Effect of Exercise on Spread of the Miconozole Nitrate OVULE in the Vagina

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2004-10-31

Brief Summary

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This study uses MRI to detect the spread of the Miconozole Nitrate OVULE within the vagina. The effect of moderate amounts of physical activity on the spread will be evaluated, and compared to no physical activity.

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Detailed Description

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Conditions

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Health Vulvovaginal Candidiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Interventions

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Miconazole nitrate

Intervention Type DRUG

Magnetic resonance imaging

Intervention Type PROCEDURE

Moderate levels of exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Not at risk for pregnancy
* Willing to abstain from intercourse 24 hours prior to MRI
* Regular menstrual cycles (every 23-38 days)
* At least 10 weeks from most recent pregnancy outcome and had 2 spontaneous menstrual cycles since
* Normal pap smear within previous 12 months
* Negative test for yeast, bacterial vaginosis and trichomonas
* Not allergic to any component of the formulation
* No contraindications to MRI
* Not participated in another investigational trial within 30 days
* No history of condition, or finding on exam, that, in the opinion of the investigator, would make participation unsafe for the volunteer or complicate interpretation of the data

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes