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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Health Vulvovaginal Candidiasis | Drug: Miconazole nitrate Procedure: Magnetic resonance imaging Behavioral: Moderate levels of exercise | Phase 4 |
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 |

- 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
- 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

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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
United States, Pennsylvania | |
University of Pennsylvania Reproductive Research Unit | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Kurt T Barnhart, MD, MSCE | University of Pennsylvania |
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 |
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 |