Method of progesterone delivery and affect thereof

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert

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424431, 424432, 424433, 5147723, 514841, 514843, 514967, A61F 606, A61F 1302, A61F 616, A61K 4730

Patent

active

055431500

ABSTRACT:
The present invention teaches that relatively low levels of serum progesterone, 1 to 6 ng/ml, may be used to prevent endometrial cancer. The vaginal delivery of progesterone using a cross-linked polycarboxylic polymer produces this low serum progesterone level while also providing the full secretory transformation of the endometrium, indicating the efficacy of the progesterone. Such low levels of serum progesterone will decrease the risk of breast cancer experienced by women undergoing hormone replacement therapy ("HRT") and minimize the potential of other undesirable progesterone associated side effects.

REFERENCES:
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Nillius, S. & Johansson, E., "Plasma Levels of Progesterone after Vaginal, Rectal or Intramuscular Administration of Progesterone", Amer. J. Obstet. Gynec., 110:470-477 (1971).
Wilson, J. and Foster, D., "Disorders of the Ovary and Female Reproductive Tract", Williams Textbook of Endocrinology 214-229 (1985).
Norman, T. et. al., "Comparative Bioavailoability of Orally and Vaginally Administered Progesterone", Fert. and Sterility, 56:1034-1039 (1991).
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Cicinelli, E., et. al., "Comparative Study of Progesterone Plasma Levels after Nasal Spray and Intramuscular Administration of Natural Progesterone in Menopausal Women", Gynecol. Obstet. Invest.,35:172-174 (1993).
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