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Method of treating atrophic vaginitis

A technique for vaginal administration and composition, applied in the field of pharmaceutical composition, capable of solving unknown problems

Inactive Publication Date: 2009-04-08
LISHU PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the effect of vaginally administered progesterone and estrogen combinations as hormone replacement therapy in a single dosage unit is unknown; no intravaginally active formulations containing estrogen and progesterone in a single dosage unit have been produced

Method used

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  • Method of treating atrophic vaginitis
  • Method of treating atrophic vaginitis
  • Method of treating atrophic vaginitis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] Example 1: Estrogen / Progesterone Vaginal Suppositories in Atrophic Vaginitis Patients

[0092] This example describes the Phase 1-2, open-label, randomized, single-blind, placebo-controlled study of the safety profile of an estrogen / progesterone vaginal suppository ("JC-001") in postmenopausal patients with atrophic vaginitis. Multiple dose trials.

[0093] The purpose of this study is as follows:

[0094] (1) The purpose of the trial was to determine the efficacy and evaluate the relative safety of placebo, unopposed estrogen, and two combined estrogen-progesterone regimens for the treatment of atrophic vaginitis in postmenopausal women.

[0095] (2) Efficacy, as measured by improvement in vaginal atrophy as measured objectively and subjectively, is to compare the efficacy of the vaginal formulations with each other and with placebo in alleviating the symptoms of atrophic vaginitis. Improved objective measures include measurement of vaginal pH and the presence of va...

Embodiment 2

[0133] Example 2: Pharmaceutical Composition Formulation in Cream Form

[0134] This example provides the formulation of the pharmaceutical composition as a vaginal cream for the treatment of symptoms associated with atrophic vaginitis. Table 6 summarizes the ingredients and their amounts.

[0135] Table 6

[0136] intensity

[0137] For each strength, the total volume per dose is 1gm.

Embodiment 3

[0138] Example 3: Pharmaceutical Composition Formulation in Cream Form

[0139] This example provides the formulation of the pharmaceutical composition as a vaginal cream for the treatment of symptoms associated with atrophic vaginitis. Table 7 summarizes the ingredients and their amounts.

[0140] Table 7

[0141] intensity

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PUM

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Abstract

This invention relates to a method and pharmaceutical composition useful in treating a condition responsive to hormone replacement therapy. Specifically, the invention is related to the long term treatment of symptoms associated with atrophic vaginitis. The composition contains effective amounts of an estrogen, a progesterone compound and a pharmaceutically accepted vehicle, carrier and / or diluent.

Description

[0001] Cross References to Related Applications [0002] This application claims priority under 35 U.S.C. §119 based on U.S. Provisional Application Serial No. 60 / 760,440, filed January 20, 2006, the disclosure of which is hereby incorporated by reference in its entirety. field of invention [0003] The present application relates to pharmaceutical compositions using a combination of estrogen and progesterone as a vaginal therapy for the treatment of symptoms associated with atrophic vaginitis. Background of the invention [0004] Atrophic vaginitis is a hormone-dependent disorder involving the reproductive tract and lower urinary tract. Typically, atrophic vaginitis becomes apparent during or after menopause, and symptoms worsen with age. Symptoms associated with genitourinary aging are due to a decline in estrogen due to follicular depletion in the ovary at menopause. This decline in estrogen accounts for most of the anatomical, cytological, bacteriological, and physiolo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/56
CPCA61K9/02A61K31/573A61K9/0034A61K31/56A61P13/10A61P15/02A61K2300/00A61K31/565A61K31/57
Inventor 詹内特·A·乔勒特弗雷德·默梅尔施坦
Owner LISHU PHARM CO LTD
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