NEEDLE ASSISTED JET INJECTION ADMINISTRATION OF TESTOSTERONE COMPOSITIONS
The present invention provides compositions and methods for treating a subject in need of treatment with testosterone, including introducing testosterone into the subject subcutaneously, intradermally, or intramuscularly, from a needle assisted jet injection device.
1 - 48 . (canceled)
49 . A method of treating hypogonadism, reduced fertility, lack of libido, erectile dysfunction, osteoporosis, or anemia in a subject in need thereof, the method comprising:
subcutaneously administering to the subject a preservative-free composition comprising a unit dose of testosterone or a pharmaceutically acceptable ester or salt thereof in a pharmaceutically acceptable carrier,
wherein after administration, a plasma level of testosterone is maintained between about 300 ng/dl and about 1100 ng/dl for a time period beginning one minute after administration and lasting up to one month after administration, and
wherein administering the preservative-free composition consists of an injection via a powered injector comprising a housing, a chamber disposed within the housing and configured to receive the preservative-free composition, and a needle operatively associated with the chamber.
50 . The method of claim 49 , comprising treating hypogonadism in the subject in need thereof.
51 . The method of claim 49 , comprising treating reduced fertility in the subject in need thereof.
52 . The method of claim 49 , comprising treating lack of libido in the subject in need thereof.
53 . The method of claim 49 , comprising treating erectile dysfunction in the subject in need thereof.
54 . The method of claim 49 , comprising treating osteoporosis in the subject in need thereof.
55 . The method of claim 49 , comprising treating anemia in the subject in need thereof.
56 . The method of claim 49 , wherein the pharmaceutically acceptable testosterone ester comprises testosterone enanthate.
57 . The method of claim 49 , wherein the unit dose is selected from 50 mg, 75 mg, and 100 mg.
58 . The method of claim 49 , wherein the unit dose is between 50 mg and 100 mg.
59 . The method of claim 49 , wherein the concentration of the unit dose is 100 mg/mL, 150 mg/mL, or 200 mg/mL.
60 . The method of claim 49 , wherein after administration, a plasma level of testosterone is maintained at a value of about 300 ng/dl or about 350 ng/dl for a time period beginning one minute after administration and lasting up to one month after administration.
61 . The method of claim 49 , wherein after administration, a plasma level of testosterone is maintained at a value of about 400 ng/dl or about 450 ng/dl for a time period beginning one minute after administration and lasting up to one month after administration.
62 . The method of claim 49 , wherein after administration, a plasma level of testosterone is maintained at a value of about 500 ng/dl or about 550 ng/dl for a time period beginning one minute after administration and lasting up to one month after administration.
63 . The method of claim 49 , wherein after administration, a plasma level of testosterone is maintained at a value of about 600 ng/dl or about 650 ng/dl for a time period beginning one minute after administration and lasting up to one month after administration.
64 . The method of claim 49 , wherein after administration, a plasma level of testosterone is maintained at a value of about 700 ng/dl or about 750 ng/dl for a time period beginning one minute after administration and lasting up to one month after administration.
65 . The method of claim 49 , wherein after administration, a plasma level of testosterone is maintained at a value of about 800 ng/dl or about 850 ng/dl for a time period beginning one minute after administration and lasting up to one month after administration.
66 . The method of claim 49 , wherein after administration, a plasma level of testosterone is maintained at a value of about 900 ng/dl or about 950 ng/dl for a time period beginning one minute after administration and lasting up to one month after administration.
67 . The method of claim 49 , wherein after administration, a plasma level of testosterone is maintained at a value of about 1000 ng/dl or about 1050 ng/dl for a time period beginning one minute after administration and lasting up to one month after administration.
68 . The method of claim 49 , wherein after administration, a plasma level of testosterone is maintained at a value of about 1100 ng/dl for a time period beginning one minute after administration and lasting up to one month after administration.
69 . The method of claim 49 , wherein the time period begins one minute after administration and lasts up to seven days after administration.