CN1761469A - 可靠地达到可接受的血清睾酮水平的方法和药物组合物 - Google Patents
可靠地达到可接受的血清睾酮水平的方法和药物组合物 Download PDFInfo
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- CN1761469A CN1761469A CNA2004800069124A CN200480006912A CN1761469A CN 1761469 A CN1761469 A CN 1761469A CN A2004800069124 A CNA2004800069124 A CN A2004800069124A CN 200480006912 A CN200480006912 A CN 200480006912A CN 1761469 A CN1761469 A CN 1761469A
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- Prior art keywords
- testosterone
- ester
- male
- injection
- dosage
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Classifications
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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
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
- A61K31/568—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 positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
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- A—HUMAN NECESSITIES
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- 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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Abstract
Description
活性成分名称: | 十一酸睾酮(TU) |
目的: | 为获得TU制剂在相隔更长的间期(12周)在超过18周的时期内长期给药4ml油溶液内的1000mg TU后的有效性及安全性的更多信息 |
方法学: | 开放、单臂、多剂量研究 |
受试者总数 | 计划:36 |
入选的诊断及主要标准 | 18到65岁性腺功能减退的男性,未经雄激素治疗其血清T(睾酮)水平低于5nmol/L,在依次完成具有最后检验的主要研究后,这些男性未显示任何有关的病理结果,向他们提供接受自主要研究延长TU治疗还是从TE(庚酸睾酮)转至TU治疗的书面知情同意书。 |
受试产品: | 十一酸睾酮(TU) |
剂量: | 接受TU的患者的剂量:8×1000mg,间期为12周 |
给药方式: | 肌内注射(臀中肌) |
治疗持续周期: | 80周84周 |
有效性终点 | 原发性变量:红细胞生成(血红蛋白、血细胞比容)、握力;继发性变量:血清睾酮(T)、二氢睾酮(DHT)、雌二醇(E2)、促黄体生成激素(LH)、促卵泡激素(FSH)、瘦素(leptin)以及性激素结合球蛋白(SHBG);骨密度;骨代谢参数;身体组成:脂质(总胆固醇、甘油三酯、低密度酯蛋白、高密度酯蛋白以及极低密度酯蛋白、载脂蛋白A1和B、脂蛋白(a)) |
安全性终点 | 不利事件(AE):血清前列腺特异性抗原;前列腺超声发现;血液学参数及肝脏(ASAT、ALAT、γ-GT、总胆红素)参数、铁蛋白、铁; |
方案 | 基值;首次注射前的平均睾酮水平(nmol/l) | 首次注射后平均相隔周数 | 相隔数周后的平均睾酮水平(nmol/l) | 第二次注射后相隔的平均周数 | 相隔数周后的平均睾酮水平(nmol/l) |
A | 7.9 | 9.2 | 7.0 | 10.8 | 8.8 |
B | 6.8 | 6.1 | 12.2 | 10.1 | 12.5 |
Claims (29)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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DKPA200300399 | 2003-03-14 | ||
DKPA200300399 | 2003-03-14 | ||
PCT/IB2004/000716 WO2004080383A2 (en) | 2003-03-14 | 2004-03-15 | Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels |
Related Child Applications (1)
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CN2010102249063A Division CN101884639A (zh) | 2003-03-14 | 2004-03-15 | 可靠地达到可接受的血清睾酮水平的方法和药物组合物 |
Publications (2)
Publication Number | Publication Date |
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CN1761469A true CN1761469A (zh) | 2006-04-19 |
CN1761469B CN1761469B (zh) | 2019-05-17 |
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CN200480006912.4A Expired - Lifetime CN1761469B (zh) | 2003-03-14 | 2004-03-15 | 可靠地达到可接受的血清睾酮水平的方法和药物组合物 |
CN2010102249063A Pending CN101884639A (zh) | 2003-03-14 | 2004-03-15 | 可靠地达到可接受的血清睾酮水平的方法和药物组合物 |
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CN2010102249063A Pending CN101884639A (zh) | 2003-03-14 | 2004-03-15 | 可靠地达到可接受的血清睾酮水平的方法和药物组合物 |
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Country | Link |
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US (2) | US7718640B2 (zh) |
EP (2) | EP1457208B9 (zh) |
JP (1) | JP4680891B2 (zh) |
KR (2) | KR20080096717A (zh) |
CN (2) | CN1761469B (zh) |
AR (1) | AR043603A1 (zh) |
AT (1) | ATE336251T1 (zh) |
AU (1) | AU2004218893B2 (zh) |
BR (2) | BRPI0400214A8 (zh) |
CA (1) | CA2518910C (zh) |
CL (1) | CL2004000527A1 (zh) |
CO (1) | CO5700724A2 (zh) |
CR (1) | CR7999A (zh) |
CY (1) | CY1105794T1 (zh) |
DE (1) | DE602004001893T2 (zh) |
DK (1) | DK1457208T3 (zh) |
EA (1) | EA011568B1 (zh) |
EC (1) | ECSP056095A (zh) |
ES (1) | ES2271772T3 (zh) |
HK (1) | HK1069325A1 (zh) |
HR (1) | HRP20050781B1 (zh) |
IL (1) | IL170473A (zh) |
IS (1) | IS2565B (zh) |
JO (1) | JO2505B1 (zh) |
ME (2) | MEP14508A (zh) |
MX (1) | MXPA04002395A (zh) |
NO (1) | NO335179B1 (zh) |
NZ (1) | NZ542321A (zh) |
PE (1) | PE20041065A1 (zh) |
PL (1) | PL1457208T3 (zh) |
PT (1) | PT1457208E (zh) |
RS (1) | RS51537B (zh) |
RU (2) | RU2354381C2 (zh) |
SA (1) | SA04250040B1 (zh) |
SI (1) | SI1457208T1 (zh) |
TW (1) | TWI345976B (zh) |
UA (1) | UA82510C2 (zh) |
UY (1) | UY28231A1 (zh) |
WO (1) | WO2004080383A2 (zh) |
ZA (2) | ZA200508313B (zh) |
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AU2014200332B2 (en) * | 2008-04-28 | 2016-10-06 | Diurnal Limited | Lipid composition |
EP2398461A1 (en) | 2009-02-18 | 2011-12-28 | Bayer Pharma Aktiengesellschaft | Formulation comprising drospirenone for subcutaneous or intramuscular administration |
US9358241B2 (en) | 2010-11-30 | 2016-06-07 | Lipocine Inc. | High-strength testosterone undecanoate compositions |
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US20180153904A1 (en) | 2010-11-30 | 2018-06-07 | Lipocine Inc. | High-strength testosterone undecanoate compositions |
US20120148675A1 (en) | 2010-12-10 | 2012-06-14 | Basawaraj Chickmath | Testosterone undecanoate compositions |
US20130178454A1 (en) * | 2011-11-17 | 2013-07-11 | Shalender Bhasin | Combination of testosterone and ornithine decarboxylase (odc) inhibitors |
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EP3659647B1 (en) | 2013-02-11 | 2024-01-24 | Antares Pharma, Inc. | Needle assisted jet injection device having reduced trigger force |
TW201521731A (zh) * | 2013-03-15 | 2015-06-16 | 利波辛股份有限公司 | 用於口服之脂平衡的長鏈睪固酮酯 |
CN105744983B (zh) * | 2013-08-12 | 2019-12-27 | 纳米医学系统公司 | 用于缓释在增溶剂中的低水溶性治疗剂的装置和方法 |
US9956164B2 (en) | 2014-04-16 | 2018-05-01 | Veyx-Pharma Gmbh | Veterinary pharmaceutical composition and use thereof |
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