JP2009155345A - 不妊症を治療するための製薬学的製剤 - Google Patents
不妊症を治療するための製薬学的製剤 Download PDFInfo
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- JP2009155345A JP2009155345A JP2009096656A JP2009096656A JP2009155345A JP 2009155345 A JP2009155345 A JP 2009155345A JP 2009096656 A JP2009096656 A JP 2009096656A JP 2009096656 A JP2009096656 A JP 2009096656A JP 2009155345 A JP2009155345 A JP 2009155345A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/08—Peptides having 5 to 11 amino acids
- A61K38/09—Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
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- 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
- A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
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- 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
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- 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
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
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- 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
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- 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
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M21/00—Bioreactors or fermenters specially adapted for specific uses
- C12M21/06—Bioreactors or fermenters specially adapted for specific uses for in vitro fertilization
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Abstract
【解決手段】前記製剤は、LH−RH拮抗物質の投与により不妊症を治療し、外因性ゴナドトロピンの投与により卵胞の成長を誘発することにより不妊症を治療するための製薬学的製剤であり、内因性LHのみを抑制し、FSH分泌作用を自然のレベルに維持し、個々のエストロゲンの発達に影響しないほど低い量のLH−RH拮抗物質を含有する。
【選択図】なし
Description
A:患者の約25%に生じる引き続く治療の取消しを誘発する卵胞の破裂を伴う早過ぎる成熟段階での黄体形成ホルモン(LH)の早発性サージ(premature surge)、および
B:危険な場合は入院を必要とし、生命の脅威である、外因性ゴナドトロピンにより誘発される卵巣の過度の刺激症候群
である。
134人の患者を多数回の配量で処理し、104人の患者を1回または2回の配量で処理した。多数回の配量は毎日0.25mg以上であった。1回の配量は3mg以上であった。これらの配量で処理した、補助的生殖技術のための制御した卵巣の排卵過度処理(COS/ART、controlled ovarian superovulation for assisted reproduction technology)を受けた患者には早発性LHサージが認められなかった。卵胞の発達に依存して3日から最高10日まで多数回の配量を適用した。
134人のうち38人が多数回の配量形式を続けた=28.4%
104人のうち33人は1回/2回の配量形式を続けた=31.7%
引き続く処理により41人の子供が生まれ、これは15人が多数回の配量を続け、29人が1回/2回の配量を続けたことを意味する。16組の妊娠がなお継続している。
1.COS/ARTに関する新たな治療原理であり、
早発性LHサージの抑制において、
均一な、連続的な卵胞の同調化
均一な、連続的なエストラジオールの発展
最適な卵胞の発達のためのきわめて低いLH値
FSHの発達が影響されない
2.3〜7日、最高14日の短い処理時間
卵胞の発達中の短い時間の表示
卵胞の発達中の低い薬剤の表示
3.突発的でないが即座のホルモンの反応
4.HMGの開始前の14〜21日間の前処理が不要
5.通常の月経周期に適合
生理的な月経周期パターンの変更が不要
刺激前のホルモン不足症候がない
6.排卵誘発後の極端に短い残留効果が見られないかまたはわずかである
7.胎児の転位中および引き続く残留効果がない
8.刺激開始前の卵巣の小胞形成がない
9.ゴナドトロピンの配量の減少
表IIはARTのための調整された卵巣の排卵過度を受けた患者のHMGおよびセテロレリックスの典型的な処理開始および継続の例を示す。
X2=卵胞成熟に依存したhMG投与の最終日(X3参照)
X3=hCG10000IU注入の日、直ちにultrasound(USS)により測定して平均直径20mmを有する少なくとも1つの卵胞またはE2≧1200pg/ml(4405pmol/l)が認められる
