Hormone composition

• US 20050209209A1
• Filed: 05/25/2005
• Published: 09/22/2005
• Est. Priority Date: 12/15/2000
• Status: Abandoned Application

• Current Assignee: NOVO Nordisk Ferncare A/G
• Original Assignee: Novo Nordisk A/S
• Inventors: Koch, Karen, Kvorning, Ingelise
• Application Number:
  US11/136,997
• Publication Number:
  US 20050209209A1
• Time in Patent Office: Days
• US Class Current: 514/182
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids

Abstract

Twice weekly administration of an analog to a Vagifem tablet which only contains 10 μg of active material has a sufficient effect.

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 μ

g estradiol, wherein administration of said amount occurs once or twice per week.

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

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

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

5. A method according to claim 4, wherein said period of time is more than 3 months.

6. A method according to claim 1, wherein said estradiol is administered in tablet form and wherein each tablet comprises, in addition to estradiol or a therapeutically equivalent amount of a salt thereof, hypromellose, lactose monohydrate, maize starch, and magnesium stearate.

7. A method according to claim 6, wherein said tablet comprises about 60-80% w/w hypromellose;

20-25% w/w lactose;

about 5-15% maize starch; and

about 0.2-1.5% magnesium stearate.

8. A method for treating atrophic vaginitis in a patient in need of such treatment, said method comprising administering vaginally to said patient a tablet comprising hypromellose, lactose monohydrate, maize starch, and magnesium stearate.

9. A method according to claim 8, wherein said tablet comprises about 60-80% w/w hypromellose;

20-25% w/w lactose;

about 5-15% maize starch; and

about 0.2-1.5% magnesium stearate.