Transdermal hormone delivery system: compositions and methods

Abstract

A transdermal hormone delivery system (THDS) is disclosed. The THDS is useful for control of fertility and as therapy for a variety of diseases and conditions treatable by robust delivery of progestin and estrogen hormones, particularly the progestin, levonorgestrel. The THDS comprises a backing layer, an adjoining adhesive polymer matrix comprising an effective amount of at least a progestin hormone, delivery of which is enhanced by one or more skin permeation enhancing agents present in pre-determined amounts. The THDS is capable of providing effective daily doses of progestin and estrogen hormones from a small surface area in contact with the skin, e.g., less than 20 square centimeters. Methods of fertility control and various types of hormone replacement therapy utilizing the THDS are also disclosed.

Description

COMPOSITIONS AND METHODS

[0001] This application is a continuation-in-part of U.S. application Ser. No. 10 / 130,913, filed May 23, 2002, which is a U.S. National Application of International Application No. PCT / US00 / 32043, filed Nov. 22, 2000, which claims benefit of U.S. Provisional Application 60 / 167,535, filed Nov. 24, 1999, the entire contents of each of which are incorporated by reference herein.FIELD OF THE INVENTION

[0002] The present invention relates to hormone treatment for control of fertility and as therapy for a variety of diseases and conditions. Specifically, the invention provides formulations and methods of use in connection with a transdermal hormone delivery system for robust delivery of steroid hormones. BACKGROUND OF THE INVENTION

[0003] Various scientific articles and patent publications are referenced herein to describe the state of the art to which this invention pertains. Each of these publications is incorporated by reference herein in its entirety.

[0004] H...

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