Estrogen compositions and therapeutic methods of use thereof

Details Estrogen compositions and therapeutic methods of use thereof Estrogen compositions and therapeutic methods of use thereof

A - Human Necessities

61

K

A61K 9/00 (2006.01) A61K 9/107 (2006.01) A61K 31/565 (2006.01) A61K 31/566 (2006.01) A61K 31/567 (2006.01) A61P 15/02 (2006.01)

Patent

CA 2617106

A pharmaceutical composition comprises at least one estrogenic compound, the composition being adapted for application in a unit dose amount to a vulvovaginal surface and having at least one nonlipoidal internal phase and at least one lipoidal external phase that is bioadhesive to the vulvovaginal surface, wherein the at least one estrogenic compound is present in an amount of about 5 to about 1000 µg estradiol equivalent per unit dose of the composition, and upon application of the composition to the vulvovaginal surface the at least one estrogenic compound is released over a period of about 3 hours to about 30 days. The composition is useful for vulvovaginal administration to treat atrophic vaginitis or a disorder associated therewith, for example in a menopausal or postmenopausal woman. A method for treating a hypoestrogenism-related condition of the urogenital system of a female patient comprises intravaginal administration of at least one estrogenic compound according to a treatment regimen wherein a series of compositions releasing a progressively increasing daily amount of the at least one estrogenic compound is administered over a period of at least about 1 month.

Composition pharmaceutique comprenant au moins un composé oestrogène, bio-adhésive, conçue pour être appliquée en dose unitaire sur une surface vulvo-vaginale, présentant au moins une phase interne non lipoïde et au moins une phase externe lipoïde. Le composé oestrogène est présent à raison de 5-1000 µg équivalent oestradiol environ par dose unitaire; après application de la composition sur la surface vulvo-vaginale. le composé oestrogène est libéré au terme au cours d'une période de 3 heures à 30 jours environ. La composition convient pour le traitement par administration vulvo-vaginale d'une vaginite atrophique ou de troubles y associés, notamment chez des femme ménopausées ou post-ménopausées. Méthode de traitement d'états du système uro-génital lié à un hypo-oestrogénisme chez un patient de sexe féminin, consistant en l'administration intravaginale d'au moins un composé oestrogène conformément à un schéma posologique donné selon lequel une dose quotidienne à augmentation progressive d'au moins un composé oestrogène est administrée pendant une période d'au moins un mois environ.

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