Trial | NCT00741845  Report issue

Title

Prevention of Persistence of Bacterial Vaginosis
Prevention of Persistence of Bacterial Vaginosis: The Effects of High Dose Intravaginal Metronidazole

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    metronidazole ...

  • Study Participants

    117
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.
Study Started
Jun 30
2008
Primary Completion
Jun 30
2009
Last Update
Mar 06
2012
Estimate

Drug intravaginal metronidazole

high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg

1 Active Comparator

intravaginal metronidazole 750mg + 200mg miconazole

2 Active Comparator

intravaginal metronidazole 750mg

3 Active Comparator

intravaginal metronidazole 37.5mg

Criteria 

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
No Results Posted