Pharmaceutical combinations for compensating for a testosterone deficiency in men while simultaneously protecting the prostate

• US 20070078091A1
• Filed: 09/08/2006
• Published: 04/05/2007
• Est. Priority Date: 06/09/1998
• Status: Abandoned Application

• Current Assignee: Bayer Schering Pharma AG (Bayer AG)
• Original Assignee: Bayer Schering Pharma AG (Bayer AG)
• Inventors: Elger, Walter, Sobek, Lothar, Hubler, Doris, Al-Mudhaffar, Abdul-Abbas, Oettel, Michael
• Application Number:
  US11/517,301
• Publication Number:
  US 20070078091A1
• Time in Patent Office: Days
• US Class Current: 514/171
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/585 containing lactone rings, e.g. oxandrolone, bufalin
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 13/08 of the prostate
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 5/26 Androgens

Abstract

This invention relates to pharmaceutical combinations for compensating for an absolute and relative testosterone deficiency in men with simultaneous prophylaxis for the development of a benign prostatic hyperplasia (BPH) or prostate cancer. The combinations according to the invention contain a natural or synthetic androgen in combination with a gestagen, an antigestagen, an antiestrogen, a GnRH analog, a testosterone-5α-reductase inhibitor, an α-andreno-receptor blocker or a phosphodiesterase inhibitor. In comparison to the combinations according to the invention, any active ingredient by itself cannot achieve the desired goal.

Claims

1-12. -12. (canceled)

13. A method of compensating for an absolute or relative testosterone deficiency in a patient who has said testosterone deficiency with simultaneous prophylaxis in said patient for the development of a benign prostatic hyperplasia or a prostate cancer comprising administering to said patient a combination of an androgenically effective amount of a natural or synthetic androgen, and a gestagenically effective amount of a gestagen.

14. A method according to claim 13, wherein the natural androgen component is testosterone, testosterone undecanoate, dehydroepiandrosterone, dehydroepiandrosterone sulfate, testosterone propionate, testosterone enanthate, testosterone buciclate, testosterone cypionate or androstene dione.

15. A method according to claim 13, wherein the synthetic androgen component is 17-methyltestosterone, fluoxymesterone, danazol, mesterolone, nandrolone decanoate, nandrolone phenylpropionate, oxandrolone, oxymetholone, or stanazolol.

16. A method according to claim 13, wherein the gestagen component is dienogest, levonorgestrel, gestodene, desogestrel, norgestimate, norethisterone, a norethisterone ester, progesterone, chloromadinone acetate, cyproterone acetate, medroxy progesterone acetate, megestrol acetate, dydrogesterone, trimegestone or nomegestrol.

17. A method of claim 13, wherein said combination is used in the form of a tablet, capsule, coated tablet, transdermal therapy system, ampoule, suppository, gel, ointment, nose drop, implant, pressed part or biodegradable microspheres.

18. A method of claim 13, wherein the dosage of androgen is 250-1500 mg i.m. every 4 to 14 weeks and the dosage is 20 μ

g to 20 mg.

19. A method according to claim 13, wherein prophylaxis for the development of a prostate cancer is achieved.

20. A method according to claim 19, wherein the gestagen is dienogest.

21. A method according to claim 13, wherein the androgen component is 17β

-hydroxy-17α

-methyl-estra-4,9,11-trien-3-one.