NCT00324818

Brief Summary

We are trying to determine if longer duration of therapy with metronidazole or combination therapy of metronidazole plus azithromycin results in better cure rates for BV

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2002

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

3.8 years

First QC Date

May 9, 2006

Last Update Submit

February 27, 2017

Conditions

Bacterial Vaginosis

Keywords

bacterial vaginosistreatment

Outcome Measures

Primary Outcomes (1)

  • cure of bacterial vaginosis (BV)

    percent of women without BV at follow up

Interventions

metronidazole and azithromycinDRUG

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Symptomatic bacterial vaginosis

You may not qualify if:

  • Pregnancy
  • Other genital infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jefferson County Department of Health STD Clinic

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

MetronidazoleAzithromycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactones

Study Officials

  • Jane Schwebke, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2006

First Posted

May 11, 2006

Study Start

July 1, 2002

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

US(1)