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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


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


Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.


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

Page last updated: August 23, 2015

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