Status:
COMPLETED
Effect of Exercise on Spread of the Miconozole Nitrate OVULE in the Vagina
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Health
Vulvovaginal Candidiasis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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 phys...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2004
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00194324
Start Date
July 1 2004
End Date
October 1 2004
Last Update
August 9 2011
Active Locations (1)
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1
University of Pennsylvania Reproductive Research Unit
Philadelphia, Pennsylvania, United States, 19104