Endometriosis treatment protocol

• US 20050101579A1
• Filed: 11/08/2004
• Published: 05/12/2005
• Est. Priority Date: 11/06/2003
• Status: Abandoned Application

• Current Assignee: Eugene R. Shippen
• Original Assignee: Eugene R. Shippen
• Inventors: Shippen, Eugene R.
• Application Number:
  US10/982,915
• Publication Number:
  US 20050101579A1
• Time in Patent Office: Days
• US Class Current: 514/167
• 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 31/57 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 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

The endometriosis treatment protocol provides for administering to a female patient in need of treatment for endometriosis a pharmaceutical composition in a form suitable for vaginal or rectal delivery having a pharmaceutically effective amount of an aromatase inhibitor, which may be either a steroid or non-steroidal. The pharmaceutical composition may be formed as a vaginal suppository, a rectal suppository, a vaginal gel, a rectal gel, a vaginal cream or a rectal cream. The pharmaceutical composition may optionally have pharmaceutically effective amounts of progesterone and calcitriol, and may be administered in combination with an oral COX-2 inhibitor. Alternatively, the pharmaceutical composition comprises an aromatase inhibitor administered vaginally or rectally and is administered in combination with oral calcitriol and the oral COX-2 inhibitor. The aromatase inhibitor is either steroidal or non-steroidal.

Claims

1. A method for treating endometriosis, comprising the step of administering to a female patient in need of such treatment a pharmaceutical composition in a form suitable for vaginal or rectal delivery, the pharmaceutical composition comprising a pharmaceutically effective amount of an aromatase inhibitor.

2. The method of claim 1, wherein the pharmaceutical composition is in a form selected from the group consisting of a vaginal suppository, a rectal suppository, a vaginal gel, a rectal gel, a vaginal cream, and a rectal cream.

3. The method of claim 1, wherein the pharmaceutical composition further comprises pharmaceutically effective amounts of progesterone and calcitriol.

4. The method of claim 1, wherein the pharmaceutical composition further comprises pharmaceutically effective amounts of progesterone.

5. The method of claim 1, further comprising the step of orally administering pharmaceutically effective amounts of calcitriol and a COX-2 inhibitor in combination with the vaginal or rectal delivery of the aromatase inhibitor.

6. The method of claim 1, further comprising the step of orally administering a pharmaceutically effective amount of a COX-2 inhibitor in combination with the vaginal or rectal delivery of the aromatase inhibitor.

7. The method of claim 1, wherein the pharmaceutical composition further comprises pharmaceutically effective amounts of progesterone and calcitriol, and wherein the pharmaceutical composition is in a form selected from the group consisting of a vaginal suppository, a rectal suppository, a vaginal gel, a rectal gel, a vaginal cream and a rectal cream.

8. The method of claim 1, wherein the aromatase inhibitor is steroidal.

9. The method of claim 1, wherein the aromatase inhibitor is non-steroidal.

10. The method of claim 1, wherein the aromatase inhibitor is selected from the group consisting of anastrozole, letrozole, exemestane and formestane.

11. The method of claim 1, wherein the aromatase inhibitor comprises between about 0.1 mg and 0.5 mg anastrozole, and wherein the pharmaceutical composition is in a form selected from the group consisting of a vaginal suppository, a rectal suppository, a vaginal gel, a rectal gel, a vaginal cream and a rectal cream.

12. The method of claim 11, wherein the aromatase inhibitor consists essentially of about 1 mg anastrozole.

13. The method of claim 12, wherein the pharmaceutical composition is administered as a once daily vaginal application.

14. The method of claim 12, wherein the pharmaceutical composition is administered as a once daily rectal application.

15. The method of claim 1, wherein the aromatase inhibitor comprises between about 0.1 mg and 10 mg letrozole and the pharmaceutical composition is in a form selected from the group consisting of a vaginal suppository, a rectal suppository, a vaginal gel, a rectal gel, a vaginal cream and a rectal cream.

16. The method of claim 15, wherein the aromatase inhibitor consists essentially of about 2.5 mg letrozole.

17. The method of claim 15, wherein the pharmaceutical composition is administered as a once daily vaginal application.

18. The method of claim 15, wherein the pharmaceutical composition is administered as a once daily rectal application.

19. The method of claim 1, wherein the aromatase inhibitor comprises between about 1 mg and 75 mg exemestane and the pharmaceutical composition is in a form selected from the group consisting of a vaginal suppository, a rectal suppository, a vaginal gel, a rectal gel, a vaginal cream and a rectal cream.

20. The method of claim 19, wherein the aromatase inhibitor consists essentially of about 25 mg exemestane.

21. The method of claim 19, wherein the pharmaceutical composition is administered as a once daily vaginal application.

22. The method of claim 19, wherein the pharmaceutical composition is administered as a once daily rectal application.

23. A method for treating endometriosis, comprising the step of administering to a female patient in need of such treatment a composition comprising pharmaceutically effective amounts of an aromatase inhibitor, progesterone, and calcitriol, wherein the composition is in the form of a vaginal suppository.

24. A method for treating endometriosis, comprising the step of administering to a female patient in need of such treatment a composition comprising pharmaceutically effective amounts of an aromatase inhibitor and progesterone, wherein the composition is in the form of a vaginal suppository.

25. A pharmaceutical composition for the treatment of endometriosis, comprising:

an effective amount of an aromatase inhibitor;

an effective amount of progesterone; and

an effective amount of calcitriol;

wherein the pharmaceutical composition is in a form selected from the group consisting of a vaginal suppository, a vaginal gel and a vaginal cream.

26. A pharmaceutical composition for the treatment of endometriosis, comprising:

an effective amount of an aromatase inhibitor;

an effective amount of progesterone; and

an effective amount of calcitriol;

wherein the pharmaceutical composition is in a form selected from the group consisting of a rectal suppository, a rectal gel and a rectal cream.

27. A pharmaceutical composition for the treatment of endometriosis, comprising:

an effective amount of an aromatase inhibitor; and

an effective amount of progesterone;

wherein the pharmaceutical composition is in a form selected from the group consisting of a rectal suppository, a rectal gel and a rectal cream.