Compositions and methods for treatment of cycle-related symptoms

• US 20070009594A1
• Filed: 06/26/2006
• Published: 01/11/2007
• Est. Priority Date: 06/28/2005
• Status: Abandoned Application

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Wyeth (Pfizer Inc.)
• Inventors: Grubb, Gary, Constantine, Ginger
• Application Number:
  US11/475,486
• Publication Number:
  US 20070009594A1
• Time in Patent Office: Days
• US Class Current: 424/464
• 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 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• 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 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/18 Feminine contraceptives
• CPC Class Codes: A61P 5/24 of the sex hormones
• CPC Class Codes: A61P 5/30 Oestrogens

Abstract

Methods are provided for treating cycle-related symptoms through administration of at least one progestin and at least one estrogen to a female subject.

Claims

1. A method for treating a female subject having cycle-related symptoms comprising administering an effective amount of at least one progestin and at least one estrogen to said female subject, wherein said effective amount is administered daily for at least about 100 days.

2. The method of claim 1 wherein said female subject has one or more psychological or physical cycle-related symptoms and said effective amount is effective for treating said one or more psychological or physical symptoms.

3. The method of claim 2 wherein said female subject has dysmenorrhea and said effective amount is effective for treating dysmenorrhea.

4. The method of claim 2 wherein said female subject has moderate to severe cycle-related symptoms and said effective amount is effective for treating moderate to severe cycle-related symptoms.

5. The method of claim 2 wherein said female subject has mild to moderate cycle-related symptoms and said effective amount is effective for treating mild to moderate cycle-related symptoms.

6. The method of claim 1 wherein at least about 4 μ

g of levonorgestrel, or a progestin dosage of corresponding potency, is administered.

7. The method of claim 1 wherein from about 60 μ

g to about 110 μ

g of levonorgestrel, or a progestin dosage of corresponding potency, is administered.

8. The method of claim 1 wherein at least about 1 μ

g of ethinyl estradiol, or an estrogen dosage of corresponding potency, is administered.

9. The method of claim 1 wherein from about 15 μ

g to about 25 μ

g of ethinyl estradiol, or an estrogen dosage of corresponding potency, is administered.

10. The method of claim 1 wherein said at least one progestin is chlormadinone acetate, norethisterone acetate, cyproterone acetate, desogestrel, gestodene, drospirenone, etonorgestrel, norgestimate, norelgestromin, or levonorgestrel.

11. The method of claim 1 wherein said at least one estrogen is ethinyl estradiol, mestranol, estradiol, estriol, estrone, or estrane.

12. The method of claim 10 wherein said at least one progestin is levonorgestrel administered at a dosage not greater than 90 μ

g per day, or a progestin dosage of corresponding potency is administered.

13. The method of claim 11 wherein said at least one estrogen is ethinyl estradiol administered at a dosage not greater than 20 μ

g per day, or an estrogen dosage of corresponding potency is administered.

14. The method of claim 1 wherein said at least one estrogen is ethinyl estradiol administered at a dosage of approximately 20 μ

g per day, and said at least one progestin is levonorgestrel administered at a dosage of approximately 90 μ

g per day, or an estrogen dosage of corresponding potency and a progestin dosage of corresponding potency is administered.

15. The method of claim 1 wherein said effective amount is administered orally, transdermally, or via depot to the subject.

16. The method of claim 1 wherein said effective amount is administered daily for at least about 4 months.

17. The method of claim 1 wherein said effective amount is administered daily for at least about 6 months.

18. The method of claim 1 wherein said effective amount is administered daily for at least about 9 months.

19. The method of claim 1 wherein said effective amount is administered daily for at least about 12 months.

20. The method of claim 1 wherein said effective amount is administered in a dosage form.

21. The method of claim 1 wherein said dosage form is a tablet or capsule.

22. The method of claim 20 wherein said dosage form is administered orally, transdermally or via depot to the subject.

23. The method of claim 1 further comprising determining an extent to which said female subject has cycle-related symptoms.

24. The method of claim 23, further comprising determining an extent to which said female subject has dysmenorrhea.

25. The method of claim 23, further comprising determining an extent to which said female subject has moderate to severe cycle-related symptoms.

26. The method of claim 23 further comprising determining an extent to which said female subject has mild to moderate cycle-related symptoms.

27. The method of claim 23 wherein said determination is made before said administering step.

28. The method of claim 23 wherein said determination is made after said administering step.

29. A kit for treating a female subject having cycle-related symptoms comprising at least about 100 dosage forms that individually comprise at least one progestin and at least one estrogen.

30. The kit of claim 29 wherein each of said dosage forms comprise at least about 4 μ

g of levonorgestrel or a progestin dosage form of corresponding potency.

31. The kit of claim 29 wherein each of said dosage forms comprise from about 60 μ

g to about 110 μ

g of levonorgestrel or a progestin dosage form of corresponding potency.

32. The kit of claim 29 wherein each of said dosage forms comprise at least about 1 μ

g of ethinyl estradiol or an estrogen dosage form of corresponding potency.

33. The kit of claim 29 wherein each of said dosage forms comprise from about 15 μ

g to about 25 μ

g of ethinyl estradiol or an estrogen dosage form of corresponding potency.

34. The kit of claim 29 wherein said at least one progestin is progesterone, chlormadinone acetate, norethisterone acetate, cyprotherone acetate, desogestrel, drospirenone, etonorgestrel, norgestimate, norelgestromin, or levonorgestrel.

35. The kit of claim 29 wherein said at least one estrogen is ethinyl estradiol, mestranol, estradiol, estriol, estrone, or estrane.

36. The kit of claim 34 wherein each of said dosage forms comprise levonorgestrel in an amount no greater than 90 μ

g or a progestin dosage form of corresponding potency.

37. The kit of claim 35 wherein each of said dosage forms comprise ethinyl estradiol in an amount no greater than 20 μ

g or an estrogen dosage form of corresponding potency.

38. The kit of claim 29 wherein each of said dosage forms comprise approximately 20 μ

g ethinyl estradiol and approximately 90 μ

g levonorgestrel, or an estrogen dosage form and a progestin dosage form of corresponding potency.

39. The kit of claim 29 that comprises at least about 185 of said dosage forms.

40. The kit of claim 29 that comprises at least about 275 of said dosage forms.

41. The kit of claim 29 that comprises is at least about 365 of said dosage forms.

42. The kit of claim 29 wherein said dosage forms are tablets, capsules, or a combination thereof.