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Mithra宣布Donesta的II期临床试验已经完成

2018-01-29 MedSci MedSci原创

Donesta雌四醇更年期综合征
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作为一家专注女性健康领域的制药公司，Mithra近日宣布其下一代激素疗法（HT）候选药物Donesta（用于缓解血管收缩更年期综合征的雌四醇，E4）的II期临床试验已经完成，顶线数据有望在2018年第一季度末公布。

作为一家专注女性健康领域的制药公司，Mithra近日宣布其下一代激素疗法（HT）候选药物Donesta（用于缓解血管收缩更年期综合征的雌四醇，E4）的II期临床试验已经完成，顶线数据有望在2018年第一季度末公布。

该项多中心试验在捷克、波兰、比利时、爱尔兰和英国进行，受试者接受为期12周的药物或安慰剂治疗。在这个双盲研究中，与安慰剂相比，Donesta总共有四个剂量水平（2.5mg，5mg，10mg和15mg）被测试。该试验的主要临床终点为确定治疗绝经后妇女血管收缩更年期综合征或潮热的每日口服最小剂量。次要终点包括评估其他更年期症状，如外阴阴道萎缩（VVA）或阴道干涩，脂质和葡萄糖代谢以及骨代谢指标。该研究还将分析关键的安全问题，包括子宫内膜厚度。

研究表明，目前基于激素疗法的治疗可能增加乳腺癌患病风险和静脉血栓栓塞事件（VTE）。由于天然雌激素E4的独特特征和作用方式，Donesta有可能在保证安全性的前提下有效治疗血管收缩更年期综合征，从而解决远未满足的医疗需求。 

原始出处：

http://www.firstwordpharma.com/node/1539192?tsid=4#axzz55NkMXJoh

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    2018-06-08 医生2402

    #I期临床#

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    2018-12-03 gracezdd

    #MIT#

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    2018-06-02 xiangyuzhou971

    #EST#

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    2018-10-19 zhouqu_8

    #II期临床试验#

    0

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    2018-02-26 839640778

    #I期临床试验#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1652819, encodeId=09ce16528197f, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Fri Jun 08 05:13:00 CST 2018, time=2018-06-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1900843, encodeId=3595190084324, content=<a href='/topic/show?id=5f9b119599d' target=_blank style='color:#2F92EE;'>#MIT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11959, encryptionId=5f9b119599d, topicName=MIT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=872f168, createdName=gracezdd, createdTime=Mon Dec 03 02:13:00 CST 2018, time=2018-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2051039, encodeId=826f2051039b1, content=<a href='/topic/show?id=95f8e042dd' target=_blank style='color:#2F92EE;'>#EST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7042, encryptionId=95f8e042dd, topicName=EST)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e9a6357, createdName=xiangyuzhou971, createdTime=Sat Jun 02 23:13:00 CST 2018, time=2018-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1931435, encodeId=0186193143527, content=<a href='/topic/show?id=a3d89601f2' target=_blank style='color:#2F92EE;'>#II期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9601, encryptionId=a3d89601f2, topicName=II期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Fri Oct 19 11:13:00 CST 2018, time=2018-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2088702, encodeId=2e212088e02cd, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, createdName=839640778, createdTime=Mon Feb 26 06:13:00 CST 2018, time=2018-02-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2040457, encodeId=faf3204045ec8, content=<a href='/topic/show?id=b579618356' target=_blank style='color:#2F92EE;'>#Donesta#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6183, encryptionId=b579618356, topicName=Donesta)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=baf586, createdName=wangbingxhy, createdTime=Fri Aug 10 05:13:00 CST 2018, time=2018-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524643, encodeId=27c015246432b, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Wed Jan 31 02:13:00 CST 2018, time=2018-01-31, status=1, ipAttribution=)]
    2018-08-10 wangbingxhy

    #Donesta#

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1652819, encodeId=09ce16528197f, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Fri Jun 08 05:13:00 CST 2018, time=2018-06-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1900843, encodeId=3595190084324, content=<a href='/topic/show?id=5f9b119599d' target=_blank style='color:#2F92EE;'>#MIT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11959, encryptionId=5f9b119599d, topicName=MIT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=872f168, createdName=gracezdd, createdTime=Mon Dec 03 02:13:00 CST 2018, time=2018-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2051039, encodeId=826f2051039b1, content=<a href='/topic/show?id=95f8e042dd' target=_blank style='color:#2F92EE;'>#EST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7042, encryptionId=95f8e042dd, topicName=EST)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e9a6357, createdName=xiangyuzhou971, createdTime=Sat Jun 02 23:13:00 CST 2018, time=2018-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1931435, encodeId=0186193143527, content=<a href='/topic/show?id=a3d89601f2' target=_blank style='color:#2F92EE;'>#II期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9601, encryptionId=a3d89601f2, topicName=II期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Fri Oct 19 11:13:00 CST 2018, time=2018-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2088702, encodeId=2e212088e02cd, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, createdName=839640778, createdTime=Mon Feb 26 06:13:00 CST 2018, time=2018-02-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2040457, encodeId=faf3204045ec8, content=<a href='/topic/show?id=b579618356' target=_blank style='color:#2F92EE;'>#Donesta#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6183, encryptionId=b579618356, topicName=Donesta)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=baf586, createdName=wangbingxhy, createdTime=Fri Aug 10 05:13:00 CST 2018, time=2018-08-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524643, encodeId=27c015246432b, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Wed Jan 31 02:13:00 CST 2018, time=2018-01-31, status=1, ipAttribution=)]
    2018-01-31 guihongzh

    #II期临床#

    0