JP2006096775A - 避妊用の組成 - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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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- 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
- A61K31/567—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 substituted in position 17 alpha, e.g. mestranol, norethandrolone
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- 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
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- 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
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
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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
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/18—Feminine contraceptives
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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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Abstract
【解決手段】合計28日の投与周期において月経周期1日目に開始して配量形態を23日間または24日間投与した後、5日間または4日間ピルを投与しないか、空ピルを投与することにより、17β−エストラジオール2.0〜6.0 mgおよびエチニルエストラジオール0.015〜0.020 mgから選択したエストロゲンと、ゲストデン0.05〜0.075 mg、レボノルゲストレル0.075〜0.125 mg、デソゲストレル0.06〜0.15 mg、3−ケトデソゲストレル0.06〜0.15 mg、ドロスピレノン0.1〜0.3 mg、シプロテロン酢酸0.1〜0.2 mg、ノルゲスチメート0.2〜0.3 mgおよびノレチステロン0.35ないし0.75 mgから選択したゲスタゲンとを含む避妊用組合せ組成物。
【選択図】なし
Description
閉経前期前の受胎可能年齢の女性に対する経口避妊薬の開発は、最近20年間は、特にエストロゲン用量およびゲスタゲン用量の減少に特徴づけられる。
本発明において、「閉経前期」および「閉経」は従来の定義で用いる。たとえば「論議の多い更年期」P.A.van Keep et al.Ed.,MTP Press(1981)の9ページなど参照。
毎日のホルモン用量は非常に低いレベルに押さえるが、通常21日間の服用期間は2日または3日長くされている。周期の残りの5日または4日は、誤服用を避けるために、プラシーボで橋渡しするか、服用しない日を5日または4日設けることが好都合である。
ゲストデン0.06〜0.075 mg、レボノルゲストレル0.100〜0.125 mg、デソゲストレル0.10〜0.15 mg、3−ケトデソゲストレル0.10〜0.15 mg、ドロスピレノン0.25〜0.30mg、シプロテロン酢酸0.1〜0.2 mg、ノルゲスチメート0.2〜0.3 mgおよびノレチステロン0.50〜0.75 mgから選択したゲスタゲンと、
を含む組成を、前述のように、避妊薬用の配量形態の作成に使用することに関する。
本発明に従い、特に好適な複合製剤は23配量単位を包含している。
特に、各配量単位中にエチニルエストラジオール20μgとゲストデン75μgを含む23配量単位と、5個の空ピル、あるいは月経周期の最後の5日間は配量単位を投与しないか、空ピルを投与することを指図するその他の指示とを包含する単相複合製剤が好都合である。
以下に概略を記す臨床的研究は、エストロゲンとしてエチニルエストラジオール、および本発明に従い可能なゲスタゲンの物質等級の代表としてゲストデンを用いて実施された。
処理は未処理の排卵前期に続く月経周期1日目に開始し、合計3処理周期に及んだ。未処理のフォローアップ周期で研究を完了した。
この所見と一致して、卵胞成熟を示した女性は、21回投与した場合は23回投与した場合に比べて著しく多かった(図2)。
エチニルエストラジオールの含量が30μg未満である通常の21日製剤と比較して、23日間投与する経口避妊用の複合製剤の長所は、次のとおりである。
2.直径30 mm以上の卵胞の発生は極めて稀である。21日製剤に比べると23日製剤では卵胞の発達の可能性がない。
4.23日製剤の大部分の服用者において17β−エストラジオールの細胞内濃度の管理および抑圧は良好である。胸部緊張、月経前症候群、およびエンドゲン濃度が高く変動が激しいことに起因する血行障害などの臨床的徴候の発生頻度は、23日製剤のもとでは著しく少ない。
本発明に従い、上記の長所、特に卵胞成熟の良好な抑圧は、単相複合製剤によって達成できる。多相製剤に比べて、単相製剤は次の種々の長所を特徴とする。
2.服用順序を守らないことによるピルの誤用がない。
3.月経遅延を容易に達成できる。
4.服用者にとって服用指示が理解しやすい。
5.包装もしくは配量単位を包含するブリスターに、服用順序を守らせるためのラベルを付ける必要がない。
本発明に従う複合製剤を包含する包装も、市販されている経口避妊薬の包装に準じて構成されるが、作用成分を含む通常の21配量単位に代えて、ここでは23または24配量単位と、5または4個の空ピル、または作用物質を含有した配量単位の服用を継続するまでの5または4日間橋渡しすることに関するその他の適当な指示がある。
