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

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT00194324
• Collaborator: Johnson & Johnson (Industry)
• Enrollment: 12
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 4

Study Details

Study Description

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 physical activity.

Condition or Disease	Intervention/Treatment	Phase
Health; Vulvovaginal Candidiasis	Drug: Miconazole nitrate; Procedure: Magnetic resonance imaging; Behavioral: Moderate levels of exercise	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: Vaginal Imaging Study to Evaluate the Effect of Exercise on the Distribution of Miconozole Nitrate OVULE
• Study Start Date: Jul 1, 2004
• Actual Study Completion Date: Oct 1, 2004

Outcome Measures

Primary Outcome Measures

1. To compare between exercise and no exercise: []

2. Time needed for the capsule to dissolve; []

3. Quantify and describe product distribution at 20 minute intervals within the first 90 minutes after insertion; []

4. Quantify systemic levels of miconozole nitrate 90 minutes and 24 hours after insertion; []

5. Quantify amount of miconozole nitrate in the vagina 90 minutes and 24 hours after insertion []

Secondary Outcome Measures

1. Product distribution will be assessed by: []

2. Linear spread from the cervix covered by the product; []

3. Percent of maximal linear spread from the cervix; []

4. Surface area covered by the product; []

5. Percent of maximal surface contact; []

6. Presence bare spots in coating; []

7. Presence of product outside the introitus []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania Reproductive Research Unit	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• Johnson & Johnson

Investigators

• Principal Investigator: Kurt T Barnhart, MD, MSCE, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00194324
• Other Study ID Numbers: 708889; RRU010
• First Posted: Sep 19, 2005
• Last Update Posted: Aug 9, 2011
• Last Verified: Aug 1, 2011

• Additional relevant MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Miconazole; Clotrimazole

Study Results

No Results Posted as of Aug 9, 2011