X4=CAVE:15mmφ以上の卵胞が12個より多いかまたは興奮期中のE2が4000pg/ml(≧14684pmol/l)より多い場合→hCG注入せず→周期の消失
X5=中心規則による黄体期支持、中心規則によるhCG注入またはプロゲステロンの経膣投与(たとえば3×200mg/日)のいずれかを中心規則により適用する
X6=早発性研究期間のすべての場合(たとえば出産の場合)に常に記録される必要がある
X7=病院または外部で2回(朝およびhCG投与の少し前に)回収されるhCGの日のホルモン決定のための血液サンプル
Ultrasound(USS);XはhCGの日までのhMGの6日の間に中心規則により処理される、USSはHCGの日に行う必要がある
Claims (8)
- セテロレリックスを多数回の配量薬量においてセテロレリックス毎日0.1〜5mgの量で投与し、外因性ゴナドトロピンの投与により卵胞の成長を誘発することにより不妊症を治療するための製薬学的製剤。
- セテロレリックスが開始周期6〜10日で1回または2回の皮下投与として1mg〜10mgの範囲内で投与され、月経周期9〜16日で排卵が誘発される、卵巣の刺激を調整するための製薬学的製剤。
- 卵巣の刺激を調整して処理し、卵巣の誘発を調整して天然のLH−RHを投与するための製薬学的製剤を製造するための、LH−RH拮抗物質の使用。
- 卵巣の刺激を調整して処理し、卵巣の誘発を調整してLH−RH作動薬を投与するための製薬学的製剤を製造するための、LH−RH拮抗物質の使用。
- 卵巣の刺激を調整して処理し、卵巣の誘発を調整して組み換えLHを投与するための製薬学的製剤を製造するための、LH−RH拮抗物質の使用。
- LH−RH拮抗物質がセテロレリックスである、請求項3記載の使用。
- LH−RH拮抗物質がセテロレリックスである、請求項4記載の使用。
- LH−RH拮抗物質がセテロレリックスである、請求項5記載の使用。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US1128296P | 1996-02-07 | 1996-02-07 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP9022359A Division JPH09227404A (ja) | 1996-02-07 | 1997-02-05 | 不妊症を治療するための製薬学的製剤 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2012288298A Division JP2013056949A (ja) | 1996-02-07 | 2012-12-28 | 不妊症を治療するための製薬学的製剤 |
Publications (1)
Publication Number | Publication Date |
---|---|
JP2009155345A true JP2009155345A (ja) | 2009-07-16 |
Family
ID=21749681
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP9022359A Pending JPH09227404A (ja) | 1996-02-07 | 1997-02-05 | 不妊症を治療するための製薬学的製剤 |
JP2009096656A Pending JP2009155345A (ja) | 1996-02-07 | 2009-04-13 | 不妊症を治療するための製薬学的製剤 |
JP2012288298A Pending JP2013056949A (ja) | 1996-02-07 | 2012-12-28 | 不妊症を治療するための製薬学的製剤 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP9022359A Pending JPH09227404A (ja) | 1996-02-07 | 1997-02-05 | 不妊症を治療するための製薬学的製剤 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2012288298A Pending JP2013056949A (ja) | 1996-02-07 | 2012-12-28 | 不妊症を治療するための製薬学的製剤 |
Country Status (3)
Country | Link |
---|---|
US (2) | US7393834B2 (ja) |
EP (1) | EP0788799A3 (ja) |
JP (3) | JPH09227404A (ja) |
Families Citing this family (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6828415B2 (en) * | 1993-02-19 | 2004-12-07 | Zentaris Gmbh | Oligopeptide lyophilisate, their preparation and use |
EP0788799A3 (en) | 1996-02-07 | 1998-10-21 | ASTA Medica Aktiengesellschaft | LHRH-Antagonists in the treatment of fertility disorders |
JP2002512975A (ja) | 1998-04-23 | 2002-05-08 | アスタ メディカ アクチエンゲゼルシャフト | 受精能力障害の治療薬 |
US8173592B1 (en) * | 1999-03-31 | 2012-05-08 | Zentaris Ivf Gmbh | Method for a programmed controlled ovarian stimulation protocol |
US7214662B2 (en) | 2001-11-27 | 2007-05-08 | Zentaris Gmbh | Injectable solution of an LHRH antagonist |
