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

Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194324
• Other study ID #: 708889
• Secondary ID: RRU010
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: August 8, 2011
• Start date: July 2004
• Est. completion date: October 2004

Study information

• Verified date: August 2011
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Health
• Vulvovaginal Candidiasis

Intervention

Drug:
• Miconazole nitrate

Procedure:
• Magnetic resonance imaging

Behavioral:
• Moderate levels of exercise

Locations

Country	Name	City	State
United States	University of Pennsylvania Reproductive Research Unit	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Johnson & Johnson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare between exercise and no exercise:
Primary	Time needed for the capsule to dissolve;
Primary	Quantify and describe product distribution at 20 minute intervals within the first 90 minutes after insertion;
Primary	Quantify systemic levels of miconozole nitrate 90 minutes and 24 hours after insertion;
Primary	Quantify amount of miconozole nitrate in the vagina 90 minutes and 24 hours after insertion
Secondary	Product distribution will be assessed by:
Secondary	Linear spread from the cervix covered by the product;
Secondary	Percent of maximal linear spread from the cervix;
Secondary	Surface area covered by the product;
Secondary	Percent of maximal surface contact;
Secondary	Presence bare spots in coating;
Secondary	Presence of product outside the introitus