Prevention of Persistence of Bacterial Vaginosis
- Registration Number
- NCT00741845
- Lead Sponsor
- Embil Pharmaceutical Co. Ltd
- Brief Summary
This purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intravaginal high dose metronidazole combined with an antifungal agent(750mg metronidazole + 200mg miconazole) and low dose (37.5mg) intravaginal metronidazole, with the rate of persistent bacterial vaginosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 117
Inclusion Criteria
- women 18-40 yrs old
- 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
- immunocompromised women
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 intravaginal metronidazole intravaginal metronidazole 750mg 3 intravaginal metronidazole intravaginal metronidazole 37.5mg 1 intravaginal metronidazole intravaginal metronidazole 750mg + 200mg miconazole
- Primary Outcome Measures
Name Time Method The specific aim of this study is to compare the rate of persistence of BV in non-pregnant women randomized to one of three different schemes of intravaginal metronidazole given nightly for 5 nights 28 days after therapy initiation
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the efficacy of high-dose intravaginal metronidazole in bacterial vaginosis recurrence prevention?
How does the combination of high-dose metronidazole and miconazole compare to standard-dose metronidazole in treating bacterial vaginosis persistence?
Which biomarkers are associated with response to high-dose intravaginal metronidazole in bacterial vaginosis patients?
What are the potential adverse events of high-dose intravaginal metronidazole and how are they managed in clinical practice?
How do alternative antianaerobic agents like clindamycin compare to metronidazole in bacterial vaginosis treatment persistence rates?
Trial Locations
- Locations (1)
Cayetano Heredia Hospital
🇵🇪Lima, Urb Ingenieria, Peru
Cayetano Heredia Hospital🇵🇪Lima, Urb Ingenieria, Peru