EP0136011A2
Expired / Lapsed
EP
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A method of hormonal treatment of peri-menopausal, menopausal and post-menopausal disorders and multi-preparation pack therefor
Assignee: Pre Jay Holdings Ltd
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Filing: 1984-08-02
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Granted: —
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Expires: 2004-08-02
Abstract
Abstract Pharmaceutical compositions comprise an estrogen and a progestogen, generally in the form of a unit dosage containing both or a pack containing unit dosages of each. The size of each unit dosage is normally between 0.005 mg and 2.5 mg estrogen and 0.25 mg and 30 mg progestogen. Slow release compositions may provide similar dosages. The administration of these low dosages continuously, or of progestogen continuously and estrogen for periods of 20 to 120 days followed by an interval of 3 to 7 days, is useful for treating menopausal (including peri- menopausal and post-menopausal) disorders in women.
Inventors
- 👤 Earl Robert Plunkett
- 👤 Bernard Martin Joseph Wolfe
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-31 09:25
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/56; A61K31/57; A61K31/565
Claims Analysis
Total Claims: 21
Claim 1
Independent Claim
43 words
A product that comprises one or more unit dosages of a composition containing an estrogen and a progestogen with a suitable pharmaceutically inert carrier, characterised in that the unit dosages each contain less than 2.5 mg estrogen and less than 30 mg progestogen.
Claim 2
Dependent Claim
43 words
A product that comprises one or more unit dosages of a composition containing an estrogen and a progestogen with a suitable pharmaceutically inert carrier, characterised in that the unit dosages each contain less than 2.5 mg estrogen and less than 30 mg progestogen.
Claim 3
Dependent Claim
21 words
A product according to claim 1 in the form of a multi-preparation pack comprising a plurality of the said unit dosages.
Claim 4
Dependent Claim
53 words
A product in the form of a parenteral slow release composition comprising an estrogen and a progestogen, preferably in the form of an implant or an intramuscular depot, characterised in that the composition releases dosages equivalent to orally administered daily dosages of 0.005 to 2.5 mg estrogen and 0.025 to 30 mg progestogen.
Claim 5
Dependent Claim
53 words
A product in the form of a parenteral slow release composition comprising an estrogen and a progestogen, preferably in the form of an implant or an intramuscular depot, characterised in that the composition releases dosages equivalent to orally administered daily dosages of 0.005 to 2.5 mg estrogen and 0.025 to 30 mg progestogen.
Claim 6
Dependent Claim
72 words
A product for use in the treatment of peri-menopausal, menopausal or post-menopausal disorders by the continuous and uninterrupted administration of a progestogen in conjunction with the administration of an estrogen comprising unit dosages of estrogen and unit dosages of progrestogen, preferably together in a single container, characterised in that a unit dosage of estrogen contains less than 2.5 mg estrogen and a unit dosage of progestogen contains less than 30 mg progestogen.
Claim 7
Dependent Claim
72 words
A product for use in the treatment of peri-menopausal, menopausal or post-menopausal disorders by the continuous and uninterrupted administration of a progestogen in conjunction with the administration of an estrogen comprising unit dosages of estrogen and unit dosages of progrestogen, preferably together in a single container, characterised in that a unit dosage of estrogen contains less than 2.5 mg estrogen and a unit dosage of progestogen contains less than 30 mg progestogen.
Claim 8
Dependent Claim
60 words
A product according to claim 4 which comprises a multi-preparation pack comprising unit dosages of estrogen sufficient for a period of treatment of 20 to 120 days, preferably 30 to 120 days, and separate unit dosages of progestogen sufficient for at least the same period of treatment and preferably for an additional period of treatment of 3 to 7 days.
Claim 9
Dependent Claim
44 words
A product according to any one of claims 1 to 5 in which the estrogen is selected from the following group with the maximum dosages indicated (in mg): and the progestogen is selected from the following group with the maximum dosages indicated (in mg):
Claim 10
Dependent Claim
44 words
A product according to any one of claims 1 to 6 in which the dosages are daily dosages and the estrogen is selected from Table 1A at the dosages indicated therein and the progestogen is selected from Table 1B at the dosages indicated therein.
Claim 11
Dependent Claim
27 words
A product according to any one of claims 1 to 7 in which the estrogen and the progestogen are selected from the combinations quoted in Table 1D.
Claim 12
Dependent Claim
19 words
A product according to claim 8 in which the estrogen is 17-beta-estradiol and the progestogen is dl- or laevo-norgestrel.
Claim 13
Dependent Claim
37 words
A product according to claim 7 in which the estrogen is 17-beta-estradiol at a dosage between 0.5 and 2.0 mg and the progestogen is dl-norgestrel at a dosage between 50 and 150 micrograms, preferably about 75 micrograms.
Claim 14
Dependent Claim
50 words
A product according to claim 3 in which the estrogen is selected from estradiol, estradiol valerate and estradiol-17-beta at a maximum total quantity of 100 milligrams and the progestogen is selected from Table 1C at the periods indicated therein and at the quantities between the minimum and maximum indicated therein.
Claim 15
Independent Claim
58 words
A method of treatment of peri-menopausal, menopausal or post-menopausal disorders in a woman comprising administering to the woman a progestogen in conjunction with an estrogen, characterised in that the progestogen is administered continuously and uninterruptedly at a daily dosage of 0.025 to 30 mg and the estrogen is administered at a daily dosage of 0.005 to 2.5 mg.
Claim 16
Independent Claim
58 words
A method of treatment of peri-menopausal, menopausal or post-menopausal disorders in a woman comprising administering to the woman a progestogen in conjunction with an estrogen, characterised in that the progestogen is administered continuously and uninterruptedly at a daily dosage of 0.025 to 30 mg and the estrogen is administered at a daily dosage of 0.005 to 2.5 mg.
Claim 17
Dependent Claim
41 words
A method according to claim 11 in which the estrogen is administered continuously for a period of 20 to 120 days, preferably 30 to 120 days, and then is omitted from being administered for a period of 3 to 7 days.
Claim 18
Dependent Claim
71 words
A product for use in the treatment of peri-menopausal, menopausal or post-menopausal disorders by the continuous and uninterrupted administration of a progestogen in conjunction with the administration of an estrogen comprising an estrogen and a progestogen, characterised in that the product is formulated to permit administration, separately or simultaneously, of unit dosages of the estrogen in amounts up to 2.5 mg and of the progestogen in amounts up to 30 mg.
Claim 19
Dependent Claim
71 words
A product for use in the treatment of peri-menopausal, menopausal or post-menopausal disorders by the continuous and uninterrupted administration of a progestogen in conjunction with the administration of an estrogen comprising an estrogen and a progestogen, characterised in that the product is formulated to permit administration, separately or simultaneously, of unit dosages of the estrogen in amounts up to 2.5 mg and of the progestogen in amounts up to 30 mg.
Claim 20
Dependent Claim
27 words
A progestogen for use at a daily dosage of 0.025 to 30 mg in combination with an estrogen for the treatment of peri-menopausal, menopausal or post-menopausal disorders.
Claim 21
Dependent Claim
27 words
A progestogen for use at a daily dosage of 0.025 to 30 mg in combination with an estrogen for the treatment of peri-menopausal, menopausal or post-menopausal disorders.
References Cited (Backward Citations)
No citation records indexed.
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