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. A method of obtaining steady state average blood concentration of testosterone comprising:
repeatedly injecting a dose of testosterone over a prescribed time period such that a steady state blood plasma level of testosterone is obtained after three or more doses.
2. The method of claim 1 , wherein the dose is selected from between 50 mg, 75 mg and 100 mg.
3. The method of claim 2 , wherein the concentration of the injected dose is 100 mg/ml, 150 mg/ml or 200 mg/ml.
4. The method of claim 1 , wherein the dose is between 50 mg and 100 mg.
5. The method of claim 1 , wherein the prescribed time period is one week.
6. The method of claim 1 , wherein the steady state blood plasma level of testosterone is reached after the fourth dose.
7. The method of claim 1 , wherein the steady state blood plasma level of testosterone is reached after the fifth dose.
8. The method of claim 1 , further comprising:
injecting another dose after the steady state blood plasma level of testosterone is reached.
9. The method of claim 8 , wherein the another dose is the same as the dose injected prior to reaching the steady state blood plasma level of testosterone.
10. The method of claim 1 , wherein once the steady state blood plasma level of testosterone is reached, the average blood plasma level obtained after injecting a subsequent dose or doses is less than + or −30% of the average blood plasma level of testosterone obtained during an immediately preceding prescribed time period.
11. The method of claim 1 , wherein the steady state blood plasma level of testosterone after the repeated injections is about 800 ng/dl to about 1100 ng/dl.
12. The method of claim 1 , wherein the steady state blood plasma level of testosterone after the repeated injections is about 500 ng/dl to about 800 ng/dl.
13. The method of claim 1 , wherein the steady state blood plasma level of testosterone after the repeated injections is about 350 ng/dl to about 500 ng/dl.
14. The method of claim 1 , wherein the dose of testosterone is injected subcutaneously.
15. The method of claim 1 , wherein the dose of testosterone is injected intramuscularly.
16. The method of claim 8 , wherein the another dose is injected subcutaneously.
17. The method of claim 8 , wherein the another dose is injected intramuscularly.
18. The method of claim 8 , wherein the another dose is injected intradermally.
19. A method of obtaining steady state average blood concentration of testosterone comprising:
repeatedly injecting a dose of testosterone subcutaneously over a prescribed time period such that a steady state blood plasma level of 300 ng/dl to about 1800 ng/dl of testosterone is obtained after three of more doses.
20. The method of claim 19 , wherein the steady state blood plasma level of testosterone is about 350 ng/dl to about 500 ng/dl.
21. The method of claim 1 , wherein the dose of testosterone is injected via a powered injector.
22. The method of claim 8 , wherein the another dose is different than the dose.
23. The method of claim 9 , wherein the another dose is injected via a different route of administration.
24. The method of claim 8 , wherein the steady state blood plasma level of testosterone is maintained at or above a therapeutically effective level while the another dose is injected.