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Claims for Patent: 5,543,150

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Claims for Patent: 5,543,150

Title: Method of progesterone delivery and affect thereof
Abstract:The present invention teaches that relatively low levels of serum progesterone, 1 to 6 ng/ml, may be used to prevent endometrial cancer. The vaginal delivery of progesterone using a cross-linked polycarboxylic polymer produces this low serum progesterone level while also providing the full secretory transformation of the endometrium, indicating the efficacy of the progesterone. Such low levels of serum progesterone will decrease the risk of breast cancer experienced by women undergoing hormone replacement therapy ("HRT") and minimize the potential of other undesirable progesterone associated side effects.
Inventor(s): Bologna; William J. (New York, NY), Levine; Howard L. (Oceanside, NY)
Assignee: Columbia Laboratories, Inc. (Coconut Grove, FL)
Application Number:08/122,371
Patent Claims: 1. A method of delivering progesterone to women comprising delivery of progesterone via a drug delivery system inserted into the vagina in an amount sufficient to cause secretory transformation of the endometrium while maintaining serum levels of progesterone below 6.0 ng/ml for a continuous period of at least forty-eight hours.

2. A method according to claim 1 wherein 10-200 milligrams of progesterone are inserted into the vagina.

3. A method according to claim 1 wherein the serum level is 1 to 4 ng/ml of progesterone.

4. A method according to claim 1 wherein adjuvants are also inserted into the vagina.

5. A method according to claim 1 wherein the vagina has been primed with estradiol.

6. A method according to any one of claims 1-5 wherein the drug delivery system comprises a cross-linked polycarboxylic polymer and progesterone.

7. A method according to claim 6 wherein the polymer is polycarbophil.

8. A method of targeting the delivery of progesterone to the endometrium comprising inserting into the vagina a drug delivery system comprising a cross-linked carboxylic polymer and progesterone wherein 10-200 milligrams of progesterone are inserted into the vagina.

9. A method according to claim 8 wherein the resulting serum level of progesterone is 1 to 4 ng/ml of progesterone.

10. A method according to claim 8 wherein the polymer is polycarbophil.

11. A method of targeting the delivery of progesterone to the endometrium comprising inserting into the vagina a drug delivery system comprising a cross-linked carboxylic polymer and progesterone wherein the drug delivery system additionally comprises at least one adjuvant.

12. A method of causing secretory transformation in the endometrium while maintaining serum levels of progesterone between about 1 to less than about 5 ng/ml.

13. A method of causing secretory transformation in the endometrium while maintaining serum levels of progesterone between about 1 to 6 ng/ml, wherein the progesterone level is achieved by inserting into the vagina a drug delivery system comprising a cross-linked polycarboxylic polymer and progesterone.

14. A method according to claim 13 wherein 10-200 milligrams of progesterone are inserted into the vagina.

15. A method according to claim 13 wherein the serum level is 1 to 4 ng/ml of progesterone.

16. A method according to claim 13 wherein the polymer is polycarbophil.

17. A method according to claim 13 wherein the drug delivery system additionally comprises at least one adjuvant.

18. A method according to claim 13 wherein the vagina has been primed with estradiol.

19. A method according to claim 13 wherein the polymer is cross-linked with 0.1 to 6.0 weight percent of the polymer of a cross-linking agent.

20. A method according to claim 12 wherein the progesterone level is maintained between about 1 to 4 ng/ml.

21. A method according to claim 20 wherein the progesterone level is maintained between about 1 to 2 ng/ml.

22. A method according to any one of claims 12, 20 and 21 wherein the progesterone is delivered via a drug delivery device inserted into the vagina.

23. A method according to claim 6 wherein the polymer is cross-linked with about 0.1 to 6.0 weight percent of the polymer of a cross-linking agent.
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