Composition and method for contraception and treatment of tumors of the mammary glands

• US 6,451,779 B1
• Filed: 04/10/2000
• Issued: 09/17/2002
• Est. Priority Date: 02/12/1997
• Status: Expired due to Fees

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Rolf-Dieter Hesch
• Inventors: Hesch, Rolf-Dieter
• Primary Examiner(s): Dees, Jose′ G.
• Assistant Examiner(s): Williamson, Michael A.
• Application Number:
  US09/403,673
• Time in Patent Office: 890 Days
• Field of Search: 424/448, 424/449, 424/422, 424/426, 424/430, 424/435, 424/436, 514/171
• US Class Current: 514/171
• 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 15/18 Feminine contraceptives
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A composition with three hormone components is administered to a mammal to cause the suppression or cessation of the menstruation cycle. Alternatively, it can be administered for treatment of tumors of the mammary gland. The composition contains at least a synthetic estrogen, a biogenetic estrogen, and a gestagen. Alternatively, the composition can include hormones which upon ingestion are metabolized to the above-mentioned hormones.

Claims

1. A method for hormonal contraception comprising administering to a mammal:

a composition comprising at least one synthetic estrogen, at least one biogenetic estrogen, and at least one gestagen wherein said at least one synthetic estrogen, said at least one biogenetic estrogen, and said at least one gestagen are administered continuously at unchanged concentrations to result in continuous suppression of the menstrual cycle.

2. The method according to claim 1 wherein the synthetic estrogen is selected from the group consisting of:

ethinylestradiol, and mestranol.

3. The method according to claim 2 wherein the synthetic estrogen is ethinylestradiol.

4. The method according to claim 3 wherein the daily administered amount of ethinylestradiol is from 1 to 20 ug.

5. The method according to claim 4 wherein the daily administered amount of ethinylestradiol is from 5 to 10 ug.

6. The method according to claim 1 wherein the biogenetic estrogen is selected from the group consisting of estradiol, estriol, estrone, and estran.

7. The method according to claim 1 wherein the second hormone component is selected from the group consisting of 17-α

-estradiol, 17-β

-estradiol, and both.

8. The method according to claim 7, wherein the daily administered amount of the α

- and β

-estradiol is from about 0.1 to 2 mg.

9. The method according to claim 1, wherein the third hormone component comprises a natural or synthetic gestagen.

10. The method according to claim 1 wherein said method is for oral administration.

11. The method according to claim 1 wherein said method is for transdermal administration.

12. The method according to claim 1 wherein said method is for intravaginal administration.

13. The method according to claim 1 wherein said method is administered as a depository injection.

14. The method according to claim 1 wherein said method is administered as hormone implant.

15. The method according to claim 1, wherein the daily units comprise all three hormone components and wherein said daily units are arranged as spacially separated and individually dispensable in a packaging unit.

16. The method of claim 1 wherein said method stops ovulation.

17. The method according to claim 1, wherein the gestagen is selected from the group consisting of progesterone, chlormadinone acetate, norethisterone acetate, cyproterone acetate, desogestrel, levonorgestrel.