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Treatment of Bacterial Vaginosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00324818
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):
Jane Schwebke, University of Alabama at Birmingham

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

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: metronidazole and azithromycin Phase 4

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}

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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Therapy and Prevention for Sexually Associated Bacterial Vaginosis
Study Start Date : July 2002
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Primary Outcome Measures :
  1. cure of bacterial vaginosis (BV)
    percent of women without BV at follow up

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Symptomatic bacterial vaginosis

Exclusion Criteria:

  • Pregnancy
  • Other genital infections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00324818

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United States, Alabama
Jefferson County Department of Health STD Clinic
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
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Principal Investigator: Jane Schwebke, MD University of Alabama at Birmingham

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Responsible Party: Jane Schwebke, Principal Investigator, University of Alabama at Birmingham Identifier: NCT00324818     History of Changes
Other Study ID Numbers: R01AI048044 ( U.S. NIH Grant/Contract )
First Posted: May 11, 2006    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Keywords provided by Jane Schwebke, University of Alabama at Birmingham:
bacterial vaginosis
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Genital Diseases, Female
Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents