Prevention of Persistence of Bacterial Vaginosis
Information source: Embil Pharmaceutical Co. Ltd
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Vaginosis
Intervention: intravaginal metronidazole (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Embil Pharmaceutical Co. Ltd
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.
Clinical Details
Official title: Prevention of Persistence of Bacterial Vaginosis: The Effects of High Dose Intravaginal Metronidazole
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
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
Locations and Contacts
Cayetano Heredia Hospital, Lima, Urb Ingenieria, Peru
Additional Information
Starting date: June 2008
Last updated: March 5, 2012
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