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

University of Pennsylvania

Status and phase: Completed; Phase 4

Conditions: Health; Vulvovaginal Candidiasis

Treatments: Procedure: Magnetic resonance imaging; Drug: Miconazole nitrate; Behavioral: Moderate levels of exercise

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00194324

RRU010

708889

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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