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Method and kits for treating vulvovaginal candidiasis with micronazole nitrate

A technique for vaginal candidiasis and miconazole nitrate, which is applied in the field of miconazole nitrate in the treatment of vulvovaginal candidiasis and multiple doses of miconazole nitrate, and can solve problems affecting patient compliance, treatment effect, and discomfort

Inactive Publication Date: 2001-03-21
MCNEIL PPC INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] These methods of treating vulvovaginal candidiasis, while highly effective, present some discomfort and inconvenience to the patient by having to repeatedly administer intravaginal miconazole nitrate
Both of these disadvantages can affect patient compliance and thus treatment efficacy
Also, relief of symptoms may take 4-5 days or longer

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] A study was conducted to compare the results of the treatment of vulvovaginal candidiasis with the following two methods: (1) a single dose of 1200 mg miconazole nitrate gelatin capsules in an ointment base for intravaginal administration, combined with MONISTAT _ Vulvar cream (apply as required, no more than twice a day, to relieve symptoms); (2) MONISTAT _ vaginal cream.

[0017] The subject population was as follows: 278 patients with vulvovaginal candidiasis participated in the trial. 266 (96%) patients were safe and effective, and 213 (77%) patients were effective at the first follow-up. 196 (71%) patients were fully effective. About 60% of patients are white, with most of the remainder either Latino or black. The average age of the patients was 33-34 years. More than 1 / 3 of patients use oral contraceptives. More than 90% of patients have mild or moderate disease. 4-7% of patients have severe disease. Baseline levels were comparable between the two treatment...

Embodiment 2

[0023] A study of the same design as reported in Example 1 was conducted in a second population. In Example 2, the test population was as follows: 280 patients with vulvovaginal candidiasis participated in the test. 271 (97%) patients were safe and effective, and 205 (73%) patients were effective at the first follow-up. 194 (69%) patients were fully effective. There were slightly fewer patients in the second group who had both the first follow-up and the overall assessment because there were more screening failures in this group. About 70% of patients are white, with most of the remainder being black or Latino. The mean age of the patients was 36.3 years. About 20-25% of patients use oral contraceptives. More than 95% of patients have mild or moderate disease. 2% of patients had severe disease. Baseline levels were comparable between the two treatment groups.

[0024] The treatment results of Example 2 are shown in Tables 3 and 4.

[0025] Overall cure rate F...

Embodiment 3

[0029] A dose-ranging study was performed to compare the outcomes of vulvovaginal candidiasis with the following two approaches: (1) various doses of a single-dose miconazole nitrate cream formulation, in combination with MONISTAT _ Vulvar cream (apply as required, no more than twice a day, to relieve symptoms); (2) MONISTAT _ 7 vaginal creams.

[0030] Patients were randomized to one of the following 5 treatment regimens:

[0031] Group 1: 16% miconazole nitrate vaginal cream containing 400mg miconazole nitrate 2.5g single intravaginal dose, combined with MONISTAT _ Vulvar cream (apply according to the instructions when needed, no more than twice a day, to relieve symptoms);

[0032] Group 2: 8% miconazole nitrate vaginal cream containing 400mg miconazole nitrate 5g single intravaginal dose, in combination with MONISTAT _ Vulvar cream (apply according to the instructions when needed, no more than twice a day, to relieve symptoms);

[0033] Group 3: 12% miconazole nitrate ...

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PUM

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Abstract

A method for treating vulvovaginal candidiasis including the steps of: (a) administering a single dose of an effective amount of miconazole nitrate in a pharmaceutically acceptable carrier intra-vaginally; and (b) applying miconazole nitrate in a pharmaceutically acceptable carrier to the vulva. Also a kit for the treatment of vulvovaginal candidiasis including: (a) a single dose of an effective amount of miconazole nitrate in a pharmaceutically acceptable carrier and in a form adapted to be administered intra-vaginally; and (b) an amount of miconazole nitrate in a pharmaceutically acceptable carrier adapted to be applied topically to the vulva.

Description

field of invention [0001] The present invention relates to a method for the treatment of vulvovaginal candidiasis with miconazole nitrate, and more particularly to the treatment of vulvovaginal candidiasis with a single dose of miconazole nitrate administered intravaginally, plus multiple doses of miconazole nitrate topically applied to the vulva method of mycosis. background of invention [0002] Treatment of vulvovaginal candidiasis is a common form of yeast infection. The treatment of vulvovaginal candidiasis with antifungal miconazole nitrate compositions is well known. The most common treatment regimen for vulvovaginal candidiasis with miconazole nitrate involves intravaginal administration of a miconazole nitrate-containing cream or other pharmaceutically acceptable carrier, daily, depending on the concentration of miconazole nitrate in the cream. Once for 1, 3 or 7 days. Commercially available kits for the treatment of vulvovaginal candidiasis with miconazole nitra...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K9/00A61K9/02A61K31/4164A61K31/4174
CPCA61K31/4174A61K9/02Y10S514/931A61K9/0034A61P15/02A61P31/10A61K31/40
Inventor D·H·乌普马利斯
Owner MCNEIL PPC INC
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