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Clinical Trials/NCT00194324
NCT00194324
Completed
Phase 4

Vaginal Imaging Study to Evaluate the Effect of Exercise on the Distribution of Miconozole Nitrate OVULE

University of Pennsylvania1 site in 1 country12 target enrollmentJuly 2004
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ConditionsHealthVulvovaginal Candidiasis
DrugsMiconazole nitrate

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health
Sponsor
University of Pennsylvania
Enrollment
12
Locations
1
Primary Endpoint
To compare between exercise and no exercise:
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2004
End Date
October 2004
Last Updated
14 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Eligibility Criteria

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

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

Study Sites (1)

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