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

This study has been completed.

First Received: September 13, 2005 Last Updated: February 20, 2009 History of Changes

Sponsors and Collaborators:	University of Pennsylvania Johnson & Johnson
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00194324

Purpose

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	Intervention	Phase
Health Vulvovaginal Candidiasis	Drug: Miconazole nitrate Procedure: Magnetic resonance imaging Behavioral: Moderate levels of exercise	Phase IV

MedlinePlus related topics: Exercise and Physical Fitness MRI Scans Yeast Infections

Drug Information available for: Miconazole nitrate Miconazole Clotrimazole Tioconazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Bio-availability Study
Official Title:	Vaginal Imaging Study to Evaluate the Effect of Exercise on the Distribution of Miconozole Nitrate OVULE

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

To compare between exercise and no exercise:
Time needed for the capsule to dissolve;
Quantify and describe product distribution at 20 minute intervals within the first 90 minutes after insertion;
Quantify systemic levels of miconozole nitrate 90 minutes and 24 hours after insertion;
Quantify amount of miconozole nitrate in the vagina 90 minutes and 24 hours after insertion

Secondary Outcome Measures:

Product distribution will be assessed by:
Linear spread from the cervix covered by the product;
Percent of maximal linear spread from the cervix;
Surface area covered by the product;
Percent of maximal surface contact;
Presence bare spots in coating;
Presence of product outside the introitus

Estimated Enrollment:	12
Study Start Date:	July 2004
Study Completion Date:	October 2004

Eligibility

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

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 yeat, 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194324

Locations

United States, Pennsylvania
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

More Information

No publications provided

Responsible Party:	University of Pennsylvania ( Kurt T Barnhart, MD, MSCE )
Study ID Numbers:	708889, RRU010
Study First Received:	September 13, 2005
Last Updated:	February 20, 2009
ClinicalTrials.gov Identifier:	NCT00194324 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Vulvovaginitis
Candidiasis
Candidiasis, Vulvovaginal
Clotrimazole
Miconazole
Vaginitis
Tioconazole

Vaginal Diseases
Genital Diseases, Female
Mycoses
Anti-Infective Agents, Local
Antifungal Agents
Vulvar Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Vulvovaginitis
Candidiasis
Candidiasis, Vulvovaginal
Clotrimazole
Miconazole
Vaginitis
Tioconazole
Vaginal Diseases

Pharmacologic Actions
Genital Diseases, Female
Anti-Infective Agents, Local
Mycoses
Therapeutic Uses
Antifungal Agents
Vulvitis
Vulvar Diseases

ClinicalTrials.gov processed this record on May 06, 2009