HealthPhase 4NCT00194324
Effect of Exercise on Spread of the Miconozole Nitrate OVULE in the Vagina
A Phase 4 study testing Miconazole nitrate, Magnetic resonance imaging and Moderate levels of exercise in people with Health and Vulvovaginal Candidiasis, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health, Vulvovaginal Candidiasis
- What is being tested?
- Miconazole nitrate, Magnetic resonance imaging and Moderate levels of exercise
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Oct 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Reproductive Research Unit
Philadelphia, Pennsylvania, 19104
About this study
Official title: Vaginal Imaging Study to Evaluate the Effect of Exercise on the Distribution of Miconozole Nitrate OVULE
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.
- Conditions
- Health, Vulvovaginal Candidiasis
- Being tested
- Miconazole nitrate, Magnetic resonance imaging, Moderate levels of exercise
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miconazole nitrateDrug
Magnetic resonance imagingProcedure or surgery
Moderate levels of exerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (7)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJul 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Investigators
- Kurt T Barnhart, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194324
- Sponsor's protocol ID
- 708889
- Other IDs
- RRU010
- Status last verified
- Aug 2011
- First submitted
- 13 Sep 2005
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Imaging Study to Evaluate the Effect of Exercise on the Distribution of Miconozole Nitrate OVULE
- ClinicalTrials.gov ID
- NCT00194324
- Acronym / sponsor ID
- 708889
- Conditions
- Health, Vulvovaginal Candidiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Jul 2004
- Study completion
- Oct 2004 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miconazole nitrate | Drug | – |
| Magnetic resonance imaging | Procedure or surgery | – |
| Moderate levels of exercise | Behavioural | – |
Primary outcome
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt T Barnhart, MD, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Miconazole nitrate, Magnetic resonance imaging and Moderate levels of exercise in people with Health and Vulvovaginal Candidiasis, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare between exercise and no exercise:. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2011.