Method of increasing testosterone and related steroid concentrations in women
First Claim
1. A method of treating, preventing or reducing the risk of developing a testosterone-deficient disorder in a female subject in need thereof, comprising:
- administering an amount of a composition to an area of skin of the subject, which delivers a therapeutically-effective amount of testosterone to the blood serum of the subject, wherein the composition comprises;
a. about 0.1% to about 10% testosterone, or a salt, ester, amide, enantiomer, isomer, tautomer, prodrug, or derivative thereof;
b. about 30% to about 98% alcohol selected from the group consisting of ethanol or isopropanol;
c. about 0.1% to about 5% isopropyl myristate;
d. about 0.1% to about 10% sodium hydroxide; and
e. about 0.1% to about 5% of a gelling agent;
wherein the percentages are on a weight to weight basis of the composition and the sum of components of the composition is about 100 weight %; and
the composition is capable of releasing the testosterone to the skin at a rate and duration that raises testosterone blood serum concentration to at least about 3 pg testosterone/ml blood serum within about 24 hours after administration.
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Abstract
The present invention relates to methods, kits, combinations, and compositions for treating, preventing or reducing the risk of developing a testosterone deficient disorder, or the symptoms associated with, or related to a testosterone deficient disorder in a subject in need thereof. The present invention also relates to a method of administering a steroid in the testosterone synthetic pathway to a subject in need thereof. In addition, the methods, kits, combinations and compositions may be used in conjunction with other pharmaceutical agents effective at treating, preventing, or reducing the risk of developing a testosterone deficient disorder. The present invention also can also be used in conjunction with a pharmacologically effective amount of an estrogenic hormone. Furthermore, the methods, kits, combinations and compositions can be used in conjunction with a pharmacologically effective amount of another steroid or pharmaceutical agent that increases serum testosterone levels in a mammal.
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Citations
30 Claims
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1. A method of treating, preventing or reducing the risk of developing a testosterone-deficient disorder in a female subject in need thereof, comprising:
- administering an amount of a composition to an area of skin of the subject, which delivers a therapeutically-effective amount of testosterone to the blood serum of the subject, wherein the composition comprises;
a. about 0.1% to about 10% testosterone, or a salt, ester, amide, enantiomer, isomer, tautomer, prodrug, or derivative thereof;
b. about 30% to about 98% alcohol selected from the group consisting of ethanol or isopropanol;
c. about 0.1% to about 5% isopropyl myristate;
d. about 0.1% to about 10% sodium hydroxide; and
e. about 0.1% to about 5% of a gelling agent;
wherein the percentages are on a weight to weight basis of the composition and the sum of components of the composition is about 100 weight %; and
the composition is capable of releasing the testosterone to the skin at a rate and duration that raises testosterone blood serum concentration to at least about 3 pg testosterone/ml blood serum within about 24 hours after administration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
- administering an amount of a composition to an area of skin of the subject, which delivers a therapeutically-effective amount of testosterone to the blood serum of the subject, wherein the composition comprises;
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28. A method of treating, preventing or reducing the risk of developing a testosterone-deficient disorder in a female subject in need thereof, comprising:
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(i) identifying a female subject having, or at risk of developing, a testosterone-deficient disorder;
(ii) administering an amount of a composition to an area of skin of the subject, which delivers a therapeutically-effective amount of testosterone to the blood serum of the subject such that the testosterone-deficient disorder or the risk of developing a testosterone-deficient disorder is reduced, wherein the composition comprises;
a. about 0.1% to about 10% testosterone, or a salt, ester, amide, enantiomer, isomer, tautomer, prodrug, or derivative thereof;
b. about 30% to about 98% alcohol selected from the group consisting of ethanol or isopropanol;
c. about 0.1% to about 5% isopropyl myristate;
d. about 0.1% to about 10% sodium hydroxide; and
e. about 0.1% to about 5% of a gelling agent;
wherein the percentages are on a weight to weight basis of the composition and the sum of components of the composition is about 100 weight %; and
the composition is capable of releasing the testosterone to the skin at a rate and duration that raises testosterone blood serum concentration to at least about 3 pg testosterone/ml blood serum within about 24 hours after administration.
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29. A method of delivering a testosterone-deficient disorder effective amount of testosterone to blood serum of a female subject in need thereof, comprising:
- contacting the skin of the subject with a composition comprising;
a. about 0.1% to about 10% testosterone, or a salt, ester, amide, enantiomer, isomer, tautomer, prodrug, or derivative thereof;
b. about 30% to about 98% alcohol selected from the group consisting of ethanol or isopropanol;
c. about 0.1% to about 5% isopropyl myristate;
d. about 0.1% to about 10% sodium hydroxide; and
e. about 0.1% to about 5% of a gelling agent;
wherein the percentages are on a weight to weight basis of the composition and the sum of components of the composition is about 100 weight %; and
the composition is capable of releasing the testosterone to the skin at a rate and duration that raises testosterone blood serum concentration to at least about 3 pg testosterone/ml blood serum within about 24 hours after administration.
- contacting the skin of the subject with a composition comprising;
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30. A method for administering a testosterone-deficient disorder effective amount of testosterone to blood serum of a female subject in need thereof, the method comprising:
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(i) providing a pharmaceutical composition comprising;
a. about 0.1% to about 10% testosterone, or a salt, ester, amide, enantiomer, isomer, tautomer, prodrug, or derivative thereof;
b. about 30% to about 98% alcohol selected from the group consisting of ethanol or isopropanol;
c. about 0.1% to about 5% isopropyl myristate;
d. about 0.1% to about 10% sodium hydroxide; and
e. about 0.1% to about 5% of a gelling agent; and
(ii) applying the composition to skin of the subject in an amount sufficient for the testosterone to reach the blood serum of the subject so as to achieve a serum concentration of at least 3 pg testosterone/ml blood serum within about 24 hours after administration;
wherein the percentages are on a weight to weight basis of the composition and the sum of components of the composition is about 100 weight %.
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Specification