NCT00741845

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Last Updated

March 6, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

August 25, 2008

Last Update Submit

March 5, 2012

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

  • 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

    28 days after therapy initiation

Study Arms (3)

1

ACTIVE COMPARATOR

intravaginal metronidazole 750mg + 200mg miconazole

Drug: intravaginal metronidazole

2

ACTIVE COMPARATOR

intravaginal metronidazole 750mg

Drug: intravaginal metronidazole

3

ACTIVE COMPARATOR

intravaginal metronidazole 37.5mg

Drug: intravaginal metronidazole

Interventions

intravaginal metronidazoleDRUG

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

123

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cayetano Heredia Hospital

Lima, Urb Ingenieria, Peru

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2008

First Posted

August 26, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2009

Last Updated

March 6, 2012

Record last verified: 2012-03

Locations

PE(1)