TREATMENT OF CONDITIONS RELATING TO HORMONE DEFICIENCIES BY ADMINISTRATION OF PROGESTINS

• US 20100137265A1
• Filed: 02/04/2010
• Published: 06/03/2010
• Est. Priority Date: 05/16/2001
• Status: Active Grant

• Current Assignee: Thomas W. Leonard
• Original Assignee: Thomas W. Leonard
• Inventors: Leonard, Thomas W.
• Granted Patent: US 8,076,319 B2
• Time in Patent Office: Days
• US Class Current: 514/170
• 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 31/566 having an oxo group in position 17, e.g. estrone
• CPC Class Codes: A61K 31/569 substituted in position 17 alpha, e.g. ethisterone
• 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 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 15/02 for disorders of the vagina
• CPC Class Codes: A61P 15/12 for climacteric disorders
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system

Abstract

The present invention includes methods for preventing endometrial hyperplasia associated with estrogen therapy through the administration of a progestin agent. The methods presented may include starting the administration of a progestin agent at a high dose, and then lowering the dose.

Claims

1-51. -51. (canceled)

52. A method of treating atrophic vaginitis in a subject, said method comprising:

administering continuously and uninterruptedly for a first predetermined time period a first dose of a progestin agent to said subject; and

administering continuously and uninterruptedly for a second predetermined time period a second dose of a progestin agent to said subject.

53. The method according to claim 52, wherein said progestin agent is selected from the group consisting of dl-norgestrel, norethindrone (norethisterone), norethindrone (norethisterone) acetate, ethynodiol diacetate, dydrogesterone, medroxyprogesterone acetate, norethynodrel, allylestrenol, lynoestrenol, quingestanol acetate, medrogestone, norgestrienone, dimethisterone, ethisterone, cyproterone acetate, desogestrel, levonorgestrel, hydroxyprogesterone caproate, 19-nortestosterone, chlormadinone acetate, megestrol acetate, norgestimate, norgestrel, trimegestone, gestodene, normegestrel acetate, progesterone, 5α

-pregnan-β

, 20β

-diol sulfate, 5α

-pregnan-3β

-ol-20-one, 16,5α

-pregnen-3β

-ol-20-one and 4-pregnen-20β

-ol-3-one-20-sulfate.

54. The method according to claim 52, wherein said first dose comprises an equivalent of 0.5 to 40 mg of a progestin agent, based on equivalent oral doses to megestrol acetate.

55. The method according to claim 52, wherein said first dose comprises an equivalent of 2 to 20 mg of a progestin agent, based on equivalent oral doses to megestrol acetate.

56. The method according to claim 52, wherein said second dose comprises an equivalent of 0.025 to 10 mg of a progestin agent, based on equivalent oral doses to megestrol acetate.

57. The method according to claim 52, further comprising administering an estrogenic compound in a daily dose.

58. The method according to claim 52, further comprising administering an androgen compound in a daily dose.

59. The method according to claim 52, wherein said first predetermined time period for said first dose of a progestin agent is at least two weeks before the administration of said second dose of a progestin agent.

60. The method according to claim 52, wherein said first predetermined time period for said first dose of a progestin agent is between two to twelve weeks before the administration of said second dose of a progestin agent.