EP0253607A1
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EP
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Combination dosage form for premenopausal women
Assignee: Wyeth
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Filing: 1987-07-13
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Granted: —
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Expires: 2007-07-13
Abstract
Abstract Disclosed herein is a method of providing hormonal replacement therapy and contraception for a pre-menopausal woman, which comprises administering to a pre-menopausal woman in need thereof a combination dosage form of an estrogen selected from 0.5-2.0 mg. of 17β-estradiol, 0.008-0.030 mg. of ethinyl estradiol, and 0.015-0.060 mg. of mestranol; and a progestogen selected from 0.025-0.100 mg. of levonorgestrel, 0.010-0.070 mg. of gestodene, 0.025-0.100 mg. of desogestrel, 0.025-0.100 mg. of 3-ketodesogestrel, and 0.085-0.35 mg. of norethindrone, said combination dosage form being administered for 23-25 days beginning at day one of the menstrual cycle, followed by 2-5 pill-free or blank pill days, for a total of 28 days in the administration cycle. The preferred dosage form of the invention is a combination of 1 mg. of 17β-estradiol and 0.050 or 0.075 mg. of levonorgestrel. The preferred administration cycle of the invention is administration of the combination dosage form for the first 24 days of the menstrual cycle and no dosage form for the last 4 days of the menstrual cycle.
Inventors
- 👤 Gertrude Virginia Upton
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-05 17:46
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/56; A61K31/565; A61K31/567; A61P; A61P13/00; A61P13/02; A61P15/00; A61P43/00
Claims Analysis
Total Claims: 19
Claim 1
Independent Claim
107 words
The use of a composition comprising an estrogen selected from 0.5-2.0 mg. of 17β-estradiol 0.008-0.030 mg. of ethinyl estradiol, and 0.015-0.060 mg. of mestranol; and a progestogen selected from 0.025-0.100 mg. of levonorgestrel, 0.010-0.070 mg. of gestodene, 0.025-0.100 mg. of desogestrel, 0.025-0.100 mg. of 3-ketodesogestrel, and 0.085-0.35 mg. of norethindrone, for the manufacture of a dosage form for providing hormonal replacement therapy and contraception for a pre-menopausal woman by administration of the dosage form for 23 to 26 days beginning at day one of the menstrual cycle, followed by 2 to 5 pill-free or blank pill days, for a total of 28 days in the administration cycle.
Claim 2
Dependent Claim
107 words
The use of a composition comprising an estrogen selected from 0.5-2.0 mg. of 17β-estradiol 0.008-0.030 mg. of ethinyl estradiol, and 0.015-0.060 mg. of mestranol; and a progestogen selected from 0.025-0.100 mg. of levonorgestrel, 0.010-0.070 mg. of gestodene, 0.025-0.100 mg. of desogestrel, 0.025-0.100 mg. of 3-ketodesogestrel, and 0.085-0.35 mg. of norethindrone, for the manufacture of a dosage form for providing hormonal replacement therapy and contraception for a pre-menopausal woman by administration of the dosage form for 23 to 26 days beginning at day one of the menstrual cycle, followed by 2 to 5 pill-free or blank pill days, for a total of 28 days in the administration cycle.
Claim 3
Dependent Claim
13 words
The use as claimed in Claim 1 in which the estrogen is 17β-estradiol.
Claim 4
Dependent Claim
15 words
The use as claimed in Claim 1 or 2 in which the progestogen is levonorgestrel.
Claim 5
Dependent Claim
18 words
The use as claimed in Claim 1 or 2 in which the progestogen is gestodene, desogestrel or 3-ketodesogestrel.
Claim 6
Dependent Claim
57 words
The use as claimed in Claim 1 in which the dosage form comprises an estrogen selected from: 0.75-1.50 mg. of 17β-estradiol, 0.012-0.025 mg. of ethinyl estradiol, and 0.025-0.050 mg of mestranol; and a progestrogen selected from: 0.035-0.085 mg. of levonorgestrel, 0.015-0.060 mg. of gestodene, 0.035-0.085 mg. of desogestrel, 0.035-0.085 mg. of 3-ketodesogestrel, and 0.10-0.30 mg of norethindrone.
Claim 7
Dependent Claim
50 words
The use as claimed in Claim 1 in which the estrogen is in a dose of 1 mg. of 17β-estradiol or an equivalent dose of ethinyl estradiol or mestranol and the progestogen is in a dose of 0.050 mg. of levonorgestrel or an equivalent dose of gestodene, desogestrel or 3-ketodesogestrel.
