TW200534860A - Multiphase product for contraception based on a natural oestrogen - Google Patents
Multiphase product for contraception based on a natural oestrogen Download PDFInfo
- Publication number
- TW200534860A TW200534860A TW094109222A TW94109222A TW200534860A TW 200534860 A TW200534860 A TW 200534860A TW 094109222 A TW094109222 A TW 094109222A TW 94109222 A TW94109222 A TW 94109222A TW 200534860 A TW200534860 A TW 200534860A
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- Prior art keywords
- phase
- estradiol
- representative
- valerate
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Classifications
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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
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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
-
- 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
- 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
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
Description
200534860 九、發明說明： 【發明所屬之技術領域】 本發明係、關於-種基於天然雌激素及與其相組合的合成 助孕素的避孕用多相產品。 【先前技術】 專利文獻揭示基於天然雌激素及與其相組合的合成助孕 素的避孕用多相產品。 EP"70 388 B1號專利說明供避孕用的多相產品 -其第一相含2至4份每曰劑量單位，而每一每曰的劑量 單位含天然雌激素為唯一的活性成分， 第一相含2組由至少一種天然雌激素及至少一種合 成或天;然的助孕素組成的每曰劑量單位’其中第一組由5 至3伤每日的劑1單位構成，而第二組由17至13日每份的劑 量單位形成， /、第一相含2至4份每曰劑量單位，而每一每曰劑量單 位含唯一的天然雌激素作為活性成分， /、中各相内每日的天然雌激素劑量單位為不變的，但 從弟1相至第3相逐漸減少，但第二相第二組内的合成或天 然助孕素的比例超過第一組内的比例， ^八最後相含2至4份每曰劑量單位，且每一每曰劑量 單位“乍為活性成分的醫藥可接受的安慰劑。 使用汽例5顯不給予雌激素戊酸鹽及雙烯孕腈(dienogest) 之組合物， 直中，於第一士 八 、不一相内有3份每曰劑量為3毫克的雌激素的戊 99919.doc 200534860 酸鹽， 於第二相内，於第一組内有4份每曰劑量為2毫克的雌激 素戊酸鹽及1毫克雙烯孕腈， 於此第二相之第二組内有16份每日劑量為2毫克的雌激 素戊酸鹽及2毫克雙烯孕腈， 於第三相内有2份每日劑量為1毫克的雌激素戊酸鹽， 及於最後一相内有3份每曰劑量單位的醫藥上可接受的 安慰劑。 關於避孕的可靠性，是用放射免疫法測定孕酮血清濃 度。限定為4.0毫微克/毫升孕酮。平均不規則出血率（突破 性出血[breakthrough bleeding]及斑點出血）由第一次服用 週期之45%下降至最後一次服用週期之53%。 此外尚知，組合產物之避孕可靠性是源自雌激素及助孕 素二種成分的效果。 另外還知道，排卵抑制劑量需1.0毫克/天的雙烯孕腈 -Dienogest: Praklinik und Klinik eines neuen Gestagens, edited by A.T. Teichmann, Walter de Gruyter Berlin/New York (1995)，101 頁）及 2.0-3.0毫克 drospirenone (Rosenbaum p，Schmidt W，Helmerhorst F M et al·，Inhibition of ovulation by a novel progestogen (drospirenone)...., Eur contracept. Reprod. Health Care 5: 16-24 (2000)) ° 此外，TAUBERT，H.-D.及 KUHL，H.(Kontrazeption mit Hormonen, editors Taubert, H.-D. et al·，Georg Thieme Verlag Stuttgart/New York (1995)，p. 160)顯示在不規則出 99919.doc 200534860 血的出現及低血清雌激素，於此例即為乙快基雕二醇，或 特定助孕素之血清濃度間並無關聯。 【發明内容】 本叙明目的在指出一種基於天然雌激素的激素避孕的組 合物’此組合物與_般以天然雌激素為基礎的排印抑制組 合物相比，在整個月經週期中達成更大的避孕可靠性，改 善月經期之出血行為並控制副作用如乳房觸痛、頭痛、麼 抑及性慾的改變等。 此目的藉本發明多相避孕產品達成 -其第一相含2份每日劑量為3毫克天然雌激素雌二醇戊 酸鹽， -其第二相含2組每日劑量單位，其中第一組是由$份每曰 劑量單位為2毫克雌二醇戊酸鹽及至少二倍或三倍合成助 孕素的排卵抑制劑量的結合物形成 及第二組是由17份每日劑量單位為2毫克雌二醇戊酸鹽 及至 >、一彳α或四乜合成助孕素的排卵抑制劑量的結合物形 成， _第三相含2份每日劑量單位為1毫克的雌二醇戊酸鹽， -及另-相含2份|日劑量單位的醫藥上可接受的安慰 劑。 