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Treatment of Bacterial Vaginosis

Primary Purpose

Bacterial Vaginosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
metronidazole and azithromycin
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginosis focused on measuring bacterial vaginosis, treatment

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Symptomatic bacterial vaginosis Exclusion Criteria: Pregnancy Other genital infections

Sites / Locations

  • Jefferson County Department of Health STD Clinic

Outcomes

Primary Outcome Measures

cure of bacterial vaginosis (BV)
percent of women without BV at follow up

Secondary Outcome Measures

Full Information

First Posted
May 9, 2006
Last Updated
February 27, 2017
Sponsor
University of Alabama at Birmingham
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00324818
Brief Title
Treatment of Bacterial Vaginosis
Official Title
Therapy and Prevention for Sexually Associated Bacterial Vaginosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Pfizer

4. Oversight

5. Study Description

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
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: 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} 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} 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}

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
Keywords
bacterial vaginosis, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
metronidazole and azithromycin
Primary Outcome Measure Information:
Title
cure of bacterial vaginosis (BV)
Description
percent of women without BV at follow up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Symptomatic bacterial vaginosis Exclusion Criteria: Pregnancy Other genital infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Schwebke, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jefferson County Department of Health STD Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

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Treatment of Bacterial Vaginosis

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