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

Phase 4

Completed

• Conditions: Health; Vulvovaginal Candidiasis

• Registration Number: NCT00194324
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study Completion: 2004-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-08
• Last Update Posted: 2011-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pennsylvania Reproductive Research Unit; 🇺🇸 Philadelphia, Pennsylvania, United States