Methods for inhibiting preterm labor and uterine contractility disorders and preventing cervical ripening

Abstract

The invention relates to methods and pharmaceutical compositions for inhibiting or preventing preterm birth, inhibiting or delaying cervical ripening, inhibiting myometrial contractility and treating or inhibiting uterine contractility disorders. The methods comprise administering an effective amount of a composition comprising steroid hormones such as soluble progesterone.

Description

[0001]This application is a continuation-in-part of, and includes a claim of priority under 35 U.S.C. §120 to, International Application No. PCT / US2011 / 027788, filed on Mar. 9, 2011, which designated the U.S. and that International Application was published under PCT Article 21(2) in English. This application also includes a claim of priority under 35 U.S.C. §119(e) to U.S. Ser. No. 61 / 311,944 filed Mar. 9, 2010 and to U.S. Ser. No. 61 / 434,309 filed Jan. 19, 2011, the contents of all of which are herein incorporated by reference.FIELD OF INVENTION[0002]The invention relates to methods for inhibiting or preventing preterm birth, delaying cervical ripening, inhibiting myometrial contractility and treating uterine contractility disorders, in subjects in need thereof. The method comprises administering an effective amount of a steroid hormone such as progesterone or a pharmaceutical equivalent, analog, derivative or a salt thereof. The invention also relates to pharmaceutical compositio...

AI Technical Summary

Benefits of technology

The invention provides methods for inhibiting preterm birth, preventing preterm birth, inhibiting cervical ripening, delaying cervical ripening, inhibiting myometrial contractility, and treating uterine contractility disorders by administering a composition containing a steroid hormone, such as progesterone, to a subject in need. The composition can be mixed with agents such as cyclodextrins, sesame oil, fish oil, corn oil, olive oil, coconut oil, krill oil, omega fatty acids, mineral oil, peppermint oil, flaxseed oil, vitamin E oil, or saline solution to render the steroid hormone soluble. The methods involve administering the composition to the subject in various ways such as topically, intravenously, subcutaneously, or nasally. The pharmaceutical compositions and kits of the invention contain the steroid hormone and a pharmaceutically acceptable carrier.

Problems solved by technology

Preterm birth (less than 37 completed weeks of gestation) is one of the major problems and challenges in obstetrics.

Despite all efforts to reduce the number of preterm births the problem is continuing to escalate.

Additionally, the neonatal and long-term health care costs of preterm infants impose a considerable economic strain both on individual families and on healthcare costs (>$26.2 billion in 2005 in the USA).

However the biochemical mechanisms that are responsible for the remarkable changes in the cervix remain poorly understood.

Although progesterone has been known to be used for recurrent or high risk preterm labor (PTL), its current use is crystalline progesterone in micronized form, and used to treat preterm labor and uterine contractile disorders by the often inconvenient and less effective routes of vaginal, oral or IM.

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