EXTENDED STEP-DOWN ESTROGEN REGIMEN
First Claim
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1. A method for the treatment of diseases, conditions or symptoms associated with deficient endogenous levels of estrogen in a woman, said method comprising the steps of (i) administering to said woman a first therapeutically effective amount of an estrogen during a first treatment period;
- (ii) after completion of the first treatment period, administering to said woman a second therapeutically effective amount of an estrogen during a second treatment period, where said second therapeutically effective amount of estrogen is less than said first therapeutically effective amount of estrogen; and
optionally (iii) after completion of the second treatment period, administering to said woman a third therapeutically effective amount of an estrogen during a third treatment period, where said third therapeutically effective amount of estrogen is less than said second therapeutically effective amount of estrogen;
or (iv) after completion of the second treatment period repeating step (i) and optionally step ii).
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Abstract
The present invention relates to methods for treating diseases, conditions or symptoms associated with deficient endogenous levels of estrogen comprising administration of a higher first dose of an estrogen followed by administration of a lower second dose of an estrogen once therapy has been effectively established. The invention further relates to a combination treatment comprising administration of an estrogen and a progestin.
30 Citations
59 Claims
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1. A method for the treatment of diseases, conditions or symptoms associated with deficient endogenous levels of estrogen in a woman, said method comprising the steps of
(i) administering to said woman a first therapeutically effective amount of an estrogen during a first treatment period; -
(ii) after completion of the first treatment period, administering to said woman a second therapeutically effective amount of an estrogen during a second treatment period, where said second therapeutically effective amount of estrogen is less than said first therapeutically effective amount of estrogen; and
optionally(iii) after completion of the second treatment period, administering to said woman a third therapeutically effective amount of an estrogen during a third treatment period, where said third therapeutically effective amount of estrogen is less than said second therapeutically effective amount of estrogen;
or(iv) after completion of the second treatment period repeating step (i) and optionally step ii). - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 53, 54)
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23. A method for the treatment of diseases, conditions or symptoms associated with deficient endogenous levels of estrogen in a woman and for simultaneously protecting the endometrium from adverse effects of estrogen, said method comprising the steps of
(i) administering to said woman a first therapeutically effective amount of an estrogen during a first treatment period, and administering to said woman a therapeutically effective amount of a progestin during one or more sub-periods of said first treatment period; -
(ii) after completion of the first treatment period, administering to said woman a second therapeutically effective amount of an estrogen during a second treatment period, where said second therapeutically effective amount of estrogen is less than said first therapeutically effective amount of estrogen, and administering to said woman a therapeutically effective amount of a progestin during one or more sub-periods of said second treatment period; and
optionally(iii) after completion of the second treatment period, administering to said woman a third therapeutically effective amount of an estrogen during a third treatment period, where said third therapeutically effective amount of estrogen is less than said second therapeutically effective amount of estrogen, administering to said woman a therapeutically effective amount of a progestin during one or more sub-periods of said third treatment period;
or(iv) after completion of the second treatment period repeating step (i) and optionally step ii). - View Dependent Claims (24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 58, 59)
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55. A pharmaceutical preparation comprising a number of separately packed and individually removable daily oral dosage units placed into a packaging unit, wherein
(i) each of said daily oral dosage units comprises an estrogen in an amount corresponding to a therapeutically equivalent amount of estradiol hemihydrate in the range of from > - 0.75 to 1.5 mg, preferably in the range of from >
0.75 to 1.25 mg, more preferably in the range of from 0.9 to 1.1 mg, most preferably 1 mg; and
(ii) a part of said daily oral dosage units further comprises a progestin in an amount corresponding to a therapeutically equivalent amount of drospirenone in the range of from 0.5 to 5 mg, preferably in the range of from 0.5 to 4 mg, more preferably in the range of from 1 to 3 mg, even more preferably in the range of from 1.5 to 2.5 mg, most preferably 2 mg.
- 0.75 to 1.5 mg, preferably in the range of from >
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56. A pharmaceutical preparation comprising a number of separately packed and individually removable daily oral dosage units placed into a packaging unit, wherein
(i) each of said daily oral dosage units comprises an estrogen in an amount corresponding to a therapeutically equivalent amount of estradiol hemihydrate in the range of from 0.05 to 0.75 mg, preferably in the range of from 0.25 to 0.75 mg, more preferably in the range of from 0.4 to 0.75 mg, even more preferably in the range of from 0.4 to 0.6 mg, most preferably 0.5 mg; - and
(ii) a part of said daily oral dosage units further comprises a progestin in an amount corresponding to a therapeutically equivalent amount of drospirenone in the range of from 0.5 to 5 mg, preferably in the range of from 0.5 to 4 mg, more preferably in the range of from 1 to 3 mg, even more preferably in the range of from 1.5 to 2.5 mg, most preferably 2 mg.
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57. A pharmaceutical preparation comprising a number of separately packed and individually removable daily oral dosage units placed into a packaging unit, wherein
(i) each of said daily oral dosage units comprises an estrogen in an amount corresponding to a therapeutically equivalent amount of estradiol hemihydrate in the range of from 0.05 to < - 0.4 mg, preferably in the range of from 0.1 to <
0.4 mg, more preferably in the range of from 0.2 to <
0.4 mg, even more preferably in the range of from 0.25 to 0.35 mg, most preferably 0.3 mg; and
(ii) a part of said daily oral dosage units further comprises a progestin in an amount corresponding to a therapeutically equivalent amount of drospirenone in the range of from 0.5 to 5 mg, preferably in the range of from 0.5 to 4 mg, more preferably in the range of from 1 to 3 mg, even more preferably in the range of from 1.5 to 2.5 mg, most preferably 2 mg.
- 0.4 mg, preferably in the range of from 0.1 to <
Specification