Prevention of ovarian cancer by administration of progestin products

• US 6,319,911 B1
• Filed: 07/16/1998
• Issued: 11/20/2001
• Est. Priority Date: 09/13/1996
• Status: Expired due to Fees

• Current Assignee: New Life Pharmaceuticals Incorporated
• Original Assignee: New Life Pharmaceuticals Incorporated
• Inventors: Rodriguez, Gustavo C.
• Primary Examiner(s): Goldberg, Jerome D.
• Application Number:
  US09/118,143
• Time in Patent Office: 1,223 Days
• Field of Search: 514/170
• 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 31/565 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: A61K 31/59 Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
• CPC Class Codes: A61K 31/593 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3

Abstract

The present invention relates to methods for preventing the development of epithelial ovarian cancer by administering progestin products, either alone or in combination with other agents such as estrogen products.

Claims

1. A method of preventing ovarian cancer comprising administering to a female subject in need thereof a multiphase regimen comprising a first phase in which an estradiol estrogen product is administered in combination with a 19-nortestosterone progestin product;

and a second phase in which an estradiol estrogen product is administered in combination with a 19-nortestosterone progestin product; and

a third phase in which a 19-nortestosterone progestin product is not administered; and

wherein said first phase is greater than 30 days and wherein the 19-nortestosterone progestin product administered in said second phase is characterized by at least twice the effective dosage of the 19-nortestosterone progestini product administered in said first phase, wherein the results obtained produce an enhanced effect.

2. The method of claim 1 wherein said first phase is greater than 60 days.

3. The method of claim 1 wherein said first phase is greater than 90 days.

4. A method of preventing ovarian cancer comprising administering to a female subject in need thereof a multiphase regimen comprising a first phase in which an estradiol estrogen product is administered;

a second phase in which an estradiol estrogen product is administered in combination with a 19-nortestosterone progestin product; and

wherein said first phase is greater than 30 days and wherein the 19-nortestosterone progestin product administered in said second phase is characterized by a dosage less than sufficient to prevent ovulation, wherein the results obtained produce an enhanced effect.

5. The method of claim 4 wherein after said second phase there is a third phase in which a progestin product is not administered.

6. The method of claim 5 wherein said first phase is greater than 60 days.

7. The method of claim 5 wherein said first phase is greater than 90 days.

8. A method of preventing ovarian cancer comprising administering to a female subject in need thereof a multiphase regimen comprising a first phase in which an estradiol estrogen product is administered;

a second phase in which an estradiol estrogen product is administered in combination with a 19-nortestosterone progestin product; and

wherein said first phase is greater than 30 days and wherein the estradiol estrogen product administered in said first phase is characterized by a dosage less than sufficient to prevent ovulation, wherein the results obtained produced an enhanced effect.

9. A method of preventing ovarian cancer comprising administering to a female subject in need thereof a multiphase regimen comprising a first phase in which an estradiol estrogen product is administered in combination with a 19-nortestosterone progestin product;

a second phase in which an estradiol estrogen product is administered in combination with a 19-nortestosterone progestin product wherein the estradiol estrogen product is administered at a lower effective dosage than in said first phase; and

a third phase in which an estradiol estrogen product is administered with a 19-nortestosterone progestin product wherein the 19-nortestosterone progestin product is administered at a higher effective dosage than in said first and second phases, wherein the results obtained produce an enhanced effect.

10. The method of claim 9 wherein the multiphase regimen has no breaks in hormone administration which would result in breakthrough bleeding.

11. The method of claim 9 wherein at least one of said phases is greater than 14 days.

12. The method of claim 11 wherein said at least one of said phases is greater than 21 days.

13. A method of preventing ovarian cancer comprising administering to a female subject in need thereof a multiphase sequence of pharmaceutical dosages comprising a first series of dosages comprising an estradiol estrogen product and a 19-nortestosterone progestin product;

and a second series of dosages comprising an estradiol estrogen product and a 19-nortestosterone progestin product wherein the first series of dosages is administered for greater than 30 days and said 19-nortestosterone progestin product in said second series is characterized by at least twice the effective dosage of the 19-nortestosterone progestin product in said first series, wherein the results obtained produce an enhanced effect.

14. The method of claim 13 which comprises administering a third series of dosages which are a placebo.

15. The method of claim 13 wherein said progestin product is levonorgestrel and wherein said estrogen product is estradiol.

16. A method of preventing ovarian cancer comprising administering to a female subject in need thereof a multiphase sequence of pharmaceutical dosages comprising a first series of dosages comprising an estradiol estrogen produce;

and a second series of dosages comprising an estradiol estrogen product and a 19-nortestosterone progestin product wherein the first series of dosages is administered for greater than 30 days and wherein the 19-nortestosterone progestin product in said second series is characterized by a dosage less than sufficient to prevent ovulation, and wherein the results obtained produce an enhanced effect.

17. A method of preventing ovarian cancer comprising administering to a female subject in need thereof a multiphase sequence of pharmaceutical dosages comprising a first series of dosages comprising an estradiol estrogen product and a 19-nortestosterone progestin product;

a second series of dosages comprising an estradiol estrogen product and a 19-nortestosterone progestin product wherein said estrogen product is administered at a lower effective dosage than in said first series; and

a third series of dosages comprising a 19-nortestosterone progestin product and an estradiol estrogen product wherein said 19-nortestosterone progestin product is administered at a higher effective dosage than in said first series, and wherein the results obtained produce an enhanced effect.

18. The regimen of claim 17 wherein at least one of said phases is greater than 14 days.

19. The method of claim 18 wherein said at least one of said phases is greater than 21 days.