US20030186892A1 (en) * | 2002-03-28 | 2003-10-02 | Rajneesh Taneja | Enhancement of endogenous gonadotropin production |
CN1684737A (zh) * | 2002-06-07 | 2005-10-19 | 阿雷斯贸易股份有限公司 | 控制性超排卵方法及该方法使用的药物试剂盒 |
RS54214B2 (sr) | 2010-09-29 | 2024-02-29 | Ferring Bv | Smeša za upotrebu u lečenju infertiliteta |
JP2024522892A (ja) | 2021-06-25 | 2024-06-21 | エクストロヴィス・アーゲー | 薬学的組成物 |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE4342091A1 (de) | 1993-12-09 | 1995-06-14 | Asta Medica Ag | Erzeugnisse zur Anwendung von initial hohen Dosen von Cetrorelix und Herstellung einer Kombinationspackung zur Verwendung bei Therapie von Krankheiten |
EP0788799A3 (en) | 1996-02-07 | 1998-10-21 | ASTA Medica Aktiengesellschaft | LHRH-Antagonists in the treatment of fertility disorders |
US5945128A (en) | 1996-09-04 | 1999-08-31 | Romano Deghenghi | Process to manufacture implants containing bioactive peptides |
DE19712718C2 (de) | 1997-03-26 | 1999-09-23 | Asta Medica Ag | Immobilisierte und aktivitätsstabilisierte Komplexe von LHRH-Antagonisten und Verfahren zu deren Herstellung |
JP2002512975A (ja) * | 1998-04-23 | 2002-05-08 | アスタ メディカ アクチエンゲゼルシャフト | 受精能力障害の治療薬 |
US8173592B1 (en) * | 1999-03-31 | 2012-05-08 | Zentaris Ivf Gmbh | Method for a programmed controlled ovarian stimulation protocol |
-
1997
- 1997-01-21 EP EP97100852A patent/EP0788799A3/en not_active Withdrawn
- 1997-02-05 JP JP9022359A patent/JPH09227404A/ja active Pending
-
2003
- 2003-09-15 US US10/661,780 patent/US7393834B2/en not_active Expired - Fee Related
-
2009
- 2009-04-13 JP JP2009096656A patent/JP2009155345A/ja active Pending
-
2010
- 2010-11-08 US US12/941,629 patent/US9107871B2/en not_active Expired - Fee Related
-
2012
- 2012-12-28 JP JP2012288298A patent/JP2013056949A/ja active Pending
Non-Patent Citations (7)
Title |
---|
JPN6009041174; Human Reproduction Vol.10,No.6, 1995, p1382-1386 * |
JPN6009041175; Human Reproduction Vol.9,No.5, 1994, p788-791 * |
JPN6011062512; Fertility and Sterility Vol.62,No.3, 1994, p468-476 * |
JPN6014006794; Journal of Assisted Reproduction and Genetics 13(3), 199603, 216-222 |
JPN7014000562; Fertility and Sterility 67(5), 199705, 917-922 |
JPN7014000600; European Journal of Obstetrics & Gynecology and Reproductive Biology 61(2), 199508, 151-155 |
JPN7014000601; Human Reproduction 11(10), 199610, 2114-2118 |
Also Published As
Publication number | Publication date |
---|---|
US7393834B2 (en) | 2008-07-01 |
JP2013056949A (ja) | 2013-03-28 |
EP0788799A3 (en) | 1998-10-21 |
US20050049200A1 (en) | 2005-03-03 |
EP0788799A2 (en) | 1997-08-13 |
US9107871B2 (en) | 2015-08-18 |
US20110306547A1 (en) | 2011-12-15 |
JPH09227404A (ja) | 1997-09-02 |
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