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

• ClinicalTrials.gov Identifier: NCT00194324
• Recruitment Status: Completed
• First Posted: September 19, 2005
• Last Update Posted: August 9, 2011
• Sponsor: University of Pennsylvania
• Collaborator: Johnson & Johnson
• Information provided by: University of Pennsylvania

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 (Clinical Trial)
• Enrollment: 12 participants
• 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: July 2004
• Actual Study Completion Date: October 2004

Arms and Interventions

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

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes 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 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

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

• Responsible Party: Kurt T Barnhart, MD, MSCE, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT00194324 History of Changes
• Other Study ID Numbers: 708889; RRU010
• First Posted: September 19, 2005
• Last Update Posted: August 9, 2011
• Last Verified: August 2011

Additional relevant MeSH terms:

Candidiasis; Candidiasis, Vulvovaginal; Mycoses; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Vulvitis; Vulvar Diseases; Miconazole; Antifungal Agents; Anti-Infective Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Steroid Synthesis Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP3A Inhibitors