本發明較佳具體實施例是雙烯孕腈，曲螺酮 (drospirenone)或至少二倍已知排卵抑制劑量的助孕素作為 活性劑。 ^ 本發明多相產品特別適於經口給予，但也可為陰道内、 99919.doc 200534860 非經腸、包括局部、 且腸、鼻内、頰内或舌下給予劑形。 口口疋以習用固體或液體載劑或稀釋劑及適於給 予所需劑量的劑形M a 川小的4樂技術習用的賦形劑以已知方 產0 叙、塗覆錠、糖衣錠或硬明膠膠囊較佳是經口給予使用。 ▲今以使用實例說明本發明。在這方面，特別說明避孕可 罪^女人的週期出血行為及給予方案的耐受性。 避孕可靠性 避孕可#性主以利用m小、雌三醇量及孕_值測定 Hoogland分數顯示。於此例中，孕_血清濃度是以放射免 疫學方f於較的週期内的日期及排_次數⑽㈣福分 數6)及只體化未破裂卵泡（H〇〇gland分數5)測定。 週期安定性 週期安定性是以每週期所記錄的出血型為基礎評估。這 方面特別注意不規則出血（斑點或突破性（breakthrough)出 血）。記錄方式是標準化的。以說明方式分析數據。 耐受性 耐X性以主觀感覺為基礎試驗，例如頭痛、壓抑、乳房 觸痛、胃腸不適（噁心/嘔吐）、水腫及性慾改變。 【實施方式】 使用實例1 使用如下計劃·· 1至2天3毫克雌二醇戊酸鹽/天 3至7天2毫克雌二醇戊酸鹽/天+2毫克雙烯孕腈/天 99919.doc 200534860 8至24天2毫克雌二醇戊酸鹽/天+3毫克雙烯孕腈/天 25至26天1毫克雌二醇戊酸鹽/天 27至28天安慰劑 研究是以93位1 8至3 5歲的婦女進行。每一例服用期達3 週期，但只觀察第2及第3週期。 於第2週期（主要目標變數）93人中有3人（3.23%)排印，於 第3週期92人中有2人排卵。
所以可記錄為，根據本發明給予方案，有96·77%排卵抑 制可靠性。 同時並發現本發明給予方案有良好耐受性。 使用實例2 1至2天3毫克雌二醇戊酸鹽/天 3至7天2毫克雌二醇戊酸鹽/天+3毫克雙烯孕腈/天 8至24天2毫克雌二醇戊酸鹽/天+4毫克雙烯孕腈/天 25至26天1毫克雌二醇戊酸鹽/天 2 7至2 8天安慰劑 、研究是以93位18至35歲的婦女進行。每―例服用期〇 週期，但只觀察第2及第3週期。 於第2週期（主要目標變數）93人中有2人（2 ·】％排印，於 第3週期92人中有2人排印。 有97.85%排卵抑 所以可記錄為，根據本發明給予方案 制可靠性。 同時並發現本發明給予方案有良好耐受性。 可用此二個使用實例記錄適宜的的排_制分別為 999 丨 9.doc 10 200534860 97.85%A 96.77%〇PiersonRAetal.，，OrthoEvra//Evra versus oral contraceptives: follicular development...
Fertil· Steril· 80(1)，34-42頁（2003)最近以習用排卵抑制劑 所作研究顯示，即使對長時間一來廣泛使用的可靠而安全 的產品仍有一定百分比的排卵。於第二治療週期中，可能 ^觀察到排印’例如以三相含左炔諾孕S同（levonorgestrel) 的口服避孕劑避孕時有14%(22人中有3人）排卵，以含左炔 諾孕_的單相口服避孕劑有排卵（25人中有6人），以三相含 罗里胺快雌酯（norgestimate)的口服避孕劑有16%(25人中有4 人）排印。所以本發明產品明顯有其價值，與Pierson et al. 所述者相較有較高的可靠性。
99919.doc
Claims (1)
- 200534860 十、申請專利範圍·· 1 · 一種避孕用的夕4 * 斤一 3夕相產品，其特點在於 第相含2份每曰劑量置乂 戊酸趟，# ^里早位的3¾克天然雌激素雌二醇 蓋 弟二相含2組每日,旦留命 甘士斤 L 份每日劑量單弟是由5 位的宅克雌二醇戊酸鹽及至少二倍或三 倍的排卵抑制劑人 — 1里的&成助孕素的結合物所形成， 短是由17份每曰劑量單位的2毫克雌二醇戍酸 孤及至 >、三倍或四倍的“抑制劑量的合成助 合物形成 第三相含2份每曰劑量單位的1毫克雌二醇戊酸鹽， 及相3 2伤每曰劑量單位的醫藥上可接受的安慰 劑0 2·根據”專利範圍第i項之多相產品，其特點在於合成懷 孕活性成分是雙稀孕腈（dienQgest)，曲螺_ (drGspiren_) 或至少一倍已知排印抑制劑量的助孕素。99919.doc 200534860 七、指定代表圖·· (一) 本案指定代表圖為：（無） (二) 本代表圖之元件符號簡單說明： 八、本案若有化學式時，請揭示最能顯示發明特徵的化學式： (無）99919.doc
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102004019743A DE102004019743B4 (de) | 2004-04-20 | 2004-04-20 | Mehrphasenpräparat zur Kontrazeption auf der Basis eines natürlichen Estrogens |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| TW200534860A true TW200534860A (en) | 2005-11-01 |
| TWI351960B TWI351960B (en) | 2011-11-11 |
Family
ID=34979546
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TW094109222A TWI351960B (en) | 2004-04-20 | 2005-03-25 | Multiphase product for contraception based on a na |
Country Status (38)
| Country | Link |
|---|---|
| US (3) | US8071577B2 (zh) |
| EP (1) | EP1740163B2 (zh) |
| JP (1) | JP4908399B2 (zh) |
| KR (1) | KR20060134168A (zh) |
| CN (1) | CN1946383B (zh) |
| AR (2) | AR048830A1 (zh) |
| AT (1) | ATE473734T1 (zh) |
| AU (1) | AU2005235418C1 (zh) |
