Hormone composition

• US 7,018,992 B2
• Filed: 12/14/2001
• Issued: 03/28/2006
• Est. Priority Date: 12/15/2000
• Status: Expired due to Term

• Current Assignee: Novo Nordisk Health Care AG (Novo Nordisk A/S)
• Original Assignee: Novo Nordisk A/S
• Inventors: Koch, Karen, Kvorning, Ingelise
• Primary Examiner(s): HUI, SAN MING R
• Application Number:
  US10/016,858
• Publication Number:
  US 20030064975A1
• Time in Patent Office: 1,565 Days
• Field of Search: 514/178
• US Class Current: 514/178
• 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 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.

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.

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 μ

g estradiol, wherein administration of said amount occurs twice weekly and wherein said estradiol is administered in tablet form.