Treatment of Bacterial Vaginosis

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00324818
First received: May 9, 2006
Last updated: November 13, 2009
Last verified: November 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

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

ClinicalTrials.gov processed this record on October 16, 2014