |
| US5422119A (en) * | 1987-09-24 | 1995-06-06 | Jencap Research Ltd. | Transdermal hormone replacement therapy |
| US5223261A (en) * | 1988-02-26 | 1993-06-29 | Riker Laboratories, Inc. | Transdermal estradiol delivery system |
| DE69420419T2 (de) * | 1993-09-29 | 1999-12-23 | Alza Corp | Hautpermeabilitaetserhöher bestehend aus monoglycerid/laktat estern |
| GR1002079B (en) * | 1994-07-26 | 1995-12-05 | Lavipharm A E | System of a special structure and composition for the rapid transdermal administration of oestrogens. |
| US6551611B2 (en) * | 1995-09-28 | 2003-04-22 | Schering Aktiengesellschaft | Hormone replacement therapy method |
| US5922349A (en) * | 1995-09-28 | 1999-07-13 | Schering Aktiengesellschaft | Hormone replacement therapy method and hormone dispenser |
| US6083528A (en) * | 1995-09-28 | 2000-07-04 | Schering Aktiengesellschaft | Hormone replacement therapy method and hormone dispenser |
| US5702720A (en) * | 1995-12-22 | 1997-12-30 | Minnesota Mining And Manufacturing Company | Transdermal device for the delivery of flurbiprofen |
| DE19548332A1 (de) * | 1995-12-22 | 1997-07-10 | Rotta Res Bv | Hormonpflaster |
| IT1283102B1 (it) * | 1996-06-06 | 1998-04-07 | Permatec Nv | Composizione terapeutica per la somministrazione transdermica di un principio attivo estrogeno o progestinico o di loro miscele |
| US5855920A (en) * | 1996-12-13 | 1999-01-05 | Chein; Edmund Y. M. | Total hormone replacement therapy |
| CA2281876A1 (en) * | 1997-02-28 | 1998-09-03 | Minnesota Mining And Manufacturing Company | Transdermal device for the delivery of testosterone |
| US6193996B1 (en) * | 1998-04-02 | 2001-02-27 | 3M Innovative Properties Company | Device for the transdermal delivery of diclofenac |
| US6312715B1 (en) * | 1998-05-01 | 2001-11-06 | 3M Innovative Properties Company | Adhesive microsphere drug delivery composition |
| DE19827732A1 (de) * | 1998-06-22 | 1999-12-23 | Rottapharm Bv | Transdermales System vom Matrix-Typ zur Abgabe von Wirkstoffen mit einer hohen Abgaberate von Steroid-Hormonen und die Verwendung eines derartigen Systems zur Hormonersatztherapie |
| DE69939019D1 (de) * | 1998-07-07 | 2008-08-14 | Transdermal Technologies Inc | Zusammensetzungen für die schnelle und nicht-irritierende transdermale verabreichung von pharmazeutika and verfahren zur formuliering davon und ihren verabreichung |
| US6586000B2 (en) * | 1999-12-16 | 2003-07-01 | Dermatrends, Inc. | Hydroxide-releasing agents as skin permeation enhancers |
-
2002
- 2002-09-30 US US10/259,892 patent/US20040062794A1/en not_active Abandoned
-
2003
- 2003-09-29 MX MXPA05003364A patent/MXPA05003364A/es not_active Application Discontinuation
- 2003-09-29 CN CNA038233819A patent/CN1684690A/zh active Pending
- 2003-09-29 CA CA002495055A patent/CA2495055A1/en not_active Abandoned
- 2003-09-29 WO PCT/US2003/030493 patent/WO2004030675A1/en not_active Ceased
- 2003-09-29 JP JP2004541774A patent/JP2006508071A/ja active Pending
- 2003-09-29 AU AU2003279000A patent/AU2003279000A1/en not_active Abandoned
- 2003-09-29 BR BR0314959-5A patent/BR0314959A/pt not_active IP Right Cessation
- 2003-09-29 RU RU2005113686/14A patent/RU2005113686A/ru not_active Application Discontinuation
- 2003-09-29 EP EP03770511A patent/EP1545547A1/en not_active Withdrawn
-
2005
- 2005-02-03 IL IL16667805A patent/IL166678A0/xx unknown
Also Published As
| Publication number | Publication date |
|---|---|
| BR0314959A (pt) | 2005-08-02 |
| CN1684690A (zh) | 2005-10-19 |
| IL166678A0 (en) | 2006-01-15 |
| RU2005113686A (ru) | 2006-01-20 |
| MXPA05003364A (es) | 2005-10-05 |
| WO2004030675A1 (en) | 2004-04-15 |
| US20040062794A1 (en) | 2004-04-01 |
| CA2495055A1 (en) | 2004-04-15 |
| EP1545547A1 (en) | 2005-06-29 |
| JP2006508071A (ja) | 2006-03-09 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MK4 | Application lapsed section 142(2)(d) - no continuation fee paid for the application |