Method of increasing testosterone and related steriod concentrations in women
First Claim
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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:
- (i) identifying a female subject having, or at risk of developing, a testosterone-deficient disorder;
(ii) administering an amount of a hydroalcoholic gel pharmaceutical 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 is improved or the risk of developing a testosterone-deficient disorder is reduced, wherein the composition comprises;
a. about 0.1% to about 10% (w/w) testosterone, or a salt, ester, amide, enantiomer, isomer, tautomer, prodrug, or derivative thereof;
b. about 30% to about 98% (w/w) alcohol selected from the group consisting of ethanol or isopropanol;
c. about 0.1% to about 5% (w/w) penetration enhancer;
d. about 0.1% to about 5% (w/w) of a gelling agent; and
e. the balance purified water;
wherein 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.
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Citations
29 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:
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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 hydroalcoholic gel pharmaceutical 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 is improved or the risk of developing a testosterone-deficient disorder is reduced, wherein the composition comprises;
a. about 0.1% to about 10% (w/w) testosterone, or a salt, ester, amide, enantiomer, isomer, tautomer, prodrug, or derivative thereof;
b. about 30% to about 98% (w/w) alcohol selected from the group consisting of ethanol or isopropanol;
c. about 0.1% to about 5% (w/w) penetration enhancer;
d. about 0.1% to about 5% (w/w) of a gelling agent; and
e. the balance purified water;
wherein 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)
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28. A method for improving sexual performance in a female subject in need thereof, comprising administering to the subject:
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(a) an amount of a hydroalcoholic gel pharmaceutical 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;
i. about 0.1% to about 10% (w/w) testosterone, or a salt, ester, amide, enantiomer, isomer, tautomer, prodrug, or derivative thereof;
ii. about 30% to about 98% (w/w) alcohol selected from the group consisting of ethanol or isopropanol;
iii. about 0.1% to about 5% (w/w) penetration enhancer;
iv. about 0.1% to about 5% (w/w) of a gelling agent; and
v. the balance water; and
(b) an amount of an agent for improving sexual performance. - View Dependent Claims (29)
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Specification