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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 19, 2005
Last Update Posted Date August 9, 2011
Study Start Date  ICMJE July 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2006)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • To compare between exercise and no exercise:
  • 1. Time needed for the capsule to dissolve
  • 2. Quantify and describe product distribution at 20 minute intervals within the first 90 minutes after insertion
  • 3. Quantify systemic levels of miconozole nitrate 90 minutes and 24 hours after insertion
  • 4. Quantify amount of miconozole nitrate in the vagina 90 minutes and 24 hours after insertion
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Product distribution will be assessed by:
  • 1. Linear spread from the cervix covered by the product
  • 2. Percent of maximal linear spread from the cervix
  • 3. Surface area covered by the product
  • 4. Percent of maximal surface contact
  • 5. Presence bare spots in coating
  • 6. Presence of product outside the introitus
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Exercise on Spread of the Miconozole Nitrate OVULE in the Vagina
Official Title  ICMJE Vaginal Imaging Study to Evaluate the Effect of Exercise on the Distribution of Miconozole Nitrate OVULE
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Health
  • Vulvovaginal Candidiasis
Intervention  ICMJE
  • Drug: Miconazole nitrate
  • Procedure: Magnetic resonance imaging
  • Behavioral: Moderate levels of exercise
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)
12
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00194324
Other Study ID Numbers  ICMJE 708889
RRU010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kurt T Barnhart, MD, MSCE, University of Pennsylvania
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University of Pennsylvania
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Johnson & Johnson
Investigators  ICMJE
Principal Investigator: Kurt T Barnhart, MD, MSCE University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP