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

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Johnson & Johnson
• Treatments: Clotrimazole; Miconazole

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