Progesterone for the treatment or prevention of spontaneous preterm birth

• US 7,884,093 B2
• Filed: 07/06/2009
• Issued: 02/08/2011
• Est. Priority Date: 02/06/2007
• Status: Active Grant

• Current Assignee: Allergan Sales LLC (Abbvie Incorporated), Columbia Laboratories, Inc. (Catalent, Inc.)
• Original Assignee: Columbia Laboratories, Inc. (Catalent, Inc.)
• Inventors: DeFranco, Emily A., O'Brien, John M. Jr., Creasy, George, Muse, Kenneth N.
• Primary Examiner(s): Padmanabhan; Sreeni
• Assistant Examiner(s): JEAN-LOUIS, SAMIRA JM
• Application Number:
  US12/497,879
• Publication Number:
  US 20090264395A1
• Time in Patent Office: 582 Days
• Field of Search: 514/177, 540/2, 604/500, 604/522
• US Class Current: 514/177
• 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 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
• CPC Class Codes: A61P 15/06 Antiabortive agents; Labour repressants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system

Abstract

A method for treating or preventing spontaneous preterm birth in pregnant women and improving neonatal morbidity and mortality. The method includes administering to a pregnant woman in need thereof an effective amount of progesterone sufficient to prolong gestation by minimizing the shortening or effacing of her cervix. Treatment and prophylaxis with progesterone in pregnant women having symptoms of short cervix has been clinically shown to increase neonatal health.

Claims

1. A method for treating short cervix in a pregnant woman in order to treat the onset of preterm labor and subsequent preterm birth comprising:

administering an effective amount of a formulation containing progesterone sufficient to prolong gestation by minimizing the shortening or effacing of the cervix.

2. The method of claim 1, wherein the method further comprises monitoring or confirming the reduction in cervical shortening or effacement after the administration of said progesterone.

3. The method of claim 1, wherein the formulation is administered vaginally and is:

a) in the form of a gel, cream, suppository, or solid dosage form;

or

b) is released by a suitable delivery device.

4. The method of claim 1, wherein the progesterone comprises one or more of the following:

a natural progesterone, or a synthetic progesterone.

5. The method of claim 4, wherein the progesterone is natural progesterone.

6. The method of claim 5, wherein said natural progesterone is administered vaginally.

7. The method of claim 4, wherein the progesterone comprises one or more synthetic progesterones.

8. The method of claim 7, wherein said synthetic progesterone is administered vaginally.

9. The method of claim 7, wherein said synthetic progesterone is selected from a group consisting of one or more of the following:

medroxyprogesterone acetate, norethindrone, norethindrone acetate, norethindrone enanthate, desogestrel, levonorgestrel, lynestrenol, ethynodiol diacetate, norgestrel, norgestimate, norethynodrel, gestodene, drospirenone, trimegestone, levodesogestrel, gestodyne, nesterone, etonogestrel, and derivatives from 19-nor-testosterone.

10. The method of claim 1, wherein said progesterone is administered daily beginning about the 18^th to 22^nd week of gestation until about the 37^th week of gestation.

11. The method of claim 1, wherein the amount of progesterone that is administered is between about 45 mg and 800 mg.

12. The method of claim 1, wherein the progesterone is administered via a drug delivery system that comprises progesterone, a water-soluble, water-swellable cross-linked polycarboxylic acid polymer, and at least one adjuvant.

13. The method of claim 1, wherein the progesterone is administered to a pregnant woman whose cervix has a length between 1.0 cm and 2.8 cm.

14. The method of claim 1, wherein the progesterone is administered to a pregnant woman whose cervix has a length between 1.0 cm and 3.0 cm.

15. The method of claim 1, wherein the progesterone comprises both natural progesterone and 17-alpha-hydroxyprogesterone caproate.

16. The method of claim 15, wherein the progesterone is administered beginning about the 2^nd to 4^th week of gestation.

17. The method of claim 11, wherein the progesterone is administered as early as gestation.

18. The method of claim 11, wherein the amount of progesterone that is administered is about 90 mg and the progesterone is natural progesterone administered vaginally.

19. A method for treating short cervix in a pregnant woman in order to treat the onset of preterm labor and subsequent preterm birth comprising:

administering an effective amount of a formulation containing progesterone sufficient to prolong gestation by minimizing the shortening or effacing of the cervix.

20. A method for treating short cervix in a pregnant woman in order to treat the onset of preterm labor and subsequent preterm birth comprising:

determining to treat short cervix in a pregnant woman in order to maintain or prolong gestation; and

administering an effective amount of a formulation containing progesterone sufficient to prolong gestation by minimizing the shortening or effacing of the cervix.