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Completed

NCT Number: NCT00194324

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

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.

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Key information

Conditions

Health Bacterial Infections and Mycoses Candidiasis Candidiasis, Vulvovaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Urogenital Diseases Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Vulvovaginal Candidiasis Vulvovaginitis

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Pennsylvania Reproductive Research Unit

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Miconazole nitrate

Drug

Magnetic Resonance Imaging

Procedure

Moderate levels of exercise

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

Vaginal Imaging Study to Evaluate the Effect of Exercise on the Distribution of Miconozole Nitrate OVULE

Important dates

Study start
2004
Study completion
2004
First posted
Sep 19, 2005
Registry last updated
Aug 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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