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

Condition(s) targeted: Health; Vulvovaginal Candidiasis

Intervention: Miconazole nitrate (Drug); Magnetic resonance imaging (Procedure); Moderate levels of exercise (Behavioral)

Phase: Phase 4

Status: Completed

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Kurt T Barnhart, MD, MSCE, Principal Investigator, Affiliation: University of Pennsylvania

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.

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

Study design: Other, Randomized, Open Label, Active Control, Crossover Assignment, Bio-availability Study

Primary outcome:

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:

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

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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 yeat, 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

University of Pennsylvania Reproductive Research Unit, Philadelphia, Pennsylvania 19104, United States

Starting date: July 2004
Ending date: October 2004
Last updated: January 3, 2008