Prevention of Persistence of Bacterial Vaginosis

Phase 3TerminatedNCT00741845

Embil Pharmaceutical Co. Ltd117 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

117

Conditions

Bacterial Vaginosis

Interventions

intravaginal metronidazoleDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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 (1)

Cayetano Heredia Hospital

Lima, Urb Ingenieria, Peru

Outcomes

Primary Outcomes

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

Time frame: 28 days after therapy initiation

Data from ClinicalTrials.gov

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