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Claims for Patent: 5,891,868

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Claims for Patent: 5,891,868

Title: Methods for treating postmenopausal women using ultra-low doses of estrogen
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.
Inventor(s): Cummings; Steven (Mill Valley, CA), Ellman; Herman (Mountain Lakes, NJ), Ettinger; Bruce (San Francisco, CA)
Assignee: Kaiser Foundation Health Plan, Inc. (Oakland, CA) Permanente Medical Group, Inc. (Oakland, CA) The Regents of the University of California (Oakland, CA) Berlex Laboratories (Richmond, CA)
Application Number:08/975,599
Patent 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 .mu.g of estrogen per day.

7. The method according to claim 1, comprising transdermally administering between about 5 .mu.g and about 15 .mu.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 .mu.g of estrogen per day.

14. The method according to claim 9, comprising transdermally administering between about 5 .mu.g and about 15 .mu.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 .mu.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 .mu.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 .mu.g and about 15 .mu.g of estrogen per day.

22. The method according to claim 17, wherein said method comprises transdermally administering about 10 .mu.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 .mu.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 .mu.g and about 15 .mu.g of estrogen per day.

28. The method according to claim 24, wherein said method comprises transdermally administering about 10 .mu.g of estrogen per day.

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