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

Phase 4CompletedNCT00194324

University of Pennsylvania12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Health Vulvovaginal Candidiasis

Interventions

Miconazole nitrateDRUG

Magnetic resonance imagingPROCEDURE

Moderate levels of exerciseBEHAVIORAL

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Pennsylvania Reproductive Research Unit

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

To compare between exercise and no exercise:

Time needed for the capsule to dissolve;

Quantify and describe product distribution at 20 minute intervals within the first 90 minutes after insertion;

Quantify systemic levels of miconozole nitrate 90 minutes and 24 hours after insertion;

Quantify amount of miconozole nitrate in the vagina 90 minutes and 24 hours after insertion

Secondary Outcomes

Product distribution will be assessed by:

Linear spread from the cervix covered by the product;

Percent of maximal linear spread from the cervix;

Surface area covered by the product;

Percent of maximal surface contact;

Presence bare spots in coating;

Presence of product outside the introitus

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.