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CompletedNCT00324818Updated Mar 1, 2017

Treatment of Bacterial Vaginosis

A Phase 4 interventional study of metronidazole and azithromycin in Bacterial Vaginosis, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to female participants aged 16 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-01.

Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
16 Years to 45 Years
Sex
Female
01

Study 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

Read the detailed description

Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV). Control of BV has been advocated for decreasing the prevalence of these complications. The etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates. Further, half of all women who meet the clinical diagnostic criteria for BV are asymptomatic and treatment of these women remains controversial. More detailed characterization of the origins, natural history and response to therapy would supply data to guide control efforts. We will approach these problems through a multifaceted interdisciplinary evaluation of women with and without BV.

The specific aims {and hypotheses} of this project are:

  1. To conduct studies to determine optimal agents and duration of therapy for BV {Hypothesis: Longer duration of therapy and combination therapy will result in higher cure rates and lower recurrence rates of BV; response to therapy differs between women with asymptomatic BV and symptomatic BV}
  2. To examine the role of condoms in the prevention of BV {Hypothesis: BV is a sexually transmitted infection, thus recurrence rates of BV will be lower among women with higher condom usage rates}
  3. To further explore the role of Mobiluncus spp., organisms strongly associated with the syndrome, by utilizing specimens derived from the above studies.

{Hypothesis: Mobiluncus is involved in the pathogenesis of BV at least in a subset of women, and the persistence of this organism is associated with lack of cure and recurrence of BV}

02

Conditions studied

  • Bacterial Vaginosis

Keywords

  • bacterial vaginosis
  • treatment
03

In context

Vaginosis, Bacterial

220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.

This study's enrollment of 600 is above the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.

Browse Vaginosis, Bacterial studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Symptomatic bacterial vaginosis

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Other genital infections
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double
Enrollment
600 participants

Interventions

  • Drugmetronidazole and azithromycin
06

What researchers measure

Primary outcomes

  1. cure of bacterial vaginosis (BV)

    percent of women without BV at follow up

07

Study locations

1 site
  • Jefferson County Department of Health STD Clinic
    Birmingham, Alabama 35294, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00324818
Lead sponsor
University of Alabama at Birmingham
Collaborators
Pfizer
Responsible party
Jane Schwebke (Principal Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
May 11, 2006
Start date
Jul 2002
Primary completion
May 2006
Completion
May 2006
Last update
Mar 1, 2017

Study contacts

Jane Schwebke, MD
principal investigator · University of Alabama at Birmingham
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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