CA2623024A1 - Use of estradiol valerate or estradiol combined with dienogest for the oral therapy of dysfunctional uterine bleeding in the form of oral contraceptives - Google Patents
Use of estradiol valerate or estradiol combined with dienogest for the oral therapy of dysfunctional uterine bleeding in the form of oral contraceptives Download PDFInfo
- Publication number
- CA2623024A1 CA2623024A1 CA002623024A CA2623024A CA2623024A1 CA 2623024 A1 CA2623024 A1 CA 2623024A1 CA 002623024 A CA002623024 A CA 002623024A CA 2623024 A CA2623024 A CA 2623024A CA 2623024 A1 CA2623024 A1 CA 2623024A1
- Authority
- CA
- Canada
- Prior art keywords
- estradiol
- dienogest
- oestradiol
- valerate
- combination
- 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
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
- 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
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- 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
- A61P15/18—Feminine contraceptives
-
- 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
Abstract
The invention relates to the use of estradiol valerate or estradiol combined with 17a- cyanomethyl-17-~-hydroxyestra-4,9-diene-3on (dienogest) for producing a multi-phase combination preparation for the oral therapy of the dysfunctional uterine bleeding in the form of oral contraceptives. Said combination of estradiol valerate or estradiol with dienogest comprises a first phase consisting of 2 daily dose units of estradiol valerate at 3 mg or estradiol of less than 3mg, a second phase consisting of 2 groups of daily dose units, whereby the first group contains 5 daily dose units of a combination of 2 mg estradiol valerate or estradiol of less than 2mg and 2 mg of dienogest and the second group contains 17 daily dose units consisting of a combination of 2 mg of estradiol valerate or estradiol of less than 2mg and 3 mg dienogest, a third phase consisting of 2 daily dose units having 1 mg estradiol valerate or estradiol of less than 2mg and an additional phase consisting of 2 daily dose units on a pharmaceutically harmless placebo. All of the daily dose units of the multi-phase combination and the pharmaceutically harmless placebo correspond to 28 days. The duration of application comprises at least one menstruation cycle and is dependent on individual wishes of the woman with respect to contraception.
Claims (3)
1. Use of oestradiol valerate or oestradiol in combination with 17.alpha.-cyanomethyl-17.beta.-hydroxyoestra-4,9-diene-3-one (dienogest), comprising a first stage, with two daily doses of 3 mg of oestradiol valerate or of less than 3 mg of oestradiol, a second stage, with two sets of daily doses, where the first set comprises five daily doses of a combination of 2 mg of oestradiol valerate or of less than 2 mg of oestradiol and 2 mg of dienogest, and the second set comprises 17 daily doses of a combination of 2 mg of oestradiol valerate or of less than 2 mg of oestradiol and 3 mg of dienogest, a third stage, with two daily doses of 1 mg of oestradiol valerate or of less than 1 mg of oestradiol, and another stage of two daily doses of a pharmaceutically acceptable placebo, in order to obtain a multi-stage combined preparation with a total of 28 daily doses for the oral treatment of dysfunctional uterine bleeding, in conjunction with oral contraception.
