Bacterial Vaginosis
Conditions
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.
Interventions
DRUGintravaginal metronidazole
high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg
Sponsors
Embil Pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Peru
Outcome results
None listed