Methods for treating postmenopausal women using ultra-low doses of estrogen

• US 5,891,868 A
• Filed: 11/21/1997
• Issued: 04/06/1999
• Est. Priority Date: 11/21/1997
• Status: Expired due to Term

• Current Assignee: Bayer Healthcare Pharmaceuticals Incorporated (Bayer AG), Kaiser Foundation Health Plan Incorporated (Kaiser Permanente Inc.), Regents of the University of California (University of California)
• Original Assignee: Berlex Laboratories Incorporated (Bayer AG), Kaiser Foundation Health Plan Incorporated (Kaiser Permanente Inc.), Permanente Medical Group Incorporated (Kaiser Permanente Inc.), Regents of the University of California (University of California)
• Inventors: Cummings, Steven, Ellman, Herman, Ettinger, Bruce
• Primary Examiner(s): Criares, Theodore J.
• Application Number:
  US08/975,599
• Time in Patent Office: 501 Days
• Field of Search: 514/171, 514/178, 514/947, 424/443, 424/449, 424/448
• US Class Current: 514/178
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/566 having an oxo group in position 17, e.g. estrone
• CPC Class Codes: A61K 9/7023 Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• CPC Class Codes: A61P 1/08 for nausea, cinetosis or vertigo; Antiemetics
• 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 19/10 for osteoporosis
• CPC Class Codes: A61P 25/06 Antimigraine agents
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system
• CPC Class Codes: A61P 5/24 of the sex hormones
• CPC Class Codes: A61P 5/28 Antiandrogens
• CPC Class Codes: A61P 5/30 Oestrogens

Abstract

The present invention provides methods for treating physical conditions resulting from postmenopausal estrogen decline in a postmenopausal subject, and in particular methods for reducing the risk of osteoporotic bone fractures in a postmenopausal subject. The present invention also provides a kit useful for carrying out the methods of the present invention.

Claims

1. A method for treating physical conditions resulting from postmenopausal estrogen decline in a postmenopausal subject, said method comprising administering to said subject, an amount of estrogen which is effective to produce a serum estradiol level in said subject of between about 5 pg/ml and about 15 pg/ml.

2. The method according to claim 1, wherein said physical conditions are selected from the group consisting of increased risk of osteoporotic bone fracture and loss of bone mineral density.

3. The method according to claim 1 wherein said amount of estrogen which is administered is effective to produce a serum estradiol level in said subject of between about 5 pg/ml and about 10 pg/ml.

4. The method according to claim 1, comprising parenterally administering said amount of estrogen.

5. The method according to claim 1, comprising transdermally administering said amount of estrogen.

6. The method according to claim 1, comprising transdermally administering not more than about 15 μ

g of estrogen per day.

7. The method according to claim 1, comprising transdermally administering between about 5 μ

g and about 15 μ

g of estrogen per day.

8. The method according to claim 1, wherein said estrogen is estradiol.

9. A method for reducing the risk of osteoporotic bone fractures in a subject afflicted with or susceptible to postmenopausal osteoporosis, said method comprising administering to said subject, an amount of estrogen which is effective to produce a serum estradiol level in said subject of between about 5 pg/ml and about 15 pg/ml.

10. The method according to claim 9, wherein said amount of estrogen which is administered is effective to produce a serum estradiol level in said subject of between about 5 pg/ml and about 10 pg/ml.

11. The method according to claim 9, comprising parenterally administering said amount of estrogen.

12. The method according to claim 9, comprising transdermally administering said amount of estrogen.

13. The method according to claim 9, comprising transdermally administering not more than about 15 μ

g of estrogen per day.

14. The method according to claim 9, comprising transdermally administering between about 5 μ

g and about 15 μ

g of estrogen per day.

15. The method according to claim 9, wherein said estrogen is estradiol.

16. A kit for use by a consumer afflicted with or susceptible to physical conditions resulting from postmenopausal estrogen decline, said kit comprising:

a) a transdermal patch for transdermally administering less than about 15 μ

g of estrogen per day; and

b) instructions describing a method of using the transdermal patch to reduce the risk of osteoporotic bone fracture in said consumer.

17. A method for treating physical conditions resulting from postmenopausal estrogen decline in a postmenopausal subject, said method comprising transdermally administering less than about 20 μ

g of estrogen per day to said subject, in the substantial absence of exogenous progestin.

18. The method according to claim 17, wherein said physical conditions are selected from the group consisting of increased risk of osteoporotic bone fracture and loss of bone mineral density.

19. The method according to claim 17, wherein said administration is prior to hysterectomy of said subject.

20. The method according to claim 17, further comprising the step of testing the serum estradiol level of the subject and determining that the serum estradiol level of the subject to be treated is normal for postmenopausal women in the same age group as the subject.

21. The method according to claim 17, wherein said method comprises administering between about 5 μ

g and about 15 μ

g of estrogen per day.

22. The method according to claim 17, wherein said method comprises transdermally administering about 10 μ

g of estrogen per day.

23. The method according to claim 17, wherein said estrogen is estradiol.

24. A method for reducing the risk of osteoporotic bone fracture in a subject afflicted with or susceptible to postmenopausal osteoporosis, said method comprising administering less than about 20 μ

g of estrogen to said subject in the absence of exogenous progestin.

25. The method according to claim 24, wherein said administration is prior to hysterectomy of said subject.

26. The method according to claim 24, further comprising the step of testing the serum estradiol level of the subject and determining that the serum estradiol level of the subject to be treated is normal for postmenopausal women in the same age group as the subject.

27. The method according to claim 24, wherein said method comprises administering between about 5 μ

g and about 15 μ

g of estrogen per day.

28. The method according to claim 24, wherein said method comprises transdermally administering about 10 μ

g of estrogen per day.

29. The method according to claim 24, wherein said estrogen is estradiol.