2. Use of oestradiol valerate or oestradiol in combination with 17.alpha.-cyanomethyl-17.beta.-hydroxyoestra-4,9-diene-3-one (dienogest), comprising a first stage, with two daily doses of 2.25 mg of oestradiol, a second stage, with two sets of daily doses, where the first set comprises five daily doses of a combination of 1.5 mg of oestradiol and 2 mg of dienogest, and, the second set comprises 17 daily doses of a combination of 1.5 mg of oestradiol and
3 mg of dienogest, a third stage, with two daily doses of 0.75 mg of oestradiol, and another stage of two daily doses of a pharmaceutically acceptable placebo, in order to obtain a multi-stage combined preparation with a total of 28 daily doses for the oral treatment of dysfunctional uterine bleeding, in conjunction with oral contraception.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP05022324A EP1787649B1 (en) | 2005-10-13 | 2005-10-13 | Use of estradiolvalerate and dienogest for oral treatment of dysfunctional uterine bleeding in a contraceptive method |
| EP05022324.7 | 2005-10-13 | ||
| PCT/EP2006/009867 WO2007042296A1 (en) | 2005-10-13 | 2006-10-12 | Use of estradiol valerate or estradiol combined with dienogest for the oral therapy of dysfunctional uterine bleeding in the form of oral contraceptives |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2623024A1 true CA2623024A1 (en) | 2007-04-19 |
| CA2623024C CA2623024C (en) | 2012-03-06 |
Family
ID=35811580
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2623024A Active CA2623024C (en) | 2005-10-13 | 2006-10-12 | Use of estradiol valerate or estradiol combined with dienogest for the oral therapy of dysfunctional uterine bleeding in the form of oral contraceptives |
Country Status (22)
| Country | Link |
|---|---|
| EP (2) | EP1787649B1 (en) |
| JP (2) | JP5735200B2 (en) |
| KR (2) | KR101218872B1 (en) |
| CN (1) | CN101312733A (en) |
| AR (1) | AR056694A1 (en) |
| AT (2) | ATE424828T1 (en) |
| CA (1) | CA2623024C (en) |
| CL (1) | CL2011000283A1 (en) |
| CY (2) | CY1110321T1 (en) |
| DE (2) | DE502005006837D1 (en) |
| DK (2) | DK1787649T3 (en) |
| DO (1) | DOP2006000221A (en) |
| ES (2) | ES2322479T3 (en) |
| HR (1) | HRP20090256T1 (en) |
| ME (1) | ME01056B (en) |
| PE (2) | PE20070555A1 (en) |
| PL (2) | PL1787649T3 (en) |
| PT (2) | PT1787649E (en) |
| SI (2) | SI1787649T1 (en) |
| TW (2) | TWI328453B (en) |
| UY (1) | UY29861A1 (en) |
| WO (1) | WO2007042296A1 (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102004019743B4 (en) | 2004-04-20 | 2008-11-27 | Bayer Schering Pharma Aktiengesellschaft | Multiphase preparation for contraception based on natural estrogen |
| ATE424828T1 (en) * | 2005-10-13 | 2009-03-15 | Bayer Schering Pharma Ag | USE OF ESTRADIOLVALERATE IN COMBINATION WITH DIENOGEST FOR ORAL THERAPY OF DYSFUNCTIONAL UTERINE BLEEDING IN UNIT WITH ORAL CONTRACEPTION |
| US8153616B2 (en) | 2005-10-17 | 2012-04-10 | Bayer Pharma Aktiengesellschaft | Combination preparation for oral contraception and oral therapy of dysfunctional uterine bleeding containing estradiol valerate and dienogest and method of using same |
| EP1930010A1 (en) | 2006-10-20 | 2008-06-11 | Bayer Schering Pharma Aktiengesellschaft | Application of estradiol valerate or 17ß-estradiol in combination with dienogest for oral therapy to maintain and/or increase the female libido |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE4429374C1 (en) * | 1994-08-12 | 1996-02-01 | Jenapharm Gmbh | Pharmaceutical preparations for contraception / hormone substitution with biogenic estrogen component |
