Hormone preparation and method

  • US 5,382,573 A
  • Filed: 10/29/1993
  • Issued: 01/17/1995
  • Est. Priority Date: 09/24/1987
  • Status: Expired due to Term
First Claim
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1. A pharmaceutical preparation for administration to a female in need of hormone replacement therapy comprising repeating cycles of a pharmaceutical regimen, each cycle comprising a series of from twenty to thirty-five consecutive daily unit doses arranged in alternating estrogen dominant phases and progestin dominant phases, each phase consisting of from one to four consecutive daily unit doses, wherein the daily unit doses of said estrogen dominant phases containi) an amount of a substance exhibiting estrogen activity orii) an amount of a substance exhibiting estrogen activity and an amount of a substance exhibiting progestin activity, and the daily unit doses of said progestin dominant phases contain an amount of a substance exhibiting estrogen activity and an amount of a substance exhibiting progestin activity, the amount of said substance exhibiting progestin activity being alternately increased in the progestin dominant phases to provide daily unit doses exhibiting progestin dominant activity and decreased in the estrogen dominant phases to provide daily unit doses exhibiting estrogen dominant activity, and wherein the amount of substance exhibiting estrogen activity per unit dose exhibits an estrogen activity equivalent to from about 0.3 to about 2.5 mg of piperazine estrone sulfate, and the amount of substance exhibiting progestin activity per unit dose ranges from 0 to an amount which exhibits a progestin activity equivalent to about 5 mg of norethindrone.

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