Health, Vulvovaginal Candidiasis
Conditions
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.
Interventions
Sponsors
Johnson & Johnson
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Presence bare spots in coating; | — |
| Product distribution will be assessed by: | — |
| Presence of product outside the introitus | — |
| 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; | — |
Countries
United States
Outcome results
None listed