Hormone replacement therapy

• US 5,468,736 A
• Filed: 02/25/1993
• Issued: 11/21/1995
• Est. Priority Date: 02/25/1993
• Status: Expired due to Term

• Current Assignee: Eastern Virginia Medical School
• Original Assignee: Eastern Virginia Medical School of The Medical College of Hampton Roads
• Inventors: Hodgen, Gary D.
• Primary Examiner(s): Jordan, Kimberly R.
• Application Number:
  US08/023,692
• Time in Patent Office: 999 Days
• Field of Search: 514/170, 514/179
• US Class Current: 514/179
• 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: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/12 for climacteric disorders
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/24 of the sex hormones

Abstract

A method of hormone replacement therapy involves the administration of estrogen together with an amount of antiprogestin which inhibits estrogen-induced endometrial proliferation in a woman.

Claims

1. A method of hormone replacement therapy which comprises administering to a woman in need of such therapy, estrogen in an hormone replacement therapy effective amount and antiprogestin in an amount which is effective both to inhibit estrogen-induced endometrial proliferation and to effect a state of .substantial amenorrhea, in the absence of progestin administration.

2. The method of claim 1 in which the antiprogestin is administered daily.

3. The method of claim 2 in which the administration is oral.

4. The method of claim 1 in which the estrogen and antiprogestin are administered daily.

5. The administration of claim 1 in which the administration is oral.

6. The method of claim 1 in which each administration contains about 0.5 to 10 mg of the antiprogestin daily.

7. The method of claim 6 in which the amount is about 1 to 5 mg.

8. The method of claim 1 in which the mode of administration is by depot.

9. The method of claim 1 in which the antiprogestin is a progestin receptor antagonist.

10. The method of claim 9 in which the antiprogestin is RU 486.

11. The method of claim 1 in which the administration extends over a minimum interval of 20 days.

12. In a method of hormone replacement therapy in which estrogen is administered in the absence of progestin administration to a woman in need of such therapy, the improvement which comprises the additional administration to said woman of antiprogestin in an amount which both inhibits estrogen-induced endometrial proliferation and effects a state of substantial amenorrhea.

13. A kit containing at least 20 tablets, a portion of which contain a hormone replacement therapy effective amount of an estrogen and at least 20 of which contain an amount of an antiprogestin which both inhibits estrogen-induced endometrial proliferation and effects a state of substantial amenorrhea.

14. The kit of claim 13 in which each tablet contains both the estrogen and antiprogestin.

15. The kit of claim 14 in which the amount of antiprogestin is about 0.5 to 10 mg.

16. The kit of claim 15 in which the amount of antiprogestin is about 1 to 5 mg.

17. The kit of claim 16 in which the antiprogestin is RU 486.

18. The kit of claim 13 in which the amount of antiprogestin is about 0.5 to 10 mg.

19. The kit of claim 13 in which the amount of antiprogestin is about 1 to 5 mg.

20. The kit of claim 13 in which the antiprogestin is a progestin receptor antagonist.