種々のゲスタゲン系作用物質の当量の規定に関するその他の詳細については、「Drug Research, 27, 2a, 296~318 (1977)に掲載されたF. Neumann et al.「用量規定の問題:性ホルモン」、および「婦人科」25:231−240 (1992)に掲載されたH. Kuhl「ホルモン避妊薬の現状」を参照されたい。
Claims (17)
ゲストデン0.05〜0.075 mg、レボノルゲストレル0.075〜0.125 mg、デソゲストレル0.06〜0.15 mg、3−ケトデソゲストレル0.06〜0.15 mg、ドロスピレノン0.1 mg〜ゲストデン0.075 mg等価用量、シプロテロン酢酸0.1 mg〜ゲストデン0.075 mg等価用量、ノルゲスチメート0.2〜0.3 mgおよびノレチステロン0.35〜0.75 mgから選択したゲスタゲンと、
を含む組合せ剤であって、合計28日の投与周期において、月経周期1日目に開始して23日間又は24日間連続投与の後、4日間又は5日間投与しないか又は空ピルを投与する方法により投与される、まだ閉経前期に達していない受胎可能年齢の女性に対する経口避妊用の組合せ剤。
前記ゲスタゲンが、0.06〜0.075 mgのゲストデン、0.100〜0.125 mgのレボノルゲストレル、0.10〜0.15 mgのデソゲストレル、0.10〜0.15 mgの3−ケトデソゲストレル、0.25〜0.3 mgのドロスピレノン、0.1〜0.2 mgのシプロテロン酢酸、0.2〜0.3 mgのノルゲスチメートおよび0.50〜0.75 mgのノレチステロンから選択される;
請求項1に記載の組合せ剤。
17β−エストラジオール2.0〜6.0 mgおよびエチニルエストラジオール0.020 mgから選択されるエストロゲン、および
ドロスピレノン0.25 mg〜ゲストデン75 μg等価用量、およびシプロテロン酢酸0.1 mg〜ゲストデン75 μg等価用量から選択されるゲスタゲン、
をそれぞれが含む、23または24投与単位;並びに
(b)5個または4個の空ピル、あるいは23または24投与単位を毎日投与した後に5日間または4日間投与しないかまたは空ピルを投与することを指図するその他の指示;
を含んでなる、経口避妊用の組合せ剤。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE4344462A DE4344462C2 (de) | 1993-12-22 | 1993-12-22 | Zusammensetzung für die Empfängnisverhütung |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP7517199A Division JPH09506888A (ja) | 1993-12-22 | 1994-12-22 | 避妊用の組成 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2010177241A Division JP2010248270A (ja) | 1993-12-22 | 2010-08-06 | 避妊用の組成 |
Publications (1)
Publication Number | Publication Date |
---|---|
JP2006096775A true JP2006096775A (ja) | 2006-04-13 |
Family
ID=6506206
Family Applications (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP7517199A Withdrawn JPH09506888A (ja) | 1993-12-22 | 1994-12-22 | 避妊用の組成 |
JP2006000148A Withdrawn JP2006096775A (ja) | 1993-12-22 | 2006-01-04 | 避妊用の組成 |
JP2010177241A Withdrawn JP2010248270A (ja) | 1993-12-22 | 2010-08-06 | 避妊用の組成 |
JP2013049933A Pending JP2013139464A (ja) | 1993-12-22 | 2013-03-13 | 避妊用の組成 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP7517199A Withdrawn JPH09506888A (ja) | 1993-12-22 | 1994-12-22 | 避妊用の組成 |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2010177241A Withdrawn JP2010248270A (ja) | 1993-12-22 | 2010-08-06 | 避妊用の組成 |
JP2013049933A Pending JP2013139464A (ja) | 1993-12-22 | 2013-03-13 | 避妊用の組成 |
Country Status (21)
Country | Link |
---|---|
US (7) | US5583129A (ja) |
EP (2) | EP1726308A3 (ja) |
JP (4) | JPH09506888A (ja) |
KR (1) | KR100369206B1 (ja) |
CN (2) | CN1142185A (ja) |
AT (1) | ATE344038T1 (ja) |
CA (1) | CA2179728C (ja) |
CZ (1) | CZ296387B6 (ja) |
DE (2) | DE4344462C2 (ja) |
DK (1) | DK0735883T3 (ja) |
ES (1) | ES2276391T3 (ja) |
HK (1) | HK1077743A1 (ja) |
HU (1) | HUT74877A (ja) |
NL (1) | NL300329I1 (ja) |
NO (1) | NO316257B3 (ja) |
NZ (1) | NZ278058A (ja) |
PL (1) | PL187818B1 (ja) |
PT (1) | PT735883E (ja) |
RU (1) | RU2169567C2 (ja) |
SK (1) | SK285965B6 (ja) |
WO (1) | WO1995017194A1 (ja) |
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