Treatment of Prevention of Unscheduled Bleeding in Women on Progestogen Containing Medication

• US 20090197843A1
• Filed: 09/27/2004
• Published: 08/06/2009
• Est. Priority Date: 09/27/2004
• Status: Abandoned Application

• Current Assignee: Pantarhei Bioscience B.V.
• Original Assignee: Pantarhei Bioscience B.V.
• Inventors: Coelingh Bennink, Herman Jan Tijmen, Boerrigter, Petrus Jacobus, Notelovitz, Morris
• Application Number:
  US11/663,794
• Publication Number:
  US 20090197843A1
• Time in Patent Office: Days
• 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 38/553 Renin inhibitors
• CPC Class Codes: A61K 38/556 Angiotensin converting enzyme inhibitors
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives

Abstract

The present invention relates to a method of treating or preventing unscheduled bleeding in women, the unscheduled bleeding being the result of repeated administration of a hormonal composition that contains a progestogen, wherein the method includes the administration of an effective amount of Renin Angiotensin System (RAS) suppressor selected from angiotensin converting enzyme inhibitors; angiotensin II receptor antagonists; renin inhibitors and combinations thereof. Other aspects of the invention relate to a pharmaceutical composition containing a RAS suppressor and a progestogen and to a pharmaceutical kit having a plurality of dosage units, wherein at least one dosage unit contains a progestogen; at least one dosage unit contains an estrogen; and at least one dosage unit contains a RAS suppressor.

Claims

1-16. -16. (canceled)

17. A method of treating or preventing unscheduled bleeding in a woman, said unscheduled bleeding being the result of repeated administration of a hormonal composition that contains a progestogen, wherein said method comprises the administration of a RAS suppressor to the woman in an effective amount to reduce or prevent the incidence of unscheduled bleeding.

18. The method according to claim 17, wherein the hormonal composition also contains an estrogen.

19. The method according to claim 17, wherein the RAS suppressor is selected from the group consisting of ACE-inhibitors;

angiotensin II receptor antagonists; and

combinations thereof.

20. The method according to claim 17, wherein the method comprises the combined administration of the RAS suppressor and the hormonal composition.

21. The method according to claim 17, wherein the unscheduled bleeding is the result of repeated administration of the hormonal composition to a woman of childbearing capability in an effective amount to prevent ovulation.

22. The method according to claim 18, wherein the unscheduled bleeding is the result of repeated administration of the hormonal composition to a perimenopausal, menopausal or postmenopausal woman in an effective amount to prevent or suppress symptoms of hypoestrogenism.

23. The method according to claim 17, wherein the method comprises the uninterrupted administration of the RAS suppressor during a period of at least one month.

24. The method according to claim 17, wherein the method comprises administering angiotensin II receptor antagonist in an amount equivalent to a daily oral dosage of at least 5 mg irbesartan.

25. The method according to claim 24, wherein the method comprises administering ACE inhibitor in an amount equivalent to a daily oral dosage of at least 1 mg captopril.

26. The method according to claim 17, wherein the RAS suppressor is administered orally or intra-uterinely.

27. The method according to claim 17, wherein the hormonal composition is administered orally, intra-uterinely or transdermally.

28. A pharmaceutical composition comprising at least 5 μ

g RAS suppressor, said RAS suppressor being selected from the group consisting of ACE inhibitors, angiotensin II receptor antagonists and renin inhibitors;

a progestogen in an amount equivalent to at least 30 μ

g levonorgestrel; and

pharmaceutically acceptable excipient.

29. The pharmaceutical composition according to claim 28, wherein the composition additionally contains an estrogen in an amount equivalent to at least 5 μ

g ethinylestradiol.

30. The pharmaceutical composition according to claim 28, wherein the composition is a solid unit dosage form for oral administration.

31. A pharmaceutical kit comprising a plurality of dosage units, wherein at least one dosage unit contains a progestogen in an amount equivalent to at least 30 μ

g levonorgestrel;

at least one dosage unit contains an estrogen in an amount equivalent to 5 μ

g ethinyl estradiol; and

at least one dosage unit contains a RAS suppressor selected from the group consisting of ACE inhibitors, angiotensin II receptor antagonists, renin inhibitors and combinations thereof.

32. The kit according to claim 31, wherein the kit comprises a plurality of dosage units that contain a progestogen, an estrogen and a RAS suppressor.