JP2012046483A5 - - Google Patents
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- JP2012046483A5 JP2012046483A5 JP2011126449A JP2011126449A JP2012046483A5 JP 2012046483 A5 JP2012046483 A5 JP 2012046483A5 JP 2011126449 A JP2011126449 A JP 2011126449A JP 2011126449 A JP2011126449 A JP 2011126449A JP 2012046483 A5 JP2012046483 A5 JP 2012046483A5
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- testosterone
- androgen
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Description
血中テストステロン濃度データの分析は、血清総テストステロン濃度が、線維筋痛症患者へのテストステロンゲルによるホルモン補充療法に応答して、確実に上昇することを明らかにした。1日目および28日目の経時的な血清総テストステロン濃度のデータを図1に示す。血清テストステロンデータの、女性の血清総テストステロン濃度の標準基準範囲との比較により、本研究の線維筋痛症患者は、当初、基準範囲の下半分の総テストステロン濃度であったことが確認された。しかし、1日目におけるホルモンの最初の用量の適用の24時間後、血清総テストステロン濃度の平均は、1日目の0時の血清濃度平均より有意に高く(図1、p=0.01)、これは、血清濃度が、28日間のタイムコース中、概して早い段階で、持続性となったことを示すものである。定常状態濃度には、24時間サンプリングの初めと終わりの平均濃度が同様であったことにより証明されるように、28日までに到達した(図1参照)。個人間をベースに分析した場合、血清テストステロンの24時間プロファイルには違いがあり、これは、このホルモンについて知られている複雑な調節に一致する。薬学動態パラメータ分析の概要は、テストステロン治療に応答して、総テストステロン最大濃度の平均が有意に増加することを明らかにした:Cmaxは、1日目の1.21ng/mLと比較して28日目で1.92ng/mLであり、p<0.05であった。総テストステロンの濃度曲線下面積の平均(24時間プロファイリング期間にわたって評価)の有意な増加もまた見いだされた:AUCは、1日目の18.36ng−h/mLと比較し、28日目で28.75ng−h/mLであり、p<0.05であった。総合して薬学動態データを考慮すると、治療により、血清総テストステロン濃度は、初期に、初めの3時間で素早く上昇し、その後、経時的に確実に持続することが明らかにされた。加えて、血清テストステロン濃度平均は、閉経前女性の基準範囲の下限から、ちょうど基準範囲の上限に上昇した。
Claims (8)
- 欠乏した血清アンドロゲンレベルに関連する状態を有する女性ヒト患者に、治療上女性に適する量のアンドロゲンを投与するために製剤された医薬組成物であって、該医薬組成物が女性に適する前記アンドロゲンの単位用量を、前記女性ヒト患者にゲルとして経皮投与するために製剤された薬学的に許容し得る担体に含み、前記アンドロゲンの女性に適する単位用量が、前記女性患者の欠乏したアンドロゲンに関連する状態を緩和し、かつ、該女性患者の血清アンドロゲンレベルを、正常な閉経前女性における基準範囲に近似した範囲内にのみ上昇させ、維持するのに有効な量である、前記組成物。
- アンドロゲンが、重量ベースで約1%の量で存在している、請求項1に記載の組成物。
- アンドロゲンが、テストステロン、テストステロンの活性代謝産物、およびテストステロン誘導体からなる群から選択される、請求項1または2に記載の組成物。
- アンドロゲンが、テストステロン、ジヒドロテストステロン、アンドロステンジオン、メチルテストステロン、およびテストステロンエステルからなる群から選択される、請求項1または2に記載の組成物。
- テストステロンエステルが、エナント酸テストステロン、およびテストステロンシピオネートからなる群から選択される、請求項4に記載の組成物。
- 欠乏した血清アンドロゲンレベルに関連する状態が、線維筋痛症、慢性疲労症候群、および減少した性的欲求からなる群から選択され、女性に適する単位用量が、女性ヒト患者の定常状態血清アンドロゲンレベルを、アンドロゲンによる副作用を惹起することなく上昇させる量である、請求項1〜5のいずれかに記載の組成物。
- 女性に適する単位用量が、遊離テストステロン血清レベルまたは24時間遊離テストステロンAUCを治療に要求されるレベルを超えて上昇させることなく、定常状態総テストステロン血清レベルを、少なくとも投与後24時間にわたり、約0.9ng/ml〜約1.4ng/mlの範囲に維持するように選択される、請求項6に記載の組成物。
