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Treatment of Bacterial Vaginosis
This study has been completed.
First Received: May 9, 2006   Last Updated: November 13, 2009   History of Changes
Sponsor: University of Alabama at Birmingham
Collaborator: 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

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

Resource links provided by NLM:


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
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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

No publications provided

Study ID Numbers: R01AI048044
Study First Received: May 9, 2006
Last Updated: November 13, 2009
ClinicalTrials.gov Identifier: NCT00324818     History of Changes
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bacterial Infections
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Vaginitis
Physiological Effects of Drugs
Vaginal Diseases
Pharmacologic Actions
Genital Diseases, Female
Anti-Bacterial Agents
Antiparasitic Agents
Vaginosis, Bacterial
Radiation-Sensitizing Agents
Azithromycin
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2010