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Claims for Patent: 7,320,970

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Claims for Patent: 7,320,970

Title:Low dose estrogen interrupted hormone replacement therapy
Abstract:A hormone replacement therapy, comprising a plurality of daily doses of a pharmaceutical preparation, the doses being administered continuously and consecutively in alternating phases of three daily doses, a relatively dominant estrogenic activity phase comprising three daily doses of a substance exhibiting estrogenic activity equivalent to about 1 mg per day of 17.beta.-estradiol per day, and a relatively dominant progestagenic activity phase of a combination of a substance exhibiting estrogenic activity equivalent to about 1 mg per day of 17.beta.-estradiol and a substance exhibiting progestogenic activity equivalent to about 90 .mu.g per day of norgestimate.
Inventor(s): Casper; Robert F. (Toronto, CA), Shangold; Gary A. (Califon, NJ), Ausmanas; Militza K. (Lake Forest, IL)
Assignee: Duramed Pharmaceutials, Inc. (Cincinnati, OH) Jencap Research Ltd. (Toronto, Ontario, CA)
Application Number:11/439,171
Patent Claims: 1. A method of treating a female in need of hormone replacement therapy, the method comprising administering: (a) three consecutive daily dosage forms or an equivalent thereof comprising a substance exhibiting estrogenic activity; followed by (b) three consecutive daily dosage forms or an equivalent thereof comprising a substance exhibiting estrogenic activity and a substance exhibiting progestogenic activity equivalent to about 90 .mu.g norgestimate per day.

2. The method of claim 1, wherein the method further comprises administering a placebo, an iron supplement, a vitamin supplement, or a combination thereof.

3. The method of claim 1, wherein the dosage forms are administered orally, parenterally, transdermally, transmucosally, intramuscularly, or intravaginally.

4. The method of claim 3, wherein the dosage forms are in oral form.

5. The method of claim 4, wherein the oral dosage form is a tablet.

6. A pharmaceutical kit comprising: (a) three consecutive daily dosage forms or an equivalent thereof comprising a substance exhibiting estrogenic activity; and (b) three consecutive daily dosage forms or an equivalent thereof comprising a substance exhibiting estrogenic activity and a substance exhibiting progestogenic activity equivalent to about 90 .mu.g norgestimate per day; wherein the dosage forms of (a) and (b) are positioned sequentially in the kit.

7. The kit of claim 6, wherein the kit further comprises administering a placebo, an iron supplement, a vitamin supplement, or a combination thereof.

8. The kit of claim 6, wherein the dosage forms are administered orally, parenterally, transdermally, transmucosally, intramuscularly, or intravaginally.

9. The kit of claim 8, wherein the dosage forms are in oral form.

10. The kit of claim 9, wherein the oral dosage form is a tablet.
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