Progestin therapy for maintaining amenorrhea

• US 6,593,317 B1
• Filed: 10/17/2000
• Issued: 07/15/2003
• Est. Priority Date: 10/21/1997
• Status: Expired due to Fees

• Current Assignee: Columbia Laboratories, Inc. (Catalent, Inc.)
• Original Assignee: Columbia Laboratories, Inc. (Catalent, Inc.)
• Inventors: de Ziegler, Dominique, Levine, Howard L., Bologna, William J.
• Primary Examiner(s): Webman, Edward J.
• Application Number:
  US09/833,259
• Time in Patent Office: 1,001 Days
• Field of Search: 514/899, 514/944, 514/177, 514/170, 514/772.6, 424/487
• 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 31/565 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: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/7023 Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/12 for climacteric disorders
• CPC Class Codes: A61P 15/18 Feminine contraceptives
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system
• CPC Class Codes: A61P 5/24 of the sex hormones
• CPC Class Codes: A61P 5/34 Gestagens

Abstract

The present invention teaches that daily, cyclical vaginal delivery of progestin may be used to provide regular, predictable withdrawal bleeding during hormone replacement therapy. The present invention also teaches that constant administration of progestin in a water-insoluble, water-swellable cross-linked polycarboxylic acid polymer may be used to maintain amenorrhea. Either regimen is accompanied by a significant decrease in adverse side effects.

Claims

1. A method of promoting regular withdrawal bleeding in a woman undergoing cyclical progestin administration comprising daily, cyclical vaginal delivery of progestin via a drug delivery system in an amount sufficient to cause secretory transformation of the endometrium without causing the typical side effects associated with progestin administration, wherein the drug delivery system comprises a water-soluble, water-swellable cross-linked polycarboxic acid polymer.

2. The method of claim 1 wherein the drug delivery system comprises a water-insoluble, water-swellable cross-linked polycarboxylic acid polymer.

3. The method of claim 2 wherein the polymer is polycarbophil.

4. The method of claim 3 wherein the progestin is progesterone.

5. The method of claim 4 wherein the amount of progesterone delivered is about 45 mg to about 90 mg per dose.

6. The method of claim 4 wherein the drug delivery system additionally comprises at least one adjuvant.

7. The method of claim 2 wherein the drug delivery system is administered daily during a set portion of every calendar month.

8. The method of claim 3 wherein the woman is also being treated with estrogen.

9. The method of claim 7 wherein the woman is also being treated with estrogen.

10. The method of claim 5 wherein the drug delivery system is administered daily during a set portion of every calendar month.

11. The method of claim 10 wherein the woman is also being treated with estrogen.