| BR (1) | BRPI0510005A (zh) |
| CA (1) | CA2561839C (zh) |
| CR (1) | CR8695A (zh) |
| CY (1) | CY1111292T1 (zh) |
| DE (2) | DE102004019743B4 (zh) |
| DK (1) | DK1740163T4 (zh) |
| EA (1) | EA010313B1 (zh) |
| EC (1) | ECSP067000A (zh) |
| ES (1) | ES2348038T5 (zh) |
| GT (1) | GT200500093A (zh) |
| HK (1) | HK1099701A1 (zh) |
| HR (1) | HRP20100513T4 (zh) |
| IL (2) | IL178510A (zh) |
| ME (1) | ME01183B (zh) |
| MX (1) | MXPA06012213A (zh) |
| MY (1) | MY143669A (zh) |
| NO (1) | NO344098B1 (zh) |
| NZ (1) | NZ550417A (zh) |
| PA (1) | PA8630901A1 (zh) |
| PE (1) | PE20060308A1 (zh) |
| PL (1) | PL1740163T5 (zh) |
| PT (1) | PT1740163E (zh) |
| RS (1) | RS51434B2 (zh) |
| SI (1) | SI1740163T2 (zh) |
| SV (1) | SV2006002090A (zh) |
| TW (1) | TWI351960B (zh) |
| UA (1) | UA83915C2 (zh) |
| UY (1) | UY28863A1 (zh) |
| WO (1) | WO2005102247A2 (zh) |
| ZA (1) | ZA200609594B (zh) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102004019743B4 (de) * | 2004-04-20 | 2008-11-27 | Bayer Schering Pharma Aktiengesellschaft | Mehrphasenpräparat zur Kontrazeption auf der Basis eines natürlichen Estrogens |
| SI1937274T1 (sl) * | 2005-10-13 | 2012-06-29 | Bayer Pharma AG | Uporaba estradiolvalerata v kombinaciji z dienogestom za oralno terapijo disfunkcionalne maternične krvavitve skupaj z oralno kontracepcijo |
| EP1787649B1 (de) * | 2005-10-13 | 2009-03-11 | Bayer Schering Pharma Aktiengesellschaft | Verwendung von Estradiolvalerat in Kombination mit Dienogest zur oralen Therapie der dysfunktionellen uterinen Blutung in Einheit mit einer oralen Kontrazeption |
| 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 |
| ES2558030T3 (es) | 2006-03-02 | 2016-02-01 | Warner Chilcott Company, Llc | Método anticonceptivo oral multifásico de ciclo prolongado |
| DE102006010329A1 (de) * | 2006-03-06 | 2007-09-13 | Höltge, Michael, Dipl.-Med. | Hormonelles Kontrazeptivum auf der Basis eines Estrogens, eines Gestagens oder einer Kombination von Estrogenen und Gestagenen unter der Zugabe von Testosteron |
| EP1930010A1 (de) * | 2006-10-20 | 2008-06-11 | Bayer Schering Pharma Aktiengesellschaft | Verwendung von Estradiolvalerat oder 17ß-Estradiol in Kombination mit Dienogest zur oralen Therapie für den Erhalt und/oder die Steigerung der weiblichen Libido |
| US20090117184A1 (en) * | 2007-11-05 | 2009-05-07 | Sabine Fricke | Use of a gestagen in combination with an estrogen and one or more pharmaceutically acceptable auxiliary agents/excipients for lactose-free oral contraception |
| US20120289534A1 (en) * | 2011-05-11 | 2012-11-15 | Kirax Corporation | Package for improved treatment of conditions |
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2004
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