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

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

Study Description
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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
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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

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Arms and Interventions
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Outcome Measures
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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
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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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194324


Locations
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United States, Pennsylvania
University of Pennsylvania Reproductive Research Unit
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Johnson & Johnson
Investigators
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Principal Investigator: Kurt T Barnhart, MD, MSCE University of Pennsylvania
More Information
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Responsible Party: Kurt T Barnhart, MD, MSCE, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00194324    
Other Study ID Numbers: 708889
RRU010
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: August 2011
Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Bacterial Infections and Mycoses
Infections
Vulvovaginitis
Vaginitis
Vaginal Diseases
Vulvitis
Vulvar Diseases
Miconazole
Clotrimazole
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
Anti-Infective Agents, Local