IP Library Granted Patent US 7,018,992
Granted Patent B2
US 7,018,992 · App. 10/016,858 · Granted Mar 28, 2006

Hormone composition

Assignee: Novo Nordisk A/S
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Quick Facts
Patent No.
US 7,018,992
App. No.
10/016,858
Granted
Mar 28, 2006
Kind
B2
Abstract

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

Claims (12)

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 μg 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 μg 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.

Assignments (5)
CHANGE OF ADDRESS OF ASSIGNEE Recorded Nov 15, 2021
From: NOVO NORDISK HEALTHCARE A/G
To: NOVO NORDISK HEALTHCARE AG
Reel/Frame 058122/0546 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 18, 2015
From: NOVO NORDISK FEMCARE AG
To: NOVO NORDISK HEALTHCARE AG
Reel/Frame 035857/0755 →
CHANGE OF ADDRESS Recorded Jun 17, 2013
From: NOVO NORDISK FEMCARE A/G
To: NOVO NORDISK FEMCARE A/G
Reel/Frame 030628/0867 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 22, 2005
From: NOVO NORDISK A/S
To: NOVO NORDISK FEMCARE A/G
Reel/Frame 017427/0467 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 20, 2002
From: KOCH, KAREN; KVORNING, INGELISE
To: NOVO NORDISK A/S
Reel/Frame 012914/0976 →
Priority Claims (3)
DK 2000 01891 · Dec 15, 2000 · national
DK 2000 01892 · Dec 15, 2000 · national
DK 2000 01890 · Dec 15, 2000 · national
Continuity (4)
Provisional Application 6026018200 · Jan 5, 2001
Provisional Application 6026018300 · Jan 5, 2001
Provisional Application 6026018400 · Jan 5, 2001
Related Publication 20030064975A1 · Apr 3, 2003