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

NCT00194324 | Completed Phase 4

• 2 other identifiers: 708889RRU010
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Health; Vulvovaginal Candidiasis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• 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;

Interventions

Miconazole nitrate DRUG

Magnetic resonance imaging PROCEDURE

Moderate levels of exercise BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Johnson & Johnson: collaborator

Study Sites (1)

University of Pennsylvania Reproductive Research Unit

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Miconazole; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Kurt T Barnhart, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: July 1, 2004
• Study Completion: October 1, 2004
• Last Updated: August 9, 2011

Record last verified: 2011-08

Locations

US (1)