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|Title:||Pharmaceutical composition and method for treating hypogonadism|
|Abstract:||A pharmaceutical composition useful for treating hypogonadism is disclosed. The composition comprises an androgenic or anabolic steroid, a C1-C4 alcohol, a penetration enhancer such as isopropyl myristate, and water. Also disclosed is a method for treating hypogonadism utilizing the composition.|
|Inventor(s):||Dudley; Robert E. (Kenilworth, IL), Drouin; Dominique (Verrieres le Buisson, FR)|
|Assignee:||BESINS HEALTHCARE INC. (Herndon, VA) UNIMED PHARMACEUTICALS, LLC (Abbott Park, IL)|
1. A method of treating hypogonadism in a human male, the method comprising the steps of: applying, once per day, a therapeutically effective dose of a pharmaceutical
composition to an area of skin of the human male, the pharmaceutical composition consisting of: (i) 0.1% to 10% (w/w) testosterone; (ii) 0.10% to 5.0% (w/w) isopropyl myristate; (iii) 30.0% to 98.0% (w/w) of ethanol, isopropanol or combinations
thereof; (iv) 0.1% to 5.0% of a polyacrylic acid, wherein the polyacrylic acid is neutralized with sodium hydroxide; and (v) water; wherein the administration of the pharmaceutical composition is as a gel and not as part of a patch, and further
wherein the administration once per day is sufficient for the testosterone to reach the bloodstream of the human male to achieve a steady state profile in which there is an increase in serum testosterone levels of the human male for a period of time of 4
hours or less before returning to an approximately constant level.
2. The method of claim 1, wherein the sodium hydroxide is 0.1 N NaOH.
3. The method of claim 1, wherein the composition consists of testosterone, isopropyl myristate, ethanol, polyacrylic acid neutralized with sodium hydroxide and water.
4. The method of claim 3, wherein the ethanol is 95% (v/v) ethanol.
5. The method of claim 1, wherein the hypogonadism is primary hypogonadism, secondary hypogonadism or age-related hypogonadism.
6. The method of claim 1, wherein the pharmaceutical composition is administered to the left upper arm, the right upper arm, the left shoulder or the right shoulder.
7. The method of claim 1, wherein the administration once per day is sufficient for the testosterone to reach the bloodstream of the human male to achieve a steady state profile in which there is an increase in serum testosterone levels of the human male for a period of time of 2 hours or less before returning to a relatively constant level.
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