Claim 8
Dependent Claim
50 words
The use as claimed in Claim 1 in which the estrogen is in a dose of 1 mg. of 17β-estradiol or an equivalent dose of ethinyl estradiol or mestranol and the progestogen is in a dose of 0.075 mg. or levonorgestrel or an equivalent dose of gestodene, desogestrel or 3-ketodesogestrel.
Claim 9
Dependent Claim
105 words
A pack for providing a hormonal replacement therapy and contraception for a pre-menopausal woman which pack comprises (a) 23 to 26 dosage forms each comprising an estrogen selected from: 0.5-2.0 mg. of 17β-estradiol 0.008-0.030 mg. of ethinyl estradiol, and 0.015-0.060 mg. of mestranol; and a progestogen selected from 0.025-0.100 mg. of levonorgestrel, 0.010-0.70 mg. of gestodene, 0.025-0.100 mg. of desogestrel 0.025-0.100 mg. of 3-ketodesogestrel, and 0.085-0.35 mg. of norethindrone and (b) 2 to 5 blank pills or other indications to indicate that the daily administration of the 23 to 26 dosage forms should be followed by 2 to 5 pill free or blank pill days.
Claim 10
Dependent Claim
105 words
A pack for providing a hormonal replacement therapy and contraception for a pre-menopausal woman which pack comprises (a) 23 to 26 dosage forms each comprising an estrogen selected from: 0.5-2.0 mg. of 17β-estradiol 0.008-0.030 mg. of ethinyl estradiol, and 0.015-0.060 mg. of mestranol; and a progestogen selected from 0.025-0.100 mg. of levonorgestrel, 0.010-0.70 mg. of gestodene, 0.025-0.100 mg. of desogestrel 0.025-0.100 mg. of 3-ketodesogestrel, and 0.085-0.35 mg. of norethindrone and (b) 2 to 5 blank pills or other indications to indicate that the daily administration of the 23 to 26 dosage forms should be followed by 2 to 5 pill free or blank pill days.
Claim 11
Dependent Claim
14 words
A pack as claimed in Claim 8 in which the estrogen selected is 17β-estradiol.
Claim 12
Dependent Claim
16 words
A pack as claimed in Claim 8 or 9 in which the progestogen selected is levonorgestrel.
Claim 13
Dependent Claim
55 words
A pack as claimed in Claim 8 in which the estrogen is selected from: 0.75-1.50 mg. of 17β-estradiol, 0.012-0.025 mg. of ethinyl estradiol, and 0.025-0.050 mg. of mestranol; and the progestogen is selected from: 0.035-0.085 mg. of levonorgestrel, 0.015-0.060 mg. of gestodene, 0.035-0.085 mg. of desogestrel, 0.035-0.085 mg. of 3-ketodesogestrel, and 0.10-0.30 mg. of norethindrone.
Claim 14
Dependent Claim
50 words
A pack as claimed in Claim 8 in which the estrogen is in a dose of 1 mg. of 17β-estradiol or an equivalent dose of ethinyl estradiol or mestranol and the progestogen is in a dose of 0.050 mg. of levonorgestrel or an equivalent dose of gestodene, desogestrel or 3-ketodesogestrel.
Claim 15
Dependent Claim
50 words
A pack as claimed in Claim 8 in which the estrogen is in a dose of 1 mg. of 17β-estradiol or an equivalent dose of ethinyl estradiol or mestranol and the progestogen is in a dose of 0.075 mg. of levonorgestrel or an equivalent dose of gestodene, desogestrel or 3-ketodesogestrel.
Claim 16
Dependent Claim
45 words
A pack as claimed in any one of Claims 8 to 13 which comprises 24 dosage forms and 4 blank pills or other indications to indicate that no dosage form or a blank pill is administered for the last 4 days of the menstrual cycle.
Claim 17
Dependent Claim
45 words
A pack as claimed in any one of Claims 8 to 13 which comprises 23 dosage forms and 5 blank pills or other indications to indicate that no dosage form or a blank pill is administered for the last 5 days of the menstrual cycle.
Claim 18
Dependent Claim
51 words
A pack according to Claim 8 comprising 24 dosage forms each comprising 1 mg. of 17β-estradiol and 0.50 mg. or 0.075 mg. levonorgestrel and 4 blank pills or other indications to indicate that no dosage form or a blank pill is administered for the last 4 days of the menstrual cycle.
Claim 19
Dependent Claim
52 words
A pack according to Claim 8 comprising 23 dosage forms each comprising 1 mg. of 17β-estradiol and 0.50 mg. or 0.075 mg. of levonorgestrel and 5 blank pills or other indications to indicate that no dosage form or a blank pill is administered for the last 5 days of the menstrual cycle.
References Cited (Backward Citations)
EP0136011A2
Cited
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