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Claims for Patent: 7,018,992

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Claims for Patent: 7,018,992

Title:Hormone composition
Abstract:Twice weekly administration of an analog to a Vagifem tablet which only contains 10 .mu.g of active material has a sufficient effect.
Inventor(s): Koch; Karen (Charlottenlund, DK), Kvorning; Ingelise (Bronshoj, DK)
Assignee: Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:10/016,858
Patent Claims: 1. A method for treating atrophic vaginitis in a patient in need of such treatment, said method comprising administering vaginally to said patient an amount of about 10 .mu.g estradiol, wherein administration of said amount occurs once or twice per week and wherein said estradiol is administered in tablet form.

2. A method according to claim 1, wherein the patient is a menopausal or post-menopausal woman.

3. A method for treating atrophic vaginitis in a patient in need of such treatment, said method comprising administering vaginally to said patient an amount of about 5 .mu.g estradiol, wherein administration of said amount occurs twice weekly and wherein said estradiol is administered in tablet form.

4. A method according to claim 1, wherein no progestogen is administered.

5. A method according to claim 1, wherein said at least once-weekly administration occurs over a period of time of more than 2 weeks.

6. A method according to claim 5, wherein said period of time is more than 1 month.

7. A method according to claim 6, wherein said period of time is more than 3 months.

8. A method according to claim 1, wherein each tablet comprises, in addition to estradiol or a therapeutically equivalent amount of a salt thereof, about 53.7 mg hypromellose, about 17.9 mg lactose monohydrate, about 8 mg maize starch, about 0.4 mg magnesium stearate.

9. A method according to claim 1, wherein each tablet is coated with a film consisting of about 0.5 mg hypromellose and about 0.06 mg macrogel 6000 (polyethylene glycol 6000 NF).

10. A method according to claim 1, wherein there is undetectable systemic absorption of said estradiol following said administration.

11. A method according to claim 1, wherein said treatment results in a vaginal pH value below bout 5.5.

12. A method according to claim 1, wherein said treatment results in one or more of: Relief of vaginal symptoms, improved urogenital atrophy, decreased vaginal pH, and improved cytologic maturation of the vaginal and/or urethral mucosa.
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