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History of Changes for Study: NCT00194324
Effect of Exercise on Spread of the Miconozole Nitrate OVULE in the Vagina
Latest version (submitted August 8, 2011) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 13, 2005 None (earliest Version on record)
2 January 3, 2006 Eligibility and Study Status
3 July 31, 2006 Outcome Measures and Study Status
4 August 30, 2007 Study Status and Study Design
5 January 3, 2008 Recruitment Status, Study Status, Oversight and Sponsor/Collaborators
6 July 26, 2008 Study Status
7 February 20, 2009 Study Status
8 January 12, 2010 Study Status
9 June 18, 2010 Study Status
10 August 8, 2011 Study Status and Eligibility
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Study NCT00194324
Submitted Date:  September 13, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: 708889
Brief Title: Effect of Exercise on Spread of the Miconozole Nitrate OVULE in the Vagina
Official Title: Vaginal Imaging Study to Evaluate the Effect of Exercise on the Distribution of Miconozole Nitrate OVULE
Secondary IDs: RRU010
Open or close this module Study Status
Record Verification: September 2005
Overall Status: Active, not recruiting
Study Start: July 2004
Primary Completion:
Study Completion: October 2004
First Submitted: September 13, 2005
First Submitted that
Met QC Criteria:
September 13, 2005
First Posted: September 19, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 13, 2005
Last Update Posted: September 19, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Pennsylvania
Responsible Party:
Collaborators: Johnson & Johnson
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Health
Vulvovaginal Candidiasis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Educational/Counseling/Training
Study Phase: Phase 4
Interventional Study Model: Crossover Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 12
Open or close this module Arms and Interventions
Intervention Details:
Drug: Miconazole nitrate
Procedure: Magnetic resonance imaging
Behavioral: Moderate levels of exercise
Open or close this module Outcome Measures
Primary Outcome Measures:
1. To compare between exercise and no exercise:
2. 1. Time needed for the capsule to dissolve
3. 2. Quantify and describe product distribution at 20 minute intervals within the first 90 minutes after insertion
4. 3. Quantify systemic levels of miconozole nitrate 90 minutes and 24 hours after insertion
5. 4. 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. 1. Linear spread from the cervix covered by the product
3. 2. Percent of maximal linear spread from the cervix
4. 3. Surface area covered by the product
5. 4. Percent of maximal surface contact
6. 5. Presence bare spots in coating
7. 6. Presence of product outside the introitus
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 45 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Not at risk for pregnancy
  • Willing to astain 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
Open or close this module Contacts/Locations
Study Officials: Kurt T Barnhart, MD, MSCE
Principal Investigator
University of Pennsylvania
Locations: United States, Pennsylvania
University of Pennsylvania Reproductive Research Unit
Philadelphia, Pennsylvania, United States, 19104
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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