Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
117 participants
INTERVENTIONAL
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
intravaginal metronidazole 750mg + 200mg miconazole
intravaginal metronidazole
high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg
2
intravaginal metronidazole 750mg
intravaginal metronidazole
high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg
3
intravaginal metronidazole 37.5mg
intravaginal metronidazole
high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg
Interventions
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intravaginal metronidazole
high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg
Eligibility Criteria
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Inclusion Criteria
* abnormal vaginal discharge or malodor
* positive QuickVue test
* positive KOH whiff test
* Positive finding of clue cells greater than or equal to 20% on wet mount
* Able to give informed consent
* willing to abstain from alcohol during the 5 day therapy and 1 day following
Exclusion Criteria
* symptomatic VVC
* pregnancy or positive pregnancy test
* menstruating or breastfeeding women
* other oral or vaginal antifungal or antimicrobial drugs w/in past 2 wks
* women with MPC, PID
18 Years
40 Years
FEMALE
No
Sponsors
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Embil Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Locations
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Cayetano Heredia Hospital
Lima, Urb Ingenieria, Peru
Countries
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Other Identifiers
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Embil-2008Peru
Identifier Type: -
Identifier Source: org_study_id
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