ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Treatment of Bacterial Vaginosis

This study has been terminated.

Sponsors and Collaborators: University of Alabama at Birmingham
Pfizer
Information provided by: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00324818
  Purpose

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


Condition Intervention Phase
Bacterial Vaginosis
Drug: metronidazole and azithromycin
Phase IV

ChemIDplus related topics:   Azithromycin    Metronidazole    Metronidazole hydrochloride    Metronidazole phosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title:   Therapy and Prevention for Sexually Associated Bacterial Vaginosis

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • cure of bacterial vaginosis

Estimated Enrollment:   600
Study Start Date:   July 2002
Estimated Study Completion Date:   May 2005

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}

  Eligibility
Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria: symptomatic bacterial vaginosis

-

Exclusion Criteria:

  • pregnancy, other genital infections
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324818

Locations
United States, Alabama
Jefferson County Department of Health STD Clinic    
      Birmingham, Alabama, United States, 35294

Sponsors and Collaborators
University of Alabama at Birmingham
Pfizer

Investigators
Principal Investigator:     Jane Schwebke, MD     University of Alabama at Birmingham    
  More Information


Study ID Numbers:   R01AI048044
First Received:   May 9, 2006
Last Updated:   December 14, 2007
ClinicalTrials.gov Identifier:   NCT00324818
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
bacterial vaginosis  
treatment  

Study placed in the following topic categories:
Genital Diseases, Female
Bacterial Infections
Metronidazole
Vaginosis, Bacterial
Azithromycin
Vaginitis
Vaginal Diseases

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




Links to all studies - primarily for crawlers