| DE19540253C2 (en) * | 1995-10-28 | 1998-06-04 | Jenapharm Gmbh | Multi-phase preparation for contraception based on natural estrogens |
| DE69724796T2 (en) * | 1996-07-26 | 2004-07-01 | Wyeth | BIPHASIC ORAL PREVENTION METHOD AND KIT CONTAINING A COMBINATION OF PROGESTINE AND AN ESTROGEN |
| US6251956B1 (en) | 1998-08-20 | 2001-06-26 | Ortho Pharmaceutical Corporation | Combination progestin oral contraceptive regimen |
| EP1462106A1 (en) * | 2003-03-28 | 2004-09-29 | Pantarhei Bioscience B.V. | Pharmaceutical compositions and kits comprising 17-beta-estradiol and a progesteron for the treatment of gynecological disorders |
| DE102004019743B4 (en) * | 2004-04-20 | 2008-11-27 | Bayer Schering Pharma Aktiengesellschaft | Multiphase preparation for contraception based on natural estrogen |
| ATE424828T1 (en) * | 2005-10-13 | 2009-03-15 | Bayer Schering Pharma Ag | USE OF ESTRADIOLVALERATE IN COMBINATION WITH DIENOGEST FOR ORAL THERAPY OF DYSFUNCTIONAL UTERINE BLEEDING IN UNIT WITH ORAL CONTRACEPTION |
-
2005
- 2005-10-13 AT AT05022324T patent/ATE424828T1/en active
- 2005-10-13 DK DK05022324T patent/DK1787649T3/en active
- 2005-10-13 SI SI200530672T patent/SI1787649T1/en unknown
- 2005-10-13 ES ES05022324T patent/ES2322479T3/en active Active
- 2005-10-13 ME MEP-2009-171A patent/ME01056B/en unknown
- 2005-10-13 DE DE502005006837T patent/DE502005006837D1/en active Active
- 2005-10-13 PL PL05022324T patent/PL1787649T3/en unknown
- 2005-10-13 PT PT05022324T patent/PT1787649E/en unknown
- 2005-10-13 EP EP05022324A patent/EP1787649B1/en not_active Revoked
-
2006
- 2006-10-12 WO PCT/EP2006/009867 patent/WO2007042296A1/en active Application Filing
- 2006-10-12 CA CA2623024A patent/CA2623024C/en active Active
- 2006-10-12 EP EP06806225A patent/EP1933843B1/en active Active
- 2006-10-12 DE DE502006008853T patent/DE502006008853D1/en active Active
- 2006-10-12 ES ES06806225T patent/ES2360302T3/en active Active
- 2006-10-12 PT PT06806225T patent/PT1933843E/en unknown
- 2006-10-12 TW TW095137564A patent/TWI328453B/en active
- 2006-10-12 PE PE2006001241A patent/PE20070555A1/en not_active Application Discontinuation
- 2006-10-12 PE PE2009001256A patent/PE20100090A1/en not_active Application Discontinuation
- 2006-10-12 PL PL06806225T patent/PL1933843T3/en unknown
- 2006-10-12 SI SI200630991T patent/SI1933843T1/en unknown
- 2006-10-12 KR KR1020107014574A patent/KR101218872B1/en active IP Right Grant
- 2006-10-12 CN CNA2006800381810A patent/CN101312733A/en active Pending
- 2006-10-12 KR KR1020087011203A patent/KR20080065651A/en not_active Application Discontinuation
- 2006-10-12 AT AT06806225T patent/ATE497387T1/en active
- 2006-10-12 DK DK06806225.6T patent/DK1933843T3/en active
- 2006-10-12 JP JP2008534936A patent/JP5735200B2/en active Active
- 2006-10-13 AR ARP060104489A patent/AR056694A1/en not_active Application Discontinuation
- 2006-10-13 DO DO2006000221A patent/DOP2006000221A/en unknown
- 2006-10-13 UY UY29861A patent/UY29861A1/en not_active Application Discontinuation
-
2007
- 2007-01-09 TW TW096100872A patent/TW200829255A/en unknown
-
2009
- 2009-05-05 HR HR20090256T patent/HRP20090256T1/en unknown
- 2009-06-11 CY CY20091100621T patent/CY1110321T1/en unknown
-
2011
- 2011-02-10 CL CL2011000283A patent/CL2011000283A1/en unknown
- 2011-05-02 CY CY20111100422T patent/CY1111406T1/en unknown
-
2012
- 2012-11-19 JP JP2012253067A patent/JP2013047269A/en active Pending
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |