Hormone composition

a technology of hormones and compositions, applied in the field of hormone compositions, can solve the problems of endometrial hyperplasia, oral estrogen therapy is associated with metabolic side effects, and the vaginal epithelium becomes more susceptible to infection and secondary inflammation, and achieves the effect of low estrogen absorption

Inactive Publication Date: 2005-09-22
NOVO NORDISK FERNCARE A G
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0008] One object of this invention is to furnish a hormone composition which gives a clinical effect on vaginal symptoms which is as good as that obtained by administration of Vagifem twice weekly.
[0012] A still further object of this invention is to furnish a hormone composition furnishing low absorption of estrogen.
[0017] A still further object of this invention is to furnish a hormone composition furnishing a reduced risk of osteporosis.
[0021] A very specific object of this invention is to furnish a hormone composition furnishing all or most of the following characteristics: Relief of vaginal symptoms, improved urogenital atrophy, decreased vaginal pH, and improved cytologic maturation of both the vaginal and urethral mucosa.

Problems solved by technology

Additionally, the vaginal epithelium becomes more susceptible to infection and secondary inflammation.
Oral estrogen therapy has been associated with metabolic side effects as well as breast and endometrial hyperplasia.
However, there was no pretreatment biopsy for comparison.

Method used

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  • Hormone composition
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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0031] 58 postmenopausal women were treated with tablets containing either 10 or 25 μg 17β-estradiol. The women inserted 1 tablet intravaginally, once daily for the initial 2 weeks of the study and then twice per week (Sunday & Thursday) for the following 10 weeks. Hence, some of the women only received tablets containing 10 μg 17β-estradiol and the remaining women only received tablets containing 25 μg 17β-estradiol. The estradiol profile when administering 25 or 10 μg 17β-estradiol was similar after the first dose (zero weeks of treatment) and after the above continuous treatment with 25 or 10 μg 17β-estradiol twice weekly for 10 weeks.

example 2

[0032] Treatment of atrophic vaginitis according to the present invention with low-dose 17β-estradiol tablets results in consistent, low absorption of estradiol without accumulation.

Objectives:

[0033] The vaginal absorption of 17β-estradiol (hereinafter designated E2) was evaluated and two low doses E2 (25 μg and 10 μg) were compared in postmenopausal women with atrophic vaginitis.

Design:

[0034] In a double-blind, randomized, parallel-group study, 58 postmenopausal women were treated with either 25 or 10 μg E2 for 12 weeks. Serum E2 and follicle stimulating hormone (hereinafter designated FSH) concentrations were measured throughout the study at specified intervals. The area under the curve, maximal concentration, and time to maximal concentration were determined for serum E2 concentrations. Maturation values of vaginal mucosal cells were assessed as an indicator of changes in the condition of the vaginal mucosa in response to treatment.

Results:

[0035] For both treatment group...

example 3

[0055] Treatment according to the present invention with low-dose 17β-estradiol tablets relieves vaginal symptoms, improves urogenital atrophy (vaginal health), and increases maturation of the vaginal and urethral epithelia (mucosa) without abnormal endometrial growth.

Objectives:

[0056] Vaginal tablets containing 25 or 10 μg 17β-estradiol (herein designated E2) or placebo were evaluated and compared in postmenopausal women with atrophic vaginitis.

Methods:

[0057] In a multicenter, randomized, double-blind, placebo-controlled, parallel-group study, 230 post-menopausal women received treatment with 25 or 10 μg E2 or placebo for 12 weeks. Efficacy was measured with composite scores of vaginal symptoms (dryness, soreness, and irritation) and vaginal health (secretions, epithelial integrity, surface thickness, and pH). Vaginal and urethral cytology analyses were also performed, and the vaginal maturation value was determined. Safety assessments included endometrial biopsies.

Results:...

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PUM

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Abstract

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

Description

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS [0001] This patent application is a continuation of copending U.S. patent application Ser. No. 10 / 016,858, filed Dec. 14, 2001. This patent application claims the benefit of U.S. Provisional Patent Application No. 60 / 260,182 filed Jan. 5, 2001, U.S. Provisional Patent Application 60 / 260,183 filed Jan. 5, 2001, and U.S. Provisional Patent Application 60 / 260,184 filed Jan. 5, 2001 and Danish Patent Application Nos. PA 2000 01890, filed Dec. 15, 2000, PA 2000 01891, filed Dec. 15, 2000, and PA 2000 01892, filed Dec. 15, 2000. [0002] The present invention relates to a composition containing oestrogen, which is to be administered vaginally.BACKGROUND OF THIS INVENTION [0003] Vaginal atrophy can occur in postmenopausal woman and estrogen deprived women who actually do not need any systemic hormone replacement therapy but just local therapy. Consequently, local, topical treatment is preferred in order to avoid the systemic side effects due to ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/56
CPCA61K31/56
Inventor KOCH, KARENKVORNING, INGELISE
Owner NOVO NORDISK FERNCARE A G
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