Status:
TERMINATED
Prevention of Persistence of Bacterial Vaginosis
Lead Sponsor:
Embil Pharmaceutical Co. Ltd
Conditions:
Bacterial Vaginosis
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00741845
Start Date
June 1 2008
Last Update
March 6 2012
Active Locations (1)
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1
Cayetano Heredia Hospital
Lima, Urb Ingenieria, Peru