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Prevention of Persistence of Bacterial Vaginosis

Primary Purpose

Bacterial Vaginosis

Status

Terminated

Phase

Phase 3

Locations

Peru

Study Type

Interventional

Intervention

intravaginal metronidazole

About this trial

This is an interventional treatment trial for Bacterial Vaginosis

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Cayetano Heredia Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm Description

intravaginal metronidazole 750mg + 200mg miconazole

intravaginal metronidazole 750mg

intravaginal metronidazole 37.5mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00741845

First Posted

August 25, 2008

Last Updated

March 5, 2012

Sponsor

Embil Pharmaceutical Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00741845

Brief Title

Prevention of Persistence of Bacterial Vaginosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Terminated

Why Stopped

Terminated for site documentation and monitoring issues - not safety, study drug, or adverse event issues.

Study Start Date

June 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Embil Pharmaceutical Co. Ltd

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Vaginosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

117 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

intravaginal metronidazole 750mg + 200mg miconazole

Arm Title

Arm Type

Active Comparator

Arm Description

intravaginal metronidazole 750mg

Arm Title

Arm Type

Active Comparator

Arm Description

intravaginal metronidazole 37.5mg

Intervention Type

Drug

Intervention Name(s)

intravaginal metronidazole

Intervention Description

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

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Cayetano Heredia Hospital

City

Lima

State/Province

Urb Ingenieria

Country

Peru

12. IPD Sharing Statement

Learn more about this trial

Prevention of Persistence of Bacterial Vaginosis

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