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Claims for Patent: 8,338,395

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Claims for Patent: 8,338,395

Title:Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
Abstract: Described are methods for providing prolonged physiologically acceptable steady state serum testosterone levels in a patient deficient in endogenous testosterone levels, methods for male contraception and methods for treating a disease or symptom associated with deficient endogenous levels of testosterone in a man, by intramuscularly administering testosterone esters in a vehicle.
Inventor(s): Hubler; Doris (Jena, DE), Fricke; Sabine (Jena, DE), Ingwersen; Jan-Peter (Berlin, DE), Kuhnz; Wilheim (Berlin, DE)
Assignee: Bayer Intellectual Property GmbH (Monheim, DE)
Application Number:12/391,655
Patent Claims: 1. A method of providing prolonged physiologically acceptable steady state serum testosterone levels in a patient deficient in endogenous testosterone levels comprising intramuscularly administering a maintenance dose of a composition comprising testosterone undecanoate and a vehicle consisting essentially of castor oil and a co-solvent, wherein the castor oil is present in the vehicle in a concentration of 42 percent or less by volume, once every 10-14 weeks following 2-4 initial doses of said composition, each initial dose being administered at an interval of 4-8 weeks.

2. The method of claim 1, which is for treating primary or secondary hypogonadism in a man.

3. The method of claim 2, wherein primary hypogonadism is treated and said primary hypogonadism is derived from: testicular failure due to cryptorchidism, bilateral testicular torsion, orchitis, orchidectomy, Klinefelter syndrome, chemotherapy or toxic damage from alcohol or heavy metals.

4. The method of claim 2, wherein secondary hypogonadism is treated and said secondary hypogonadism is caused by idiopathic gonadotropin releasing hormone (GnRH) deficiency or pituitary-hypothalamic injury from tumours, trauma or radiation.

5. The method of claim 1, which is for treating a disease or symptom associated with a deficient level of testosterone in a man who is in therapy with a progestin or a gonadotropin suppressive agent.

6. The method according to claim 1, in which 2 initial doses are administered at an interval of 4 weeks between injections, followed by the maintenance dose once every 10-14 weeks.

7. The method of claim 6, in which the maintenance dose is administered once every 10 weeks.

8. The method according to claim 1, in which 2 initial doses are administered at an interval of 6 weeks between injections, followed by the maintenance dose once every 10-14 weeks.

9. The method of claim 8, in which the maintenance dose is administered once every 12 weeks.

10. The method according to claim 1, in which the co-solvent is benzyl benzoate.

11. The method of claim 10, wherein castor oil and benzyl benzoate are in a ratio of from 1:1 to 1:1.6 (v/v).

12. The method according to claim 1, which provides steady state serum testosterone levels ranging from about 10 nmol/L to about 35 nmol/L.

13. The method according to claim 1, in which each dose contains 750 mg of testosterone undecanoate.

14. A method of treating a disease or symptom associated with deficient endogenous levels of testosterone in a man, comprising administering by intramuscular injection a composition comprising testosterone undecanoate (TU) and a vehicle consisting essentially of castor oil and a co-solvent, the castor oil being present in the vehicle at a concentration of 42 percent or less by volume, the method further comprising: (i) an initial phase comprising 2 initial intramuscular injections of a dose of TU at an interval of 4 weeks between injections, each dose including 500 mg to 1000 mg of TU, followed by, (ii) a maintenance phase comprising subsequent intramuscular injections of a dose of TU at an interval of 10 weeks between injections, each dose including 500 mg to 1000 mg of TU.

15. The method of claim 14, in which the castor oil is present in the vehicle in a concentration ranging from 25 to 42 percent by volume.

16. The method of claim 14, in which the co-solvent is benzyl benzoate.

17. The method of claim 16, in which the benzyl benzoate is present in the vehicle in a concentration ranging from 58 to 75 percent by volume.

18. The method of claim 14, in which each dose contains 750 mg of TU.

19. The method according to claim 14, wherein the man is a hypogonadal man, a man with a hypophyseal disease or a man in therapy with a gonadotropin-suppressive agent or progestin.

20. The method according to claim 14, wherein said disease or symptom is associated with primary or secondary hypogonadism or a hypophyseal disease.

21. The method according to claim 20, wherein said disease or symptom is associated with primary hypogonadism which is derived from testicular failure due to cryptorchidism, bilateral testicular torsion, orchitis, orchidectomy, Klinefelter syndrome, chemotherapy or toxic damage from alcohol or heavy metals.

22. The method according to claim 20, wherein said disease or symptom is associated with secondary hypogonadism caused by idiopathic gonadotropin releasing hormone (GnRH) deficiency or pituitary-hypothalamic injury from tumours, trauma or radiation.

23. The method according to claim 14, further comprising administering a progestin or a further gonadotropin suppressive agent.

24. A method for male contraception in a man comprising intramuscularly administering to the man a maintenance dose of a composition comprising testosterone undecanoate and a vehicle consisting essentially of castor oil and a co-solvent, wherein the castor oil is present in the vehicle in a concentration of 42 percent or less by volume, once every 10-14 weeks following 2-4 initial doses of said composition, each initial dose being administered at an interval of 4-8 weeks.

25. The method of claim 1, in which each dose contains 250 mg/ml of testosterone undecanoate.

26. The method of claim 14, in which each dose contains 250 mg/ml of testosterone undecanoate.

27. The method of claim 14, in which each dose contains 250 mg/ml of testosterone undecanoate.
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