- 約7.5mgのテストステロンの単位用量を含み、かつ、遊離テストステロン血清レベルを約4.69pg/mlを超えて、または24時間遊離テストステロンAUCを約71.38pg−h/mlを超えて上昇させることなく、定常状態総テストステロン血清レベルを、少なくとも投与後24時間にわたり、約0.9ng/ml〜約1.4ng/mlの範囲に維持するように製剤されている、請求項7に記載の組成物。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/464,310 US20040259852A1 (en) | 2003-06-18 | 2003-06-18 | Trandsdermal compositions and methods for treatment of fibromyalgia and chronic fatigue syndrome |
US10/464,310 | 2003-06-18 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006517316A Division JP5717312B2 (ja) | 2003-06-18 | 2004-06-15 | 線維筋痛症候群または慢性疲労症候群の処置のための経皮的組成物および方法 |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2012046483A JP2012046483A (ja) | 2012-03-08 |
JP2012046483A5 true JP2012046483A5 (ja) | 2012-08-30 |
JP5651540B2 JP5651540B2 (ja) | 2015-01-14 |
Family
ID=33517268
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006517316A Expired - Fee Related JP5717312B2 (ja) | 2003-06-18 | 2004-06-15 | 線維筋痛症候群または慢性疲労症候群の処置のための経皮的組成物および方法 |
JP2011126449A Expired - Fee Related JP5651540B2 (ja) | 2003-06-18 | 2011-06-06 | 線維筋痛症候群または慢性疲労症候群の処置のための経皮的組成物および方法 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006517316A Expired - Fee Related JP5717312B2 (ja) | 2003-06-18 | 2004-06-15 | 線維筋痛症候群または慢性疲労症候群の処置のための経皮的組成物および方法 |
Country Status (6)
Country | Link |
---|---|
US (3) | US20040259852A1 (ja) |
EP (2) | EP2000143B1 (ja) |
JP (2) | JP5717312B2 (ja) |
AU (2) | AU2004251075B2 (ja) |
CA (1) | CA2529575C (ja) |
WO (1) | WO2005000236A2 (ja) |
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-
2003
- 2003-06-18 US US10/464,310 patent/US20040259852A1/en not_active Abandoned
-
2004
- 2004-06-15 CA CA2529575A patent/CA2529575C/en not_active Expired - Fee Related
- 2004-06-15 EP EP08154166.6A patent/EP2000143B1/en not_active Expired - Lifetime
- 2004-06-15 WO PCT/US2004/019201 patent/WO2005000236A2/en active Search and Examination
- 2004-06-15 EP EP04776655A patent/EP1638575A4/en not_active Withdrawn
- 2004-06-15 AU AU2004251075A patent/AU2004251075B2/en not_active Ceased
- 2004-06-15 JP JP2006517316A patent/JP5717312B2/ja not_active Expired - Fee Related
-
2005
- 2005-12-16 US US11/303,813 patent/US7799769B2/en not_active Expired - Fee Related
-
2010
- 2010-07-15 US US12/837,310 patent/US8999963B2/en not_active Expired - Fee Related
-
2011
- 2011-03-02 AU AU2011200914A patent/AU2011200914B2/en not_active Ceased
- 2011-06-06 JP JP2011126449A patent/JP5651540B2/ja not_active Expired - Fee Related
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